RECIST

Repare Therapeutics to Regain Global Rights to Camonsertib

Retrieved on: 
Monday, February 12, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Health Technology, RECIST, PKMYT1, Patient, Therapy, ATR, Pharmaceutical industry

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced today that it will regain global development and commercialization rights to camonsertib (RP-3500), a potential best-in-class oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), following termination of its collaboration agreement with Roche.

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced today that it will regain global development and commercialization rights to camonsertib (RP-3500), a potential best-in-class oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), following termination of its collaboration agreement with Roche.
  • Repare regains full control of all rights for camonsertib, a potential best-in-class inhibitor of ATR.
  • Repare expects to report additional camonsertib and lunresertib combination therapy data from the expansion cohorts of this trial in the second half of 2024.
  • Repare continues to expect that its existing cash, cash equivalents, and marketable securities will provide sufficient capital to fund planned operations into mid-2026.

RadioMedix and Orano Med receive FDA Breakthrough Therapy Designation for AlphaMedixTM in gastroenteropancreatic neuroendocrine tumors First Targeted Alpha Therapy to receive a Breakthrough Therapy Designation

Retrieved on: 
Monday, February 12, 2024
Oncology, Health, FDA, Clinical Trials, Radiology, Pharmaceutical, Toxicity, BTD, MD, GEP-NET, News, Breakthrough therapy, Breakthrough, Safety, Patient, RECIST, Alpha, PRRT, Pharmaceutical industry

AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.

Key Points: 
  • AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.
  • AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.
  • “The FDA's Breakthrough Therapy Designation underscores AlphaMedixTM potential as an innovative treatment that could redefine how patients with neurendocrine tumors are treated.
  • “Receiving FDA Breakthrough Therapy Designation for AlphaMedixTM is a great achievement for everyone involved and confirms the strong interest of the medical community for Targeted Alpha Therapies with lead-212.

Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 8, 2024
Carcinoma, Neoplasm, Melanoma, NMSC, Merkel-cell carcinoma, REPL, Angiosarcoma, SITC, PFS, Clinical trial, Research, RECIST, Society, Hercules, Patient, CSCC, Type, FDA, Marketing, Investment, RP1, Food, MCC, Immunotherapy, Skin, Nivolumab, Uveal melanoma, Annual general meeting, BLA, RP2, Pharmaceutical industry

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Key Points: 
  • WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.
  • We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024.
  • Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
  • Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.

MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene

Retrieved on: 
Tuesday, January 30, 2024
PD-L1, FOLFOX, Immune system, Division, Clinical trial, RECIST, Patient, Stomach, Therapy, ICIS, Pembrolizumab, Brown University, Nivolumab, Associate, Stomach cancer, Mink, Cancer, Clinical research, Malignancy

“Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors.

Key Points: 
  • “Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors.
  • The activity, tolerability, and ease of off-the-shelf administration of iNKT-based cell therapies position them as an attractive approach for overcoming cancer resistance.”
    Gastric cancer, the fifth most common malignancy globally, is incurable with only 12% responsive to ICIs1,2.
  • This phase study (NCT05108623) was designed to evaluate agenT-797, an unmodified iNKT cell therapy, in solid tumors refractory to ICIs.
  • Kono K, Nakajima S, Mimura K. Current status of immune checkpoint inhibitors for gastric cancer.

AIM ImmunoTech Announces that the First Subject is Enrolled in the Phase 1b/2 Study Evaluating Ampligen® in Combination with AstraZeneca’s Imfinzi® for the Treatment of Late-Stage Pancreatic Cancer

Retrieved on: 
Monday, January 22, 2024
AIM, Tumor microenvironment, Patient, Progression-free survival, MD, Neoplasm, Partnership, Cancer, Big Pharma, RECIST, FOLFIRINOX, Erasmus MC, Blood, Disease, Safety, Toxicity, Doctor of Philosophy, Patent, DLT, Pancreatic cancer, Pharmaceutical industry

Data strongly suggests Ampligen has therapeutic synergy when combined with checkpoint inhibitors — potentially increasing cancer treatment efficacy and subject survival rates.

Key Points: 
  • Data strongly suggests Ampligen has therapeutic synergy when combined with checkpoint inhibitors — potentially increasing cancer treatment efficacy and subject survival rates.
  • A successful DURIPANC Study could make AIM an especially attractive partnership or buyout target for Big Pharma.
  • Strong positive clinical data from the DURIPANC study would also support our belief that Ampligen could synergistically enhance anti-PD-L1 therapies.
  • The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

Coherus Presents Positive Phase 2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2024 ASCO GI Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024
Tumor microenvironment, IO, HCC, VEGF, CHRS, Patient, Biology, Progression-free survival, Associate, IL-27, Neoplasm, City, DCR, Survival, Bevacizumab, Cancer, Liver cancer, Immunotherapy, RECIST, PFS, Safety, Bev, Liver, Toxicity, Biomarker, Oncology, Palladium

REDWOOD CITY, Calif., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced data from the lead-in portion of the Phase 2 clinical trial evaluating casdozokitug (casdozo), a selective and potent IL-27-targeting antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (uHCC). These data are being presented at the 2024 ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 at Moscone West in San Francisco, California. Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment. Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.

Key Points: 
  • These data are being presented at the 2024 ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 at Moscone West in San Francisco, California.
  • Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment.
  • Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.
  • Coherus plans to evaluate the combination of casdozo/toripalimab-tpzi(Coherus’ anti-PD-1 antibody)/bev in future clinical trials.

Exelixis Announces Detailed Results of Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer Presented at ASCO GU 2024

Retrieved on: 
Thursday, January 25, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Exelixis, Huntsman Cancer Institute, Patient, Prostate cancer, PST, Progression-free survival, NHT, OS, ASCO, Survival, Clinical research, University, Society, Metastasis, RECIST, PFS, BIRC, ITT

The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).

Key Points: 
  • The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).
  • The PFS analysis was conducted in the first 400 randomized patients in the intent-to-treat (PFS ITT) population and per protocol.
  • While a trend toward OS improvement was observed, the data were immature and did not meet the threshold for statistical significance.
  • The PFS benefit and the trend for an OS benefit were observed across subgroups of high-risk populations, as presented in Table 1.

Junshi Biosciences Announces Publication of Results from TORCHLIGHT, a Randomized Phase 3 Trial of Toripalimab for the Treatment of Metastatic or Recurrent Triple-negative Breast Cancer in Nature Medicine

Retrieved on: 
Wednesday, January 10, 2024
Development, Oncology, Patient, Progression-free survival, OS, DCR, Survival, Dor, PD, Immunotherapy, RECIST, Aes, CSCO, Triple-negative breast cancer, PFS, Safety, HR, TNBC, ITT, Pharmaceutical industry

TORCHLIGHT is the first registered Phase 3 study to achieve positive results in advanced TNBC immunotherapy in China.

Key Points: 
  • TORCHLIGHT is the first registered Phase 3 study to achieve positive results in advanced TNBC immunotherapy in China.
  • A total of 300 patients had PD-L1-positive TNBC: 200 in the toripalimab arm and 100 in the control arm.
  • TORCHLIGHT’s results show that the addition of toripalimab to nab-paclitaxel significantly improved PFS for PD-L1-positive patients with metastatic or recurrent TNBC, while maintaining an acceptable safety profile.
  • The groundbreaking outcomes of this study has the potential to address unmet clinical needs and offer Chinese TNBC patients better treatment options.”

AIM ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

Retrieved on: 
Wednesday, January 10, 2024
AIM, Patient, ICI, MD, Erasmus MC, Partnership, Trial of the century, Big Pharma, RECIST, FOLFIRINOX, Disease, Safety, Toxicity, Doctor of Philosophy, PDAC, Patent, AstraZeneca, DLT, Pancreas, Pancreatic cancer, Pharmaceutical industry

OCALA, Fla., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that enrollment is open at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of pancreatic cancer (the “DURIPANC Study”). Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing survival rates and efficacy.

Key Points: 
  • Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing survival rates and efficacy.
  • AIM announced in January 2023 that it had entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca.
  • The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.
  • Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses).

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Retrieved on: 
Friday, January 12, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Histopathology, Weight loss, Gynaecology, Bevacizumab, Cisplatin, Hypothyroidism, University, Cancer, Risk, COVID-19, Diarrhea, Hyperthyroidism, Brachytherapy, Neoplasm, Perforated ulcer, Hepatitis, FIGO, CRT, Pyelonephritis, Colitis, Vagina, ClinicalTrials.gov, PD-L1, RECIST, Disease, Patient, Fever, CPS, Chemoradiotherapy, Vomiting, MRK, Death, Nephritis, Progression-free survival, OS, Radiation, Anemia, Survival, EBRT, Abdominal pain, Intraparenchymal hemorrhage, Uterus, Cervical cancer, Constipation, PFS, Fatal, Obstetrics, Hematopoietic stem cell transplantation, Pneumonitis, Nausea, Pelvic pain, Dysuria, Fatigue, GOG, Arm, Rash, Food, Merck & Co., Sepsis, Toxicity, News, Urinary tract infection, Appetite, Pharmaceutical industry

Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Key Points: 
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
  • The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.
  • In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303).