On July 12, 2024 Senhwa Biosciences’ reported that its new drug Pidnarulex (CX-5461) has demonstrated efficacy in treating various solid tumors with BRCA2 or PALB2 gene defects (Press release, Senhwa Biosciences, JUL 12, 2024, View Source;data-abstract-of-pidnarulex-accepted-for-presentation-at-2024-esmo-congress-302195586.html [SID1234644809]). The abstract of this clinical trial has been selected for presentation at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress. This achievement is a significant milestone for Senhwa Biosciences and the Canadian clinical team, as it includes terminal cancer patients who although have undergone various prior treatments are found in stable condition, continuously receiving Pidnarulex (CX-5461) treatment in this trial. This highlights that Pidnarulex (CX-5461) aligns with the trend of developing new drugs for precision medicine.

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The clinical trial is an open-label, multinational, multicenter study, divided into a Main Study Cohort and an Exploratory Cohort. The Main Study Cohort includes patients with various tumors (pancreatic cancer, breast cancer, ovarian cancer, and prostate cancer) with BRCA2 and/or PALB2 gene defects. The Exploratory Cohort includes ovarian cancer patients with BRCA1 gene defects and/or other homologous recombination deficiency (HRD) genes. The primary objective of the trial is to determine the optimal dose for patients with specific gene defects while the secondary objectives are set to assess the safety and tolerability of Pidnarulex (CX-5461), and to evaluate late-onset toxicity, antitumor activity as well as improvement in patients’ quality of life. Patients enrolled in this clinical trial have undergone 2 to 10 different treatment regimens; some of them are even resistant to platinum-based chemotherapy and PARP inhibitors, leaving no other treatment options available. Encouragingly, these terminal patients have shown clinical benefits provided by the Pidnarulex (CX-5461) treatment.

The 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress will be held from September 13 to 17, 2024, in Barcelona, Spain, welcoming both in-person and online participations. This congress will showcase the latest cutting-edge cancer translational data and provide a platform for oncology professionals and scientists to network and share research and innovations. The ESMO (Free ESMO Whitepaper) Congress is a cornerstone event in oncology, recognized globally for its significant contributions to cancer treatment and research. It is one of the top three cancer medical conferences worldwide, alongside ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper). The abstract for the clinical trial of Pidnarulex (CX-5461) treating various solid tumors with BRCA1, BRCA2, and/or PALB2 gene defects (1b) was written and submitted by the Canadian clinical partner, Princess Margaret Cancer Centre. The abstract title is expected to be available online by the end of July, with the full abstract and related data to be published on September 9.

Senhwa Biosciences’ new drug, Pidnarulex (CX-5461), is currently being applied in breast cancer, ovarian cancer, pancreatic cancer, hematologic malignancies, and prostate cancer. As a new drug candidate for solid tumors in collaboration with National Institutes of Health (NIH), the first stage of clinical trials will begin in 2024. With the remarkable efforts of NIH’s professionals and medical network, Senhwa Biosciences expects the clinical outcomes of Pidnarulex (CX-5461) treating multiple cancers will make significant strides in the fight against various types of cancer.

On July 12, 2024 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported a poster presentation at the upcoming ESMO (Free ESMO Whitepaper) Congress, taking place in Barcelona, Spain, 13-17 September 2024 (Press release, Adagene, JUL 12, 2024, View Source [SID1234644801]).

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The poster will report results of an ongoing phase 1b/2 trial of Adagene’s masked anti-CTLA-4 SAFEbody in combination with the anti-PD-1 treatment pembrolizumab. The title is:

Increased Therapeutic Index of Muzastotug (Muza, ADG126), a Masked Anti-CTLA-4 SAFEbody, in Combination with Pembrolizumab (Pembro) Enables Significant Clinical Benefits and Supports Further Clinical Development in Patients with Metastatic MSS CRC

The poster will be published in accordance with the ESMO (Free ESMO Whitepaper) embargo policy on the company’s website at www.adagene.com/pipeline/publications.

On July 12, 2024 Phio Pharmaceuticals Corp., a Delaware corporation (the "Company") reported the company entered into inducement letter agreements (the "Inducement Letter Agreements") with certain holders (the "Holders") of certain of its existing warrants to purchase up to an aggregate of 545,286 shares of the Company’s common stock, $0.0001 par value (the "Common Stock"), originally issued to the Holders in February 2020 through December 2023, having exercise prices between $324.00 and $9.72 per share (the "Existing Warrants") (Filing, Phio Pharmaceuticals, JUL 12, 2024, View Source [SID1234644805]).

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The shares of Common Stock issuable upon exercise of the Existing Warrants are registered pursuant to effective registration statements on Form S-1 (Nos. 333-239779, 333-234032, 333-238204, 333-271521, 333-272526 and 333-276146) and Form S-3 (No. 333-252588).

Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.45 per share in consideration of the Company’s agreement to issue new unregistered Series C Warrants (the "Series C Warrants") to purchase up to 583,098 shares of Common Stock and new unregistered Series D Warrants (the "Series D Warrants" and, together with the Series C Warrants, the "New Warrants") to purchase up to 507,474 shares of Common Stock (collectively, the "New Warrant Shares"), issued and sold at a price of $0.125 per New Warrant. The Series C Warrants will have an exercise price of $5.45 per share, will be exercisable immediately upon issuance and have a term equal to five and one-half years from the date of issuance. The Series D Warrants will have an exercise price of $5.45 per share, will be exercisable immediately upon issuance and have a term equal to eighteen months from the date of issuance.

The Company has agreed to file a registration statement providing for the resale of the New Warrant Shares issuable upon the exercise of the New Warrants (the "Resale Registration Statement"), within 20 calendar days from the date of the Inducement Letter Agreements. Pursuant to the Inducement Letter Agreements, the Company agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any Common Stock or Common Stock equivalents or file any registration statement or any amendment or supplement to any existing registration statement (other than the Resale Registration Statement contemplated by the Inducement Letter Agreements and described above) until the earlier of (i) a period of 90 calendar days after the closing of the offering and (ii) the day following the date that the Company’s closing price on five consecutive trading days equals or exceeds $6.50 (each of which shall be after 30 calendar days after the closing of the offering).

The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $3.1 million, prior to deducting placement agent fees and estimated offering expenses. The closing of the offering occurred on July 12, 2024.

On June 27, 2024, the Company entered into an engagement letter with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which Wainwright agreed, among other things, to serve as the exclusive placement agent for the Company, on a reasonable best-efforts basis, in connection with the above-mentioned transaction. The Company will pay Wainwright (i) an aggregate cash fee equal to 7.5% of the gross proceeds from the exercise of the Existing Warrants and, if the New Warrants are exercised for cash, upon such exercise, and (ii) a management fee equal to 1.0% of the aggregate gross proceeds from the exercise of the Existing Warrants and, if the New Warrants are exercised for cash, upon such exercise. In connection with the above-mentioned offering, the Company also agreed to pay Wainwright $35,000 for non-accountable expenses, $50,000 for accountable expenses and $15,950 for clearing fees. Additionally, in connection with the above-mentioned offering, the Company agreed to issue to Wainwright or its designees as compensation, warrants to purchase up to 40,896 shares of Common Stock, equal to 7.5% of the aggregate number of Existing Warrants exercised in the offering and, if the New Warrants are exercised for cash, further warrants to purchase shares of Common Stock equal to the 7.5% of the aggregate number of New Warrants so exercised (the "Placement Agent Warrants"). The Placement Agent Warrants have or will have a term of five and one half years from the closing of the offering or the exercise of the New Warrants, as applicable, and an exercise price of $6.8125 per share of Common Stock.

The foregoing summaries of the Inducement Letter Agreements, the New Warrants and the Placement Agent Warrants do not purport to be complete and are subject to, and qualified in their entirety by, the forms of such documents attached as Exhibits 10.1, 4.1, and 4.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.

On July 12, 2024 EORTC reported that the primary endpoint has been reached in the EORTC-1333-GUCG/PEACE III Trial (Press release, EORTC, JUL 12, 2024, View Source [SID1234644802]).

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The phase III EORTC-1333-GUCG/PEACE III trial is a randomised multicentre phase III trial comparing enzalutamide vs. a combination of radium-223 dichloride and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

The full results will be presented at an upcoming medical meeting.

We extend our gratitude to the patients, investigators, and research teams who participated in the EORTC-1333-GUCG/PEACE III Trial and made this achievement possible.

This trial is supported by an investigator driven clinical trial agreement from Bayer HealthCare Pharmaceuticals Inc. and Astellas Pharma Europe. This trial is a collaboration between EORTC, UNICANCER, Clinical Trial Ireland (CTI), Canadian Urological Oncology Group (CUOG) and Latin American Cooperative Oncology Group (LACOG).

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On July 12, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that the first patient has been dosed in a Phase 1/2 trial in China, conducted by GenFleet Therapeutics, evaluating GFH375/VS-7375, a KRAS G12D (ON/OFF) inhibitor (Press release, Verastem, JUL 12, 2024, View Source [SID1234644806]).

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GFH375/VS-7375, was selected as Verastem’s lead discovery program from its collaboration with GenFleet established in 2023. GFH375/VS-7375 is an oral, potent and selective KRAS G12D dual inhibitor of ON (GTP) and OFF (GDP) states. Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024 demonstrated oral bioavailability across preclinical species, strong anti-tumor activity as a single agent and potency against intracranial tumor models suggesting the potential to treat brain metastases.

"In a short amount of time, we identified GFH375/VS-7375, a novel KRAS G12D (ON/OFF) inhibitor, as our lead discovery program last year and now the first patient has been dosed in the Phase 1/2 study by GenFleet in China," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We look forward to leveraging the initial clinical dose escalation data to accelerate our development path in the U.S., as there are currently no FDA-approved KRAS G12D-targeted treatments despite the high prevalence of this KRAS mutation in various cancers, including pancreatic, colorectal, lung and uterine."

The Phase 1 study is being conducted in approximately 20 hospitals currently in China and will evaluate the safety and efficacy of GFH375/VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The Phase 1 study will determine the recommended Phase 2 dose (RP2D) and then further evaluate in Phase 2 the efficacy and safety of GFH375/VS-7375 in patients with advanced solid tumors, such as pancreatic ductal adenocarcinoma, colorectal cancer and non-small cell lung cancer.

About GFH375/VS-7375

GFH375/VS-7375 is a potential best-in-class, potent and selective oral KRAS G12D (ON/OFF) inhibitor, identified as the lead discovery program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. GenFleet’s IND for GFH375/VS-7375 was approved in China in June 2024 and the Phase 1/2 trial in KRAS G12D-mutant solid tumors was subsequently initiated and the first patient has been dosed in July 2024. The collaboration includes three discovery programs, the first being the KRAS G12D inhibitor, and provides Verastem Oncology with exclusive options to license three compounds selected for collaboration after successful completion of pre-determined milestones in Phase 1 trials. The licenses would give Verastem Oncology development and commercialization rights outside of the GenFleet territories of mainland China, Hong Kong, Macau, and Taiwan.