Cell therapy

Poseida Therapeutics Announces Leadership Transition

Retrieved on: 
Monday, October 9, 2023

SAN DIEGO, Oct. 9, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced the appointment of Mark Gergen as Executive Chairman and the transition of Kristin Yarema, Ph.D., currently President, Cell Therapy, to the role of President and Chief Executive Officer, each expected to be effective January 1, 2024.

Key Points: 
  • "I am proud of the progress Poseida has made since I joined the company almost six years ago.
  • It has been an honor to work with the Poseida team to make significant advances in our capabilities and position," said Mark Gergen, current Chief Executive Officer of Poseida Therapeutics.
  • "With this leadership transition, our goal is to set the Company up for success in its next phase of growth as we continue to redefine cell and gene therapy."
  • A 30-year biotechnology industry veteran, Mr. Gergen joined Poseida in February 2018.

MaxCyte Announces Preliminary Third Quarter 2023 Revenue and Updates Full Year 2023 Revenue Guidance

Retrieved on: 
Wednesday, October 4, 2023

Core business revenue of $6.4 - 6.6 million in the third quarter of 2023, a decrease of 33 - 35% compared to the third quarter of 2022.

Key Points: 
  • Core business revenue of $6.4 - 6.6 million in the third quarter of 2023, a decrease of 33 - 35% compared to the third quarter of 2022.
  • Strategic Partnership License (SPL) Program-related revenue of $1.4 million in the third quarter of 2023, compared to $0.8 million in the third quarter of 2022.
  • MaxCyte will host a conference call today, Wednesday, October 4 at 4:30pm ET to discuss these preliminary revenue results.
  • MaxCyte plans to release final financial results for the third quarter 2023 after the U.S. market close on Wednesday, November 8, 2023.

Bristol Myers Squibb Highlights Advancing Pipeline and Differentiated Research Platforms to Support Long-Term Sustainable Growth at R&D Day

Retrieved on: 
Thursday, September 14, 2023

Bristol Myers Squibb (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to discuss the company’s R&D strategy and capabilities and to provide insight into its robust pipeline supporting long-term sustainable growth.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to discuss the company’s R&D strategy and capabilities and to provide insight into its robust pipeline supporting long-term sustainable growth.
  • “We are further enhancing our R&D engine to strengthen scientific leadership, accelerate our promising pipeline and drive increased productivity.
  • Key pipeline updates for the newly anticipated registrational assets include:
    CD19-directed NEX T cell therapy BMS-986353, expanding into clinical trials for immunologic diseases, including severe, refractory systemic lupus erythematosus.
  • “Our research strategy will enable us to increase the number and quality of potentially transformational early-stage candidates, leveraging our differentiated research platforms, and accelerate the path from proof-of-concept to regulatory approval.”
    R&D Day takes place at 9 a.m.

Didier Landais is appointed 4P-Pharma's CEO to lead the company into a new chapter of its development

Retrieved on: 
Tuesday, September 5, 2023

During the latest strategic board meeting, the appointment of Didier Landais as the new CEO of 4P-Pharma was confirmed.

Key Points: 
  • During the latest strategic board meeting, the appointment of Didier Landais as the new CEO of 4P-Pharma was confirmed.
  • View the full release here: https://www.businesswire.com/news/home/20230905514097/en/
    Founded in 2014 by Revital Rattenbach, 4P-Pharma is entering a new era of its development.
  • On September 1st, 2023, Didier Landais succeeds Revital Rattenbach as CEO of 4P-Pharma.
  • As CEO, Didier Landais holds the responsibility for the company's overall strategy in terms of science, partnerships, and external growth.

U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions

Retrieved on: 
Tuesday, August 29, 2023

These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.

Key Points: 
  • These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.
  • HI-E increase of at least 8 weeks was achieved by 74.1% (n=109) of Reblozyl patients vs. 51.3% (n=79) of epoetin alfa patients (p
  • RBC-TI of at least 12 weeks was achieved by 66.7% (n=98) of Reblozyl patients vs. 46.1% (n=71) of epoetin alfa patients (p=0.0003).
  • Patients treated with Reblozyl demonstrated durable responses with nearly 2.5 years of median RBC-TI ≥12 weeks (126.6 weeks, week 1 to end of treatment).

AGC Biologics Partners with Asahi Kasei Pharma Corporation on Clinical Antibody Project

Retrieved on: 
Tuesday, August 15, 2023

AGC Biologics , a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new agreement with Asahi Kasei Pharma Corporation to produce clinical drug substance for antibody-based therapies at AGC Biologics’ Seattle manufacturing site.

Key Points: 
  • AGC Biologics , a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new agreement with Asahi Kasei Pharma Corporation to produce clinical drug substance for antibody-based therapies at AGC Biologics’ Seattle manufacturing site.
  • Under the agreement, AGC Biologics will leverage its monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei Pharma drug substance.
  • “We look forward to partnering with Asahi Kasei Pharma to help achieve their goals with this important project.”
    AGC Biologics runs multiple mammalian cGMP manufacturing lines at various scales at its Seattle facility.
  • To learn more about AGC Biologics’ biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle .

MiNK Therapeutics Reports Second Quarter 2023 Results

Retrieved on: 
Thursday, August 10, 2023

NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today provided a corporate update and reported financial results for the second quarter 2023.

Key Points: 
  • The trial is planned to be fully externally funded and expected to accrue quickly with an anticipated launch in early 3Q2023.
  • These include responses and durable disease stabilization in patients with gastric cancer, NSCLC, testicular cancer, and beyond.
  • MiNK also plans to advance agenT-797 in patients with viral ARDS through an externally funded platform trial.
  • We ended the second quarter 2023 with a cash balance of $10.6 million as compared to $14.9 million in March 31, 2023, and $19.6 million at December 31, 2022.

Poseida Therapeutics Announces Strategic Investment by Astellas and Provides Business Update

Retrieved on: 
Monday, August 7, 2023

SAN DIEGO, Aug. 7, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced a $50 million strategic investment by Astellas, which is comprised of the purchase of 8,333,333 shares of common stock at $3.00 per share for an aggregate purchase price of $25 million and an additional $25 million one-time payment for certain strategic rights, and provided a business update.

Key Points: 
  • "We are excited to announce a strategic investment by Astellas, a premier global pharmaceutical company that shares our strategic vision for the future of genetic engineering and cell and gene therapies.
  • This investment further validates our technology and approach and also reflects our broad strategic options in progressing the business," said Mark Gergen, Poseida's Chief Executive Officer.
  • "Based on this investment and cost control measures implemented in the business, we are extending our cash runway guidance as we remain focused on being good stewards of capital.
  • "The strategic investment by Astellas, together with our disciplined capital expenditure, cost control initiatives and expected payments and milestones from the Roche collaboration, put us on a firm financial foundation," said Johanna Mylet, Chief Financial Officer of Poseida.

Dr. Laura Salazar-Fontana, Former FDA CMC and Immunogenicity Reviewer, Joins NDA Partners as Expert Consultant

Retrieved on: 
Thursday, July 20, 2023

WASHINGTON, July 20, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Laura Salazar-Fontana, a regulatory science professional with over 15 years of experience in the development of biotherapeutic drugs acquired as FDA regulator, biotechnology regulatory lead, and independent consultant, has joined the firm as an Expert Consultant. Dr. Salazar-Fontana was formerly a CMC and Immunogenicity Reviewer at the US Food and Drug Administration (CDER) and has held multiple leadership roles in large and mid-size pharma companies both as regulator and as translational scientist for immunology and biomarkers. She has extensive experience preparing CMC and immunogenicity regulatory documentation for biotherapeutics, including biosimilars, and cell and gene therapy products.

Key Points: 
  • NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Laura Salazar-Fontana, a regulatory science professional with over 15 years of experience in the development of biotherapeutic drugs, has joined the firm as an Expert Consultant.
  • Dr. Salazar-Fontana was formerly a CMC and Immunogenicity Reviewer in FDA's Center for Drug Evaluation and Research (CDER).
  • She has extensive experience preparing CMC and immunogenicity regulatory documentation for biotherapeutics, including biosimilars, and cell and gene therapy products.
  • We are pleased to welcome Dr. Salazar-Fontana to NDA Partners and to the Biologics Practice."

Significantly Reduce Manufacturing Cost and Increased Local Production: SCG Cell Therapy Opens State-of-the-art Cell Therapy Manufacturing Facility and R&D Centre in Singapore

Retrieved on: 
Wednesday, July 19, 2023

SCG Cell Therapy celebrates the opening of its new Cell Therapy Manufacturing Facility and R&D Centre, launching a new first-of-its-kind automatic cell therapy manufacturing system in Singapore, pioneering Singapore's Manufacturing 2030 Vision.

Key Points: 
  • SCG Cell Therapy celebrates the opening of its new Cell Therapy Manufacturing Facility and R&D Centre, launching a new first-of-its-kind automatic cell therapy manufacturing system in Singapore, pioneering Singapore's Manufacturing 2030 Vision.
  • Facility will substantially increase local production capacity while significantly reducing the cost of cell therapy.
  • In 2021, SCG collaborated with the Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF) to validate its proprietary closed and automated cell therapy manufacturing system.
  • "Apart from the cGMP facility, SCG Cell Therapy is also opening an R&D centre to facilitate the research of its pipeline of cell therapy product candidates.