Bluejay Therapeutics Presents Positive Preliminary BJT-778 Data from Phase 2 Clinical Trial in Chronic Hepatitis D at EASL 2024 Congress

100% of treated patients in Arm 1 achieved virologic response by Week 28

Most patients also achieved ALT normalization and composite response

BJT-778 was well tolerated across all arms at doses up to 900mg

SAN MATEO, Calif., June 5, 2024 (GLOBE NEWSWIRE) — Bluejay Therapeutics, a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced positive preliminary data from the Phase 2 study of BJT-778, a fully human IgG1 monoclonal antibody that acts against hepatitis B surface antigen (anti-HBsAg mAb), in patients with chronic hepatitis D (CHD). The data were presented in a late-breaking poster at the European Association for the Study of the Liver (EASL) Congress 2024.

In the first test arm, 100% of treated patients achieved a virologic response (at least a 2 log reduction in hepatitis D virus (HDV) RNA or becoming HDV RNA undetectable) by Week 28 while receiving treatment with BJT-778. All subjects had reductions of alanine aminotransferase (ALT) from baseline, including two-thirds of subjects whose ALT became normal, reflecting a beneficial effect on liver inflammation. These results highlight the potential of BJT-778 as a monotherapy treatment for CHD.

“We are pleased to present the first look at the safety and clinical activity of BJT-778, which supports the potential for BJT-778 to address unmet needs for the millions of people in the world living with chronic hepatitis D,” said Dr. Keting Chu, Founder and CEO of Bluejay.

As of May 24, 2024, 31 patients have been enrolled in the Phase 2 portion of the study. Patients in Arm 1 (n=10) are receiving 300 mg of BJT-778 subcutaneously (SC) once weekly for 48 weeks, Arm 2 (n=11) are receiving 600 mg SC once weekly for 12 weeks followed by once every two weeks for 36 weeks, and Arm 3 (n=10) are receiving 900 mg SC every two weeks for 4 weeks followed by once every four weeks for 44 weeks. All patients in Arm 1 have reached at least 24 weeks of treatment. All patients in Arm 2 have reached 12 weeks of treatment, while Arm 3 subject data is currently limited to less than 4 weeks. Endpoints include safety and tolerability, changes from baseline in HDV RNA and ALT levels, and proportion of subjects who achieve virologic response (HDV RNA ≥ 2 logs or HDV RNA undetectable), ALT normalization, and composite response (both virologic response and ALT normalization).

Key Findings

Preliminary Efficacy

  • In Arm 1, all 10 (100%) subjects achieved a virologic response by Week 28. ALT declined from baseline in all patients, including 67% (6/9) who achieved ALT normalization, while one subject had a normal ALT at baseline, which declined. 67% (6/9) achieved the approvable endpoint of composite response (virologic response + ALT normalization). Two others were 1 U/L away from the upper limit of normal. The mean reduction of HDV RNA from baseline at Week 24 was 3.6 logs.
  • In Arm 2, 8/10 (80%) patients achieved a virologic response by Week 12. ALT declined in most subjects, even among the 7 patients whose baseline ALT was within the normal range. Three out of four patients with abnormal ALT at baseline normalized by Week 12.

Preliminary Safety

  • Across all 3 treatment arms, BJT-778 at doses up to 900mg has been well tolerated, with no reported serious or Grade 3/4 adverse events, and no discontinuations due to AEs.

About BJT-778

BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb 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 antiviral immunity and contribute to functional cure for chronic hepatitis B (CHB) when combined with other agents. BJT-778 has received orphan and PRIME designation from EMA based on early results from the Phase 1/2 study in CHD.

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. In addition to BJT-778, Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver targeted transcript inhibitor (BJT-628), with the goal of finding combinations that achieve functional cure. For more information on Bluejay, please visit the company’s website at www.bluejaytx.com.

Contact

bluejay@argotpartners.com

Bluejay Therapeutics Receives Positive Opinion on Orphan Designation from the European Medicines Agency for BJT-778 for the Treatment of Chronic Hepatitis D

SAN MATEO, Calif., May 29, 2024 (GLOBE NEWSWIRE) — Bluejay Therapeutics, a private clinical-stage biopharmaceutical company focused on viral and liver diseases with unmet medical needs, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company’s application for orphan designation for BJT-778 for the treatment of chronic hepatitis D (CHD).

“We are delighted that the EMA has issued a positive opinion for orphan designation for BJT-778. This recognition underscores the urgent need for new treatment options for people living with this devastating chronic infection,” said Keting Chu, Founder and CEO of Bluejay Therapeutics. “We are eager to accelerate the development of BJT-778 and make it available to patients as soon as possible. We look forward to continuing our collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients with CHD.”

In addition to orphan designation, BJT-778 has also been granted Priority Medicines (PRIME) designation by the EMA for the treatment of chronic HDV, an endorsement to the therapy’s potential to address a high unmet need in patients with these serious conditions.

About BJT-778

BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) 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 antiviral immunity and contribute to a functional cure for chronic hepatitis B (CHB). BJT-778’s preclinical safety and efficacy profiles make it an ideal candidate for combination therapies with existing and emerging treatments for CHB and chronic hepatitis D (CHD). BJT-778 is currently being evaluated for the treatment of CHD and as a functional cure for chronic HBV.

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. The Company’s lead program, BJT-778, is a potentially best-in-class fully human IgG1 anti-HBsAg mAb, being developed for both chronic HBV and HDV. Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver-targeted transcript inhibitor (BJT-628), with the goal of achieving higher rates of functional cure. For more information on Bluejay, please visit the company’s website at www.bluejaytx.com.

Contact

bluejay@argotpartners.com

Bluejay Therapeutics Secures $182 Million in Series C Financing to Propel Clinical Pipeline

SAN MATEO, Calif., May 09, 2024 (GLOBE NEWSWIRE) — Bluejay Therapeutics, a leader in the development of novel therapeutics, today announced the successful closure of a $182 million Series C financing round. This capital infusion will accelerate the clinical development of BJT-778, as the treatment for chronic hepatitis D (HDV). The funds will also support the progression of additional promising candidates in Bluejay’s robust pipeline for the treatment for chronic hepatitis B. As previously announced, BJT-778 has received PRIME designation from EMA based on early results from the Phase 1/2 study in HDV.

This financing round was co-led by Frazier Life Sciences and a life science focused institutional investment firm, with significant contributions from both new and existing investors, including RA Capital Management, T. Rowe Price, Wellington Management, Novo Holdings, RiverVest Venture Partners, Octagon Capital, Arkin Bio Ventures, HBM Healthcare Investments and Unicorn Capital.

Following the completion of the Series C financing, Bluejay is excited to welcome New Board Member, Daniel Estes, a General Partner at Frazier, to its Board of Directors.

“We are immensely grateful for the robust support from both new and returning investors, which reflects confidence in our strategy and our team’s ability to deliver on our mission,” said Dr. Keting Chu, Founder and CEO of Bluejay Therapeutics. “This funding not only empowers us to drive our lead assets through critical clinical trials but also enhances our capacity to address significant unmet medical needs in global health.”

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. The Company’s lead program, BJT-778 is a potentially best-in-class fully human IgG1 monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb), being developed for both chronic HBV and HDV. BJT-778 is designed to provide anti-HBV and anti-HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for CHB. Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver targeted transcript inhibitor (BJT-628), with the goal of achieving higher rates of functional cure. For more information on Bluejay, please visit the company’s website at www.bluejaytx.com.

Contact

bluejay@argotpartners.com

Bluejay Announces Receipt of PRIME Designation from European Medicines Agency (EMA) for BJT-778 for the Treatment of Chronic Hepatitis Delta Virus Infection

Currently Enrolling Phase 2 Study of BJT-778 in HDV; Interim Data Expected second half of 2024

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection. BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb that acts as an anti-viral to HDV by neutralizing and facilitating the clearance of HDV virions. The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company’s Phase 1/2 study that included subjects with chronic HDV.

“We are grateful for EMA’s decision to grant PRIME designation to BJT-778 for treatment of chronic HDV, affirming its potential to fulfill the unmet medical need as a new therapeutic option for this severe disease. This will accelerate our development process to provide a well-tolerated and efficacious treatment for patients globally and save lives,” said Keting Chu, Chief Executive Officer at Bluejay. “We eagerly anticipate our continued collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients.”

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. The Company’s lead program, BJT-778 is a potentially best-in-class fully human IgG1 monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb), being developed for both chronic HBV and HDV. BJT-778 is designed to provide anti-HBV and anti-HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for CHB. Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver targeted transcript inhibitor (BJT-628), with the goal of achieving higher rates of functional cure. For more information on Bluejay, please visit the company’s website at www.bluejaytx.com.

Contact

info@bluejaytx.com

Bluejay Therapeutics expands management team and hired Christopher Holterhoff as senior Vice President, head of business development

SAN MATEO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) — Bluejay Therapeutics, Inc. a private clinical stage biopharmaceutical company focused on viral and liver diseases, today announced the appointment of Christopher Holterhoff as Senior Vice President, Head of Business Development. Mr. Holterhoff will lead Bluejay’s business and corporate development function and will play a significant role in Bluejay’s corporate strategy and strategic planning activities. He will be a member of Bluejay’s Executive team, reporting to Keting Chu, Founder and CEO of Bluejay Therapeutics.

“I am delighted to welcome Chris to the senior leadership team at Bluejay”, stated Mrs. Chu. “Chris has an outstanding track record in business & corporate development with both public and private biotech and pharma companies. His business development experience, as well as his strategic aptitude will play a critical role as we execute on our vision of building a leading biotechnology company focused on curative treatments for serious viral and liver diseases.”

“Bluejay is extremely well-positioned with a pipeline of first-in-class or best-in-class treatment options addressing serious and highly prevalent viral and liver diseases where there exists substantial unmet medical need. I am thrilled to join the organization at such a pivotal time in its development, and I look forward to working with Bluejay’s exceptional team and leveraging my experience in business development to advance the company’s promising pipeline toward approval for patients who are in dire need of new treatment options.”

Mr. Holterhoff has nearly two decades of diverse experience encompassing business & corporate development, corporate finance & strategy, and capital markets.

Before joining Bluejay, he served as VP, Business & Corporate development at LEXEO Therapeutics, where he led all business development, strategic transactions and played a significant role in the company’s capital raising activities. Prior to LEXEO, Mr. Holterhoff served as executive director of business development at Amicus Therapeutics where he executed on new strategic business opportunities for Amicus’ gene therapy pipeline, including license agreements, M&A transactions, and R&D collaborations, and led the alliance management function. Earlier in his career, he worked in healthcare investment banking at MTS Health Partners, where he advised public and private biotechnology and pharmaceutical companies on strategic buy and sell side transactions and financings and served as a senior publishing equity research analyst at Oppenheimer & Co. Inc., providing coverage of biotechnology and pharmaceutical companies.

Mr. Holterhoff holds an MBA from Columbia University, MS in Biotechnology from Georgetown University, and BS from Providence College.

Mr. Holterhoff joins a seasoned executive leadership team, including:

Keting Chu, M.D., Ph.D., founder and chief executive officer, was previously a partner at LYFE Capital and venture partner at Apple Tree Partners, and was responsible for venture philanthropy at The Leukemia and Lymphoma Society. Dr. Chu was also the CEO of several companies, including Mission Therapeutics, DigitAB, and BioCubed Corporation. Earlier in her career, she held R&D leadership roles at Five Prime Therapeutics and Chiron Corporation.

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.

Nancy Shulman, M.D., CMO, has over 20 years of clinical development experience including 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®.

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.

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.

Bluejay Therapeutics Advances in Hepatitis B and D Trials: Successfully Completes BJT-778 Phase 1a Study and Begins Phase 1b Trial Enrollment

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.

Bluejay Therapeutics Received Regulatory Clearance to Initiate Clinical Studies of BJT-778 for Treatment of Chronic Hepatitis B and Chronic Hepatitis D

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.

Bluejay Therapeutics Raises $41 Million in Series B Round to Drive Clinical Trials in Chronic Hepatitis

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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Bluejay Therapeutics Announces the Appointment of Nancy Shulman, M.D., as Chief Medical Officer

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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