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Immunology

Pharming Announces Presentation of Positive Results of Phase III Leniolisib Trial in APDS at Clinical Immunology Society 2022 Annual Meeting – Yahoo…

Principal Investigator Dr. V. Koneti Rao Will Share Data Supporting the Investigational Treatment for Activated PI3K Delta Syndrome (APDS)

LEIDEN, Netherlands, March 28, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) announces that Principal Investigator V. Koneti Rao, MD, FRCPA, a staff physician in the Primary Immune Deficiency Clinic at the National Institutes of Health in Bethesda, Maryland, will present positive findings from the Phase III pivotal clinical trial of leniolisib for patients with activated phosphoinositide 3-kinase delta (PI3K) syndrome (APDS) at the Clinical Immunology Society (CIS) 2022 Annual Meeting in Charlotte, North Carolina.

Pharming_Group_NV_Logo

The presentation for healthcare practitioners and other experts will take place on April 1, 2022, from 11:30 to 11:45 ET/17:30 to 17:45 CET and will be accessible on site and virtually. To attend, please register here:

https://cis.clinimmsoc.org/education/meetings/am22/program/amprogram

Leniolisib is being developed for the targeted treatment of APDS, a rare primary immunodeficiency caused by genetic variants that currently has no approved therapy. On February 2, 2022, Pharming announced that the Phase III trial of leniolisib, sponsored by Novartis, has met both of its co-primary endpoints by demonstrating improvements in lymphoproliferation and immunophenotype correction, and that the treatment was well tolerated by patients.

Pharming plans to begin submitting global regulatory filings for leniolisib, a small-molecule PI3K inhibitor, in the first half of 2022 and, subject to approval, launching the treatment in the U.S. in the first quarter of 2023 and starting a series of European launches in the second half of 2023.

Nicholas Hartog, MD, FAAAAI, FACAAI, a specialist in allergy and immunology at Spectrum Health Helen Devos Children's Hospital in Grand Rapids, Michigan, said: "I'm eager to learn more about the positive results of this Phase III study of leniolisib in patients with APDS. A promising therapy for this rare and challenging disease sparks hope in physicians like me, who are dedicated to improving care for affected patients and reducing their symptoms. I could not be more excited about the opportunity for a personalized and precision-based therapy on the horizon for this patient population."

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Anurag Relan, Chief Medical Officer of Pharming, commented: "Pharming is committed to bringing new therapies to people with rare diseases and will work closely with regulatory authorities across the globe in an effort to make this innovative option available to physicians who care for patients with primary immunodeficiencies. We are excited to be pursuing a development program that aims to bring patients the first targeted therapy option for APDS, as this disease significantly impacts their lives, yet treatment has been limited to supportive therapies such as antibiotics and immunoglobulin replacement therapy."

In his presentation during a plenary session titled "Precision Medicine for Hyperinflammatory Disorders," Dr. Rao will explain the study's design, share its primary and secondary findings, and detail patient disposition and safety results. The annual CIS meeting will be dedicated to exploring immune deficiency and dysregulation.

About Activated Phosphoinositide 3-Kinase Syndrome (APDS)

APDS is a rare primary immunodeficiency that affects approximately one to two people per million. Also known as PASLI, it is caused by variants in either of two genes, PIK3CD or PIK3R1, that regulate maturation of white blood cells. Variants of these genes lead to hyperactivity of the PI3K (phosphoinositide 3-kinase delta) pathway.1,2 Balanced signaling in the PI3K pathway is essential for physiological immune function. When this pathway is hyperactive, immune cells fail to mature and function properly, leading to immunodeficiency and dysregulation.1,3 APDS is characterized by severe, recurrent sinopulmonary infections, lymphoproliferation, autoimmunity, and enteropathy.4,5 Because these symptoms can be associated with a variety of conditions, including other primary immunodeficiencies, people with APDS are frequently misdiagnosed and suffer a median 7-year diagnostic delay.6 As APDS is a progressive disease, this delay may lead to an accumulation of damage over time, including permanent lung damage and lymphoma.4-7 The only way to definitively diagnose this condition is through genetic testing.

About leniolisib

Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially anti-neoplastic activities. Leniolisib inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3). PIP3 serves as an important cellular messenger specifically activating AKT (via PDK1) and regulates a multitude of cell functions such as proliferation, differentiation, cytokine production, cell survival, angiogenesis, and metabolism. Unlike PI3K and PI3K, which are ubiquitously expressed, PI3K and PI3K are expressed primarily in cells of hematopoietic origin. The central role of PI3K in regulating numerous cellular functions of the adaptive immune system (B-cells and, to a lesser extent, T cells) as well as the innate immune system (neutrophils, mast cells, and macrophages) strongly indicates that PI3K is a valid and potentially effective therapeutic target for several immune diseases.

To date, leniolisib has been well tolerated during both the Phase 1 first-in-human trial in healthy subjects and the Phase II/III registration-enabling study.

About the Phase II/III leniolisib Trial

Sponsored by Novartis, the Phase II/III registration-enabling study was composed of two parts, the first being a 12-week open-label dose escalation part that included six patients with APDS and determined the dose of leniolisib to be given in the Phase III part.

The Phase III part consisted of a randomized, placebo-controlled, blinded trial of leniolisib that enrolled 31 patients who had APDS and were age 12 or older. The patients were randomly assigned according to a 2:1 ratio to receive either leniolisib 70mg twice daily or placebo for 12 weeks. The co-primary endpoints of the randomized study evaluated reduction in lymph node size and correction of immunodeficiency as shown by an increase in nave B cells. Following study treatment, patients were permitted to roll over to an open-label extension study evaluating long-term safety, tolerability, and efficacy.

About Pharming Group N.V.

Pharming Group N.V. is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.

The flagship of our portfolio is our recombinant human C1 esterase inhibitor (rhC1INH) franchise. C1INH is a naturally occurring protein that down regulates the complement and contact cascades in order to control inflammation in affected tissues.

Our lead product, RUCONEST, is the first and only plasma-free rhC1INH protein replacement therapy. It is approved for the treatment of acute hereditary angioedema (HAE) attacks. We are commercializing RUCONEST in the United States, the European Union and the United Kingdom through our own sales and marketing organization, and the rest of the world through our distribution network.

In addition, we are investigating the clinical efficacy of rhC1INH in the treatment of further indications, including pre-eclampsia, acute kidney injury and severe pneumonia as a result of COVID-19 infections.

We are also studying our oral precision medicine, leniolisib (a phosphoinositide 3-kinase delta, or PI3K delta, inhibitor), for the treatment of activated PI3K delta syndrome, or APDS. World-wide rights for leniolisib were licensed from Novartis AG in 2019. Leniolisib met both of its primary end points in a registration enabling Phase 2/3 study in the United States and Europe. We are targeting global regulatory filings for leniolisib from Q2 2022 onwards.

Additionally, we entered into a strategic collaboration with Orchard Therapeutics to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex-vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of HAE.

Furthermore, we are leveraging our transgenic manufacturing technology to develop next-generation protein replacement therapies, most notably for Pompe disease, which is currently in preclinical development.

Forward-looking Statements

This press release contains forward-looking statements, including with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, Pharming's ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of its business, and Pharming's expectations regarding its projected working capital requirements and cash resources. These statements are subject to a number of risks, uncertainties and assumptions, including but not limited to: the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2020 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release.

Inside Information

This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

References:

1. Lucas CL, et al. Nat Immunol. 2014;15:88-97.

2. Elkaim E, et al. J Allergy Clin Immunol. 2016;138(1):210-218.

3. Nunes-Santos C, Uzel G, Rosenzweig SD. J Allergy Clin Immunol. 2019;143(5):1676-1687.

4. Coulter TI, et al. J Allergy Clin Immunol. 2017;139(2):597-606.

5. Maccari ME, et al. Front Immunol. 2018;9:543.

6. Jamee M, et al. Clin Rev Allergy Immunol. 2019;May 21.

7. Condliffe AM, Chandra A. Front Immunol. 2018;9:338.

For further public information, contact:

Pharming Group, Leiden, The Netherlands Sijmen de Vries, CEO: T: +31 71 524 7400 Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: investor@pharming.com

FTI Consulting, London, UK Victoria Foster Mitchell/Alex Shaw T: +44 203 727 1000

FTI Consulting, USA Jim Polson T: +1 (312) 553-6730

LifeSpring Life Sciences Communication, Amsterdam, The Netherlands Leon Melens T: +31 6 53 81 64 27 E: pharming@lifespring.nl

US PR: Emily VanLare E: Emily.VanLare@precisionvh.com T: +1 (203) 985 5596

EU PR: Dan Caley E: Dan.caley@aprilsix.com T: +44 (0) 787 546 8942

Logo: https://mma.prnewswire.com/media/1454235/Pharming_Group_NV_Logo.jpg

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Pharming Announces Presentation of Positive Results of Phase III Leniolisib Trial in APDS at Clinical Immunology Society 2022 Annual Meeting - Yahoo...

Immunology

DICE Therapeutics Expands Management Team and Board of Directors – Yahoo Finance

DICE Therapeutics, Inc.

Mary Riley, J.D., appointed as general counsel

Lisa Bowers, MHSA, and Mittie Doyle, M.D., FACR, join board of directors

SOUTH SAN FRANCISCO, Calif., March 28, 2022 (GLOBE NEWSWIRE) -- DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, today announced the appointment of Mary Riley as general counsel and the additions of Lisa Bowers and Mittie Doyle, M.D., FACR, to DICEs board of directors. Concurrently, Stephen Zachary, Ph.D., will be stepping down from the Companys board.

Mary, Lisa and Mittie are excellent additions to the DICE team with extensive biopharmaceutical industry experience and expertise in their respective fields, said Kevin Judice, Ph.D., CEO of DICE Therapeutics. We are pleased to welcome them to DICE during this important time in the Companys growth and evolution. We would also like to thank Stephen for his many contributions during his time on our board, including during the early stages of the Companys formation.

Mary Riley, J.D., as general counselMs. Riley joins DICE following a 15-year tenure at Genentech, most recently serving as vice president, litigation, where she served on the legal leadership team and was responsible for managing a wide range of legal matters. She also previously led Genentechs business law group and employment law group, where she served as a member of the human resources leadership team. Before joining Genentech, Mary was a partner at Heller Ehrman LLP and held roles at other corporate law firms. Mary received a J.D. from Fordham University School of Law and a B.A. from College of the Holy Cross.

Lisa Bowers, MHSA, to board of directorsMs. Bowers is the chief commercial officer of Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company founded to address a critical unmet need, the lack of therapeutic development in pediatric cancer. Prior to joining Day One, Lisa served as the chief executive officer and founder of Rhia Ventures, a social venture investment organization focused on reproductive health. She was also the chief operating officer of the Tara Health Foundation and had an extensive career at Genentech/Roche, where she held P&L accountability for Genentechs cystic fibrosis business and was the head of the North American supply chain region, accountable for more than $20 billion of medicine across the U.S. and Canada. Prior to these roles, Ms. Bowers led Genentechs patient access services and the companys strategic marketing function for managed care organizations. Ms. Bowers has been a board observer for Cadence Health and is a member of the board for Planned Parenthood Mar Monte. She received a Master of Health Services Administration from the University of Michigan School of Public Health and a B.A. from Yale University.

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Mittie Doyle, M.D., FACR, to board of directorsDr. Doyle is a proven research physician who has held numerous leadership roles in clinical development. She currently serves as chief medical officer of Aro Biotherapeutics, a biotechnology company pioneering the development of tissue-targeted genetic medicines. Prior to joining Aro, Dr. Doyle served as vice president, global therapeutic area head, immunology at CSL Behring. Prior to her time at CSL, Dr. Doyle held senior level roles at Shire Pharmaceuticals, Flexion Therapeutics and Alexion Pharmaceuticals. During her career, she has led clinical development across a broad range of immune mediated and orphan diseases and led teams with responsibilities for design and execution of first-in-human through Phase 2 and 3 trials, resulting in several global regulatory approvals. Dr. Doyle received an M.D. from Yale Medical School and completed her postdoctoral training at Harvard Medical School including a residency in internal medicine at Massachusetts General Hospital and clinical/research fellowship in rheumatology and immunology at Brigham and Womens Hospital. She received a B.A. from Princeton University.

About DICE Therapeutics, Inc.DICE Therapeutics, Inc. is a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas. DICE is initially focused on developing oral therapeutics against well-validated targets in immunology, with the goal of achieving comparable potency to their systemic biologic counterparts, which have demonstrated the greatest therapeutic benefit to date in these disease areas. The Companys DELSCAPE platform is designed to discover selective oral small molecules with the potential to modulate protein-protein interactions (PPIs) as effectively as systemic biologics. DICEs lead therapeutic candidates are oral antagonists of the pro-inflammatory signaling molecule, IL-17, which is a validated drug target implicated in a variety of immunology indications. DICE is also developing oral therapeutic candidates targeting 47 integrin and V1/V6 integrin for the treatment of inflammatory bowel disease and idiopathic pulmonary fibrosis, respectively.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Companys future plans and prospects, the Companys current cash position and anticipated runway, and the anticipated therapeutic properties and potential of the Companys therapeutic candidates. In addition, when or if used in this press release, the words may, could, should, anticipate, believe, estimate, expect, intend, plan, predict and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Companys forward-looking statements due to a variety of factors, including risks and uncertainties related to the Companys ability to advance DC-806, DC-853 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Companys therapeutic candidates, the timing and results of preclinical and clinical trials, our ability to fund development activities and achieve development goals, the impact of the COVID-19 pandemic on the Companys business, its ability to protect its intellectual property and other risks and uncertainties described under the heading Risk Factors in the Companys annual report on Form 10-K filed on March 28, 2022, and its other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein.

Contact:Katie Engleman, 1ABkatie@1abmedia.com

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DICE Therapeutics Expands Management Team and Board of Directors - Yahoo Finance

Immunology

RAPT Therapeutics Announces Biomarker Data from Phase 1b Trial of RPT193 Consistent with Disease Modification in Atopic Dermatitis – Yahoo Finance

RAPT Therapeutics, Inc.

Significant improvement in atopic dermatitis gene signatures in patients treated with RPT193 reported in late-breaking presentation at the American Academy of Dermatology Annual Meeting

SOUTH SAN FRANCISCO, Calif., March 28, 2022 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced biomarker data from the companys randomized placebo-controlled Phase 1b clinical trial of RPT193 in patients with moderate-to-severe atopic dermatitis (AD) were consistent with previously reported top-line data which showed clear improvement in key exploratory efficacy measures. The biomarker data, which were presented in a late-breaking oral session at the American Academy of Dermatology Annual Meeting by Emma Guttman-Yassky, M.D., Ph.D., the Waldman Professor and System Chair of Dermatology and Immunology at the Icahn School of Medicine at Mount Sinai, showed patients treated with RPT193 experienced a statistically significant improvement (p<0.001) in the meta-analysis derived atopic dermatitis (MADAD) score, a well-established gene signature that tracks with disease severity. Additionally, administration of RPT193 resulted in improvements in immune pathways known to be dysregulated in AD, such as Th2, Th22 and Th1. These biomarker data were derived from biopsies taken from the lesional and non-lesional skin of patients enrolled in the Phase 1b trial.

These biomarker results support the potential of RPT193 as a once-daily, oral treatment that actually may be altering the course of atopic dermatitis versus just treating symptoms of the disease, said Dr. Guttman. Specifically, changes in atopic dermatitis-related biomarkers showed significant correlations with clinical efficacy and disease improvement. Furthermore, the demonstration of changes in gene signatures likely explain the added benefit patients experienced up to two weeks after RPT193 treatment had ended. Im excited to continue further biomarker analyses from this trial and to see RPT193 clinical development advance and expand into other inflammatory conditions.

Brian Wong, M.D., Ph.D., President and CEO of RAPT, added, We thank Dr. Guttman and her lab for the rigorous evaluation of patient samples from our Phase 1b trial of RPT193 in atopic dermatitis. These data are supportive of the unique mechanism of RPT193 that resulted in impressive reductions in disease severity, both during treatment and after dosing cessation in the trial. We look forward to initiating our Phase 2b clinical trial in atopic dermatitis and to expanding our exploration of RPT193 in a Phase 2a trial in asthma.

About the Phase 1a/1b Study of RPT193The Phase 1b trial was part of a combined Phase 1a/1b clinical study of RPT193. The Phase 1a portion of the Phase 1a/1b trial was a standard single and multiple dose-escalation study in healthy volunteers. The data from the Phase 1a study demonstrated pharmacokinetics and pharmacodynamics that support once-daily oral dosing with RPT193, and blinded safety data supported initiation of the Phase 1b portion of the trial.

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The Phase 1b portion of the trial was a randomized, double-blind, placebo-controlled study examining RPT193 as monotherapy in 31 patients with moderate-to-severe AD who had an inadequate response to, or were intolerant of, topical corticosteroids. The primary endpoint of the Phase 1b study was safety. Secondary and exploratory endpoints included pharmacokinetics, biomarkers and clinical efficacy as evaluated by multiple measurements, including percent change in the Eczema Area and Severity Index (EASI) score, change in body surface area (BSA) affected by AD, the validated Investigator Global Assessment (vIGA) and pruritus Numerical Rating Scale (NRS). The Phase 1b trial was not powered to achieve statistical significance for any particular endpoint.

Last year, RAPT reported results from the Phase 1b trial, which demonstrated that at Day 29, i.e., after the four-week treatment period, clear benefit over placebo was observed on EASI score, EASI-50, vIGA 0/1 (clear or almost clear skin), BSA and pruritus NRS-3 and 4 (3- or 4-point reduction on the numerical rating scale for itch). By the end of study, including the 2-week follow-up period (Day 43), RPT193 demonstrated improvement in EASI, EASI-50, EASI-75, EASI-90, vIGA 0/1 and BSA. In a post-hoc statistical analysis comparing RPT193-treated patients to placebo-treated patients, statistically significant improvements in EASI, EASI-50 and BSA were observed at Day 43. RPT193 was well tolerated in the Phase 1b study. No serious adverse events were reported, and all adverse events reported were mild or moderate in intensity.

About RPT193 RPT193 is a small molecule oral therapy in development for the treatment of atopic dermatitis and other inflammatory diseases. RPT193 is designed to selectively inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4, a receptor highly expressed on Th2 cells. Preclinical data suggest that RPT193 also has the potential to modulate Th2 cell function by lowering the secretion of Th2 cytokines upon stimulation. In allergic inflammatory diseases such as AD, chemokines recruit Th2 cells via CCR4 into inflamed tissues, where the Th2 cells secrete proteins known to drive the inflammatory response. The role of Th2 cells has been clinically validated by injectable biologics targeting this pathway. Patients with atopic dermatitis express higher levels of CCR4 ligands compared with healthy humans; these ligands also correlate with the severity of disease. RAPT believes that by inhibiting CCR4, RPT193 has the potential to bring therapeutic benefit to patients across a broad spectrum of inflammatory diseases, including atopic dermatitis, asthma, chronic spontaneous urticaria, allergic rhinitis with nasal polyps, chronic rhinosinusitis and eosinophilic esophagitis.

About Atopic Dermatitis Atopic dermatitis is a highly prevalent chronic, inflammatory skin disease characterized by skin barrier disruption and immune dysregulation. Patients with AD have chronically inflamed skin lesions that can cause debilitating pruritus (itch), which can severely impair quality of life. While there is a marketed injectable product for the treatment of AD, RAPT believes RPT193, if approved, could fill an unmet medical need for the treatment of inflammatory disorders with the convenience of once-daily oral dosing. There are ~19M adults and ~10M children affected by AD in the US.

About RAPT Therapeutics, Inc.RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively. The company is also pursuing a range of targets that are in the discovery stage of development.

Forward-Looking StatementsThis press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about interpretations of the biomarker data from the Phase 1b clinical trial of RPT193, clinical development progress including the anticipated advancement of RPT193 to a Phase 2b trial in AD as well as a Phase 2a trial in asthma or other indications and the potential of RPT193 to treat AD or other inflammatory diseases. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPTs Form 10-K filed with the Securities and Exchange Commission on March 10, 2022 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.

Investor Contact:Alexandra Santosasantos@wheelhouselsa.com

Media Contact:Aljanae Reynoldsareynolds@wheelhouselsa.com

Link:
RAPT Therapeutics Announces Biomarker Data from Phase 1b Trial of RPT193 Consistent with Disease Modification in Atopic Dermatitis - Yahoo Finance

Immunology

Allergen immunotherapy during the COVID-19 pandemic-A survey of the German Society for Allergy and Clinical Immunology – DocWire News

This article was originally published here

Clin Transl Allergy. 2022 Mar;12(3):e12134. doi: 10.1002/clt2.12134.

ABSTRACT

BACKGROUND: When the coronavirus pandemic 2019 (COVID-19) emerged, concerns were also raised regarding the safety of allergen immunotherapy (AIT). The German Society for Allergology and Clinical Immunology (DGAKI) conducted a survey to collect real-world data on the daily routine of administering subcutaneous AIT (SCIT) and sublingual AIT (SLIT) during the COVID-19 pandemic.

METHODS: A web-based retrospective survey using the online platform survio with 26 standardized questions was used to survey physicians treating allergic patients during the pandemic.

RESULTS: Three hundred and forty-five physicians who regularly offer and perform AIT in German-speaking countries responded to the questions. 70.4% of the respondents stated that they regularly initiated and dosed up SCIT for inhalant allergies (41.4% venom-SCIT, 73.6% SLIT), and 85.2% of the respondents stated that they continued SCIT for inhalant allergies during the maintenance phase in a regular way (59.1% venom-SCIT, 90.4% SLIT) in healthy patients without current symptoms indicating an infection with COVID-19. With regard to tolerability, there was no evidence for increased occurrence of adverse events in patients without current symptoms of COVID-19 infection during the pandemic.

CONCLUSIONS: This retrospective study demonstrated adherence to national and international position papers of AIT during the COVID-19 pandemic in German-speaking countries. Besides, the survey has confirmed a good tolerability of AIT for both SCIT and SLIT.

PMID:35344300 | DOI:10.1002/clt2.12134

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Allergen immunotherapy during the COVID-19 pandemic-A survey of the German Society for Allergy and Clinical Immunology - DocWire News

Immunology

Stanford Children’s Health launches new Center for Pediatric IBD and Celiac Disease with $70 million donation – Stanford Report – Stanford University…

Stanford Childrens Health has launched its new Center for Pediatric Inflammatory Bowel Disease (IBD) and Celiac Disease to increase access to care and advance research to improve outcomes for children, thanks to a $70 million gift by an anonymous donor. Children with IBD and celiac disease require comprehensive and dedicated care to achieve the best outcome and control of their disease. The new center will bring together expert clinicians, researchers, IBD and celiac disease nurses, dietitians, psychologists and social workers to build a world-class program for state-of-the-art clinical care.

Michael J. Rosen, director of the Center for Pediatric IBD and Celiac Disease. (Image credit: Stanford Childrens Health)

We aim to build the nations destination center for innovation in pediatric IBD and celiac disease care, as well as a major research hub for these conditions, said Michael J. Rosen, MD, director of the new center. Rosen, a pediatric gastroenterologist at Stanford Childrens Health, is also the Stanford University Endowed Professor for Pediatric IBD & Celiac Disease.

The gastrointestinal disorders addressed by the center will include Crohns disease, ulcerative colitis, indeterminate colitis and very-early-onset IBD. The joint services we offer will give children from birth to age 22 the best chance to live full and productive lives, Rosen said.

Clinicians and researchers will partner with Stanford Medicine scientists in microbiome science, human immunology, genetics, epithelial biology, biomedical engineering and data science to further the understanding of the root causes of IBD and celiac disease in children; advance precision medicine; and help develop the treatments of tomorrow. Experts in the center will also accelerate the understanding of these chronic conditions, collect and share data and synchronize approaches to improve diagnosis and gastroenterology treatment.

We extend our deepest appreciation to the donor for this transformative gift, said Mary Leonard, MD, the Adalyn Jay Physician in Chief at Lucile Packard Childrens Hospital Stanford and Arline and Pete Harman Professor and chair of the Department of Pediatrics at Stanford School of Medicine. Thanks to their commitment, we can bring together the best minds across Stanford Medicine to change the trajectory for children with IBD and celiac disease.

The Center for Pediatric IBD and Celiac Disease will work closely with top pediatric subspecialists in fields such as advanced endoscopy, surgery, pain management, mental health, nutrition and integrative medicine at Stanford to address the comprehensive care needs of children with IBD and celiac disease across the spectrum of severity.

Our close collaboration with expert clinical immunologists and geneticists enables us to provide advanced diagnostic and treatment options to children with IBD and celiac disease disorders that do not respond to standard treatment, said Rosen. This collaborative work can make a real difference in the coming years by improving our ability to personalize treatment, curate biospecimens and patient-reported outcomes data for the worlds investigators and develop clear guidance on which drugs are safest and most effective for each child.

Funding from this new $70 million gift, along with National Institutes of Health grants and foundation-funded research programs, allows Stanford Childrens Health to expand engagement with key clinical and scientific program partners, provide access to more patients and advance the use of data and innovative technologies to improve care for children coping with IBD and celiac disease.

For more information on the Center for Pediatric IBD and Celiac Disease, go to: ibdceliac.stanfordchildrens.org.

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Stanford Children's Health launches new Center for Pediatric IBD and Celiac Disease with $70 million donation - Stanford Report - Stanford University...

Immunology

Molecular Partners Announces Publication of Preclinical Data from CD40 Therapeutic Candidate MP0317 in Cancer Immunology Research – Yahoo Finance

Molecular Partners

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., March 24, 2022 (GLOBE NEWSWIRE) -- Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced the publication of preclinical data from MP0317 in Cancer Immunology Research, a journal of the American Association for Cancer Research. MP0317 is the Companys second immuno-oncology program to enter clinical studies and is designed to target both FAP (fibroblast activation protein), a protein found in high density around tumors, and the immunostimulatory protein CD40, to enable tumor-localized immune activation.

The CD40 receptor, which is expressed on dendritic cells, B cells and macrophages, is an attractive target for cancer immunotherapy. However, administration of CD40-targeting monoclonal antibodies has challenges with achieving a meaningful clinical response. Low concentrations result in minimal efficacy, but higher concentrations rapidly lead to systemic toxicity, limiting the therapeutic window achievable with systemic CD40 activation. The DARPin therapeutic candidate MP0317 is designed to specifically induce CD40-mediated immune activation only in the FAP-rich local tumor environment, preventing systemic immune activation.

The published study confirms that MP0317 is inducing FAP-dependent CD40-mediated B and myeloid cell activation, thus supporting the candidate intended mechanism of action of tumor-localized immune activation without the systemic toxicity observed with other CD40-targeting agents. This study suggests that MP0317, as a DARPin therapeutic candidate, has the potential for a broader therapeutic window and thus improved clinical activity compared to CD40 agonist antibodies. The publication can be found in this link.

MP0317 is currently being tested in a Phase 1 clinical trial sponsored by the Company. The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express FAP. In addition to evaluating monotherapy dynamics, the study will gather biomarker data to support the establishment of combination studies of MP0317 with other therapies in specific indications.

Initial data from the ongoing Phase 1 clinical trial are expected in the second half of 2022.

About Molecular Partners AG Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. http://www.molecularpartners.com; Find us on Twitter - @MolecularPrtnrs

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Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of Molecular Partners current or future product candidates, including expectations regarding timing of clinical trial data, and the potential therapeutic and clinical benefits of Molecular Partners product candidates. These statements may be identified by words such as expect, may, plan, potential, will, would and similar expressions, and are based on Molecular Partners current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners expectations include Molecular Partners ongoing and planned clinical trials and preclinical studies for Molecular Partners product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and Molecular Partners ability to obtain and maintain regulatory approvals for Molecular Partners product candidates; the extent of clinical trials potentially required for Molecular Partners product candidates; Molecular Partners plans to develop and potentially commercialize Molecular Partners product candidates; the clinical utility and ability to achieve market acceptance of Molecular Partners product candidates; the potential impact of the COVID-19 pandemic on Molecular Partners operations or clinical trials; Molecular Partners plans and development of any new indications for Molecular Partners product candidates; Molecular Partners commercialization, marketing and manufacturing capabilities and strategy; Molecular Partners intellectual property position; Molecular Partners ability to identify and in-license additional product candidates; Molecular Partners reliance on third party partners and collaborators over which we may not always have full control; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners Annual Report on Form 20-F for the year ended December 31, 2021, filed with the SEC on March 15, 2022, and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners website at http://www.molecularpartners.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and except to the extent required by law, Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Molecular Partners Announces Publication of Preclinical Data from CD40 Therapeutic Candidate MP0317 in Cancer Immunology Research - Yahoo Finance

Immunology

Aristea Therapeutics Announces Dosing of First Patient in Phase 2b Trial of RIST4721 in Palmoplantar Pustulosis – PR Newswire

SANDIEGO, March 28, 2022 /PRNewswire/ -- Aristea Therapeutics (Aristea), a clinical-stage immunology focused drug development company advancing novel therapies to treat serious inflammatorydiseases, today announcedthe dosing of the first patient in its Phase 2b trial evaluating RIST4721, a CXCR2 antagonist, for the treatment of palmoplantar pustulosis (PPP), arare inflammatory skin disorder.

"This is a promising time in the company's progress, andwe are glad to have commenced our Phase 2b trial of RIST4721 in PPP," stated James M. Mackay, Ph.D., President and CEO of Aristea. "This is a condition with no approved therapies in the United States or Europe, and we are excited to keep moving forward in developing a potential treatment option for these patients in need."

PPP is a rare chronic inflammatory skin condition characterized by the recurrent appearance of sterile pustules filled with neutrophils on the palms of the hands and soles of the feet. Patients with PPP suffer from inflammation and cracking of the skin, causing pain, bleeding, itching and burning. This disease makes the performance of daily tasks extremely difficult and patients have dramatic challenges to their quality of life. There are no approved therapies in the United States or Europe, and those suffering from PPP have limited therapeutic options. PPP is a rare condition and most commonly seen among women ages 40-69 and those with a history of smoking tobacco.

RIST4721-202 is a randomized, double-blind, placebo-controlled, Phase 2b, 12-week, dose-ranging study of RIST4721, a CXCR2 antagonist, in subjects with moderate to severe palmoplantar pustulosis. This trial is currently recruiting patients within North America (clinicaltrials.govNCT05194839).

"Our Phase 2a trial demonstrated that RIST4721 is well tolerated in subjects with moderate to severe PPP over 28 days and may represent an effective treatment option," commented Dr. Nihar Bhakta, Aristea's Chief Medical Officer. "The Phase 2b, with a longer treatment duration and a larger pool of subjects, will help us move closer to bringing this potential therapy to those suffering from this burdensome condition."

Aristea has Phase 2a studies in development for RIST4721 in four additional CXCR2-mediated diseases: familial Mediterranean fever, Behcet's disease, hidradenitis suppurativa, and inflammatory bowel disease.

About Aristea Therapeutics

Aristea Therapeutics (Air-iss-tay-uh) is a clinical-stage immunology focused drug development company developing novel therapies to treat serious inflammatory diseases. The Aristea team is leveraging its broad industry expertise and proven success in drug development to form synergistic partnerships and build a pipeline of novel drugs. Aristea's lead program, RIST4721, is currently in Phase 2b clinical development. Aristea is headquartered in San Diego, CA.

To learn more, please visit http://www.aristeatx.com and follow us on Twitter (@Aristeatx) and LinkedIn (Aristea Therapeutics).

For media inquiries contact:David Schull or Ignacio Guerrero-Ros, Ph.D.Russo Partners858-717-2310646-942-5604[emailprotected][emailprotected]

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Aristea Therapeutics Announces Dosing of First Patient in Phase 2b Trial of RIST4721 in Palmoplantar Pustulosis - PR Newswire

Immunology

The University of Texas MD Anderson Cancer Center Launches James P. Allison Institute – The ASCO Post

By The ASCO Post StaffPosted: 3/24/2022 1:14:00 PM Last Updated: 3/24/2022 12:52:10 PM

Today, The University of TexasMD AndersonCancer Center launched theJamesP. Allison Institute, a visionary research and innovation hub withinMD Andersondesigned to foster groundbreaking science, to develop new treatments, and to bring the benefits ofimmunotherapyto all patients.

The Allison Institute will advance exceptional discovery, translational, and clinical research to integrate immunobiology across disciplines and unlock the full potential of science and medicine for human health. The institute builds upon the legacy of its namesake,James P. Allison, PhD, who was awarded the 2018 Nobel Prize in Physiology or Medicine for his fundamental discoveries in T-cell biology and his invention of ipilimumab, the firstimmune checkpoint inhibitorto treat cancer.

James P. Allison, PhD

Immunotherapy has transformed cancer care over the past decade but, unfortunately, not all patients benefit equally. Our goal is to change that, said Dr. Allison, Regental Chair ofImmunologyat MD Anderson and Director of the Allison Institute. Our vision is to lead the world in immunotherapy research by empowering interdisciplinary scientific excellence and by accelerating discoveries into novel and synergetic therapies that enable cures.

Unlike the traditional pillars of cancer caresurgery, radiation, chemotherapy, and targeted therapiesimmunotherapy does not target the tumor directly but instead works to unleash the immune system. By gaining a comprehensive understanding of immunobiology, the institute will develop treatment approaches that effectively integrate these pillars to work in concert and prime immune cells for an antitumor response that can eliminate cancer.

Additional Faculty

Together with Dr. Allison, the institute will be led by renowned experts in immunotherapy and cancer research.Padmanee Sharma, MD, PhD, Professor ofGenitourinary Medical Oncologyand Immunology, will serve as Scientific Director of the Allison Institute, andRaghu Kalluri, MD, PhD, Professor and Chair ofCancer Biology, will serve as Director of Operations.

From left to right: Raghu Kalluri, MD, PhD, Padmanee Sharma, MD, PhD, and James P. Allison, PhD. Photo credit: MD Anderson

Our unique ability to seamlessly integrate fundamental discovery science with translational drug development and impactful clinical research offers an unprecedented opportunity to realize the promise of immunotherapy and to take a critical step toward finally ending cancer, saidPeter WT Pisters, MD, President ofMD Anderson. The Allison Institute is an essential component of our institutionalstrategyto make the greatest impact on the most people, and I am confident the work of the institute will have a lasting impact on all of humanity.

Empowering Scientific Breakthroughs

Dr. Allison was not driven initially to discover a new cancer therapy, but rather to understand the mysteries of T cells and the immune system. His curiosity and persistence drove him to groundbreaking discoveries in immune checkpoint proteins. Similarly, discovery research across all disciplines is central to the mission of the Allison Institute.

We will empower our researchers to make scientific breakthroughs that advance our understanding of immunobiology and enable exciting new therapeutic opportunities, Dr. Sharma said. Starting with high-impact discovery science, we will follow the evidence toward biological insights, novel treatment targets, and innovative new technologies.

Leveraging the strength ofMD Andersonsdrug discovery capabilities and clinical expertise together with strategic biopharma collaborations, the Allison Institute will rapidly advance discoveries from the lab to the clinic and back again, with clinical insights informing ongoing laboratory studies. These efforts will bring both new medicines and tailored combinations that can be evaluated in well-designed studies throughMD Andersonsleading clinical research engine.

To achieve maximum impact, Allison Institute researchers will seek to learn as much as possible from the patients they aim to help. Cutting-edge data science will generate unparalleled insights from clinical trials in real time. Employing the reverse translational research model ofMD Andersonsimmunotherapy platform, co-led by Drs. Allison and Sharma, these insights will guide simultaneous laboratory studies to answer critical questions for future trials.

Innovative Research Model to Drive Progress

The ambitious goals of the Allison Institute necessitate a unique organizational approach to change the way researchers come together, share ideas, and accelerate progress.

We endeavor to be a worldwide leader in research and innovation, and that requires moving away from the traditional departmental silos toward dynamic teams assembled and reassembled to answer specific questions, Dr. Kalluri said. By recruiting and engaging the top minds around the world, we will unleash individual brilliance in a collaborative environment.

The Allison Institute will establish a diverse and inclusive environment with a culture of excellence and innovation. A priority of the institute will be to train and nurture rising stars who will lead the next generation of immunotherapy pioneers, thus ensuring progress is maintained for decades to come.

Allison Institute members will encompass several categories of researchers, including established and rising scientists housed within the institute as well as internal and external scientists contributing to collaborative projects. Project-focused teams will be assembled to integrate expertise across scientific disciplines. As progress is made or new questions are revealed, teams will be reassembled to respond to the evolving scientific landscape.

These teams will have access to the well-established infrastructure already present atMD Anderson, including innovativeresearch platforms, cutting-edge data science efforts, and the drug discovery and development capabilities of theTherapeutics Discovery division.

In this context,MD Andersonwill make strategic capital investments to establish specialized core facilities and platforms that will support both the work of the institute andMD Andersonpriority research efforts. The institute will be housed in state-of-the-art facilities now being constructed on theTMC3life-science campusand future laboratory space onMD Andersonssouth campus.

The strategic direction of the Allison Institute also will be guided by an external scientific advisory board composed of leading experts that have committed to regular evaluations of the research portfolio and programs. The advisory board will be co-led by Robert Schreiber, PhD, the Andrew M. and Jane M. Bursky Distinguished Professor of Pathology and Immunology at Washington University School of Medicine in St. Louis, and Elaine Mardis, PhD, Co-Executive Director of the Steve and Cindy Rasmussen institute for Genomic Medicine at Nationwide Childrens Hospital and Professor of Pediatrics at The Ohio State University College of Medicine.

The Allison Institute is an exciting, bold, forward-looking and timely development that will bring together outstanding investigators with diverse and cutting-edge expertise closely aligned with the superb clinical and translational engine for whichMD Andersonis known, Dr. Schreiber said. When one considers the leadership of the Institute and the commitment fromMD Anderson, there is no doubt in my mind that the Allison Institute will rapidly become known as the paradigm for cancer research in the world.

For more information about the Allison Institute and to view a live stream of the announcement, visitMDAnderson.org/AllisonInstitute.

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The University of Texas MD Anderson Cancer Center Launches James P. Allison Institute - The ASCO Post

Immunology

Harbour BioMed Reports Full Year 2021 Financial Results: Empower Value Creation with Global Innovation Capabilities – BioSpace

CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, March 24, 2022 /PRNewswire/ -- Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on oncology and immunology, today reported full year 2021 annual results. During the reporting period, the Company's product development continued to make outstanding breakthroughs, unleashing the power of innovative technology platforms and globalization advantages.

"2021 was a year of strong momentum for Harbour BioMed. The company has been making significant progress with respect to our highly differentiated pipeline products and business operations," said Jingsong Wang, Founder, Chairman and Chief Executive Officer. "Our 10 clinical trials are ongoing while two of them, Batoclimab and Tanfanercept, are in pivotal phase III trials and are progressing towards BLA (Biologics License Application) submission. We've seen encouraging data of the global clinical trials of HBM4003 and solid progress of multiple assets through pre-clinical development. The value of our platforms has been further validated with more than 50 leading partners around world.

Moving forward in 2022, we will continue to explore more differentiated novel therapeutics on a global basis, leveraging in-house technology platforms and strong research and development capabilities. I believe that each of our innovative products empowered by our unique platforms has the potential to benefit the patients globally, accelerating our mission to lead a healthy life with breakthrough medicines globally."

Recent Highlights:

Continued advancement across broad pipeline of core assets

Multiple assets are progressing through pre-clinical development

The Company is actively exploring new scientific discoveries in novel therapeutic areas to address unmet medical needs

The Company's scientific research team strives to scale new heights in science with its strong research and development capabilities

Further advanced its global strategy through multiple collaborations

Driving antibody drug development through innovation

The Company remains committed to the discovery and development of differentiated antibody therapeutics focusing on oncology and immunology. Powered by Harbour BioMed's unique technology platforms, it has developed a differentiated portfolio and innovation engine for sustained long-term expansion and growth of its self-developed pipeline.

Harbour BioMed is at the forefront of developing next generation immuno-oncology therapeutics, including innovative immune cell engager bispecific antibodies, unique Treg depletion mechanism, and novel immune escape pathway. Cancer treatment market unfolds vast opportunities, and the Company seeks to develop oncology therapeutics that address situations where 70%-80% of patients do not respond to or are resistant to PD1/PD-L1, in its pursuit of next-generation immuno-oncology therapeutics which tap the potential value of this $100 billion market.

With the R&D advantages of HBM's unique and highly efficient antibody discovery platforms under one organizational umbrella, the Company developed a number of first-in-class clinical and preclinical products. Among them, the bispecific antibody HBM7008 (B7H4/4-1BB) and the monoclonal antibody HBM1020 (B7H7) which represents the next generation of immune checkpoint inhibitors with significant differentiated advantages. In addition, the monoclonal antibody HBM1022 targets the Treg cell protein CCR8. CCR8 is recognized globally as a challenging target but one which is garnering increased attention in immuno-oncology. The Company's use of mRNA immunization technology combined with its proprietary antibody platforms allow for a suite of solutions of G protein-coupled receptor (GPCR) antibody discovery. These noted products were all developed by the Company and indicative of the encouraging progress HBM has made in overcoming the challenges faced across the competitive landscape. The Company looks forward to continuing this success with promising clinical results as these and other programs move forward in their development lifecycles.

The rapid advancement of HBM's clinical pipeline has continued into 2022, with multiple milestones reported in the first quarter. In February, the fully human monoclonal antibody HBM9378 (or SKB378) generated from the Company's H2L2 platform was approved for an investigational new drug ("IND") clinical trial application for the treatment of moderate to severe asthma; in the same month, HBM7008 (B7H4/4-1BB), the world's first-in-class product from the HBICE bispecific antibody platform, was officially approved by the Independent Review Board (IRB) in Australia and could potentially provide improved efficacy with better safety as compared to traditional monoclonal antibody therapies. The Company expects 4-6 products to enter the clinical stage this year and to rapidly push forward innovative products with blockbuster potential, laying a solid foundation for building a global competitive advantage.

HBM's cutting-edge fully human antibody platforms enable unique innovation and differentiation

HBM's antibody discovery platforms are the engine of its portfolio innovation: HBICE - a fully human bispecific antibody platform for immune cell engagers, a fully human heavy-chain-only antibody HCAb platform for monoclonal antibodies, and a fully human heavy and light chain antibody H2L2 platform with global patent protection. These robust technology platforms drive the Company to continuously advance antibody drug development while move towards more novel and challenging targets to address unmet medical needs, providing the momentum for sustained therapeutics innovation worldwide.

It is worth noting that, in the field of bispecific antibodies development, the Company's fully human HBICE bispecific platform for immune cell engagers, the highly differentiated bispecific antibody technology platform globally, is built upon the fully human HCAb based formats for immune cell engagers, which is also a patented achievement independently developed by the Company. The HBICE platform focuses on immune cell engagers, which can flexibly generate multiple molecular structures adapting to different biological mechanisms of action and effectively solving the problem of heavy and light chain mismatch in antibody engineering. The technology platform connects tumor cells with immune cells, activates immune cells, and kills tumor cells specifically, which can improve the effectiveness of treatment and reduce the risk of cytokine storm, avoiding the toxicity risk of systemic activation. Thus, safety is significantly improved, which is conducive to creating more innovative, differentiated, and safe products.

HBM is actively strengthening globalization presence to empowering its long-term development goals

As innovation and development across the biopharmaceutical industry continues to become more global, the Company is thriving on its three global innovation research centers and four major clinical sites, which reflects the Company's global ambition and continued investment into its R&D capabilities. By integrating R&D centers established in the US, the Netherlands and China, the Company is capable to consolidate leading global scientific and technological innovation resources. By maximizing regional innovation success, resource utilization is improved and translational clinical research results are advanced, accelerating bringing about differentiated innovative therapeutics, facilitating cooperation within the industry for the benefit of patients. At the same time, following the strategy of international research and development, HBM set up with four clinical sites in China, the US, Australia, and Europe to speed up the global development of its self-developed products.

Importantly, innovative solutions shape the global biopharmaceutical industry. The Company is jointly developing the next generation of innovative therapeutics through its proprietary technology platforms and global innovation network; an approach that has been validated by over 50 industry and academia partners with more than 10 products having entered the clinical stage. External collaborations include those with Eli Lilly, AbbVie, Pfizer, BeiGene, Innovent, Dana-Farber Hospital of Harvard Medical School, and Icahn School of Medicine of Mount Sinai Medical System in New York. Our global footprint enables the value proposition the Company's antibody technology platforms, which can be continuously tapped into and increasing the commercial income generating potential of its R&D capabilities.

In addition, the Company previously announced that it will initiate exploration of NK cell and ADC therapeutics. The Company hopes to leverage its novel technology across these frontier therapeutic areas, expand the application of its technology platforms, and lead next drug development programs to address areas of significant unmet clinical needs.

Accelerating clinical development to unlock potential value

As of now, the Company has independently developed more than ten highly differentiated products, two of which are in pivotal clinical phase III trials and are moving towards Biologics License Application (BLA) submission namely Batoclimab (HBM9161), which has obtained the national Breakthrough Therapeutics Designation for myasthenia gravis, and Tanfanercept (HBM9036), the first globally innovative biological drug for dry eye disease in China.

Specifically, Batoclimab is a next generation fully human monoclonal antibody that selectively binds to and inhibits the neonatal crystal fragment receptor (FcRn) and has the potential for breakthrough treatment of various autoimmune diseases. Tanfanercept is the most advanced product candidate currently being developed by the Company for the treatment of moderate-to-severe dry eye disease, which has a bright market potential in the emerging dry eye drug market in China. These two products are highly differentiated and have large potential market opportunities.

As people begin to emerge from the global pandemic, good health is even more in focus now. In the increasingly competitive biopharmaceutical market, innovation is no doubt the core commodity. Harbour BioMed has built a broad moat with its innovation engine and differentiated pipeline, leveraging its unique and robust antibody technology platforms, regional global innovation ecosystem, and accelerated clinical operations of its core products.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

The Company's proprietary antibody technology platforms Harbour Mice generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.

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Company Codes: HongKong:2142

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Harbour BioMed Reports Full Year 2021 Financial Results: Empower Value Creation with Global Innovation Capabilities - BioSpace

Immunology

Measuring blood platelets to understand their role in health and disease | British Society for Immunology – British Society for Immunology |

This is aBSI Regional & Affinity Group Webinarbrought to you by the BSIAberdeen Immunology Group.

The session will be presented by Dr Matthew Linden, Associate Professor of Haematology and Head of the Discipline of Pathology and Laboratory Science at the University of Western Australia, on the topic 'Measuring blood platelets to understand their role in health and disease'.

Platelets are circulating, anuclear fragments in blood formed from bone marrow megakaryocytes. While their role in thrombosis and haemostasis is well established, recent research has demonstrated that complex platelet subsets exist with primary immune function that play significant roles in inflammation, wound repair, host response to infection and tumourigenesis.

In this seminar,Dr Matthew Linden will outline an integrated systems-biology approach to platelet characterisation through transcriptomic, proteomic and phospho-proteomic, flow, image and mass cytometric approaches, in vitro and in vivo functional studies. He will present their data showing the complex platelet-immune interplay in normal healthy development of children and in the elderly, the influence of diet, exercise and common medications, cancer and metastasis, long-term immune changes in response to trauma and a range of thrombo-inflammatory conditions.

This webinar isfree for BSI members.Non-members will be charged 10.Book your place here.

Follow@bsicongress and@AbdnImmunologyon Twitter to stay up to date.

The BSI Regional & Affinity Group webinar series is supported by Miltenyi Biotec.

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Measuring blood platelets to understand their role in health and disease | British Society for Immunology - British Society for Immunology |