News

Feb 28 2022

Nuvation Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

Feb 28 2022

NEW YORK, NY – February 28, 2022 – 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 reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a business update.“In 2021, the Nuvation Bio team made significant progress for our lead cyclin-dependent kinase 2/4/6 inhibitor program in the clinic. NUV-422 received FDA Fast Track Designation for the treatment of high-grade gliomas, including glioblastoma multiforme, and clearance of two IND applications for the treatment of advanced breast cancer and prostate cancer,” said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. “We are well positioned to build upon this momentum in 2022 and expect to achieve additional milestones across our broad pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers. We look forward to sharing clinical development updates this year.”

READ MORE

Feb 23 2022

Poseida Therapeutics Hosts Second Annual Virtual R&D Day Highlighting Novel Pipeline Assets and Latest Technology Innovations

Feb 23 2022

SAN DIEGO, CA – February 23, 2022 — Poseida Therapeutics, Inc. (NASDAQ: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today beginning at 10:00am ET / 7:00am PT.

“R&D Day is a time for us to showcase not only our progress in the clinic but our redefining work in cell and gene therapy using our proprietary genetic engineering technologies in new and innovative ways,” said Eric Ostertag, M.D., Ph.D., Executive Chairman of Poseida Therapeutics. “Today we are excited to share new data demonstrating the promise of our platforms. For the first time, we will highlight our capabilities in site-specific transposon-based DNA delivery, which is a technology that could revolutionize gene therapy by allowing insertion of large therapeutic transgenes into potentially any site in nearly any cell type or tissue.”

Presentations will cover updates on both platforms and product candidates and will be delivered by the Company’s executive leadership, scientists, clinical team members, and key opinion leaders including Scientific Advisory Board member Dr. Luca Gattinoni, Director of the Division of Functional Immune Cell Modulation at the Leibniz Institute for Immunotherapy, whose research focuses on T-cell-based immunotherapies with an emphasis on T-cell differentiation; and Dr. Susan Slovin, the Associate Vice Chair, Academic Administration, Department of Medicine at Memorial Sloan Kettering, an oncologist with expertise in prostate cancer, clinical immunology, and other genitourinary malignancies and a clinical investigator on Poseida’ s P-PSMA-101 clinical trial.

READ MORE

Feb 16 2022

MARKER THERAPEUTICS ANNOUNCES CLINICAL PROGRAM UPDATES AND PIPELINE EXPANSION

Feb 16 2022

HOUSTON, TX – February, 16, 2022 — Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced an update on the Company’s clinical programs, manufacturing processes and pipeline.

READ MORE

Feb 14 2022

CIDARA THERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF ITS INVESTIGATIONAL NEW DRUG APPLICATION FOR CD388 FOR UNIVERSAL PREVENTION AND TREATMENT OF INFLUENZA

Feb 14 2022

SAN DIEGO, CA – February 14, 2022 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for its lead flu drug-Fc conjugate (DFC), CD388 – a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and treatment of seasonal and pandemic influenza. Cidara intends to initiate a Phase 1 study in healthy volunteers before the end of the current quarter.

READ MORE

Feb 10 2022

ObsEva Enters into Licensing Agreement with Theramex for the Commercialization of Linzagolix

Feb 10 2022

GENEVA, Switzerland – February 10, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced a strategic licensing agreement with Theramex, a leading global pharmaceutical company specializing in women’s health, to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia.

READ MORE

Feb 9 2022

AVROBIO Reports Interim Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Cystinosis

Feb 9 2022

CAMBRIDGE, MA – February 9, 2022 — AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today reported interim data from a collaborator-sponsored, ongoing Phase 1/2 clinical triali of AVR-RD-04, an investigational gene therapy for cystinosis, at the 18th Annual WORLDSymposium™ in San Diego.

The first three patients infused with AVR-RD-04 remain off oral cysteamine, with follow up durations ranging between 12- and 26-months post-gene therapy infusion. Sustained engraftment has been observed in each of these patients, as demonstrated by stable vector copy number (VCN) levels. A fourth patient was infused in November 2021. No adverse events related to the drug product have been reported in the four patients infused to date.

READ MORE

Feb 8 2022

Zosano Pharma Announces Pricing of $15.4 Million Public Offering of Common Stock and Warrants

Feb 8 2022

FREMONT, CA- February 08, 2022 — Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 51,250,000 units, each consisting of one share of common stock and one warrant to purchase one share of common stock, at a public offering price of $0.30 per unit. The warrants have an exercise price of $0.30 per share, are immediately exercisable and will expire five years from the date of issuance. Zosano has granted the underwriter a 30-day option to purchase up to an additional 7,687,500 shares of common stock and/or additional warrants to purchase up to 7,687,500 shares of common stock.

READ MORE

Feb 1 2022

AVROBIO Announces the Appointment of Sean O’Bryan as Chief Regulatory Officer

Feb 1 2022

CAMBRIDGE, MA – February 1, 2022 — AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today announced the appointment of Sean O’Bryan as chief regulatory officer. Sean brings a wealth of experience in regulatory strategy and product development to AVROBIO, as well as keen insight into the field of cell and gene therapy, where he has spent most of his career.

READ MORE

Jan 31 2022

Viracta Therapeutics Announces First Patient Dosed in Phase 1b/2 Trial of Nana-val in Patients with Advanced Epstein-Barr Virus-Positive Solid Tumors

Jan 31 2022

SAN DIEGO, CA – January 31, 2022 — Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the first patient has been dosed in the multinational Phase 1b/2 trial of its all-oral combination product, Nana-val (nanatinostat and valganciclovir), in patients with Epstein-Barr virus-positive (EBV+) recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) and other advanced EBV+ solid tumors. The trial is designed to evaluate the safety and preliminary efficacy of Nana-val alone and in combination with the PD-1 inhibitor pembrolizumab.

READ MORE

Jan 27 2022

BridgeBio Pharma Announces Dosing of First Patient in Phase 1/2 Trial of Investigational Gene Therapy for Congenital Adrenal Hyperplasia (CAH)

Jan 27 2022

PALO ALTO, CA – January 27, 2022 — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first patient has been dosed in ADventure, its Phase 1/2 clinical trial of BBP-631, an investigational adeno-associated virus (AAV) 5 gene therapy for the treatment of classic congenital adrenal hyperplasia (CAH). CAH is one of the most prevalent genetic diseases, with more than 75,000 cases estimated in the United States and European Union.

READ MORE