PKMYT1

Acrivon Therapeutics Reports Initial Positive Clinical Data for ACR-368 and Pipeline Program Progress Today at Corporate R&D Event

Retrieved on: 
수요일, 4월 24, 2024
Cancer, Ovarian cancer, RECIST, AP3, Trial of the century, IND, PKMYT1, Dor, Patient, Endometrial cancer, Medicine, WEE1, Event, Neoplasm, ACRV, Clinical trial, Therapy, File, Pharmaceutical industry

WATERTOWN, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics (AP3), to host a corporate R&D event. The company plans to present initial positive clinical data from the ongoing registrational-intent Phase 2 ACR-368 clinical trials, which showed prospective validation of the proprietary ACR-368 OncoSignature patient selection biomarker test with a 50% confirmed objective response rate (ORR) in patients with ovarian and endometrial cancers. Acrivon is also sharing new preclinical data for ACR-2316, now with accelerated IND filing timelines, as well as actionable findings with the machine learning-enabled AP3 platform.

Key Points: 
  • Acrivon is also sharing new preclinical data for ACR-2316, now with accelerated IND filing timelines, as well as actionable findings with the machine learning-enabled AP3 platform.
  • “Today we present initial clinical data from our ongoing Phase 2 clinical trial which we believe highlights the power of our next generation proteomics-based AP3 precision medicine platform,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics.
  • Consistent with past trials, the ACR-368 treatment-related adverse event profile was predominantly reversible and transient with only mechanism-based, hematological adverse events.
  • The webcast will be available for at least 30 days following the event.

Debiopharm & Repare Therapeutics Announce First Patient Dosed in Phase 1/1b Mythic Trial Evaluating the Synthetic Lethal Combination of WEE1 AND PKMYT1 Inhibition

Retrieved on: 
화요일, 4월 30, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Cancer, Safety, Pharmacokinetics, Infection, MD, Doctor of Philosophy, PKMYT1, Patient, WEE1, Clinical trial, Pharmaceutical industry

In this trial, Debiopharm and Repare seek to assess the safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of this PKMYT1 and WEE1 inhibitor combination.

Key Points: 
  • In this trial, Debiopharm and Repare seek to assess the safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of this PKMYT1 and WEE1 inhibitor combination.
  • In early January, Debiopharm and Repare announced a collaboration to evaluate the clinical combination of Debio 0123, an oral, brain-penetrant, highly selective WEE1 kinase inhibitor and lunresertib, a first-in-class, selective and potent oral small molecule inhibitor of PKMYT1.
  • This combination provides us a unique opportunity to optimize dosing between two selective compounds and overcome limitations inherent to dual-inhibitor approaches.
  • We expect this clinical collaboration will allow us to optimize the excellent synergy we saw preclinically to maximize patient benefit and tolerability.”

Exelixis Announces First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
화요일, 4월 30, 2024
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Education, PFS, Abbreviated New Drug Application, European Patent Office, Experiment, Breast, NET, ASCO, RCC, Associate, Translation, European Medicines Agency, Hearing, PIN, Drug development, European Patent Convention, Metastasis, Conference, Liver disease, ADC, Stada Arzneimittel, Tablet, Baylor College of Medicine, Distinguishing, Therapy, NHT, Calendar, BIRC, Huntsman Cancer Institute, OS, Dean (education), Docetaxel, PKMYT1, Checkmate, Prostate cancer, ITT, EPO, USP1, University, PARP, Immunotherapy, Superior, PLK4, Patent, Royalty payment, Patient, Society, Acquisition, Translational research, Neoplasm, Share repurchase, Annual general meeting, Baylor University

Exelixis’ 2024 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.

Key Points: 
  • Exelixis’ 2024 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended March 31, 2024, Exelixis earned $39.6 million in royalty revenues.
  • In January, Exelixis announced the appointments of Mary C. Beckerle, Ph.D., and S. Gail Eckhardt, M.D., to the Exelixis Board of Directors, effective January 5, 2024.
  • Exelixis management will discuss the company’s financial results for the first quarter of 2024 and provide a general business update during a conference call beginning at 5:00 p.m.

Repare Therapeutics & Debiopharm Announce First Patient Dosed in Phase 1/1b MYTHIC Trial Evaluating the Synthetic Lethal Combination of PKMYT1 and WEE1 Inhibition

Retrieved on: 
화요일, 4월 30, 2024
Research, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Cancer, Safety, Pharmacokinetics, Infection, MD, Doctor of Philosophy, PKMYT1, Patient, WEE1, Clinical trial, Therapy, Pharmaceutical industry

In this trial, Debiopharm and Repare seek to assess the safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of this PKMYT1 and WEE1 inhibitor combination.

Key Points: 
  • In this trial, Debiopharm and Repare seek to assess the safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of this PKMYT1 and WEE1 inhibitor combination.
  • In early January, Repare and Debiopharm announced a collaboration to evaluate the clinical combination of lunresertib, a first-in-class, selective and potent oral small molecule inhibitor of PKMYT1, and Debio 0123, an oral, brain-penetrant, highly selective WEE1 kinase inhibitor.
  • “We are excited to have treated our first patient with lunresertib and Debio 0123,” said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare.
  • This combination provides us a unique opportunity to optimize dosing between two selective compounds and overcome limitations inherent to dual-inhibitor approaches.

Acrivon Therapeutics Presents Data at AACR Annual Meeting Highlighting the Capabilities of Acrivon Predictive Precision Proteomics (AP3) for the Discovery of ACR-2316, a Novel, Selective WEE1/PKMYT1 Inhibitor, and the Identification of Actionable Resistan

Retrieved on: 
수요일, 4월 10, 2024
IC50, AP3, Drug resistance, Proteomics, PDX, CDX, Cell cycle, PKMYT1, Patient, Medicine, WEE1, Neoplasm, ACRV, AACR, Drug development, Biomarker, Drug discovery, Therapy, Ovarian cancer, Pharmaceutical industry

WATERTOWN, Mass., April 10, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics (AP3), today announced data from two posters that the company presented at the American Association for Cancer Research (AACR) Annual Meeting.

Key Points: 
  • “Uniquely enabled by AP3, we designed a selective and potent dual inhibitor of both WEE1 and PKMYT1, ACR-2316, designed for potent single agent activity.
  • We presented preclinical data showing its superior activity versus benchmark WEE1 and PKMYT1 single-agent inhibitors in multiple cancer models and look forward to advancing this compound into the clinic.
  • The complete responses observed with ACR-2316 in human tumor xenograft mouse models were associated with strong WEE1 and balanced PKMYT1 inhibition activity in tumors.
  • This corresponded with the subsequent upregulation of ACR-368 OncoSignature biomarkers, indicating that the OncoSignature assay can predict which ULDG sensitized tumors would be responsive to treatment with ACR-368.

Acrivon Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
목요일, 3월 28, 2024
WEE1, Research, ACRV, Ovarian cancer, Carcinoma, Drug discovery, Patient, Neoplasm, Cell cycle, AP3, IC50, Proteomics, Abstract, AACR, PKMYT1, Clinical trial, Therapy, Toxicology, Mass spectrometry, GLP, Medicine, LDG, Pharmaceutical industry

“On the heels of a productive 2023, we are off to a tremendous start in 2024, which is an important and data-driven year for Acrivon,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon.

Key Points: 
  • “On the heels of a productive 2023, we are off to a tremendous start in 2024, which is an important and data-driven year for Acrivon,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon.
  • We remain on track to present more mature clinical data during the first half of 2024.
  • Additionally, our novel WEE1/PKMYT1 inhibitor ACR-2316 continues to demonstrate robust and superior single-agent preclinical activity and tolerability as demonstrated in head-to-head benchmark studies.
  • As of December 31, 2023, the company had cash, cash equivalents and marketable securities of $127.5 million, which is expected to fund operations into the fourth quarter of 2025.

Acrivon Therapeutics to Present Data at AACR Annual Meeting Demonstrating Power of Acrivon Predictive Precision Proteomics (AP3) Platform and its Internally-Discovered, Potent WEE1/PKMYT1 Development Candidate, ACR-2316

Retrieved on: 
화요일, 3월 5, 2024
Drug resistance, Neoplasm, Drug design, AACR, Therapy, Patient, ACRV, Medicine, AP3, PKMYT1, WEE1, Gemcitabine, Pharmaceutical industry

WATERTOWN, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing its proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics (AP3), today announced the company will be presenting data at the American Association for Cancer Research (AACR) Annual Meeting taking place April 5 – 10, 2024 in San Diego, CA.

Key Points: 
  • “The data we will be presenting reinforce the broad applicability of our highly differentiated, actionable AP3 platform technology,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics.
  • “ACR-2316 is our first fully internally-discovered development candidate which was rapidly generated through co-crystallography-based drug design and uniquely leverages AP3.
  • Our platform enables us to generate selective, potent single-agent active molecules, such as ACR-2316, that we believe can address some of the key limitations of current WEE1 and PKMYT1 inhibitors.
  • We look forward to presenting these two datasets at AACR next month.”

Repare Therapeutics to Regain Global Rights to Camonsertib

Retrieved on: 
월요일, 2월 12, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Health Technology, RECIST, PKMYT1, Patient, Therapy, ATR, Pharmaceutical industry

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced today that it will regain global development and commercialization rights to camonsertib (RP-3500), a potential best-in-class oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), following termination of its collaboration agreement with Roche.

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced today that it will regain global development and commercialization rights to camonsertib (RP-3500), a potential best-in-class oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), following termination of its collaboration agreement with Roche.
  • Repare regains full control of all rights for camonsertib, a potential best-in-class inhibitor of ATR.
  • Repare expects to report additional camonsertib and lunresertib combination therapy data from the expansion cohorts of this trial in the second half of 2024.
  • Repare continues to expect that its existing cash, cash equivalents, and marketable securities will provide sufficient capital to fund planned operations into mid-2026.

Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
화요일, 2월 6, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Molecule, Royalty payment, Conference, Liver disease, Calendar, Breast, Immunotherapy, RCC, PIN, ASCO, NHT, Progression-free survival, Safety, FDA, PLK4, ADC, ITT, PKMYT1, Associate, University, Baylor University, PARP, USP1, Society, Neck, Science, Acquisition, Biology, Superior, Huntsman Cancer Institute, Dean (education), Metastasis, PFS, Translational research, Drug development, Distinguishing, Head, Food, NET, Baylor College of Medicine, Cancer, Share repurchase, BIRC, OS, SCCHN, Neoplasm, Congress, National Cancer Institute, Abbreviated New Drug Application, Research, Docetaxel, Translation, Prostate cancer, Therapy, ESMO, Education, Experiment, Checkmate, Pharmaceutical industry

In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.

Key Points: 
  • In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2023, Exelixis earned $40.7 million and $148.5 million, respectively, in royalty revenues.
  • In October 2023, detailed results were presented from the phase 3 CABINET pivotal trial at the 2023 ESMO Congress.
  • Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024

Retrieved on: 
일요일, 1월 7, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Associate, Baylor College of Medicine, PKMYT1, BRCA, FDA, Breast, Progression-free survival, Society, Insilico Medicine, Cancer, Distinguishing, Translational research, Neck, PLK4, Workforce, Conference, Translation, Biology, IND, Colorectal cancer, MSN, NHT, University, PARP, Doctor of Philosophy, Calendar, District court, Harvard University, Immunotherapy, Food, Johnson & Johnson, NET, Huntsman Corporation, Cell adhesion, Therapy, TKI, USP1, Neoplasm, Experiment, Patient, NCI, Corporation, Baylor University, Huntsman Cancer Institute, Research, Acquisition, Dean (education), Education, Pnet, Head, Shareholder, Share repurchase, PFS, ADC, Pharmaceutical industry

The preliminary 2023 financial information presented in this press release has not been audited and is subject to change.

Key Points: 
  • The preliminary 2023 financial information presented in this press release has not been audited and is subject to change.
  • The complete Exelixis Fourth Quarter and Fiscal Year 2023 Financial Results are planned for release after market on Tuesday, February 6, 2024.
  • Exelixis expects to substantially complete the restructuring in the first quarter of 2024 and recognize a restructuring charge of approximately $25 million.
  • In 2024, the company expects to designate two new programs to DC status, including a small molecule PLK4 inhibitor and an additional ADC.