PD-1

Barinthus Bio Provides a Financial Update and Announces Anticipated 2024 Corporate Milestones

Retrieved on: 
Friday, January 5, 2024
Book, Immune system, IND, PD-1, HBV, HPV, Prostate cancer, Nivolumab, Record, Clinical trial, Cancer, NUC, Bank statement, SNAP, Hepatitis B virus, Human papillomavirus infection, Safety, Autoimmunity, APOLLO, Vaccine

OXFORD, United Kingdom, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today provided a preliminary financial update and announced its 2024 corporate objectives.

Key Points: 
  • OXFORD, United Kingdom, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today provided a preliminary financial update and announced its 2024 corporate objectives.
  • Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
  • “2024 promises to be another exciting year for Barinthus Bio, with multiple data readouts expected across our hepatitis B virus (HBV) infection, human papillomavirus (HPV) infection and prostate cancer programs, as well as the planned initiation of the first in human study of our SNAP platform-based candidate VTP-1000 in Celiac Disease,” said Gemma Brown, Chief Financial Officer of Barinthus Bio.
  • * Barinthus Bio has worldwide rights for all product candidates.

Compass Therapeutics Provides Corporate Update

Retrieved on: 
Friday, January 5, 2024
Patient, CRC, Stage 2, IND, FDA, BTC, Research and development, PD-1, DLL4, CD137, PET, Melanoma, MD, Doctor of Philosophy, Therapy, Mesothelioma, Paclitaxel, Carcinoma, SCLC, Safety, Development, NSCLC, PD-L1, Pharmaceutical industry

As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.

Key Points: 
  • As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.
  • Effective January 9, 2024, Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and Chief Executive Officer will transition to President of Research and Development and be appointed Vice Chair of the Compass board of directors.
  • BOSTON, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported a business update.
  • Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and current Chief Executive Officer will transition to President of Research and Development and assume the role of Vice Chair of the Compass board of directors.

Sutro Biopharma Highlights Potential Multi-Cancer Opportunity for Luvelta, a FolRα-targeting ADC

Retrieved on: 
Thursday, January 4, 2024
CBFA2T3, Lung cancer, ESMO, Division, Woman, IND, Ovarian cancer, Drug discovery, PD-1, PROC, Spacecraft, Neutropenia, SAN, Gynecologic Oncology (journal), RAM, Endometrial cancer, Q&A, STRO, University, ASH, Bevacizumab, Patient, Phenotype, Acute myeloid leukemia, Safety, Webcast, ADC, NSCLC, AML, Birth control

SOUTH SAN FRANCISCO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), is hosting an investor webcast today highlighting the significant potential of luveltamab tazevibulin (luvelta), a novel folate receptor-α (FolRα) targeting ADC. The presentation will include an overview of the clinical data supporting luvelta’s broad opportunity to address the unmet need in several FolRα-expressing cancers, including platinum-resistant ovarian cancer (PROC), endometrial cancer, CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), and non-small cell lung cancer (NSCLC).

Key Points: 
  • “Luvelta has been studied in over 180 patients to-date, and has demonstrated both promising clinical activity and a tolerable safety profile.
  • We are optimistic about its potential to change the cancer treatment landscape,” said Bill Newell, Sutro’s Chief Executive Officer.
  • “This includes the potential to be the first ADC to treat ovarian cancer patients with low to medium FolRα expression, which could double the current eligible patient population relative to the FolRα-targeting ADC on the market.
  • Sutro management and Dr. Monk will participate in a Q&A session at the end of the presentation.

Starton Therapeutics Announces Initial Key Safety and Efficacy Signals with STAR-LLD in Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, January 3, 2024
Quality of life, Leukopenia, URTI, Constipation, Lower respiratory tract infection, IND, Insomnia, CD8, Diarrhea, PD-1, DVT, Anemia, Gastroenteritis, Tremor, Fatigue, Common, CD4, Nausea, Multiple myeloma, Neutropenia, Abdominal pain, Therapy, Lenalidomide, Pharmacokinetics, Weakness, Dizziness, Thrombocytopenia, Cytotoxic T cell, Dexamethasone, Appetite, Periodic breathing, Bortezomib, Toxicity, Back pain, Patient, Safety, Peripheral edema, Deep vein thrombosis, Vomiting, Cough, Rash, Bronchitis

Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date. Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks. In comparison, adverse events in these patients observed during a prior regimen containing Revlimid® included nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the more common side effects of lenalidomide (Revlimid®), which include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have been observed with STAR-LLD. Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects. These data suggest that STAR-LLD may prove to be superior in tolerability to oral Revlimid, expanding the number of patients that get the full Revlimid® benefit and improving quality of life.

Key Points: 
  • Patient acceptance of self-administration using the ambulatory pump for lenalidomide delivery has been confirmed in this study.
  • Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date.
  • Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks.
  • Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects.

Coherus Announces U.S. Launch of LOQTORZI™

Retrieved on: 
Tuesday, January 2, 2024
DCR, Platinum, NPC, Partnership, Neoplasm, Nasopharyngeal carcinoma, Survival, ABC, Immune system, Risk, CHRS, Prognosis, McKesson Corporation, FDA, PD-1, Hope, Progression-free survival, NCCN, Research, Education, Cisplatin, HCPCS, Cancer, Sarcoma, Death, Cardinal, Patient, OS, PFS, NDC, PD-L1, Pharmaceutical industry

REDWOOD CITY, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States. LOQTORZI is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.

Key Points: 
  • In December, the NCCN committee classified LOQTORZI as a preferred category 1 treatment option in combination with gemcitabine and cisplatin.
  • LOQTORZI has demonstrated impressive clinical benefits, including PFS and OS, offering R/M NPC patients new hope for extended survival,” said Paul Reider, Chief Commercial Officer of Coherus.
  • Contact Coherus BioSciences Customer Services at 1-844-562-6004 for more information.
  • Coherus expects a product-specific, permanent J-code to be assigned to LOQTORZI in mid-2024.

IO Biotech Announces First Patient Dosed in Phase 2 Neoadjuvant/Adjuvant Solid Tumor Basket Trial

Retrieved on: 
Thursday, December 21, 2023
Research, PD-1, SCCHN, Vaccine, Lung cancer, Disease, Melanoma, MD, Doctor of Philosophy, Clinical trial, Cancer, Head, Patient, Neck, Pharmaceutical industry

“In patients with advanced melanoma, the activity and tolerability profile of IO102-IO103 and a PD-1 inhibitor has been demonstrated in the Phase 1/2 trial and we are now conducting a pivotal Phase 3 trial in patients with advanced melanoma, with enrollment completed in that study and an interim analysis planned in 2024.

Key Points: 
  • “In patients with advanced melanoma, the activity and tolerability profile of IO102-IO103 and a PD-1 inhibitor has been demonstrated in the Phase 1/2 trial and we are now conducting a pivotal Phase 3 trial in patients with advanced melanoma, with enrollment completed in that study and an interim analysis planned in 2024.
  • Dosing the first patient in this trial demonstrates our commitment to further explore the potential our therapeutic cancer vaccine may offer to a broader group of patients with cancer.
  • Leading global experts from centers of excellence in this field in the US, Australia and Europe are involved in this clinical trial.
  • We look forward to following the progress of this study.”

Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-617, a Novel Fusion Protein Uniquely Harnessing Both IL-2 and IL-12 Cytokines

Retrieved on: 
Thursday, December 14, 2023
Cytokine, Neoplasm, Survival, PD-1, MBA, Pharmacokinetics, PD, CGEM, MPH, Patient, Safety, Pembrolizumab

CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial.

Key Points: 
  • CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial.
  • “CLN-617 is a first-in-class cytokine therapy uniquely combining human IL-2, IL-12, a collagen binding domain, and a size-enhancing domain in a single molecule designed for intratumoral injection.
  • These unique characteristics are intended to promote retention of the cytokines in the injected tumor and potentially provide enhanced safety and efficacy.
  • We look forward to working with investigators to explore the potential of CLN-617, Cullinan Oncology’s sixth program in clinical development.”

BioAtla Hosting Virtual R&D Day to Highlight BA3071 CAB-CTLA-4 Phase 1 Data in Multiple Solid Tumor Types

Retrieved on: 
Wednesday, December 13, 2023
Melanoma, CAB, PR, Survival, Tumor microenvironment, DLT, PD-1, Incidence, Nivolumab, MD, SAN, Therapy, Cancer, Toxicity, Conditional, Ipilimumab, Patient, Translational research, Research institute, Pharmaceutical industry

SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today is hosting a virtual R&D Day on its novel conditionally and reversibly active antibody targeting CTLA-4, BA3071. BA3071 is in Phase 2 development as a potential therapeutic for multiple solid tumor indications known to be responsive to CTLA-4 treatment as monotherapy, and in combination with a PD-1 blocking agent.

Key Points: 
  • BA3071 is in Phase 2 development as a potential therapeutic for multiple solid tumor indications known to be responsive to CTLA-4 treatment as monotherapy, and in combination with a PD-1 blocking agent.
  • The event will feature Omid Hamid, MD, Chief, Translational Research and Immunotherapy, and Director, Melanoma Therapeutics at The Angeles Clinic and Research Institute, and highlights Phase 1 dose escalation trial results for BA3071.
  • In addition, the relatively low incidence of immune-related adverse events suggests our CAB antibody has the potential to address the current limitations of CTLA-4-targeted therapies."
  • Exposure levels of BA3071 were similar to that of ipilimumab analog, with significantly less GI toxicity when combined with nivolumab in a non-human primate model.

Coherus Announces Updated NCCN Clinical Practice Guidelines Positioning LOQTORZI™ (toripalimab-tpzi) as Preferred Category 1 Regimen for First-Line Treatment of Cancer of the Nasopharynx

Retrieved on: 
Monday, December 11, 2023
DCR, Immunotherapy, NPC, Food, Neoplasm, Nasopharyngeal carcinoma, Survival, Risk, Immune system, CHRS, FDA, PD-1, Progression-free survival, Disease, NCCN, Cisplatin, Cancer, Head, Death, National Comprehensive Cancer Network, Patient, OS, PFS, PD-L1, Pharmaceutical industry

REDWOOD CITY, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) announced today that the National Comprehensive Cancer Network (NCCN) has updated the clinical practice guidelines for nasopharyngeal carcinoma (NPC) to include LOQTORZI™ (toripalimab-tpzi) as a preferred, category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine. The guidelines also recommend LOQTORZI monotherapy as the only preferred treatment in subsequent lines of therapy if disease progression on or after a platinum-containing therapy.

Key Points: 
  • The guidelines also recommend LOQTORZI monotherapy as the only preferred treatment in subsequent lines of therapy if disease progression on or after a platinum-containing therapy.
  • “Inclusion in the NCCN guidelines as a preferred category 1 treatment is an important step forward in treating patients with R/M NPC.
  • We now have a new standard of care for this rare form of head and neck cancer,” said Tarek Mekhail, M.D., Medical Director at AdventHealth Cancer Institute in Orlando, Florida.
  • As the first and only FDA-approved treatment for NPC, LOQTORZI has demonstrated the potential to significantly extend survival while slowing disease progression,” said Rosh Dias, M.D., Chief Medical Officer at Coherus.

Regeneron to Share Progress of Novel Combination Therapies in Oncology at ESMO IO

Retrieved on: 
Thursday, December 7, 2023
Regeneron Pharmaceuticals, CD28, ESMO, Translation, SBRT, Ovarian cancer, PD-1, Pain, Cytokine release syndrome, Fatigue, Nausea, Congress, HCC, Death, Cancer, CD3, Oncology, Patient, Senior, Pharmaceutical industry

TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of new and updated data on multiple combination therapies from its oncology pipeline at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023 from December 6 to 8 in Geneva, Switzerland. Highlights include first Phase 1 dose-escalation data for the investigational costimulatory bispecific antibody REGN5668 (MUC16xCD28) in combination with PD-1 inhibitor Libtayo® (cemiplimab) showing encouraging initial activity in patients with recurrent ovarian cancer. Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).

Key Points: 
  • Additionally, a late-breaking oral presentation will detail the first results from a Phase 2 trial investigating neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy (SBRT) in patients with early-stage hepatocellular carcinoma (HCC).
  • “Our ESMO IO presentations highlight the continued progress of Regeneron’s oncology pipeline, which was strategically curated to have the potential to offer novel and differentiated combinations targeting several types of difficult-to-treat cancers.
  • Dose escalation is ongoing and has included administration of REGN5668 doses beyond 300 mg in combination with Libtayo.
  • Regeneron presentations at ESMO IO: