Category Archives: 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...

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

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

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

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

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 |

Unforgettable: The women that changed Biotech – Euro Weekly News

[from left to right, Ozlem Tureci, Kizzmekia Corbett, Katalin Kariko and Emma Walmsley. Sources: Wikipedia.com, Harvard.com, Britannica.com, fortune.com]

On March 20222, we mentioned Women in History Month celebrating and acknowledging womens contributions to human history. In celebration of this significant month and before it officially comes to an end, we gathered a few women who changed the face of Biotech and led us in the fight against COVID-19:

Ozlem Tureci is the Co-Founder and Chief Medical Officer of BioNTech, a German biotech company that developed the worlds first authorized mRNA vaccine for preventing COVID-19. She led Project Lightspeed, BioNTechs successful and historic project for developing the vaccine, which was completed in less than one year. Tureci and her husband, Ugur Sahin, co-founder and CEO of BioNTech, make an inspiring Power Couple in the pharma industry.

Tureci is a woman of many specialties as she is a physician, Immunologist, cancer researcher, and entrepreneur. Turecis current focus is on cancer research; she led the efforts in the discovery of cancer antigens and the development of individualized as well as off-the-shelf mRNA vaccines. She aims to use personalized approaches to help the patients immune system defend itself against cancer. This is a unique and more effective approach when dealing with cancer treatment methods. In addition to her ongoing research and initiatives, Tureci is a professor at the University Medical Center Mainz and Helmholtz Institute for Translational Oncology Mainz (HI-TRON) for personalized immunotherapy.

Ozlem Tureci is an inspirational business and biotech leader. Her dedication, love of science, motivation, and brilliance contributed to the creation of this list of accomplishments that we are sure will only continue to grow.

Katalin Kariko is a Hungarian American biochemist known as one of the heroes of the development of the Covid-19 vaccine. Her work and development of In Vitro-Transcribed mRNA Therapies laid the groundwork for research for the vaccines developed by the Pfizer-BioNTech partnership with Moderna.

Karikos ideas in mRNA development were considered to be unorthodox for many years and were not always understood or approved by surrounding scientists. Her biggest challenge was to receive the grants necessary to fund her research. Kariko did not give up and through her persistence she prevailed which led her to life-changing discoveries, helping the world conquer the covid-19 pandemic.

Kariko received multiple well-deserved awards as acknowledgment for her breakthroughs and life-changing research. Some of the awards include the Breakthrough Prize in life sciences and Glamour Women of The Year. Many also argue that she deserves a Nobel Peace Prize we definitely agree!

Dr. Kizzmekia Corbett is an American viral immunologist and assistant professor of Immunology and infectious diseases at Harvard University. She played an integral part in the creation and development of Modernas COVID-19 vaccine. Dr. Corbett was appointed to the Vaccine Research Center (VRC) at the NIAID NIH institute and was the scientific lead of the VCRs Covid-19 Team.

Dr. Corbett is now leading her private lab at Harvard University, called the T.H Chan School of Public Healths department of immunology and infectious diseases. In her lab, Dr. Corbett focuses on viral immunology that can assist in pandemic preparedness and the development of universal vaccines.

Dr. Corbett was highlighted in February 2021 in the Times Time100 Next list, under the categoryInnovators. Her passion and humane approaches are disclosed to all. Corbett feels strongly about a family work environment and believes that each person is a crucial and equal part of the system.

Last but not least, Emma Walmsley is the CEO of GlaxoSmithKline (GSK), a British multinational pharmaceutical company, and is considered the first woman ever to run a major pharmaceutical company. GSK collaborated with Sanofi, a French multinational healthcare company, to contribute to the worldwide effort in developing the Covid-19 vaccine.

Since taking over the role of CEO at GSK, Walmsley has led a global reconstruction program that aims to save the company significant amounts of money. The program shifted the companys focus to four main areas of research and development: respiratory, HIV, Oncology, and immune inflammation.

Walmsley presented a courageous and strong approach when joining GSK, not afraid to take charge and shake things up. Thanks to Walmsley, GSK is also one of the prominent Biotech companies to take an open stand against the injustices currently occurring in Ukraine.

These magnificent women didnt fight alone in the war against Covid-19. Many other women, who were not mentioned in this list, contributed to the causes, changing the fields of Science and Biotech as we knew them.

This article is written by Katherine Gray.

Katherine Gray is a Boston-based Journalist who specializes in Health Care. Also active at The Activist Lab, Katherine often deals with topics such as social injustice in the fields of Health and Science.

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Unforgettable: The women that changed Biotech - Euro Weekly News

Dr. Catherine Kibirige develops HIV tests to advance vaccine and cure research – Afro American

By Megan Sayles, AFRO Business Writer, Report for America Corps Member msayles@afrocom

Dr. Catherine Kibirige was a teenager when she decided her career would center on HIV research.

Her parents were natives of Uganda, but she was born in Kenya after they were exiled during the Ugandan Civil War. Eventually, her father got a job in London as an engineer, and he sent for Kibirige and her sister to come join him.

While in secondary school, Kibirige learned that Uganda had been severely hit by HIV and AIDS. The first cases of HIV in Africa were recorded and characterized in the Rakai District, a community in the central region of Uganda.

Wed just come out of a civil war, so it was very devastating. On top of all the issues with the civil war, thered been famine, thered been desolation and then we had HIV, said Kibirige. It really had a huge impact on us as a nation and I lost a lot of close relatives. I knew I wanted to be involved in HIV research.

After college, Kibirige traveled to Uganda to volunteer with the Ministry of Health and work in the Rakai Health Sciences Program, a collaboration between researchers at Makerere, Columbia, Johns Hopkins Universities and the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases.

She was offered a job on a study of HIV, AIDS and related STDs just a few months after she started volunteering. Two years into the position, she was sponsored to come to the United States to obtain her doctorate of philosophy from the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health.

Her first post-doctoral fellowship was with the U.S. Militarys HIV Research Program, which at the time was administering a vaccine trial in Thailand. The trial was using an assay, a lab test used to find and measure the amount of a specific substance, that did not detect all of the circulating HIV subtypes.

Kibirige redeveloped the assay so it would be ultra-sensitive and better cover HIV subtypes and variants.

She then went back to Johns Hopkins University for a second post-doctoral fellowship to further optimize the assays and broaden their utility.

Now, Kibirige is expanding on her work as a research associate at Imperial College London in the Human Immunology Laboratory. She maintains a provisional patent on the assay she developed.

Her hope is to commercialize her assay in Uganda to help Africa move away from donor dependence.

We need to get to the point now where were actually making our own reagents, doing our own vaccine research and not having to import everything. One of the things that really stood out to me when I worked for Rakai is everything is imported, even the paper towels and [cotton] swabs.

In Uganda those with HIV face significant barriers to accessing treatment monitoring, leading to a surge in drug resistance. District hospitals have to send blood samples to the national HIV testing lab in Kampala, the countrys capital. Results can get lost, and even if they dont, they take months to get back to the district hospitals.

Currently, Kibirige is in negotiations to transfer her assays manufacturing process to Uganda. She intends for her assay to be a low-cost, ambient-temperature and prolonged-shelf life alternative to viral load testing.

Shes also in the early stages of establishing a startup that will streamline the process of transporting the assays for use in resource-limited areas in Uganda.

I just want to encourage women- especially women in science and technology- to really pursue their dreams, stick to whatever vision they have and just be open to exploring different kinds of avenues, said Dr. Kibirige.

Never give up.

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Dr. Catherine Kibirige develops HIV tests to advance vaccine and cure research - Afro American

Manitobans ‘living in the dark’ with COVID risk, experts fear – Winnipeg Free Press

Manitobans and their health-care system are vulnerable to a sneak attack from another devastating COVID-19 wave after the province cut back on virus data collection and reporting, experts warn.

The government has ditched weekday updates of its coronavirus dashboard, which contained case counts, the positivity rate, hospitalizations and deaths, in favour of weekly epidemiology reports.

As the government lifted all of its restrictions earlier this month, chief provincial public health officer Dr. Brent Roussin encouraged Manitobans to assess their own personal risk going forward.

But Manitobans are unable to do that without transparency from the government amid limited testing and a lack of contact tracing, said Dr. Julie Lajoie, a research associate working in virology and immunology at the University of Manitoba.

"We are living in the dark in terms of what is happening with COVID in Manitoba," said Lajoie.

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Based on upward trends in Quebec and Ontario and anecdotal evidence, she suspects infections are rising in Manitoba and is expecting a fifth wave to hit the province.

"I think there is no way were not going to see it," she said. "It is coming or it is already on us."

However, it is difficult to know the true scale of COVID in Manitoba and to predict a new wave without reliable data, she said, adding case counts are being underreported because access to PCR tests is limited and rapid test results are not tallied up.

A lag means hospitalization and municipal wastewater data are not as useful, she said.

Wastewater trends up to March 13 were released Monday by the Public Health Agency of Canada. The province insists it cannot release that data because it is "owned, collected and posted by the National Microbiology Lab."

Lajoie said one of the main indicators for Manitoba is whats happening in other provinces. Quebec appears to be heading into a sixth wave, and Ontarios positivity rate has jumped to its highest level since January, when the Omicron variants wave was peaking.

Both provinces reported a decrease in intensive-care admissions Monday.

"We can only rely on whats happening around us," said Lajoie. "We have to take into consideration that thats happening in Manitoba, as well."

Without data that is properly collected and analyzed, it is impossible to identify trends and intervene before it is too late, warned Winnipeg critical-care physician Dr. Doug Eyolfson.

"Its dangerous. The health system cant react to a situation if it doesnt know what the trends are," said Eyolfson, a former Liberal member of Parliament. "The only indicator we have right now is hospitalization rates, and thats a lagging indicator."

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"Its dangerous. The health system cant react to a situation if it doesnt know what the trends are," said Doug Eyolfson.

In a COVID recovery plan published March 15 the day restrictions were lifted Shared Health said it was preparing for a potential increase in virus transmission and hospital admissions.

As of last Thursday, eight of Winnipegs 39 long-term care homes had active COVID outbreaks, the Winnipeg Regional Health Authoritys website stated Monday.

Eyolfson, who works at Grace Hospital, said he is still seeing COVID cases, but the numbers arent as high as they were during the previous wave.

He said the provinces decision to ditch its vaccine mandate for non-essential businesses March 1 and its mask mandate for indoor public places March 15 was "premature."

"Im seeing less and less mask use everywhere I go now," he said." The phrase, living with the virus sounds good to say, but, unfortunately, people are still dying with the virus."

MIKAELA MACKENZIE / FREE PRESS FILES

Health Minister Audrey Gordon defended the governments data collection and reporting methods, insisting the province is providing sufficient information and will provide specific data requested by media.

Health Minister Audrey Gordon defended the governments data collection and reporting methods, insisting the province is providing sufficient information and will provide specific data requested by media.

She said the province continues to see a "downward trend," with eight of 19 intensive-care unit cases "active" as of Monday.

The government is making rapid antigen tests available at public places such as libraries and grocery stores, and people who receive a positive test result should call their physician or Health Links for information, she said.

"I dont think we have misled Manitobans in that we have stated that the new cases are, at times, underreported because individuals who are, like myself, triple-vaccinated, if they test positive their symptoms might be mild," Gordon said while visiting a new ambulance station in Portage la Prairie.

She urged people to stay home if they feel ill.

"What Im hearing is that most of the cases are mild to moderate symptoms and individuals are able to manage those symptoms very safely at home and with the care of their health-care provider," said Gordon.

Manitobas virtual COVID outpatient program has saved "many, many hospital days" by helping people to manage their symptoms at home, she said.

NDP health critic Uzoma Asagwara said Manitobans need access to "clear and transparent public health data" to help them make informed decisions about staying safe.

"With hospitals preparing for a surge in cases and public-health measures removed, right now seems like a bad time to leave families in the dark. The PCs should be sharing more info with Manitobans, not less," said Asagwara.

Liberal Leader Dougald Lamont claims the province hasnt learned from past mistakes.

"Its scary, because the Stefanson PCs actually seem to be going out of their way to be as unprepared as possible, making another wave of COVID more likely," he said. "The new Omicron (subvariant, known as BA.2) is even more infectious than the last. We need easy-to-reach PCR testing across the province, contact tracing, wastewater testing and reporting, daily updates, free masks, and vaccines and boosters need to be readily available for everyone. This would actually blunt the next wave. Instead, were flying blind."

Manitoba can "live with the virus" and avoid shutting down sectors by keeping precautions such as a mask mandate for indoor public places, improved ventilation in schools and daycares, and a mandatory self-isolation period for people who test positive, said Lajoie.

These are things that can help to reduce the spread of the virus, ease pressure on the health-care system and prevent cases of long COVID, she said.

"Its simple action and it will make a really big difference in the long run," she said. "Were all tired of COVID, but COVID is not tired of us. We still need to be careful."

Dr. Nazeem Muhajarine, a community health and epidemiology professor at the University of Saskatchewan, said the governments approach is not a good way to manage the pandemic.

"We are really flying blind these days without regular reporting and detailed reporting of COVID-19 numbers," said Muhajarine. "How could we assess our own risk without data given or shown to us? Its a no-win situation."

Muhajarine is not convinced COVID-19 has become endemic, as hospitalization rates are higher than expected and the more infectious Omicron strain circulates in the community.

Manitobans have been encouraged to get three doses of a COVID vaccine to protect themselves against Omicron and any future variants that are highly contagious.

"(Two) is still good to prevent severe infection, but we know against Omicron that a third dose is really needed," Lajoie said.

As of Monday, 44.7 per cent of eligible Manitobans had received three shots.

So far, only people 12 and older with weakened immune systems are being encouraged to get a fourth dose.

With files from Danielle Da Silva

chris.kitching@freepres.mb.ca

Twitter: @chriskitching

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Manitobans 'living in the dark' with COVID risk, experts fear - Winnipeg Free Press

Why the UK cant rely on boosters to get through each new wave of Covid – The Guardian

This time in 2020, we watched with horror as the realities of the pandemic and its death toll unfurled. Most hardly dared imagine that effective vaccines might appear in a fraction of the time taken for previous efforts, effectively stemming the pandemic tide.

But despite the success of the vaccines in greatly reducing the odds of hospitalisation or death, viral evolution had plenty more to throw at us. The onslaught of highly immune-evasive variants was, for most of us in immunology and virology, unforeseen. Wed come to think of the coronavirus family as being rather more stable less error-prone in terms of mutations than many viruses. And we had never before had to roll out relatively new ways of developing vaccines, involving mRNA or recombinant adenoviruses, at this scale and in the heat of battle.

Having started out brilliantly, the real-life state of play today is self-evidently suboptimal. The vaccines rapidly induce hugely high levels of protective, neutralising antibodies in most people, but these levels wane within months of each sequential dose. Meanwhile, Omicron and the subvariant BA.2 have managed to mutate almost every amino acid residue targeted by protective antibodies, escaping protection. And so you have the unhappy equilibrium currently endured by the UK: more than 300,000 new cases a day, as of late last week, and a continuing caseload of more than 3 million, with hospital admissions and excess deaths holding steady at a new high setpoint. All this despite one of the highest vaccination rates in the world.

We are living in a precarious truce imposed through frequent mRNA boosters to keep the viral caseload manageable. But there are signs this isnt sustainable, and that a strategy simply consisting of boosters in perpetuity may not be fit for purpose. Recent case surges in Hong Kong, Denmark and Scotland emphasise the fragility of that balance. And new evidence from the past two years suggests that encounters with different variants of Covid or different vaccine types can alter the effectiveness of later jabs in surprising ways an effect called immune imprinting. This raises the possibility that booster performance could be even less predictable and effective in the future.

Sars-CoV-2 began as a single variant, which we term the Wuhan strain. But we now inhabit a world where no two people share precisely the same exposure history: we have never been infected, or were asymptomatically, mildly or severely infected during any or a combination of the Wuhan to Alpha, Delta, Omicron or BA.2 waves, and weve all had somewhere from zero to four doses of diverse vaccines. The combination of these exposures gives each of us a unique immune memory repertoire.

Imagine a huge jar of pills of different colours, each especially good for responding to a given present or future variant. Someone whose experience has been an Alpha infection plus three doses of Pfizer may have brilliantly built up lots of green pills at the expense of others. But this is less good for you if the next variant mainly needs yellow pills. It turns out the order and type of exposure can affect how our immune system responds later on.

In a recent paper reported in the journal Science, we compared protective immunity between people infected in the first wave with the original strain and in the second wave with the Alpha variant. In second wave-infected people, encounters with an Alpha infection plus two vaccine doses gave lower protective (known as neutralising) antibody responses against the Wuhan and Beta variant, yet higher responses against Delta. Given the number of vaccines and strains, these interactions are unpredictable, but will shape how our immunity holds for future waves. It needs more investigation.

These are complex problems demanding careful research, long-term planning, trials and even some intelligent crystal ball-gazing. We must evaluate many approaches. Some places have announced a fourth dose rollout for first generation Pfizer vaccines (which cross-neutralises recent variants, but very suboptimally); some vaccine makers have pivoted to targeting the Omicron spike; others are working on polyvalent vaccines to include several different versions of spike, or clever structural approaches to target those parts of spike that would be the same across all past and future variants, and maybe even across those coronaviruses still awaiting crossover from bats and pangolins.

This latter approach is exciting and the subject of recent efforts across many teams, including research trials through the US National Institutes of Health and at Cambridge University. There are also advanced programmes considering intranasal nose vaccination to achieve local mucosal immunity, increasing the chances of blocking transmission at that site altogether, and vaccine platforms that could be much more durable.

The take-home message is that the pandemic is very much with us and evolving dynamically, with a long, bumpy road ahead. The option to sleepwalk through this, taking automatic-pilot choices based on what was good enough in the first wave is one we adopt at our peril. We must look at options besides simply boosting through every successive wave. At a time when the US has cut future vaccine research funding, and the UK also needs to maintain its momentum, this should be an urgent priority.

Danny Altmann is a professor of immunology at Imperial College London, who has contributed advice to the Cabinet Office, APPG on long Covid, and the EU

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Why the UK cant rely on boosters to get through each new wave of Covid - The Guardian