HCC

ONK Therapeutics and NAYA Biosciences Announce Research Partnership to Advance Combination Therapy of Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies and FLEX-NK™ Bispecific Antibodies

Retrieved on: 
Wednesday, December 6, 2023

Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.

Key Points: 
  • Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody.
  • The companies’ R&D teams will collaboratively evaluate ONK’s optimally gene-edited NK cell therapy, ONKT105, with NAYA’s NY-303 bispecific antibody before selecting the best candidates for potential clinical development.
  • ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells.
  • They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKp46 activating receptors.

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

Retrieved on: 
Tuesday, December 5, 2023

The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

Key Points: 
  • The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.
  • The ORR was comparable between the two study groups (52.5% for RP1 plus cemiplimab vs. 51.4% for cemiplimab alone, p=0.692).
  • The registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients and completed enrollment earlier this year.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.

HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses

Retrieved on: 
Friday, December 1, 2023

These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab.

Key Points: 
  • These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab.
  • Data from the EMC and RCC cohorts of this trial led to the initiation of registration enabling programs.
  • This combination treatment showed promising antitumor activity in advanced cervical cancer and NSCLC patients, particularly for patients with PD-L1 positive status.
  • Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3.

 Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio

Retrieved on: 
Tuesday, December 26, 2023

Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ: RYZB) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ: RYZB) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors.
  • Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance.
  • BofA Securities, Inc., is serving as financial advisor to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

Senti Bio Announces Third Quarter 2023 Results and Pipeline Updates

Retrieved on: 
Monday, November 13, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the third quarter of 2023.

Key Points: 
  • “The third quarter was highly productive for Senti as we continued advancing SENTI-202 towards IND clearance and further developed our platform technology,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio.
  • Through this collaboration, Celest will lead clinical development, operations, and manufacturing for the advancement of SENTI-301A with technical support from Senti Bio.
  • Approximately 35% of Senti Bio’s employees transitioned from Senti Bio to GeneFab, which will support the clinical manufacturing of Senti Bio’s chimeric antigen receptor natural killer (CAR-NK) programs, including SENTI-202.
  • As of September 30, 2023, Senti Bio held cash, cash equivalents and short-term investments of $39.4 million.

RayzeBio Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023

SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today reported financial results for the third quarter ended September 30, 2023 and provided an update on key corporate initiatives.

Key Points: 
  • SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today reported financial results for the third quarter ended September 30, 2023 and provided an update on key corporate initiatives.
  • As part of the IPO and subsequently at ESMO in October 2023, RayzeBio reported the interim results of the Phase 1b portion of the ACTION-1 clinical trial, where RayzeBio enrolled a total of 17 patients.
  • Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2023 were $18.2 million, compared to $18.8 million for the third quarter of 2022.
  • Net Loss: Net loss for the third quarter of 2023 was $18.2 million, compared to the net loss for the third quarter of 2022 which was $20.4 million.

Alnylam Highlights Significant Progress with Platform Innovation and Clinical Pipeline at R&D Day

Retrieved on: 
Wednesday, December 13, 2023

We expect our track record of strong pipeline and commercial execution to continue through the end of 2025 and beyond,” said Akshay Vaishnaw, M.D., Ph.D., Chief Innovation Officer of Alnylam.

Key Points: 
  • We expect our track record of strong pipeline and commercial execution to continue through the end of 2025 and beyond,” said Akshay Vaishnaw, M.D., Ph.D., Chief Innovation Officer of Alnylam.
  • In addition, Alnylam will share an update on delivery advances driving ALN-BCAT, which will soon begin clinical testing in patients with hepatocellular carcinoma (HCC).
  • A peak mean TTR reduction of 97% was achieved at Day 29 and a mean TTR reduction of 93% was sustained at Day 180.
  • The Company’s R&D Day event will be held today, Wednesday, Dec. 13, from 8:30 a.m. to 12:45 p.m.

AM Best Affirms Credit Ratings of Houston Casualty Group Members and Affiliates

Retrieved on: 
Friday, December 8, 2023

AM Best has affirmed the Financial Strength Rating (FSR) of A++ (Superior) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “aa+” (Superior) of the property/casualty (P/C) members of Houston Casualty Group.

Key Points: 
  • AM Best has affirmed the Financial Strength Rating (FSR) of A++ (Superior) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “aa+” (Superior) of the property/casualty (P/C) members of Houston Casualty Group.
  • The outlook of these Credit Ratings (ratings) is stable.
  • The ratings also reflect the rating enhancement it receives from its affiliation with Houston Casualty Group.
  • The FSR of A++ (Superior) and the Long-Term ICRs of “aa+” (Superior) have been affirmed with stable outlooks for the following members of the Houston Casualty Group:

NiKang Therapeutics Enters into Clinical Trial Collaboration and Supply Agreement to Evaluate NKT2152 in Combination with Standard-of-Care in First-Line Advanced Hepatocellular Carcinoma

Retrieved on: 
Friday, December 8, 2023

This collaboration will utilize Roche’s MORPHEUS-LIVER phase 1b/2 platform for rapid and efficient combination development.

Key Points: 
  • This collaboration will utilize Roche’s MORPHEUS-LIVER phase 1b/2 platform for rapid and efficient combination development.
  • This randomized multi-regional phase 1b/2 trial is intended to evaluate the efficacy and safety of NKT2152 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab in patients with unresectable/advanced HCC not previously treated with systemic therapy.
  • Under the collaboration, Roche will sponsor the study, and each company will supply its respective anti-cancer agent to support the trial.
  • “Based on the compelling scientific rationale and supporting preclinical studies, we have a keen interest in assessing NKT2152 in HCC patients.

Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update

Retrieved on: 
Thursday, November 30, 2023

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.
  • Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022.
  • The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.
  • The Company's consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.