PD-1

IDEAYA Announces Clinical Collaboration to Evaluate IDE161 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Endometrial Cancer

Retrieved on: 
Tuesday, March 12, 2024
MSD, PARG, Apoptosis, Prostate cancer, Endometrial cancer, Colorectal cancer, RECIST, Patient, MSI, Merck & Co., Pembrolizumab, Medicine, MSS, Breast cancer, HRD, Therapy, ADP, PD-1, Pharmaceutical industry

"We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

Key Points: 
  • "We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
  • "We are very pleased to collaborate with Merck on this trial evaluating IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer.
  • Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial.
  • The mechanistic rationale and preclinical data to support the IDE161 and PD-1 clinical combination will be provided as part of a future R&D update.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

Retrieved on: 
Wednesday, March 6, 2024
Radiation, Doctor of Philosophy, Immunotherapy, News, FOLFIRINOX, Growth, CADL, PR, CXCR4, Lead, PRS, Multiple myeloma, Poster, Pancreatic cancer, Gemcitabine, Fast Track, Liver, Incidence, Cancer, City, HSC, Chung, TME, Overalls, FACP, Therapy, Sickle cell disease, Columbia University, MAPK, Immune system, SNF, G-CSF, Woman, AIO, SCD, AACR, PD-1, Conference, TILS, Tumor microenvironment, BioLineRx, Clinical trial, Survival, Oncology, Filgrastim, Collection, American Cancer Society, Caregiver, USD, SWI, MD, Blood, FDA, TSX, Biotechnology, Pancreatic Cancer Action Network, Stem cell, RAS, Valaciclovir, PDAC, Patient, Natalizumab, ONC, PEI, Pharmaceutical industry

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Therapy, SAN, Ulcerative colitis, Week, CDAI, B cell, Atopic dermatitis, BTLA, Q2, PD-1, Inflammation, Annual general meeting, AAD, UC, Idealized cognitive model, Rheumatoid arthritis, IGA, Patient, BDCA2, IND

“We will have a number of important events in 2024 including the top-line data readout of ANB032's Phase 2b trial in atopic dermatitis by year end,” adds Faga. “We also plan to move our third and fourth ICMs -- ANB033, our anti-CD122 antagonist, and ANB101 -- into the clinic this year, with IND filings planned for Q2 and H2, respectively.”

Key Points: 
  • “Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis.
  • The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
  • The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
  • Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.

Plus Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Tuesday, March 5, 2024
Glioblastoma, Breast cancer, PSTV, Rhenium, Decompression (diving), FDA, Food, GMP, PD-1, Ependymoma, Conference, Safety, Plus Therapeutics, Respect, Therapy, Food and Drug Administration, Webcast, Patient, CSF, LM, PD-L1, Pharmaceutical industry

AUSTIN, Texas, March 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights.

Key Points: 
  • ET
    AUSTIN, Texas, March 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights.
  • Complete ReSPECT-LM Phase 1 dose escalation trial enrollment, determine the maximum tolerated dose, and recommended Phase 2 dose.
  • Implement Plus’ CNSide cerebral spinal fluid (CSF)-based tumor cell quantification assay as an exploratory clinical endpoint in all ReSPECT-LM trial patients in Q1 2024.
  • The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

Coherus Completes Divestiture of Ophthalmology Franchise

Retrieved on: 
Monday, March 4, 2024
Nasopharyngeal carcinoma, Ophthalmology, CHRS, FDA, Sale, PD-1, Tumor microenvironment, Latham & Watkins, Ranibizumab

REDWOOD CITY, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS) today announced the completion of the previously announced divestiture of its CIMERLI® (ranibizumab-eqrn) ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC, to Sandoz, Inc. for upfront all-cash consideration of $170 million. This divestiture included Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, and access to proprietary commercial software.

Key Points: 
  • REDWOOD CITY, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS) today announced the completion of the previously announced divestiture of its CIMERLI® (ranibizumab-eqrn) ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC, to Sandoz, Inc. for upfront all-cash consideration of $170 million.
  • This divestiture included Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, and access to proprietary commercial software.
  • Coherus received upfront, all-cash consideration of $170 million plus certain purchase price adjustments, which will be finalized following the closing pursuant to the agreement between Coherus and Sandoz.
  • J.P. Morgan Securities LLC acted as the Company’s financial advisor, and Latham & Watkins LLP acted as legal counsel to Coherus in connection with the transaction.

Iovance Biotherapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates 

Retrieved on: 
Wednesday, February 28, 2024
IOV, NSCLC, Acquisition, Cohort, Units of paper quantity, Research, MAA, TIL, Information, FDA, Melanoma, Food, Cancer, Growth, U.S. FDA, PD-1, European, Interim, Safety, NDS, Endometrial cancer, Food and Drug Administration, Second generation, Patent, Patient, MMR, Clinical trial, Investment, Intellectual property, Travel, Pharmaceutical industry

SAN CARLOS, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported fourth quarter and full year 2023 financial results and corporate updates.

Key Points: 
  • The Iovance Cell Therapy Center ( iCTC ) began commercial manufacturing for Amtagvi patients within a week of approval.
  • More than 700 patients have been treated with Iovance TIL therapy manufactured using proprietary Iovance processes as of December 31, 2023.
  • Revenue for the fourth quarter and year ended December 31, 2023, was $0.5 million and $1.2 million, respectively, and comprised of product sales following the Proleukin® acquisition in May 2023.
  • Research and development expenses were $87.5 million for the fourth quarter ended December 31, 2023, an increase of $6.9 million compared to $80.6 million for the same period ended December 31, 2022.

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

Retrieved on: 
Wednesday, February 28, 2024
Neoplasm, RMB, SHPL, Net, EZH2, Growth, FC, Tax, Follicular lymphoma, FX, Fast Track, TCFD, Ethics, Marketing, RCC, Health, CER, Sintilimab, ITP, Disclosure, Plasma protein binding, Lancet, MET, Completeness, D-19, Paclitaxel, Met, NDA, NSCLC, EGFR, NRDL, Atopic dermatitis, ESG, CRC, PD-1, Completion, Phases of clinical research, Task force, Half-life, Chills, Potential, Breakthrough therapy, NMPA, Investment, FGFR, Research, PFS, AstraZeneca, EMA, ADS, Annual report, ASCO, FDA, Carbon accounting, VEGFR, Lung, COVID-19, Alopecia areata, PMDA, Lilly, Patient, Cancer, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, February 28, 2024
Active, VSIG4, MSS, National Cancer Institute, Society, Sensei, Lung cancer, Patient, Immunotherapy, Trial of the century, Head, Neoplasm, VISTA, SITC, MBA, Annual general meeting, Therapy, Histology, Biology, NSCLC, ESMO, Kinetics, CRC, PD-1, Conference, Safety, Cemiplimab, Pharmacokinetics, CRADA, CD39, IND, Colorectal cancer, Translation, NCI, Aes, Part-time, FDA, Research and development, Administration, KOL, Cancer, Pharmaceutical industry

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2023, and provided corporate updates.

Key Points: 
  • “2023 saw the entry of our differentiated anti-VISTA antibody, SNS-101, into clinical development,” said John Celebi, President and Chief Executive Officer.
  • Recent updates include:
    A total of 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase of this study.
  • On October 23, 2023 , Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) 2023.
  • On November 1, 2023, Sensei announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer.

Compass Therapeutics Announces Publication of CTX-8371 Preclinical Data in OncoImmunology, its Bispecific Antibody Checkpoint Inhibitor, now Advancing to First-in-Human Clinical Trial

Retrieved on: 
Wednesday, February 28, 2024
FDA, Therapy, R&D, MD, IND, Doctor of Philosophy, CD137, PD-1, PD-L1, Pharmaceutical industry

CTX-8371 is a fully-human, tetravalent bispecific antibody, discovered and developed by Compass Therapeutics as a next generation checkpoint blocker.

Key Points: 
  • CTX-8371 is a fully-human, tetravalent bispecific antibody, discovered and developed by Compass Therapeutics as a next generation checkpoint blocker.
  • The data highlighted the unique mechanism-of-action of CTX-8371, inducing dual blockade of PD-1 and PDL-1 and cleavage of cell surface PD-1.
  • In addition, CTX-8371 demonstrates enhanced anti-tumor activity relative to approved anti-PD-1 blockers and anti-PD-L1 blockers in a series of in vitro and in vivo experimental settings.
  • “These compelling data are a testament to the functionality of our novel checkpoint inhibitor and we are excited to continue evaluating its potential in clinical studies.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.