News

NEW YORK, NY – December 15, 2021 — Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme. NUV-422 received Orphan Drug Designation for the treatment of patients with malignant gliomas from the FDA in the first quarter of 2021.

MENDHAM, NJ and WARMINSTER, PA –  December 14, 2021 – Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor.

The multi-center, double-blind, combination clinical trial plans to enroll 40 patients including a cohort of 10 patients with chronic HBV infection assigned 8:2 to active drugs (ATI-2173+AB-729) or matching placebos. The active drugs (ATI-2173+AB-729) or placebos will be administered in combination with 300 mg of tenofovir disoproxil fumarate. ATI-2173 and tenofovir disoproxil fumarate will be administered orally and by injections once daily for 90 days. AB-729 will be administered by subcutaneous injection at Day 28 and Day 90. Following this 90-day treatment period, patients will be followed-up for safety and sustained antiviral responses for six additional months.

MENDHAM, NJ and WARMINSTER, PA – December 14, 2021 – Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor.

NEW YORK, NY – Dec. 13, 2021 — Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of prostate cancer. The FDA accepted the Company’s first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM), and a second IND for the treatment of advanced breast cancer in December 2021.

WALTHAM, MA – December 11, 2021 — Syndax Pharmaceuticals, Inc. (“Syndax,” the “Company” or “we”) (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated positive data from its Phase 1/2 trial of axatilimab in patients with recurrent or refractory chronic graft-versus-host disease (cGVHD) despite two or more prior lines of therapy. Axatilimab is the Company’s anti-CSF-1R monoclonal antibody. The data are being featured during an oral session at the 63rd American Society of Hematology (ASH) Annual Meeting on Saturday, December 11, 2021 at 3:05 p.m. ET.

“There exists an urgent need for novel and effective therapies in patients with cGVHD,” said Michael Meyers, M.D, M.P.H., Chief Medical Officer of Syndax. “The broad activity and tolerability observed underscores axatilimab’s potential to play a meaningful role in the cGVHD treatment landscape, and further supports the importance of the ongoing AGAVE-201 trial.”

WALTHAM, MA – December 09, 2021 —  Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced today that the Hart-Scott-Rodino (HSR) antitrust waiting period had expired and that the parties closed the exclusive worldwide collaboration and license agreement between Syndax and Incyte to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody.

In connection with closing, Incyte paid Syndax the $117 million upfront initial license fee, and Syndax closed on Incyte’s $35 million equity investment in the company.

NEW YORK, NY – Dec. 8, 2021– Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast cancer. The FDA accepted the Company’s first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM). The Company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). The Company is continuing to enroll patients in the Phase 1 dose escalation portion of the study.

AUSTIN, TX – December 6, 2020 — Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that the pivotal Phase 3 study, PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), met the primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p <0.0001). Importantly, pronounced and sustained plasma arginine reduction was accompanied by a positive trend in Gross Motor Function Measure Part E (GMFM-E), a key clinical assessment of a patient’s mobility, including the ability to walk, run and jump.

DUARTE, CA – Dec. 01, 2021 — Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, today announced the enrollment of the first baby into a Japan-based clinical trial evaluating growth and safety associated with an Exclusive Human Milk Diet including Prolacta’s 100% human milk-based fortifiers (Prolacta’s EHMD).

The Japan-based study — “JASMINE: A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants” — began in October 2021. In Japan, Prolacta’s human milk-based products will be registered as a drug.

BOSTON, MA and LOUISVILLE, KY – November 30, 2021 – Talaris Therapeutics, Inc., (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the initiation of the company’s Phase 2 FREEDOM-3 trial in diffuse cutaneous systemic sclerosis (dcSSc), a severe form of the rare autoimmune disease scleroderma. This trial will explore the safety of the company’s investigational allogeneic cell therapy, FCR001, delivered with non-myeloablative conditioning, in these patients, as well as its potential to halt the progression of organ damage or induce clinical remission in individuals with dcSSc. The University of Michigan is the first FREEDOM-3 clinical site to be activated and has now begun screening for eligible patients. Additional sites are expected to be activated in 2022.