Binimetinib

Immuneering Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 1, 2024

“We look forward to sharing topline data from the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this month.

Key Points: 
  • “We look forward to sharing topline data from the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this month.
  • Presented preclinical data demonstrating encouraging anti-tumor activity for IMM-1-104 and IMM-6-415: In October 2023, Immuneering presented preclinical data at AACR-NCI-EORTC.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $11.9 million compared with $9.9 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $4.4 million compared with $4.1 million for the same period of 2022.

Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

Retrieved on: 
Tuesday, December 12, 2023

CAMBRIDGE, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-6-415, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, twice-daily small molecule, in development for the treatment of advanced RAF or RAS mutant solid tumors.

Key Points: 
  • “The clearance of the IND application for IMM-6-415 is another important milestone in our efforts to create safer, more durable, and more effective treatment options for large groups of cancer patients,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation.
  • We are proud that the IMM-6-415 clinical trial will be open to an even broader group of solid tumor patients with ANY mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria.
  • In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.
  • “Furthermore, IMM-6-415 as a single agent demonstrated high sensitivity in a wide range of MAPK-driven tumor types, including models of RAS or RAF mutant disease.

Pasithea Therapeutics Announces Positive In Vivo Preclinical Efficacy Data for PAS-004 from NRAS Mutation Cancer Xenograft Models

Retrieved on: 
Monday, December 11, 2023

SOUTH SAN FRANCISCO, Calif. and MIAMI, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced positive preclinical results from two in vivo studies evaluating the anti-tumor efficacy of PAS-004 in NRAS mutation cancer xenograft models.

Key Points: 
  • In the first study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the lung cancer NCI-H1299 cell-line-derived xenograft model.
  • PAS-004 at dose levels of 10 mg/kg and 5 mg/kg, once daily, significantly inhibited tumor growth as compared to vehicle control.
  • The anti-tumor efficacy of PAS-004, when taken at equivalent doses was shown to be superior to that of binimetinib and selumetinib.
  • In the second study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the liver cancer xHepG2 cell-line-derived xenograft model.

Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma

Retrieved on: 
Monday, December 11, 2023

SAN DIEGO, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to naporafenib in combination with trametinib (MEKINIST®) for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti‑programmed death-1 (ligand 1) (PD‑(L)1)-based regimen, and whose tumors contain an NRAS mutation (NRASm). Naporafenib is an orally available, Phase 3-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRASm melanoma and other RAS/MAPK pathway-altered solid tumors.

Key Points: 
  • Naporafenib is an orally available, Phase 3-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRASm melanoma and other RAS/MAPK pathway-altered solid tumors.
  • “The outcomes for patients with NRASm melanoma after frontline immunotherapy (IO) treatment are dismal with low response rates and short median progression free survival (mPFS).
  • Effective treatment options are needed for patients following progression on frontline IO with anti-CTLA-4 and/or anti-PD-(L)1 antibodies.
  • Erasca recently reported that End of Phase 2 meetings with the FDA and European health authorities confirmed the SEACRAFT-2 Phase 3 trial design and provided clarity on the registrational pathway.

Immuneering Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, November 9, 2023

CAMBRIDGE, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, today reported financial results for the third quarter ended September 30, 2023, and provided business updates.

Key Points: 
  • “Completing our Phase 1 dose escalation of IMM-1-104 with no observed dose-limiting toxicities was an important step in that direction.
  • The Phase 2a portion of the study will also include the addition of new sites and investigators focused on these cancer types.
  • Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2023 were $10.1 million, compared with $9.4 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2023 were $3.9 million, compared with $3.8 million for the quarter ended September 30, 2022.

Kinnate Biopharma Inc. Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, November 9, 2023

(Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, today announced financial results for the third quarter of 2023 and recent corporate updates.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, today announced financial results for the third quarter of 2023 and recent corporate updates.
  • Third quarter research and development expenses for 2023 were $24.5 million, compared to $23.5 million for the same period in 2022.
  • Third quarter general and administrative expenses for 2023 were $6.6 million, compared to $7.8 million for the same period in 2022.
  • Third quarter net loss for 2023 was $30.7 million, compared to $30.7 million for the same period in 2022.

Immuneering Presents Preclinical Data Demonstrating Encouraging Anti-Tumor Activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC Conference

Retrieved on: 
Thursday, October 12, 2023

Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.

Key Points: 
  • Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.
  • Pharmacogenomic data were used to generate a model predictive of response to IMM-1-104 and identify biomarker-aligned patient subpopulations.
  • IMM-1-104 was tested in combination with gemcitabine or paclitaxel in humanized 3D models of pancreatic cancer, demonstrating enhanced activity and combination therapy potential.
  • As monotherapy, IMM-6-415 demonstrated anti-tumor activity in over 50% (34 of 66) of the 3D-TGA models tested, including 30 BRAF mutant preclinical models in which 19 (63%) showed activity.

Kinnate Biopharma Inc. Announces Pipeline Updates, Strategic Reprioritization and Workforce Restructuring

Retrieved on: 
Monday, September 18, 2023

(Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.
  • Additionally, Kinnate will pause development of KIN-7136 and explore strategic alternatives for exarafenib monotherapy and KIN-3248, as part of the reprioritization plan.
  • We believe that reprioritizing our programs is the most effective approach to unlock the full promise of our innovative therapies.”
    Farzan added, “The reprioritization plan unfortunately impacts our workforce.
  • Kinnate will implement a corporate restructuring by reducing the Company’s workforce by approximately 70%.

Kinnate Biopharma Inc. Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, August 8, 2023

(Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, today announced financial results for the second quarter of 2023 and recent corporate updates.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, today announced financial results for the second quarter of 2023 and recent corporate updates.
  • Second quarter research and development expenses for 2023 were $26.3 million, compared to $19.8 million for the same period in 2022.
  • Second quarter general and administrative expenses for 2023 were $7.8 million, compared to $7.6 million for the same period in 2022.
  • Second quarter net loss for 2023 was $31.9 million, compared to $27.1 million for the same period in 2022.

Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting

Retrieved on: 
Thursday, May 25, 2023

Pfizer Inc. (NYSE: PFE) will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.
  • With the recently announced proposed acquisition of Seagen*, a leader in antibody-drug conjugate technology, Pfizer is further accelerating its fight against cancer to deliver the next generation of Oncology breakthroughs.
  • “Placing patients at the center of everything we do is a critical component of advancing cutting-edge science and improving outcomes for patients,” said Dany Habr, M.D., Oncology Chief Medical Affairs Officer, Pfizer.
  • **Pfizer has exclusive rights to BRAFTOVI and MEKTOVI in the U.S., Canada, and all countries in the Latin American, African, and Middle Eastern regions.