Verastem Oncology

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.

Verastem Oncology Announces Preclinical Presentations for New Oral G12D Inhibitor and for Avutometinib and Defactinib Combination as a Backbone of Therapy for RAS/MAPK Driven Cancers at AACR Annual Meeting 2024

Retrieved on: 
Tuesday, March 5, 2024

The presentations will highlight anti-tumor efficacy of GFH375 (VS-7375), a potent and selective orally bioavailable KRAS G12D (ON/OFF) inhibitor, and will also show data of RAF/MEK clamp plus FAK inhibition in pancreatic ductal adenocarcinoma (PDAC) models supporting the ongoing RAMP 205 trial.

Key Points: 
  • The presentations will highlight anti-tumor efficacy of GFH375 (VS-7375), a potent and selective orally bioavailable KRAS G12D (ON/OFF) inhibitor, and will also show data of RAF/MEK clamp plus FAK inhibition in pancreatic ductal adenocarcinoma (PDAC) models supporting the ongoing RAMP 205 trial.
  • Additional presentations will support the use of avutometinib and FAK inhibitor combination in cutaneous melanoma models to overcome resistance to BRAF and MEK inhibitors, resistance to immunotherapy, and brain metastasis.
  • “For the first time, GenFleet and Verastem will present potency, selectivity, anti-tumor efficacy, and bioavailability data on GFH375 (VS-7375), a potential best-in-class orally active KRAS G12D (ON/OFF) inhibitor.
  • We look forward to an IND submission by GenFleet in China in H1 2024,” said Jonathan Pachter, Ph.D., chief scientific officer of Verastem Oncology.

Verastem Oncology Outlines Key 2024 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib and Defactinib and Broader Pipeline in RAS Pathway-Driven Cancers

Retrieved on: 
Monday, January 29, 2024

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.

Key Points: 
  • Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.
  • “We have made significant progress in our commitment to advancing new solutions for RAS pathway-driven cancers and look forward to an exciting and catalyst-filled year ahead.
  • Safety and tolerability continued to be favorable and consistent with previously reported data.
  • Entered into a discovery and development collaboration with GenFleet Therapeutics (“GenFleet”) to advance three oncology discovery programs targeting RAS pathway-driven cancers.

Verastem Oncology Granted Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, January 18, 2024

“Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumor regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC,” said Dan Paterson, President and CEO, Verastem Oncology.

Key Points: 
  • “Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumor regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC,” said Dan Paterson, President and CEO, Verastem Oncology.
  • “Given that KRAS G12C is the most common KRAS mutation in NSCLC, the advancement of the combination is important in understanding potential new treatment approaches.
  • The pharmacokinetic profile of avutometinib in combination with sotorasib in the RAMP 203 trial was similar to results in monotherapy studies.
  • These initial RAMP 203 results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October, 2023.

Bone Biologics Appoints Healthcare Finance Veteran Robert E. Gagnon to Board of Directors

Retrieved on: 
Thursday, January 11, 2024

Bone Biologics Corporation (“Bone Biologics” or the “Company”) (Nasdaq: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today announced that effective immediately Robert E. Gagnon has been named to the Company’s board of directors.

Key Points: 
  • Bone Biologics Corporation (“Bone Biologics” or the “Company”) (Nasdaq: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today announced that effective immediately Robert E. Gagnon has been named to the Company’s board of directors.
  • The number of directors of Bone Biologics remains at four.
  • “We are delighted that a professional of Rob’s stature has agreed to join our board of directors,” said Jeffrey Frelick, president and chief executive officer of Bone Biologics.
  • Mr. Gagnon currently serves on the Board of Directors at Verastem Oncology and Purple Biotech.

Verastem Oncology to Participate in the B. Riley Securities 4th Annual Oncology Conference

Retrieved on: 
Thursday, January 11, 2024

Verastem Oncology (Nasdaq: VSTM) (the “Company), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the Company will participate in a fireside chat at the B. Riley Securities 4th Annual Oncology Conference on Thursday, January 18, 2024 at 4:00 p.m.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM) (the “Company), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the Company will participate in a fireside chat at the B. Riley Securities 4th Annual Oncology Conference on Thursday, January 18, 2024 at 4:00 p.m.
  • ET.
  • To access the live webcast of the fireside chat, please contact your B. Riley Securities sales representative.

Verastem Oncology Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, January 5, 2024

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the grant of stock options to purchase 19,251 shares of its common stock to six new employees.

Key Points: 
  • Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the grant of stock options to purchase 19,251 shares of its common stock to six new employees.
  • The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employees’ acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options have an exercise price equal to $8.30 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on January 2, 2024.
  • The stock options to purchase 19,251 shares of common stock that were granted to the six new employee will vest at a rate of twenty-five percent (25%) on the one-year anniversary of each employee’s date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date.

ENSEM Expands its Leadership Team with the Appointment of Jeff Kutok, M.D., Ph.D. as Chief Scientific Officer

Retrieved on: 
Wednesday, January 3, 2024

WALTHAM, Mass., Jan. 3, 2024 /PRNewswire/ -- Ensem Therapeutics Inc., a biotechnology company focusing on high value and difficult-to-drug oncology targets, today announced the appointment of Dr. Jeff Kutok as Chief Scientific Officer, effectively immediately.

Key Points: 
  • WALTHAM, Mass., Jan. 3, 2024 /PRNewswire/ -- Ensem Therapeutics Inc., a biotechnology company focusing on high value and difficult-to-drug oncology targets, today announced the appointment of Dr. Jeff Kutok as Chief Scientific Officer, effectively immediately.
  • "Dr. Kutok is a seasoned executive with the right credentials to guide ENSEM's science into the future," stated Shengfang Jin, Ph.D., President & Chief Executive Officer of ENSEM.
  • Dr. Kutok previously served as Executive Vice President and Chief Scientific Officer at Infinity Pharmaceuticals, Inc. where he was responsible for the company's scientific strategy, preclinical development, and translational science.
  • "I am thrilled to join the ENSEM team at this exciting time," stated Dr. Jeff Kutok, Chief Scientific Officer at ENSEM.

Verastem Oncology Selects Oral KRAS G12D Inhibitor GFH375/VS-7375 as Lead Program in Discovery and Development Collaboration with GenFleet Therapeutics

Retrieved on: 
Monday, December 18, 2023

Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced a potential best-in-class KRAS G12D oral inhibitor as the lead program of its discovery and development collaboration with GenFleet Therapeutics (“GenFleet”).

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced a potential best-in-class KRAS G12D oral inhibitor as the lead program of its discovery and development collaboration with GenFleet Therapeutics (“GenFleet”).
  • KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancer.
  • As previously announced, the discovery and development collaboration between Verastem Oncology and GenFleet aims to advance three oncology discovery programs related to RAS pathway-driven cancers.
  • The licenses would give Verastem Oncology development and commercialization rights outside of China while GenFleet would retain development and commercialization rights inside of China.

Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Retrieved on: 
Wednesday, December 13, 2023

“Patients and treating physicians have advocated for more research and development in support of LGSOC.

Key Points: 
  • “Patients and treating physicians have advocated for more research and development in support of LGSOC.
  • At Verastem Oncology, we are moving with urgency to offer a Phase 3 study specifically directed at this disease in an effort to address this need,” said Dan Paterson, President and Chief Executive Officer, Verastem Oncology.
  • RAMP 301 is a global trial with enrollment open in the U.S. and planned enrollment in Canada, the United Kingdom, Europe, Australia, and Korea.
  • Dr. Grisham and Dr. Banerjee are paid consultants for Verastem Oncology.