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SAN DIEGO, July 9, 2020 /PRNewswire/ -- Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, today announced the pricing of its initial public offering of 14,000,000 shares of its common stock at a price to the public of $16.00 per share. The gross proceeds to Poseida from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $224.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on July 10, 2020 under the symbol "PSTX". The offering is expected to close on July 14, 2020, subject to satisfaction of customary closing conditions. In addition, Poseida has granted the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the initial public offering price less underwriting discounts and commissions. BofA Securities, Piper Sandler and William Blair are acting as joint book-running managers for the offering.

First patient dosed in AVROBIO’s global Phase 1/2 clinical trial of AVR-RD-02 for Gaucher disease type 1

Second patient dosed in investigator-sponsored Phase 1/2 clinical trial of AVR-RD-04 for cystinosis

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 6, 2020-- AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced that the first patient has been dosed in the company’s GuardOne clinical trial, a Phase 1/2 investigational study evaluating AVR-RD-02 for Gaucher disease type 1. The company also announced that the second patient has been dosed in the ongoing investigator-sponsored Phase 1/2 clinical trial of AVR-RD-04 for cystinosis. “The first patient dosed is an important milestone for the Gaucher disease community and our AVR-RD-02 program. Gaucher disease type 1 leads to an array of serious symptoms and the current standard of care does not halt disease progression,” said Geoff MacKay, AVROBIO’s president and CEO. “With a single dose of our investigational lentiviral gene therapy, we aim to prevent the buildup of a fatty substrate in specialist immune cells called macrophages, as well as debilitating symptoms throughout the body, including the brain.” The company’s Phase 1/2 trial of AVR-RD-02 for Gaucher disease type 1 is currently recruiting patients in Australia and Canada, with new clinical sites expected to open in the U.S. and Israel by year-end.

SAN DIEGO, June 25, 2020 — Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, today announced the closing of a Series D financing round, raising $110 million. The financing was led by funds advised by Fidelity Management Research Company, LLC, with participation  by Adage Capital Management and Schonfeld Strategic Advisors.  A number of current investors also participated in the financing. BofA Securities is acting as sole placement agent for the financing. “This financing supports the approach we are taking to leverage our broad proprietary gene engineering platform technologies, including the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, for the creation of numerous differentiated cell and gene therapy product candidates,” said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. Poseida’s portfolio includes allogeneic and autologous CAR-T product candidates in both hematological and solid tumor oncology indications, as well as liver-directed gene therapy programs in orphan genetic diseases.

— After Two Years of Daily Treatment, More Than 80% of Patients Were Successfully Desensitized to 2000 mg Peanut Protein or Equivalent of About 14 Peanut Kernels—

— Majority of Patients Treated Daily Also Reported Lower Rates of Adverse Events and Showed Higher Rates of Desensitization Compared to Non-Daily Dosing Groups —

BRISBANE, Calif.--(BUSINESS WIRE)--Jun. 8, 2020-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced new two-year data that suggest long-term efficacy of daily treatment with PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp] in patients with peanut allergy. Patients dosed daily in the study also showed ongoing immunomodulation and higher rates of desensitization that increased over time compared to those patients who were administered non-daily dosing. Furthermore, the majority of patients in the daily dosing groups reported lower adverse event (AE) rates compared to those in the non-daily dosing groups, with an overall safety profile of long-term daily dosing with PALFORZIA that was better than non-daily dosing.

SAN DIEGO, May 20, 2020 — Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary non-viral gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, today announced the first patient has been dosed in its Phase 1 clinical trial evaluating P-PSMA-101, its autologous CAR-T therapeutic candidate, in metastatic castration-resistant prostate cancer. The study represents a promising advancement in evolving cell therapies to treat solid tumors. As part of its research, Poseida’s Phase 1 open label, multi-center, dose-escalating trial will include cohorts receiving single and multiple doses of P-PSMA-101, with the goal of determining the best dose with the fewest side effects.

Houston, TX—April 29, 2020—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 that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-401, a multi-tumor-associated antigen (MultiTAA)-specific T cell product for the treatment of patients with acute myeloid leukemia (AML), following allogeneic stem cell transplant.

- Preliminary Phase 1 results represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias -- Data featured in New Drugs on the Horizon oral session at the 2020 AACR Virtual Annual Meeting I -- U.S. FDA grants orphan drug designation to SNDX-5613 for the treatment of adult and pediatric acute myeloid leukemia -

AUSTIN, Texas, April 08, 2020 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing next-generation human enzyme therapeutics as solutions for diseases with high unmet medical need, today announced the approval of its Clinical Trial Application (CTA) by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for ACN00177, a novel engineered human enzyme therapy designed to treat Homocystinuria, a serious metabolic disorder characterized by elevated plasma homocysteine levels, leading to a wide range of life-altering complications and reduced life expectancy.

BRISBANE, Calif.--(BUSINESS WIRE)-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the first patients in the United States are being treated with PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first approved treatment for peanut allergy. Following the release of the medication lots by the U.S. Food and Drug Administration (FDA), specialty pharmacies are shipping PALFORZIA initial dosing kits to allergists for in-office administration to their peanut-allergic patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. “We are pleased that peanut-allergic children are being treated with PALFORZIA just six weeks after its FDA approval. Our anticipation of and preparedness for the REMS program allowed for a swift and smooth implementation of those requirements. In addition, our U.S.-based supply chain remains fully operational and commercial supply is available,” said Jayson Dallas, M.D., President and CEO of Aimmune. “Since our REMS website went live on February 21, well over 600 allergists are certified and ready to prescribe PALFORZIA to their patients. Our field team is continuing to meet with allergists to provide direction and information on the REMS process to help additional physicians and practices become certified and provide training on how to safely incorporate PALFORZIA into their practices.”

— Additional Data Highlight PALISADE Study Patient Baseline Characteristics and Associated Treatment Response — and Improvements in Self-Reported Quality of Life Following Long-Term Treatment with PALFORZIA

— Survey Results Reinforce Immunotherapy Practice Patterns for Food Allergy in Real-World Setting and Daily Impact of Peanut Allergy on Quality of Life Among Patients and Caregivers

BRISBANE, Calif.--(BUSINESS WIRE)-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and bringing new treatments to people with potentially life-threatening food allergies, today announced new data from the clinical development program for PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first peanut allergy treatment approved by the U.S. Food and Drug Administration (FDA). An analysis from ARC004, the open-label follow-on trial to the 52-week PALISADE trial, showed that patients tolerated more peanut protein, experienced fewer adverse events and continued immunomodulation – changes in the body's immune system – as evidenced by reductions in peanut-specific immunoglobulin (IgE) blood levels after an additional 56 weeks of daily treatment with PALFORZIA.