SAN MATEO, Calif., June 1, 2023 — Bluejay Therapeutics, a company dedicated to developing innovative treatments for viral and liver diseases, announces the successful completion of Phase 1a and enrolment of the initial Phase 1b cohorts for BJT-778, a potential best-in-class monoclonal antibody targeting hepatitis B surface antigen.

BJT-778-001 is a double-blind, placebo-controlled single ascending dose study involving healthy volunteers and subjects with chronic hepatitis B (CHB) and chronic hepatitis D infection (CHD). Across all doses tested, BJT-778 demonstrated excellent safety and tolerability in healthy volunteers, with no dose-limiting toxicities observed. “We’re pleased with the ongoing progress of the study, which includes the successful completion of the healthy volunteer phase and the dosing of all subjects in the first cohorts of patients with CHB and CHD,” commented Dr. Nancy Shulman, Chief Medical Officer of Bluejay. “The favorable safety profile of BJT-778 observed thus far is encouraging.” The company plans to dose subsequent cohorts later this month.

“These significant achievements, the completion of the Phase 1a study and the completion of the first cohort’s enrollment in the Phase 1b study, represent critical milestones for Bluejay Therapeutics,” said Dr. Keting Chu, founder and CEO of Bluejay. “We anticipate building on this success as we strive to broaden our portfolio of treatments and cures for viral and liver diseases.”

About Bluejay Therapeutics

Bluejay Therapeutics is a clinical stage private biopharmaceutical company committed to developing effective treatments and cures for viral and liver diseases (www.bluejaytx.com). Its initial target indications are CHB and CHD, diseases that have a global prevalence and an urgent need for improved medical solutions. Bluejay is advancing two potential therapeutic approaches: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and orally liver-targeted HBV transcript inhibitors. The company has developed a platform for liver-directed drug targeting, with potential applications to multiple therapeutic agents. For more information on potential collaborations with Bluejay Therapeutics regarding partnering opportunities or preclinical or clinical research programs, please contact us at info@bluejaytx.com.

SAN MATEO, Calif., Dec. 1, 2022 — Bluejay Therapeutics announced today that it received approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) and from the local Ethics Committee to proceed with a first-in-human study of BJT-778, a best-in-class monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb). BJT-778 neutralizes and clears hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for chronic hepatitis B (CHB). BJT-778’s remarkable preclinical safety and efficacy profiles make it an ideal candidate for combination therapies with existing and emerging therapies for CHB and chronic hepatitis D (CHD). With the commencement of this trial, Bluejay has successfully transitioned into a clinical stage company.

Dr. Nancy Shulman, Chief Medical Officer, said, “We’re excited that BJT-778 will be evaluated in healthy volunteers and in subjects with CHB and CHD. BJT-778 will be tested for safety and clinical efficacy in single ascending dose cohorts, followed by repeated doses in CHB and CHD subjects that will pave the way to evaluate BJT-778 as a part of combination therapies.”

“This is a significant milestone for Bluejay to reach in less than one and a half years since beginning of operations, a true reflection of the capability and expertise of Bluejay team. We look forward to achieving more milestones like this, such as growing the Bluejay product development pipeline for innovative cures and treatments of viral and liver diseases,” said Dr. Keting Chu, founder and CEO of Bluejay Therapeutics.

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatment and cures for viral and liver diseases (www.bluejaytx.com). The company’s first target indications are CHB and CHD. CHB remains a worldwide prevalent disease with urgent unmet medical need. CHD is a disease with high rate of morbidity and mortality like cancer, and no FDA approved therapy in the US. Bluejay is advancing two approaches with the potential for high rates of functional cure: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and orally bioavailable liver-targeted HBV transcript inhibitors. Most recently, Bluejay has developed a platform for liver-directed drug targeting that will be applicable to multiple therapeutic agents. To learn more about the potential to collaborate with Bluejay Therapeutics on partnering opportunities, preclinical or clinical research programs, please contact us at info@bluejaytx.com.

SAN MATEO, Calif., Aug. 16, 2022 (GLOBE NEWSWIRE) — Bluejay Therapeutics announced today that it has closed a $41 million Series B round of finance led by Arkin Bio Ventures. This round includes participation from other new and existing investors including Synergenics LLC, RiverVest Venture Partners, Yonjin Capital, Octagon Capital and InnoPinnacle International.

Bluejay Therapeutic is a virology and liver disease-based company with two advanced preclinical programs that are focused on the reduction of HBsAg load and the reconstitution of antiviral immunity aiming to achieve a functional cure for chronic HBV infection (CHBV).

Funding from this round will support the clinical development of the lead program, BJT-778, a human anti-HBsAg monoclonal antibody, to demonstrate proof-of-concept in CHBV patients. It will also fund development of BJT-574, an orally bioavailable small molecule HBsAg inhibitor, into first-in-human clinical trials.

Within the last year, Bluejay has achieved a number of significant milestones including the initiation of the IND-enabling studies for the lead asset BJT-778. In addition, Bluejay strengthened its leadership by recruiting Dr. Nancy Shulman as Chief Medical Officer and further bolstered the clinical team with Carole Ann Moore and Dr. Simon Ducher as the heads of clinical operation and regulatory affairs, respectively.

With the completion of the Series B financing, Bluejay is welcoming Dr. William J. Rutter, the Chairman and CEO of Synergenics LLC, Dr. Alon Lazarus, Investment Manager at Arkin Bio Ventures and Dr. Ting Jia, founder and chief investment officer at Octagon Capital, to its board of directors.

“Bill and Alon’s extensive experience across therapeutic areas will be invaluable to Bluejay at this time of growth for our company. We are very excited to have them on the team,” said Dr. Keting Chu, Founder, Chairman of the Board and CEO of Bluejay Therapeutics.

“In light of the recent developments and the exciting data in the field of HBV, we believe Bluejay is well positioned to contribute significantly in the pursuit of regimens that will generate functional cures in CHBV patients. We look forward to generating clinical data soon and are excited to support Bluejay’s excellent team.” Said Dr. Alon Lazarus, Investment Manager at Arkin Bio Ventures.

“RiverVest looks forward to continuing our support of Keting’s fantastic team at Bluejay as we enter the clinic in an area of high unmet medical need. We welcome the expertise and thoughtfulness of our new Board members as we reach important clinical milestones,” said Dr. Nancy Hong, Managing Director at RiverVest.

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SAN MATEO, Calif., Feb. 02, 2022 (GLOBE NEWSWIRE) — Bluejay Therapeutics, a private biopharmaceutical company focused on the development of innovative cures for infectious diseases, today announced that Nancy Shulman, M.D., joined Bluejay as chief medical officer, bringing over 20 years of clinical development experience with her to Bluejay Therapeutics.

“Nancy is an experienced infectious disease clinician and expert clinical drug developer with successful track record in drug development including antivirals in both large pharmaceutical companies and startup biotech companies, and I am pleased to welcome her to the executive team,” said Keting Chu, M.D., Ph.D., founder and chief executive officer of Bluejay. “We will undoubtedly benefit from her prior experience leading the strategy and execution of both clinical research and clinical development across AbbVie’s infectious disease portfolio, as well as her experience advancing antivirals at Genentech/Roche.”

Prior to Bluejay, Dr. Shulman worked at Roche, Genentech, AbbVie, and most recently at Ambys Medicines, where she was the vice president of translational medicine. She brings broad clinical development experience ranging from first-in-human and translational studies through Phase 4 studies, including extensive experience in the virology/hepatology disease area, but also in immunology and oncology. She has been a part of multiple INDs and was a key leader on the NDA approvals of the HCV antivirals Viekira Pak^®, Viekirax^®, and Mavyret^®.

Prior to joining industry, Nancy was an NIH-funded clinical/translational HIV researcher at Stanford University and was on the faculty in the Division of Infectious Diseases. She holds a B.A. in Biochemistry with a minor in Chinese from the University of Texas at Austin and an M.D. from the University of Kansas. She completed her residency in internal medicine and pediatrics at the University of Chicago and her infectious disease fellowship at Stanford.

Dr. Shulman added, “I have dedicated a significant part of my career to the treatment of infectious diseases, working on numerous agents for chronic viral infections, as well as evaluating a number of strategic pipeline expansion opportunities for large biotech and pharma. I was excited to learn of the HBV therapeutics being developed at Bluejay with first- or best-in-class therapeutic potential, and I am eager to bring effective treatments to the patients in need.”

Dr. Shulman joins a seasoned executive leadership team, including:

• Hassan Javanbakht, Ph.D., chief scientific officer, was previously at Hoffman La-Roche, Gilead sciences and SQZ biotechnologies where he worked on developing novel antivirals and immunomodulators to treat HIV, HBV, influenza and other infectious diseases. He was part of the team that advanced Elipida^® (RO4970335), a potent and highly selective NNRTI, into clinical development . He led the teams that developed a first-in-class small-molecule viral expression inhibitor (RG7834) and a liver-targeted anti-HBV locked nucleic acid (RG6004). His work also led to discovery of PAPD5/7 as host factors for HBV expression. He has authored more than 45 peer-reviewed scientific publications in high-impact journals and holds more than 11 issued patents and applications.
• Kevin Lin, M.D., vice president of development, has over 30 years of experience in the biotechnology industry in the areas of process development, technology transfer, scale up, troubleshooting, GMP manufacturing, and CMC regulatory submission. He has worked at several biotech companies, such as Bayer Healthcare, Catalant, Avid Bioservices, ImmunityBio, and Kindred Biosciences.
• Jeff Zablocki, Ph.D., vice president of chemistry, has led chemistry teams at AbbVie, Gilead, CV Therapeutics, Amgen, and Searle. Dr. Zablocki has discovered 15 development compounds including 3 approved agents: Lexiscan™ – an adenosine A2A agonist used in over 60 million patients as a pharmacological stress agent capturing a large market share; Ranexa™ for stable angina; and Voxilaprevir™ for Hepatitis C where he helped address pre-clinical metabolism challenges by applying novel medicinal chemistry approaches.

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Bluejay Therapeutics will present in the 2nd annual Global IR @ JPM (Jan. 19-20 EST).

Bluejay Therapeutics’ presentation would be delivered live, via Zoom, as part of our Day 2 Global Biotech track (7:30-9:30 p.m. EST on Jan. 20).

Since 1993, BioCentury Inc. has been internationally recognized as the leading provider of value-added information, analysis and data for biotechnology and pharmaceutical companies, investors, academia and government on the strategic issues essential to the formation, development and sustainability of life science ventures. Register

SAN MATEO, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) — BlueJay Therapeutics, a private biopharmaceutical company focused on cures for infectious diseases, today announced that chairman and chief executive officer, Dr. Keting Chu, M.D., Ph.D., will present at the 2^nd Global IR @ JPM Conference on Thursday, January 20, 2022 in the biotech track to be held 7:30 – 9:30 p.m. ET.

Dr. Chu will provide an overview of the company, including BlueJay’s two therapeutic approaches with potential high rate of functional cure for HBV infections — its best-in-class anti-HBsAg monoclonal antibody approach and novel, first-in-class HBsAg inhibitor program — its preeminent management team with a proven track record in anti-infectives, strong patent position and backing by top healthcare investors.

To access the live webcast, please visit https://www.eventbrite.com/e/2022-global-ir-jpm-virtual-demo-day-tickets-220953005387.

About BlueJay Therapeutics
BlueJay Therapeutics is a private biopharmaceutical company focused on cures for infectious diseases. The company’s first target indication is chronic Hepatitis B, which remains a worldwide prevalent disease with urgent unmet medical need. BlueJay is advancing two innovative approaches with the potential for high rate of functional cure: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and first-in-class HBsAg oral small molecule inhibitors. The company believes that by reducing hepatitis B surface antigen and restoring adaptive immunity a functional cure could be achieved for patients. For more information on BlueJay, please visit the company’s website at www.bluejaytx.com.

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Basel, Switzerland, 17 November 2021 – BlueJay, a developer of innovative therapeutics for functional cures of chronic hepatitis B virus (HBV) infection, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, have entered a manufacturing agreement for BJT-778, one of BlueJay’s lead candidates. This monoclonal antibody (mAb), targeting the HBV surface antigen (HBsAg), is currently under preclinical development for the restoration of patient’s adaptive immunity and functional cure for chronic HBV infection.    

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Bluejay is applying a combination of therapies in-licensed from Novartis with an aim to cure chronic HBV by reducing viral surface antigen in both the liver and blood.

Founder, Chairman and CEO Keting Chu said she had been interested in building a company around HBV assets from Novartis AG (NYSE:NVS; SIX:NOVN) after the pharma exited infectious disease in 2018. A Novartis alum herself, Chu met Novartis Institutes for BioMedical Research’s Jennifer Leeds at a California Life Sciences Institute meeting a few years ago; the connection set the stage for an in-licensing deal. Leeds is executive director and head of BD&L search and evaluation, West Coast and Canada.

Chu said she believed in the assets, knowing that NIBR’s Donald Ganem was involved in their discovery and early development. Ganem, who was VP and head of global infectious diseases research at NIBR in 2011-18, is a professor emeritus of microbiology and immunology at University of California San Francisco, where Chu attended graduate school.

Chu launched Bluejay Therapeutics Inc. in 2019 with exclusive global rights to three of the pharma’s therapies: BJT-778, a mAb against HBV surface antigen (HBsAg); BJT-574, a small molecule HBsAg inhibitor; and a small molecule capsid inhibitor.

Most recently a Lyfe Capital partner, Chu has led multiple start-ups in addition to holding research and executive roles at The Leukemia & Lymphoma Society, Five Prime Therapeutics Inc., Chiron Corp. and Novartis.    

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