News
Jan 30
2020
Science Magazine Publishes Results from Preclinical Study on the Activity of Menin-MLL Inhibition for the Treatment of NPM1 Acute Myeloid Leukemia
Jan 30
2020
WALTHAM, Mass., Jan. 30, 2020 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Science magazine has published a preclinical report supporting the potential role of MLL1-Menin inhibition in the management of nucleophosmin (NPM1) mutant acute myeloid leukemia (AML). The article, "Therapeutic targeting of preleukemia cells in a mouse model of NPM1 mutant acute myeloid leukemia," will be published in the journal's January 31, 2020 issue and is currently available online.
This study examined the activity of VTP-50469, an orally-available inhibitor of MLL1-Menin interaction and close analog of the Company's lead Menin inhibitor, SNDX-5613, for the treatment of established NPM1 AML and the possible prevention of the disease in high-risk populations. Using preclinical models of NPM1 AML, the authors established that the presence of an NPM1 mutation is a clear indicator of pre-leukemic activity and represents a critical step in the development of AML. VTP-50469 was shown to eradicate NPM1 mutant cells at various stages of disease development, suggesting that Menin-MLL inhibition could potentially serve either as a targeted preventive therapy or as a treatment of established disease.
Jan 13
2020
Verona Pharma Reports Positive Top-line Data in 4 Week Phase 2b COPD Study with Nebulized Ensifentrine on Top of Tiotropium Therapy
Jan 13
2020
LONDON, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces positive top-line data from a 4 week, 416 patient, Phase 2b dose-ranging study evaluating nebulized ensifentrine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or placebo as an add-on treatment to tiotropium (Spiriva® Respimat®), a long acting anti-muscarinic (“LAMA”) bronchodilator, in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”).
The study met its primary endpoint of improved lung function, with ensifentrine added on to inhaled tiotropium, a LAMA commonly used to treat COPD. Ensifentrine produced a clinically and statistically significant, and dose-dependent improvement in peak forced expiratory volume in one second (“FEV1”)1 at week 4 compared to placebo added on to tiotropium.
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Jan 10
2020
Aclaris Therapeutics Announces Positive Results From Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor
Jan 10
2020
WAYNE, Pa., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from ATI-450-PKPD-101, a Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Phase 1 clinical trial of the investigational compound ATI-450. Preliminary data demonstrated that ATI-450:
READ MORE about Aclaris Therapeutics Announces Positive Results From Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor
- resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
- was generally well-tolerated at all doses tested in the trial;
- had dose proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours; and
- had no meaningful food effect or drug-drug interaction (DDI) with methotrexate.
Dec 18
2019
BridgeBio Pharma’s Origin Biosciences Enters Partnership With Medison To Commercialize BBP-870 In Israel For MoCD Type A
Dec 18
2019
BOSTON, December 18, 2019 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences, a company focused on developing and commercializing a treatment for Molybdenum Cofactor Deficiency (MoCD) Type A, and Medison Pharma Ltd., a leading commercial biotech partner that operates in Israel, Canada and Central and Eastern European countries, have entered into an exclusive license agreement under which Medison received rights from Origin to distribute, market, sell and otherwise commercialize Origin’s drug product known as fosdenopterin (BBP-870/ORGN001) in Israel.
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Dec 18
2019
Arcus Biosciences, in Collaboration with Genentech, Announces Two Randomized Clinical Studies to Advance AB928, a Dual Adenosine Receptor Antagonist, into Novel Combinations for Colorectal and Pancreatic Cancers
Dec 18
2019
Collaboration leverages Genentech’s MORPHEUS studies to accelerate development of AB928, a potential best-in-class therapy targeting the adenosine axis to stimulate immune responses against cancer
HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company discovering and developing highly-differentiated therapies, today announced a clinical collaboration with Genentech, a member of the Roche group, for the evaluation of novel combinations with AB928, Arcus’s dual antagonist of adenosine receptors A2aR and A2bR, for colorectal (CRC) and pancreatic (PDAC) cancers. The collaboration will utilize the MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus control groups, in two studies:- Third-line metastatic CRC: two combination arms, (1) AB928 plus atezolizumab (TECENTRIQ®) and regorafenib, and (2) atezolizumab plus regorafenib, will be randomized versus regorafenib monotherapy.
- First-line metastatic PDAC: the combination of AB928 plus atezolizumab and gemcitabine/nab-paclitaxel will be randomized versus gemcitabine/nab-paclitaxel.
Dec 9
2019
ObsEva Announces Positive Results from Uterine Fibroids Phase 3 Study (PRIMROSE 2) of Linzagolix
Dec 9
2019
- Phase 3 trial (PRIMROSE 2) met primary and secondary efficacy endpoints
- 93.9% responder rate for 200 mg with ABT (p < 0.001)
- 56.7% responder rate for 100 mg without ABT (p < 0.001)
- Both doses achieved important clinically relevant secondary endpoints including amenorrhea (p < 0.001), reduction in pain (p < 0.001), improvement in quality of life (p < 0.001) and improvement in hemoglobin levels (p < 0.002)
Dec 5
2019
Sunesis Pharmaceuticals Announces Data from Ongoing Phase 1b/2 Trial of Vecabrutinib in Patients with CLL and Other B-Cell Malignancies
Dec 5
2019
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced data from the Company’s Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.
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Dec 3
2019
Atreca Announces FDA Clearance of Investigational New Drug Application for ATRC-101
Dec 3
2019
REDWOOD CITY, Calif., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on the development of novel cancer therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application. Atreca expects to initiate a first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors in early 2020.
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Dec 3
2019
BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission Of New Drug Application With The U.S. FDA For BBP-870 For The Treatment Of MoCD Type A
Dec 3
2019
BOSTON, December 3, 2019 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.
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Dec 2
2019
PellePharm Completes Enrollment Of Pivotal Phase 3 Clinical Trial Of Patidegib Topical Gel In Patients With Gorlin Syndrome
Dec 2
2019
– Trial rapidly enrolled in 8 months
– Trial size expanded to accommodate 24 more patients than planned
SAN FRANCISCO – December 2, 2019 – PellePharm, Inc., a BridgeBio Pharma, Inc. (Nasdaq: BBIO) company, today announced the completion of enrollment for its pivotal Phase 3 clinical trial of Patidegib Topical Gel 2% vs. vehicle gel in patients with Gorlin Syndrome. PellePharm is a late clinical-stage biopharmaceutical company committed to targeting rare forms of basal cell carcinoma.
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