Sunitinib

Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 8, 2023

WALTHAM, Mass. and BOULDER, Colo., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • and BOULDER, Colo., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2023.
  • R&D Expenses: Research and development expenses were $38.9 million for the second quarter of 2023 as compared to $29.5 million for the second quarter of 2022.
  • R&D expenses include non-cash stock compensation expense of $3.6 million for the second quarter of 2023 compared to $2.1 million for the second quarter of 2022.
  • G&A expenses include non-cash stock compensation expense of $3.6 million for the second quarter of 2023 compared to $2.4 million for the second quarter of 2022.

Beactica Therapeutics appoints Jarl Ulf Jungnelius M.D. to its Board of Directors as it advances towards clinical-stage activities

Retrieved on: 
Monday, June 19, 2023

STOCKHOLM, June 19, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced the appointment of Jarl Ulf Jungnelius M.D.

Key Points: 
  • STOCKHOLM, June 19, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced the appointment of Jarl Ulf Jungnelius M.D.
  • The appointment marks another step in Beactica's strategic plan to become a clinical-stage company.
  • "We are delighted to welcome Jarl Ulf Jungnelius to the Board of Beactica Therapeutics," said Dr Per Källblad, CEO of Beactica Therapeutics.
  • "His extensive experience in the corporate clinical development of life-changing oncology drugs will be valuable as Beactica accelerates its strategic plan to become a clinical-stage company."

Beactica Therapeutics appoints Jarl Ulf Jungnelius M.D. to its Board of Directors as it advances towards clinical-stage activities

Retrieved on: 
Monday, June 19, 2023

STOCKHOLM, June 19, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced the appointment of Jarl Ulf Jungnelius M.D.

Key Points: 
  • STOCKHOLM, June 19, 2023 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision oncology company, today announced the appointment of Jarl Ulf Jungnelius M.D.
  • The appointment marks another step in Beactica's strategic plan to become a clinical-stage company.
  • "We are delighted to welcome Jarl Ulf Jungnelius to the Board of Beactica Therapeutics," said Dr Per Källblad, CEO of Beactica Therapeutics.
  • "His extensive experience in the corporate clinical development of life-changing oncology drugs will be valuable as Beactica accelerates its strategic plan to become a clinical-stage company."

Cogent Biosciences Announces Positive Lead-In Data from Ongoing Phase 3 PEAK Trial Evaluating Bezuclastinib in Combination with Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST)

Retrieved on: 
Saturday, June 3, 2023

WALTHAM, Mass. and BOULDER, Colo., June 03, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive lead-in data from its ongoing Phase 3 PEAK trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST). The data are being presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. 

Key Points: 
  • and BOULDER, Colo., June 03, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive lead-in data from its ongoing Phase 3 PEAK trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST).
  • The data are being presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • As of the cutoff date of March 29, 2023, the combination of bezuclastinib and sunitinib was generally well-tolerated with an encouraging safety profile.
  • Cogent is actively enrolling patients in Part 2 of the Phase 3 registration-enabling PEAK trial, which is expected to include approximately 388 second-line, post imatinib GIST patients.

Sarah Cannon Research Institute to Present Latest Oncology Research Insights at 2023 ASCO® Annual Meeting

Retrieved on: 
Thursday, June 1, 2023

Sarah Cannon Research Institute (SCRI) announced that its network of research leaders have been selected to deliver insights through more than 135 abstracts and presentations at the 2023 American Society of Clinical Oncology (ASCO®) Annual Meeting June 2-6, 2023.

Key Points: 
  • Sarah Cannon Research Institute (SCRI) announced that its network of research leaders have been selected to deliver insights through more than 135 abstracts and presentations at the 2023 American Society of Clinical Oncology (ASCO®) Annual Meeting June 2-6, 2023.
  • In 2022, SCRI joined together with US Oncology Research as one company to transform oncology research and improve care in more than 24 states across the U.S. Operating as SCRI, the unified research network has over 1,300 physicians enrolling patients to more than 1,000 trials annually.
  • “The collaborations across SCRI’s expanded network are accelerating progress and serving more patients closer to where they live,” says Howard A.
  • “We are looking forward to this year’s Annual Meeting where we will be discussing the results of trials that are advancing therapies across a variety of cancers.”
    For a comprehensive list of abstracts and presentations, click here .

RayzeBio Announces First Patient Dosed in Phase 3 ACTION-1 Study, Evaluating RYZ101 (Actinium-225 DOTATATE) in Neuroendocrine Tumors

Retrieved on: 
Wednesday, May 31, 2023

“Patients with GEP-NETs have very limited options upon progression after Lutetium-177 labelled somatostatin analogue therapy,” said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology.

Key Points: 
  • “Patients with GEP-NETs have very limited options upon progression after Lutetium-177 labelled somatostatin analogue therapy,” said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology.
  • Patients randomized to SOC are allowed to crossover to RYZ101 upon disease progression.
  • “We are very encouraged by the continued interest in and potential of RYZ101.
  • I look forward to working with the GEP-NET community to advance RYZ101 in this important therapeutic indication.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Thursday, May 25, 2023

After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for KEYTRUDA plus LENVIMA versus 69.6% and 60.2% for sunitinib, respectively.
  • Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received KEYTRUDA plus LENVIMA versus 60.3% of patients who received sunitinib.

Deciphera Pharmaceuticals to Present Data from INTRIGUE Phase 3 Study of QINLOCK® (ripretinib) and Trial-in-Progress Poster for INSIGHT Pivotal Phase 3 Study of QINLOCK® at the 2023 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Thursday, May 25, 2023

“As we prepare to initiate our INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations, we are excited to share details on the study design and additional supporting data from the INTRIGUE study.

Key Points: 
  • “As we prepare to initiate our INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations, we are excited to share details on the study design and additional supporting data from the INTRIGUE study.
  • In the all-patient intent-to-treat population, overall survival was 35.5 months in the QINLOCK arm and 30.9 months in the sunitinib arm.
  • The favorable safety profile was consistent with our primary analysis, with fewer patients on QINLOCK experiencing Grade 3/4 treatment-emergent adverse events compared to sunitinib.
  • Presentation details are as follows:
    Title: Overall survival and long-term safety in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: Updated analyses from INTRIGUE.

Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders

Retrieved on: 
Wednesday, March 22, 2023

Brain penetrant inhibitors of TYK2/JAK1 have the potential to bring this validated immune target to brain disorders.

Key Points: 
  • Brain penetrant inhibitors of TYK2/JAK1 have the potential to bring this validated immune target to brain disorders.
  • There are currently no brain penetrant, selective, dual TYK2/JAK1 inhibitors approved for brain disorders.
  • We have delivered what we believe is a best-in-class dual TYK2/JAK1 molecule and the team at Biohaven has the clinical development expertise to explore its utility in brain disorders.
  • We are excited to work with Chris and the team at Highlightll to advance this novel and highly differentiated dual TYK2/JAK1 inhibitor in the treatment of brain disorders."

Deciphera Pharmaceuticals Announces QINLOCK® Included in NCCN Guidelines® for the Treatment of Second-Line GIST Patients and FDA Grants Breakthrough Therapy Designation for QINLOCK in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18

Retrieved on: 
Tuesday, March 14, 2023

“The Breakthrough Therapy Designation reflects the substantial clinical benefit of QINLOCK in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from the INTRIGUE Phase 3 study.

Key Points: 
  • “The Breakthrough Therapy Designation reflects the substantial clinical benefit of QINLOCK in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from the INTRIGUE Phase 3 study.
  • If approved, we believe QINLOCK has the potential to become the standard-of-care for this group of second-line GIST patients around the world.
  • Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving QINLOCK compared to patients receiving sunitinib.
  • Patients with mutations in KIT exon 11 and exon 17/18 only (n=52) derived substantially improved clinical benefit with QINLOCK versus sunitinib.