Monoclonal antibody

Phanes Therapeutics' PT217 granted Fast Track Designation by the FDA

Retrieved on: 
Monday, April 8, 2024
Diagnosis, Survival, Carcinoma, Monoclonal antibody, Patient, SAN, Lung, Fast Track, Cancer, CD47, DLL3, Therapy, Safety, Pharmacokinetics, Platinum, FDA, SCLC, Food, Pharmaceutical industry

SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

Key Points: 
  • SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.
  • PT217 was also granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022.
  • "PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC and EP-NECs in various settings," said Ming Wang, Founder and CEO of Phanes Therapeutics.
  • Last month, PT886 was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.

PanTher Therapeutics Announces Appointment of John Edwards as Executive Chair of the Board of Directors

Retrieved on: 
Friday, April 5, 2024
Oncology, Medical Devices, Health, Surgery, Clinical Trials, Biotechnology, Boston University, Toxicity, Hematology, Genetics, Executive, Monoclonal antibody, Shire (pharmaceutical company), Merck, Acquisition, BMS, Cancer, University, Doctor of Philosophy, Panther, MBA, Marketing, Neoplasm, Therapy, Chemical engineering, Genetics Institute, F-star, FDA, Pharmaceutical industry

PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company developing high-dose, long lasting, localized treatments for cancer, announced that John Edwards has been appointed as the Executive Chair of the Board of Directors.

Key Points: 
  • PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company developing high-dose, long lasting, localized treatments for cancer, announced that John Edwards has been appointed as the Executive Chair of the Board of Directors.
  • “John has been an outstanding addition to our Board and management team since joining the company in September.
  • His experience includes involvement with ten FDA approved biologics and eight biotech companies with successful exits, including Tilos Therapeutics, Siamab, Adnexus, F-star and Genetics Institute.
  • During his time as Executive Chair at Tilos, he helped the company from founding to acquisition by Merck in just two years.

Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029: Pioneering New Drug Class with Versatile Therapeutic Potential - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 14, 2024
Other Health, Health, Science, Pharmaceutical, Research, Multiple myeloma, Toxicity, Antigen, Haemophilia A, Cell, Autoimmunity, Patent, Carcinoma, Risk, Inflammation, Haemophilia, Malignancy, Monoclonal antibody, Neoplasm, Tissue, Patient, Tumor microenvironment, Antibody, Cancer, Bladder cancer, Leukemia, Diabetic retinopathy, Indication, Cytokine, Immune system, Therapy, Infection, Priority, Physician, Engineering, Escape Room, Acute lymphoblastic leukemia, Vaccine

The "Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029" report has been added to ResearchAndMarkets.com's offering.
  • Bispecific antibodies are engineered proteins intended to simultaneously bind two different antigens, typically found on distinct cell types.
  • Therefore, bispecific antibodies have demonstrated enough clinical success to validate their potential as a major new drug class.
  • Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029 Report Highlights:
    Bispecific Antibodies Development Proprietary Platforms Insight: > 30 Platforms
    Global Bispecific Antibodies Market Size 2023: > USD 8 Billion
    Clinical & Commercial Insight on Approved Bispecific Antibodies: 12 Antibodies
    Global Bispecific Antibodies Clinical Trials by Company, Indication & Phase: > 800 Antibodies
    FDA & EMA Fast Track Approval, Orphan Designation, Priority Status Insights

Selvita launches biologic drug discovery and development services

Retrieved on: 
Monday, March 18, 2024
SLV, Monoclonal antibody, Isotype, Engineering, Doctor of Philosophy

KRAKOW, Poland, March 18, 2024 /PRNewswire/ -- Selvita S.A. [WSE: SLV] announced today a strategic initiative to significantly expand its services portfolio and enter the field of biologic drug discovery and development, by adding comprehensive therapeutic antibody discovery and development capabilities to its portfolio.

Key Points: 
  • KRAKOW, Poland, March 18, 2024 /PRNewswire/ -- Selvita S.A. [WSE: SLV] announced today a strategic initiative to significantly expand its services portfolio and enter the field of biologic drug discovery and development, by adding comprehensive therapeutic antibody discovery and development capabilities to its portfolio.
  • The company will employ a highly proficient team of experts specializing in the discovery and development of therapeutic antibodies and rent fully equipped state-of-the-art laboratories.
  • Antibody discovery and development form the cornerstone of our expansion into a comprehensive suite of services for biologics drug discovery and development.
  • By venturing into this new field, Selvita is poised to augment its existing portfolio of services in small molecules' discovery and development.

EQS-News: Rentschler Biopharma contributes to nearly 25% of FDA approved biopharmaceuticals in 2023

Retrieved on: 
Wednesday, March 13, 2024
Therapy, Senior, Caregiver, DCAT, SVP, FDA, Technology transfer, Food, Business development, CDMO, CDER, Monoclonal antibody, Patient, Cancer

Laupheim, Germany, Milford (MA), USA, and Stevenage, UK, March 6, 2024 – In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.

Key Points: 
  • Laupheim, Germany, Milford (MA), USA, and Stevenage, UK, March 6, 2024 – In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.
  • Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.
  • For the four newly approved products, Rentschler Biopharma provided support with integrated capabilities, including consulting, regulatory services, process development, technology transfer and manufacturing.
  • Benedikt von Braunmühl, CEO of Rentschler Biopharma, said: “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide.

Rentschler Biopharma contributes to nearly 25% of FDA approved biopharmaceuticals in 2023

Retrieved on: 
Wednesday, March 6, 2024
Therapy, Senior, Caregiver, DCAT, SVP, FDA, Food, Technology transfer, Business development, CDMO, CDER, Monoclonal antibody, Patient, Cancer

and STEVENAGE, United Kingdom, March 06, 2024 (GLOBE NEWSWIRE) -- In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.

Key Points: 
  • and STEVENAGE, United Kingdom, March 06, 2024 (GLOBE NEWSWIRE) -- In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals.
  • Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.
  • For the four newly approved products, Rentschler Biopharma provided support with integrated capabilities, including consulting, regulatory services, process development, technology transfer and manufacturing.
  • Benedikt von Braunmühl, CEO of Rentschler Biopharma, said: “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide.

EpimAb Biotherapeutics to Present Late-breaking Abstract on Preclinical Results of EMB-07 at the 2024 American Association for Cancer Research Annual Meeting

Retrieved on: 
Wednesday, March 6, 2024
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Safety, Monoclonal antibody, AACR, TCE, Patient, Vaccine

EpimAb Biotherapeutics, a global clinical stage biotechnology company specializing in the development of bispecific antibodies, is pleased to announce the acceptance of a late-breaking abstract featuring our novel T-cell engager (TCE) EMB-07 as a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California between April 5-10, 2024.

Key Points: 
  • EpimAb Biotherapeutics, a global clinical stage biotechnology company specializing in the development of bispecific antibodies, is pleased to announce the acceptance of a late-breaking abstract featuring our novel T-cell engager (TCE) EMB-07 as a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California between April 5-10, 2024.
  • This presentation will highlight the preclinical results for EMB-07, a novel ROR1 targeting TCE designed with an optimized efficacy, safety and pharmacokinetic profile.
  • Furthermore, the presentation will discuss the TCE’s differentiated in vitro potency relative to benchmark molecules constructed using different modalities.
  • The presentation details are as follows:
    “With EMB-07 EpimAb is applying a unique and proprietary approach to target ROR1, a protein expressed on the surface of a multitude of solid and liquid tumor cells,” Dr. Chengbin Wu, Founder and CEO of EpimAb commented.

Global Therapeutic Antibody Market Forecast to Reach USD 428.20 Billion by 2029: In-Depth Analysis by Antibody Type, Source, and Application - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 29, 2024
Biotechnology, Pharmaceutical, Health, Prevalence, Application, SWOT, Monoclonality, COVID-19, Conditional sentence, Monoclonal antibody, Vaccine

Global Therapeutic Antibody Market reveals significant insights into market segmentation, including monoclonal antibodies, bispecific antibodies, and more.

Key Points: 
  • Global Therapeutic Antibody Market reveals significant insights into market segmentation, including monoclonal antibodies, bispecific antibodies, and more.
  • This in-depth report examines the forecast growth trends and market dynamics from 2024 to 2029, with a specific focus on key regions and countries contributing to the global market expansion.
  • The market is analyzed by product type, source, and application, offering a thorough understanding of the therapeutic antibody landscape.
  • Through a careful examination of industry trends, drivers, and challenges, the report provides an insightful forecast and analysis that bolsters understanding of the Global Therapeutic Antibody Market's future trajectory.

Pfizer Oncology Hosts Innovation Day, Highlighting Fully Integrated Organization, Robust Portfolio, and Strategic Priorities to Drive Long-Term Sustainable Growth

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, NSCLC, Acquisition, Breast cancer, Head, Recurrence, Boshoff, CREST, MBC, Encorafenib, Growth, HR, Spacecraft, PFE, Prostate, Metastasis, Pembrolizumab, Lung, ADC, Monoclonal antibody, Webcast, Patient, Lymphoma, Multiple myeloma, Brentuximab vedotin, PD-L1, Cancer, Fine chemical

A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors .

Key Points: 
  • A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors .
  • “With the completion of the Seagen acquisition in 2023, Pfizer has significantly expanded its Oncology organization to amplify its efforts to advance new standards of care and improve outcomes for patients,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • Pfizer’s Oncology portfolio is focused on three core scientific modalities: small molecules, antibody drug conjugates (ADCs), and bispecific antibodies, including other immuno-oncology biologics.
  • Please read full Prescribing Information , including BOXED WARNING, for ELREXFIOTM (elranatamab-bcmm).

PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 14, 2024
SHIELD, Marketing, Research, New Drug Application, Interim analysis, Completeness, PLEX, Conference, Monoclonal antibody, Dicarboxylic acid, Patient, Survival, PIPE, G&A, Pharmaceutical industry

Financial results for the full year ended December 31, 2023

Key Points: 
  • Financial results for the full year ended December 31, 2023
    R&D expenses, net for the year ended December 31, 2023, were $16.1 million, compared to $28 million in 2022.
  • G&A expenses for the year ended December 31, 2023, were $5.5 million, compared to $8.0 million for 2022.
  • Marketing and business development expenses for the year ended December 31, 2023, were $1.2 million, compared to $2.9 million for 2022.
  • PolyPid expects that its pro forma cash balance will be sufficient to fund operations into late third quarter 2024.