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Arvinas Announces Upcoming Vepdegestrant Poster Presentations at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress

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木曜日, 5月 9, 2024

Congress, CDK, Proteolysis, HER2, Breast cancer, Oncology, ARVN, ESMO, Chimera, Patient, Team Impulse, Poster, Clinical trial, PROTAC

NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that two posters, including updated clinical trial data, for vepdegestrant will be presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress held from May 15-17, 2024, in Berlin, Germany.

Key Points:

NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that two posters, including updated clinical trial data, for vepdegestrant will be presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress held from May 15-17, 2024, in Berlin, Germany.
Vepdegestrant is a novel investigational PROTAC® estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
Poster session details are as follows:
Time: 12:00 – 1:00 p.m. CET/ 6:00 – 7:00 a.m.
ET
Poster Title and Number: Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, plus palbociclib (palbo) in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer: updated phase 1b cohort results, Poster 218P
Presentation Type and Abstract Number: Abstract, 453
Poster Title and Number: TACTIVE-K: phase 1b/2 study of vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with PF-07220060, a cyclin-dependent kinase (CDK)4 inhibitor, in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer, Poster 264
Presentation Type and Abstract Number: Trial-in-Progress (TiP), 488

Olema Oncology Announces New Clinical Data for Palazestrant in Combination with Ribociclib to be Presented at the 2024 ESMO Breast Cancer Annual Congress

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水曜日, 5月 8, 2024

Oncology, Congress, ID, Patient, ESMO, SAN, Breast cancer, Birth control

SAN FRANCISCO, May 08, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced that it will present new clinical data from the Company’s ongoing Phase 1b/2 clinical study of palazestrant in combination with CDK4/6 inhibitor ribociclib in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress 2024 taking place May 15-17, 2023, in Berlin, Germany.

Key Points:

SAN FRANCISCO, May 08, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced that it will present new clinical data from the Company’s ongoing Phase 1b/2 clinical study of palazestrant in combination with CDK4/6 inhibitor ribociclib in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress 2024 taking place May 15-17, 2023, in Berlin, Germany.
Details of the ESMO Breast Cancer Annual Congress 2024 poster presentation are:
A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-), advanced and/or metastatic breast cancer (ID 407)

C4 Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights

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水曜日, 5月 8, 2024

WATERTOWN, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today reported financial results for the first quarter ended March 31, 2024, as well as recent business highlights.

Key Points:

Revenue: Total revenue for the first quarter of 2024 was $3.0 million, compared to $3.8 million for the first quarter of 2023.
General and Administrative (G&A) Expense: G&A expense, net of a one-time $0.5 million restructuring charge, was $10.3 million for the first quarter of 2024.
Net Loss and Net Loss per Share: Net loss for the first quarter of 2024 was $28.4 million, compared to $34.8 million for the first quarter of 2023.
Net loss per share for the first quarter of 2024 was $0.41 compared to $0.71 for the first quarter of 2023.

Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC

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月曜日, 5月 6, 2024

FDA, Congress, Safety, Food, Oncology, Pancreatic cancer, ESMO, Biologics license application, PDAC, ASCO, Disease, Patient, Society, BTD, Lung, BLA, Annual general meeting, NSCLC, Pharmaceutical industry

“FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical Officer at Merus.

Key Points:

“FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical Officer at Merus.
The FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.
Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy.
Zeno is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer

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水曜日, 5月 8, 2024

Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Randomized controlled trial, Safety, Food, Terminal, Survival, PET, ESMO, Patient, Physician, Biopsy, Head, Standard of care, Pharmaceutical industry

“Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer.

Key Points:

“Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer.
The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone.
The FDA accepted the selection criteria and the proposed study design, which now permits CEL-SCI to enroll patients in the confirmatory study.
The goal of our smaller confirmatory study is to confirm these positive results in a prospectively defined target population.

Repare Therapeutics Provides Business and Clinical Update and Reports First Quarter 2024 Financial Results

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火曜日, 5月 7, 2024

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2024.

Key Points:

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2024.
“This was a quarter of clinical progress as we await key, near-term data on a rich set of distinctive clinical approaches for our four wholly-owned compounds in 2024,” said Lloyd M. Segal, President and Chief Executive Officer of Repare.
We are seeing continuing trends of patient response and benefit, and we are on track to report the updated dataset in the fourth quarter of 2024.
The increase in revenue for the three-month period was primarily due to the $40.0 million Roche milestone achievement in the first quarter of 2024.

Medivir to present data for the combination of fostrox + Lenvima in HCC at ESMO GI

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月曜日, 4月 29, 2024

Oncology, Poster, Congress, DNA, Cancer, Hepatocellular carcinoma, Patient, Medivir, ESMO, DNA repair, HCC

The abstract, titled "Liver pharmacodynamics in an open-label phase Ib/IIa study of fostroxacitabine bralpamide (fostrox, MIV-818) in combination with lenvatinib in 2L/3L hepatocellular carcinoma" will be presented at the conference by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea.

Key Points:

The abstract, titled "Liver pharmacodynamics in an open-label phase Ib/IIa study of fostroxacitabine bralpamide (fostrox, MIV-818) in combination with lenvatinib in 2L/3L hepatocellular carcinoma" will be presented at the conference by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea.
Dr Chon is one of the investigators in the ongoing phase Ib/IIa study.
The presentation will include pharmacodynamic data from patients in the ongoing phase Ib/IIa clinical study with fostrox + Lenvima combination, evaluating the impact on normal liver function and DNA damage in tumor cells vs healthy cells.
The presentation will also include an update on efficacy endpoints as the study has continued to mature and patients have been able to stay on treatment.

NANOBIOTIX Provides Business Update and Reports Full Year 2023 Financial Results

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水曜日, 4月 24, 2024

PARIS and CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, provided an update on operational progress and reported financial results for the year ended December 31, 2023, and announced the filing of its universal registration document (URD) for the financial year ended December 31, 2023 with the French financial market authority (Autorité des marchés financiers or AMF), as well as of the Annual Report on Form 20-F for the financial year ended December 31, 2023 with the U.S. Securities and Exchange Commission (SEC).

Key Points:

“2023 was an incredible year of progress for Nanobiotix and our NBTXR3 program.
“During 2023, we reported prolonged survival from Study 102 in head and neck cancer further reinforcing the design of our ongoing pivotal NANORAY-312 trial.
Cash and Cash Equivalents: As of December 31, 2023, Nanobiotix had €75.3 million in cash and cash equivalents, compared to €41.4 million as of December 31, 2022.
During the call, Laurent Levy, chief executive officer, and Bart van Rhijn, chief financial officer, will briefly review the Company’s year-end results and an update on business activities before taking questions from participants.

Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

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月曜日, 4月 22, 2024

“2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.

Key Points:

“2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
Presented at IDWeek 2023: In October 2023, Cidara presented new preclinical and clinical data on Novel Cloudbreak Influenza Drug-Fc Conjugate CD388 at IDWeek 2023.
Net loss for the three months ended December 31, 2023 was $3.2 million, compared to a net loss of $13.6 million for the three months ended December 31, 2022.
Net loss for the full year ended December 31, 2023 was $22.9 million, compared to a net loss of $33.6 million for the year ended December 31, 2022.

ORIC Pharmaceuticals Announces First Patients Dosed Across Three Expansion Cohorts in Phase 1b Trial of ORIC-114 in Patients with Mutated NSCLC

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月曜日, 4月 15, 2024

CNS, Progression-free survival, Patient, EGFR, ESMO, Safety, SAN, HER2, Lung cancer, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications. Based upon these data, ORIC selected the two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection. These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations. The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC.

Key Points:

These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations.
The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC.
“Following the positive dose escalation data reported at ESMO 2023, we are excited to announce the advancement of ORIC-114 into Phase 1b dose expansion,” said Pratik Multani, M.D., chief medical officer of ORIC.
Patients previously treated with an exon 20 targeted agent were eligible, including patients with CNS metastases that were either treated or untreated but asymptomatic.