On January 6, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Verastem Oncology issued a press release on December 30, 2024 that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation (Press release, Chugai, JAN 6, 2025, View Source [SID1234649424]). The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. Avutometinib was created by Chugai, and its clinical development is being conducted by Verastem Oncology.

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On January 6, 2025 BioLineRx Ltd. (Nasdaq: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has entered into definitive agreements for the purchase of an aggregate of 50,000,000 of the Company’s American Depositary Shares (ADSs) (or ADS equivalents) and accompanying warrants to purchase up to an aggregate of 50,000,000 ADSs, at a purchase price of $0.20 per ADS (or per ADS equivalent) and accompanying warrant in a registered direct offering (Press release, BioLineRx, JAN 6, 2025, View Source [SID1234649423]). The warrants will have an exercise price of $0.20 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for research and development activities, the expansion of the Company’s pipeline of potential drug candidates, and working capital and general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-276323) filed with the Securities and Exchange Commission ("SEC") on December 29, 2023 and declared effective on January 5, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On January 6, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time in San Francisco, California (Press release, Ascendis Pharma, JAN 6, 2025, View Source [SID1234649422]).

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A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On January 6, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, reported the first patient dosed in the Phase 1a/b study of ADRX-0405 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, JAN 6, 2025, View Source [SID1234649421]).

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"Advancing our second program into clinical trials marks an important milestone for Adcentrx and further validates the potential of our ADC technology platform," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "STEAP1 is an attractive ADC target, and we are excited about the first-in-class potential for ADRX-0405. We believe this novel ADC offers a unique approach to treating patients with STEAP1-expressing cancers, such as metastatic castration-resistant prostate cancer, where a significant unmet need remains for new targeted therapies."

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label dose escalation and dose expansion study being conducted across sites in the U.S. The trial is enrolling patients with select advanced solid tumors, with the primary objectives of characterizing the safety and tolerability of ADRX-0405 and determining its optimal dose. The company anticipates an initial data readout in 4Q 2025.

About ADRX-0405

ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in normal healthy tissue.

Adcentrx’s proprietary i-Conjugation technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

On January 6, 2025 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that patient enrolment has been completed in the investigatorinitiated INSIGHT-003 trial. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the antiPD-1 therapy, KEYTRUDA (pembrolizumab) and doublet chemotherapy as first line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC) (Press release, Immutep, JAN 6, 2025, View Source [SID1234649416]).

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The Phase I trial has reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF.

First Overall Survival results from INSIGHT-003 were reported on 14 November 2024, showing mature data in patients with a minimum follow-up of 22 months (N=21) achieved a median Overall Survival of 32.9 months and a 24-month Overall Survival rate of 81.0%1 . These results compare favourably to the 22.0-month median OS and 24-month OS rate of 45.5% from a registrational trial of anti-PD-1 and doublet chemotherapy in nonsquamous 1L NSCLC regardless of PD-L1 expression.

Additional data updates from INSIGHT-003 are expected in 2025 and beyond. For more information on the trial, please visit clinicaltrials.gov (NCT03252938).

About INSIGHT-003
INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF and several other German centres. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in first line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.