NRAS

Kinnate Biopharma Inc. Sells Its Investigational Pan-RAF Inhibitor, Exarafenib, to Pierre Fabre Laboratories

Retrieved on: 
Friday, March 1, 2024

Kinnate has entered into an Asset Purchase Agreement (the “APA”) with Pierre Fabre Laboratories for global rights to exarafenib and other pan-RAF program assets.

Key Points: 
  • Kinnate has entered into an Asset Purchase Agreement (the “APA”) with Pierre Fabre Laboratories for global rights to exarafenib and other pan-RAF program assets.
  • SAN FRANCISCO, SAN DIEGO and CASTRES, France, March 01, 2024 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .
  • (Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, and Pierre Fabre Médicament, SAS (“Pierre Fabre Laboratories”), a global player in oncology, today announced their agreement to the sale of the Company’s investigational pan-RAF inhibitor, exarafenib, and other pan-RAF program assets pursuant to the APA entered into by the parties.
  • In addition, Pierre Fabre Laboratories will assume up to $5 million of trade payables for the transferred assets.

Cardiff Oncology Announces First Patient Dosed in Randomized First-line RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)

Retrieved on: 
Thursday, February 29, 2024

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the first patient was dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC). The trial, whose clinical execution is being conducted by Pfizer Ignite, Pfizer’s new end-to-end service for biotech companies, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard-of-care (SoC) vs. SoC alone.

Key Points: 
  • “Today’s announcement represents an important milestone for Cardiff Oncology and for patients with RAS-mutated mCRC, who have had no new therapies approved in almost 20 years,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology.
  • We are especially pleased with the opportunity to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib.
  • Contingent upon the results of CRDF-004, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
  • Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024.

Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

Retrieved on: 
Thursday, February 29, 2024

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.

Key Points: 
  • Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment.
  • The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.
  • “The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting.
  • We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
    In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC.

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Tuesday, February 27, 2024

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

Media Alert: Intel at Open Confidential Computing Conference 2024

Retrieved on: 
Friday, March 8, 2024

Clouds are varied in their infrastructure and multiple confidential computing vendors, each potentially with multiple product generations, offering confidential CPUs, GPUs and other special-purpose processing units.

Key Points: 
  • Clouds are varied in their infrastructure and multiple confidential computing vendors, each potentially with multiple product generations, offering confidential CPUs, GPUs and other special-purpose processing units.
  • Technical readiness and market momentum will converge in 2024 to accelerate growth and adoption of confidential computing.
  • Intel and Nvidia deliver confidential computing technologies that establish independent TEEs on the CPU and GPU, respectively.
  • Intel technology enables the Private Data Exchange to leverage confidential computing, which processes sensitive data out of view from unauthorized software or system administrators.

Verastem Oncology Receives Orphan Drug Designation from FDA for Avutometinib Alone or in Combination With Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Retrieved on: 
Tuesday, March 5, 2024

“The FDA Orphan Drug Designation for avutometinib alone or in combination with defactinib in low-grade serous ovarian cancer is an important step in recognizing this rare cancer as a distinct disease that currently has no FDA-approved treatments,” said Dan Paterson, president and chief executive officer of Verastem Oncology.

Key Points: 
  • “The FDA Orphan Drug Designation for avutometinib alone or in combination with defactinib in low-grade serous ovarian cancer is an important step in recognizing this rare cancer as a distinct disease that currently has no FDA-approved treatments,” said Dan Paterson, president and chief executive officer of Verastem Oncology.
  • “We are rapidly advancing the development program for avutometinib and defactinib in low-grade serous ovarian cancer with our ongoing Phase 3 clinical trial to deliver this new combination treatment to patients as quickly as possible.
  • LGSOC is a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate.
  • While chemotherapy is the standard of care for this disease, there are no treatments specifically approved by the FDA to treat LGSOC.

Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Retrieved on: 
Wednesday, February 14, 2024

SAN DIEGO, Feb. 14, 2024 (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 two clinical trial collaboration and supply agreements (CTCSAs) with Novartis (NYSE: NVS) for the MEK inhibitor trametinib (MEKINIST®).

Key Points: 
  • Erasca is sponsoring the trials, and Novartis is supplying trametinib at no cost.
  • “Both trials are supported by compelling anti-tumor activity with a tolerable and manageable adverse event profile demonstrated in clinical data generated by Novartis.
  • Both RAS Q61X solid tumors and NRASm melanoma represent high unmet needs with no approved targeted therapies for these respective mutation types.
  • Erasca is exploring whether naporafenib in combination with trametinib can improve outcomes and help provide meaningful therapeutic benefit for these advanced solid tumor indications.

i3Forum, GSMA, and ITW Global Leaders Forum (GLF) Announce Cooperation to Restore Trust in International Communications

Retrieved on: 
Tuesday, February 6, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240205510037/en/
    GSMA and GLF stated their support for the Restore Trust initiative spearheaded by i3Forum.
  • The Restore Trust initiative is an effort to build long term cooperation between the International Communications Industry and National Regulatory Authorities (NRAs) globally, and eradicate international nuisance communications.
  • The loss of public trust in communications is driven by the proliferation of unwanted/illegal voice calls and messages (e.g.
  • It is a growing global phenomenon that has a deep impact across all levels of society, businesses and citizens.

SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024

Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

Key Points: 
  • Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.
  • These presentations demonstrated rapid, sustained and consistent improvements in pain and functional status in patients receiving OGSIVEO using multiple assessment tools.
  • Initiate Phase 1 trial of SW-682, SpringWorks’ TEAD inhibitor, in Hippo mutant solid tumors in the first half of 2024.
  • A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

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.