REDWOOD CITY, Calif., – December 19, 2024 (GLOBENEWSWIRE) – Bluejay Therapeutics, Inc., a clinical-stage biopharmaceutical company rapidly progressing transformative therapies for viral hepatitis and other serious liver diseases, today announced that company Founder and Chief Executive Officer Keting Chu, M.D., Ph.D., will present a corporate overview at the 43^rd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis San Francisco on Monday, January 13, 2025, at 3 p.m. PST. Dr. Chu and her leadership team will also participate in one-on-one investor meetings at the conference.

About Bluejay Therapeutics

Bluejay Therapeutics is a clinical-stage biopharmaceutical company focused on the development of potentially life-changing treatments for viral hepatitis and liver diseases. The company is currently investigating brelovitug (BJT-778) for the treatment of chronic hepatitis D and chronic hepatitis B. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted hepatitis B virus (HBV) transcript inhibitor (BJT-628). For more information on Bluejay Therapeutics, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn.

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SAN MATEO, Calif., – November 21, 2024 (GLOBENEWSWIRE) – Bluejay Therapeutics, a clinical-stage biopharmaceutical company that is rapidly progressing transformative therapies for viral hepatitis and other serious liver diseases, today announced the expansion of its leadership team and board of directors.

This news follows the company’s recent announcement of new data from its Phase 2 study of BJT-778, a best-in-class investigational, fully human, high-affinity monoclonal antibody (mAb) that targets hepatitis B virus surface antigen (anti-HBsAg) as a potential monotherapy for adults with chronic hepatitis D (CHD). Bluejay is advancing BJT-778 into larger, randomized controlled studies.

“The expansion of our management team and board adds financial, commercial and business development leadership as we move quickly to advance our innovative lead asset, BJT-778, into pivotal trials,” said Keting Chu, M.D., Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. “We are building our organization to accelerate the development of BJT-778 and meet the goal of improving patients’ lives.”

The new additions to the Bluejay Therapeutics leadership team include:

• Peter García, Chief Financial Officer, who has more than 30 years of financial executive leadership experience in the biopharmaceutical and technology sectors. Most recently, he served as CFO and corporate secretary of ALX Oncology Holdings Inc., where he led their initial public offering. Prior to that, García served as vice president and CFO at PDL BioPharma, Inc. In addition, he served as CFO of BioTime, Inc. (now Lineage Cell Therapeutics), Marina Biotech, Nanosys, Nuvelo, Novacept, IntraBiotics Pharmaceuticals and Dendreon. García currently serves on the board of directors at Durect Corporation. He holds an MBA from UCLA Anderson School of Management and a bachelor’s degree from Stanford University.

• Melissa Koomey, Chief Commercial Officer, who brings more than 30 years of experience in global biopharmaceutical product commercialization across therapeutic areas, with a focus on product launches, to Bluejay Therapeutics. Koomey spent the past 12 years in leadership positions at Gilead Sciences, most recently serving as head of global commercial operations. Previously, she led Gilead’s $13 billion U.S. HIV Business Unit, was General Manager of Gilead’s operations in Canada, and also led the U.S. sales and marketing team for hepatitis B. She currently serves on the board of directors of Thryv Therapeutics. Koomey previously led commercial teams at FibroGen, Pfizer and Novartis. She holds an MBA from Harvard Business School and a bachelor’s degree from Yale College.

• Roland Gendron, Senior Vice President and Head of Business Development, who brings more than 20 years of biotech and corporate development experience to Bluejay Therapeutics. Most recently, Gendron served as the Head of Oncology Corporate Development at Gilead Sciences, where he was responsible for the leadership and oversight of oncology transactions. Before Gilead, he was Vice President of Business Development at CytomX Therapeutics and before that Senior Director of Corporate Development at Seagen (formerly Seattle Genetics), where he sourced new opportunities and executed corporate initiatives contributing to the company’s growth from a $5 billion to $30 billion global organization. Gendron holds an MBA from the University of California Berkeley and a master’s degree in chemistry from the University of Victoria.

The new additions to the Bluejay Therapeutics Board of Directors include:

• Eric Dobmeier, Lead Independent Director, who is the former President and Chief Executive Officer of Chinook Therapeutics and Silverback Therapeutics. Prior to that, he spent 15 years at Seagen (formerly Seattle Genetics), where he served as Chief Operating Officer. Dobmeier currently serves on the boards for Structure Therapeutics, Janux Therapeutics and several other private biotechnology companies. He is also a venture partner for Samsara BioCapital. Dobmeier holds a J.D. from the University of California Berkeley School of Law and an undergraduate degree from Princeton University.

• Dan Spiegelman, Chair of Audit Committee, who is the former Chief Financial Officer of BioMarin Pharmaceutical and CV Therapeutics, and former Treasurer at Genentech. Spiegelman co-founded Rapidscan Pharma Solutions, which was sold to GE Healthcare. He is also a venture partner for Samsara BioCapital. He currently serves on the board of directors for Kyverna Therapeutics, Spruce Biosciences, vTv Therapeutics, Maze Therapeutics and Tizona Therapeutics. Spiegelman holds an MBA from the Stanford Graduate School of Business and a bachelor’s degree from Stanford University.

About Bluejay Therapeutics

Bluejay Therapeutics is a clinical-stage biopharmaceutical company focused on the development of potentially life-changing treatments for viral hepatitis and liver diseases. The company is currently investigating BJT-778 for the treatment of chronic hepatitis D and chronic hepatitis B. Additionally, Bluejay is advancing several innovative programs with the goal of finding a combination regimen to achieve functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted hepatitis B virus (HBV) transcript inhibitor (BJT-628). For more information on Bluejay, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn.

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Phase 2 study results to be presented at The Liver Meeting® 2024 of AASLD 

BJT-778 900 mg dosed every four weeks showed promising efficacy by Week 24: 100% virologic response with 50% of participants with undetectable HDV RNA (TND) and 75% combined response of virologic response and ALT normalization 

All doses studied were safe and well tolerated with no ≥ grade 3 adverse events (AEs), no severe AEs and no treatment discontinuations due to AEs 

Bluejay will also present data from its chronic hepatitis B functional cure development program, including a preclinical study on improving HBsAg uptake and T cell stimulation of BJT-778 and the preclinical characterization of cavrotolimod, a spherical TLR9 agonist 

SAN MATEO, Calif., – Nov. 15, 2024 (GLOBE NEWSWIRE) – Bluejay Therapeutics, a clinical-stage biopharmaceutical company rapidly progressing transformative therapies for viral hepatitis and other serious liver diseases, today announced new data from its Phase 2 study of BJT-778, a best-in-class investigational, fully human, high-affinity monoclonal antibody (mAb) that targets hepatitis B virus surface antigen (anti-HBsAg). The Phase 2 study is investigating BJT-778 as a potential monotherapy for adults with chronic hepatitis D (CHD). CHD is the most aggressive form of viral hepatitis.  

These data will be presented in detail in an oral presentation on Nov. 18 at The Liver Meeting^® 2024 of the American Association for the Study of Liver Diseases (AASLD). The company will also present data from its chronic hepatitis B (CHB) functional cure development program, including preclinical studies on uptake and T cell stimulation by BJT-778 and the preclinical characterization of cavrotolimod, a spherical TLR9 agonist and potential combination partner for BJT-778. 

“For the more than 12 million patients globally with chronic hepatitis D, the most severe and aggressive form of viral hepatitis, there are limited treatment options,” said presenting author Kosh Agarwal, MD, Consultant Hepatologist and Transplant Physician of the Institute of Liver Studies at King’s College Hospital in London, United Kingdom. “We need to do better for patients. These BJT-778 phase 2 data show that this monotherapy regimen has the potential to be an important treatment advance in CHD.” 

BJT-778 CHD Phase 2 Study Results 

In this phase 2 study, participants with quantifiable hepatitis D virus (HDV) RNA and hepatitis B virus (HBV) suppressed on nucleos(t)ides were assigned to one of three doses of BJT-778: 300 mg weekly (QW) (n=18); 600 mg every week for 12 weeks, then every two weeks (Q2W) (n=11); and 900 mg every four weeks after a loading dose administered at week two (Q4W) (n=18). Patients with compensated cirrhosis and those with well-controlled HIV were allowed.    

Key endpoints of the study include safety and tolerability; virologic response (defined as ≥2 log10 HDV RNA IU/mL reduction from baseline or HDV RNA target not detected [TND]); ALT normalization in those participants with abnormal ALT at baseline; and the combined response of virologic response plus ALT normalization. According to FDA guidance, this combined endpoint is a reliable predictor of clinical benefit and directly supports approval of new drugs in CHD. 

BJT-778 achieved 100% virologic response across all dose arms and up to 78% of participants reached the combined endpoint of virologic response and ALT normalization. These parallel declines in HDV viral load and ALT were observed across all doses, indicating a beneficial effect on liver inflammation as the result of viral load reduction.  

By the last timepoint available for each dose, the results were as follows: 

• 300 mg QW (n=10): By Week 44, this group had 100% virologic response, including 60% with HDV RNA below the Lower Limit of Quantification (<LLOQ [HDV RNA 10 IU/mL]) and 50% with undetectable HDV RNA (<LLOQ, TND); 

• 600 mg Q2W (n=10): By Week 36, had 100% virologic response, including 50% <LLOQ and 40% <LLOQ, TND; and 

• 900 mg Q4W (n=8): By Week 24, had 100% virologic response, including 75% <LLOQ and 50% <LLOQ, TND. 

A favorable safety profile of BJT-778 was observed with all doses being safe and well tolerated. There were no ≥ grade 3 AEs, no severe AEs and no treatment discontinuations due to AEs. 

“BJT-778 has the potential to be both practice-changing for physicians and life-changing for patients,” said Nancy Shulman, MD, Chief Medical Officer of Bluejay Therapeutics. “A monotherapy for HDV with 100% virologic response, high rates of ALT normalization, a strong safety profile and convenient dosing regimens is now achievable. These results support advancing BJT-778 into larger, randomized controlled studies and we plan to commence these studies as soon as possible.” 

Longer-term, 48-week data across all dose arms are expected to be shared in the second half of 2025. 

Chronic Hepatitis B (CHB) Functional Cure Development Program 

As part of its program investigating combination therapy approaches to achieve functional cure of CHB, Bluejay Therapeutics announced data showing that in a preclinical study, BJT-778 significantly increased uptake of hepatitis B surface antigen (HBsAg) compared to control Ab or HBsAg alone. Enhanced uptake of HBsAg resulted in increased HBV-specific CD4 T cell activation, supporting a dual mechanism of action through removal of circulating HBsAg and stimulation of HBV-specific T cell immunity. 

The company also announced preclinical characterization data on cavrotolimod (CAVRO), a spherical TLR9 agonist. These data show that CAVRO selectively activates TLR9 and induces the production of key cytokines in human peripheral blood mononuclear cells, as well as T cells, NK cells and myeloid dendritic cells, indicating a strong cellular immune response which may result in sustained control of hepatitis B infection. In addition, cytokine responses to repeated dosing in non-human primates remained stable over time with no significant fluctuations in pharmacodynamic response. A Phase 1b study has been initiated to evaluate CAVRO in participants with CHB. 

Oral presentation details are as follows:  

  

Title: BJT-778, Anti-HBsAg Monoclonal Antibody, Achieved 100% Virologic Response in Subjects with Chronic Hepatitis D (CHD): Phase 2 Study Results  

Presentation number: 239  

Session: Hepatitis D: Natural History and Treatment   

Date: Monday, Nov. 18  

Time: 6-6:15p.m. PT  

Presenter: Kosh Agarwal, MD, Institute of Liver Studies, King’s College Hospital, London, UK  

  

Poster presentation details are as follows:  

  

Title: Pre-clinical Characterization of Cavrotolimod, a TLR9 Agonist for the Treatment of Chronic Hepatitis B   

Presentation number: 1414  

Session: Hepatitis B  

Date: Friday, Nov. 15  

Time: 1-2p.m. PT  

Presenter: Hilario J. Ramos, PhD, Bluejay Therapeutics  

  

Title: Uptake and T Cell Stimulation by BJT-778-HBsAg Immune Complexes: Insights into Anti-HBs Monoclonal Antibody Function  

Presentation number: 1406  

Session: Hepatitis B  

Date: Friday, Nov. 15  

Time: 1-2p.m. PT  

Presenter: Loghman Salimzadeh, PhD, Schwartz-Reisman Liver Research Centre, University Health Network, Toronto, Ontario, Canada  

About BJT-778 

BJT-778 is a high potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) of the hepatitis B virus. BJT-778 neutralizes and removes hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles, which makes BJT-778 a potentially safe and highly efficacious treatment for CHD, a condition with urgent unmet medical need. In addition, BJT-778 has also shown immunomodulatory functions in CHB patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. BJT-778 has received Orphan and PRIME designation from the European Medicines Agency based on early results from a Phase 1/2 study in CHD. 

About Cavrotolimod 

Cavrotolimod (CAVRO) is a proprietary spherical toll-like receptor 9 (TLR9) agonist oligonucleotide designed to activate both innate and adaptive immune responses. It is being investigated for its potential to enhance antiviral immunity in patients with CHB and improve the functional cure rate as a part of combination regimens. 

About Bluejay Therapeutics 

Bluejay Therapeutics is a clinical-stage biopharmaceutical company focused on the development of potentially life-changing treatments for viral hepatitis and liver diseases. The company is currently investigating BJT-778 for the treatment of CHD and CHB. Additionally, Bluejay is advancing several innovative programs with the goal of finding a combination regimen to achieve functional cure for CHB, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted HBV transcript inhibitor (BJT-628). For more information on Bluejay, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn. 

Contact:

media@orangefiery.com

SAN MATEO, Calif., – October 16, 2024 (BUSINESSWIRE) – Bluejay Therapeutics, a clinical-stage biopharmaceutical company advancing transformative therapies for viral hepatitis and liver diseases, today announced three upcoming presentations highlighting new data from its chronic hepatitis D (CHD) and chronic hepatitis B (CHB) programs at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^®, taking place November 15-19, in San Diego, California. Bluejay will present one oral presentation and two posters.

“Our data presentations at AASLD this year demonstrate our rapid progress toward addressing critical unmet needs for patients with CHD and CHB,” said Keting Chu, MD, Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. “These findings bolster our confidence that BJT-778 has the potential to deliver clinically meaningful benefits and ultimately change patients’ lives.”

Oral presentation details are as follows:

Title: BJT-778, Anti-HBsAg Monoclonal Antibody, Achieved 100% Virologic Response in Subjects with Chronic Hepatitis D (CHD): Phase 2 Study Results

Presentation number: 239

Session: Hepatitis D: Natural History and Treatment

Date: Monday, Nov. 18

Time: 6-6:15p.m. PT

Presenter: Kosh Agarwal, MD, Institute of Liver Studies, King’s College Hospital, London, UK

Poster presentation details are as follows:

Title: Pre-clinical Characterization of Cavrotolimod, a TLR9 Agonist for the Treatment of Chronic Hepatitis B

Presentation number: 1414

Session: Hepatitis B

Date: Friday, Nov. 15

Time: 1-2p.m. PT

Presenter: Hilario J. Ramos, PhD, Bluejay Therapeutics

Title: Uptake and T Cell Stimulation by BJT-778-HBsAg Immune Complexes: Insights into Anti-HBs Monoclonal Antibody Function

Presentation number: 1406

Session: Hepatitis B

Date: Friday, Nov. 15

Time: 1-2p.m. PT

Presenter: Loghman Salimzadeh, PhD, Schwartz-Reisman Liver Research Centre, University Health Network, Toronto, Ontario, Canada

Additional details on the posters and oral presentation will be shared on November 15, 2024.

For more details about The Liver Meeting of AASLD, visit: https://www.aasld.org/the-liver-meeting.

About BJT-778

BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) specifically 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 makes BJT-778 a potentially safe and highly efficacious treatment for CHD, a condition with urgent unmet medical needs. In addition, BJT-778 has also shown immunomodulatory functions in CHB patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. BJT-778 has received orphan and PRIME designation from the European Medicines Agency based on early results from the Phase 1/2 study in CHD.

About cavrotolimod

Cavrotolimod is a proprietary toll-like receptor 9 (TLR9) agonist oligonucleotide designed to activate both innate and adaptive immune responses. It is being investigated for its potential to enhance antiviral immunity in patients with CHB and improve the functional cure rate as a part of combination regimens.

About Bluejay Therapeutics

Bluejay Therapeutics is a clinical-stage biopharmaceutical company focused on the development of potentially life-changing treatments for viral hepatitis and liver diseases. The company is currently investigating BJT-778 for the treatment of CHD and CHB. Additionally, Bluejay is advancing several innovative programs targeting CHB, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted hepatitis B virus (HBV) transcript inhibitor (BJT-628), with the goal of finding a combination regimen that achieves a functional cure for CHB. For more information on Bluejay, please visit the company’s website at www.bluejaytx.com.

Contact

media@orangefiery.com

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

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

Presentations include late-breaking abstract highlighting preliminary results from Phase 2 study of BJT-778 in chronic hepatitis D (CHD)

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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

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

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.