On September 22, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported that it will host a webcast to disclose initial phase 2 clinical trial results for BDTX-1535 in patients with recurrent EGFRm NSCLC on Monday, September 23, 2024, at 8:00am ET (Press release, Black Diamond Therapeutics, SEP 22, 2024, View Source [SID1234646782]).

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Webcast information

The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event.

On September 23, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM) (Press release, Ideaya Biosciences, SEP 22, 2024, View Source [SID1234646788]). Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM.

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The investor webcast presentation agenda to review the interim Phase 2 clinical data and regulatory update for darovasertib in neoadjuvant UM will be the following:

Market introduction: annual incidence of UM
Registrational trial design based on FDA Type C meeting guidance
Phase 2 clinical data update
Baseline characteristics
AE profile
Clinical efficacy from Phase 2 company-sponsored and IST
The investor webcast and conference call will include participation from a key opinion leader. IDEAYA management, Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences, and Darrin Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences, will also serve as presenters. The link to the investor webcast will be available on the Investor Relations Events section of the Company’s website at: View Sourceevents" target="_blank" title="View Sourceevents" rel="nofollow">View Source." target="_blank" title="View Sourceevents" target="_blank" title="View Sourceevents" rel="nofollow">View Source." rel="nofollow">View Source Registration is available at View Sourceevents" target="_blank" title="View Sourceevents" rel="nofollow">View Source or View Source in advance of the event.

IDEAYA’s darovasertib investor webcast presentation, as well as an updated corporate presentation, which will incorporate the updated darovasertib clinical data and regulatory update, will be available on the company’s website, at its Investor Relations portal (View Source) at approximately 8:00 am ET on Monday, September 23, 2024.

On September 21, 2024 Intas Pharmaceuticals Limited ("Intas") reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY (serplulimab, approved as Hansizhuang in China), in European markets (Press release, Intas Pharmaceuticals, SEP 21, 2024, View Source [SID1234646790]).

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Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug status designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC).

Serplulimab will be commercialised by Intas through its subsidiary, Accord Healthcare Ltd (Accord), across more than 30 countries in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe. This positive opinion from CHMP marks another step closer for both Henlius and Intas to provide serplulimab for patients in Europe.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius’ patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide."

Paul Tredwell, Executive Vice President of EMENA at Accord, said "I am thrilled with the CHMP’s positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis."

Alex Falgas, Senior Vice President of Business Development at Accord said "The CHMP’s positive opinion on serplulimab is a pivotal moment in our mission to provide world-class cancer treatments to patients in Europe. This strengthens our oncology portfolio and reinforces Accord’s commitment to alleviating the global cancer burden, ensuring greater access to innovative therapies for those in need."

According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. [1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer cases, and is associated with early metastasis, rapid disease progression, and an extremely poor prognosis.

The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC.

On September 20, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers (Press release, Merck & Co, SEP 20, 2024, View Source [SID1234646767]). The first opinion recommends the approval of KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy. The second positive opinion recommends the approval of KEYTRUDA in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and final decisions are expected in the fourth quarter of 2024.

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"At Merck, we are deeply committed to expanding the role of KEYTRUDA to improve outcomes for more patients facing difficult-to-treat gynecologic cancers as we work to address the impact of women’s cancers around the world," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "These positive CHMP opinions bring us one step closer to providing new immunotherapy-based regimens to more patients with endometrial and cervical cancer in the European Union who may benefit. We look forward to the European Commission’s decisions."

The recommendation in primary advanced or recurrent endometrial carcinoma is based on the NRG-GY018 trial, also known as KEYNOTE-868, evaluating KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent. In this study, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus carboplatin and paclitaxel. If approved, this would mark the third indication for KEYTRUDA in endometrial cancer in Europe. KEYTRUDA plus LENVIMA (lenvatinib) was approved in November 2021 for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation, and KEYTRUDA monotherapy was approved in April 2022 for these patients who have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors. In June 2024, KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, was approved in the U.S. for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

The recommendation in newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer is based on the KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, in which KEYTRUDA in combination with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS versus CRT alone. If approved, this would mark the second indication for KEYTRUDA in cervical cancer in Europe. KEYTRUDA plus chemotherapy, with or without bevacizumab, was approved in April 2022 for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). In January 2024, KEYTRUDA in combination with CRT was approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

About endometrial carcinoma

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. Globally, endometrial cancer is the sixth most common cancer in women and 15th most common cancer overall. Worldwide, it is estimated there were approximately 420,368 patients diagnosed with endometrial cancer and 97,723 patient deaths from the disease in 2022. In Europe, it is estimated there were approximately 124,874 patients diagnosed with endometrial cancer and 30,272 patient deaths from the disease in 2022.

About cervical cancer

Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. All women are at risk for cervical cancer, and it is most frequently diagnosed between the ages of 35 and 44. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most common cancer in women globally. Worldwide, it is estimated there were approximately 662,301 patients diagnosed with cervical cancer and 348,874 patient deaths from the disease in 2022. In Europe, it is estimated there were approximately 58,219 new cases of cervical cancer diagnosed and 26,950 patient deaths from the disease in 2022.

On September 19, 2024, Veru Inc. (the "Company") reported to have entered into an Amended and Restated Forbearance Agreement and Amendment to September 2024 Note (the "Amended Forbearance Agreement") with Onconetix, Inc. f/k/a Blue Water Vaccines Inc. (the "Borrower"). The Amended Forbearance Agreement amends and restates the entirety of the Forbearance Agreement, dated as of April 24, 2024 (the "Original Forbearance Agreement"), which related to certain defaults by the Borrower under a Promissory Note in the principal amount of $5,000,000 due on April 19, 2024 (the "April 2024 Promissory Note") and a Promissory Note in the principal amount of $5,000,000 due on September 30, 2024 (as amended, the "September 2024 Promissory Note" and together with the April 2024 Promissory Note, the "Promissory Notes") that were issued by the Borrower to the Company to reflect payment obligations pursuant to the Asset Purchase Agreement, dated as of April 19, 2023 (the "Asset Purchase Agreement"), between the Company and the Borrower (Filing, 8-K, Veru, SEP 20, 2024, View Source [SID1234646768]).

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Pursuant to the Amended Forbearance Agreement, the forbearance period relating to the Company’s agreement to forbear from exercising its rights and remedies on account of the failure by the Borrower to pay the amounts due under the April 2024 Promissory Note on the due date of April 19, 2024 continues to end on the earlier of (a) March 31, 2025 and (b) the occurrence of an Event of Default (as defined in the Amended Forbearance Agreement) (such period, the "April 2024 Forbearance Period"). The Amended Forbearance Agreement extends the due date for the September Promissory Note until the earlier to occur of: (i) June 30, 2025 or (ii) the occurrence of any Event of Default under the Amended Forbearance Agreement. The Amended Forbearance Agreement also effected certain modifications to the payment terms in the Original Forbearance Agreement and amended certain terms of the September 2024 Promissory Note as summarized below.

The Borrower agreed in the Amended Forbearance Agreement to make the following required payments (the "Required Payments") during the April 2024 Forbearance Period first to accrued and unpaid interest under the April 2024 Promissory Note and then any remainder to the outstanding principal amount of the April 2024 Promissory Note:

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monthly payments equal to 25% (increased from 15% in the Original Forbearance Agreement) of cash receipts of the Borrower or its subsidiaries from certain sale or licensing revenues or payments, which increased amount shall begin on October 20, 2024 for cash receipts in September 2024; and

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payment of 20% (increased from 10% in the Original Forbearance Agreement) of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by the Borrower or any of its subsidiaries during the April 2024 Forbearance Period, which increased amount will begin for any net proceeds received after September 19, 2024.

The remaining balance of the April 2024 Promissory Note will be due at the end of the April 2024 Forbearance Period.

The Borrower and the Company also agreed to the following amendments to the September 2024 Promissory Note in the Amended Forbearance Agreement:

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As noted above, an extension of the maturity date to June 30, 2025;

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The accrual of interest at the rate of 10% per annum on any unpaid principal balance of the September 2024 Promissory Note commencing on October 1, 2024 through the date that the outstanding principal balance under the September 2024 Promissory Note is paid in full.

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Any amounts owed on the September 2024 Promissory Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of the Borrower and the Company, in shares of the Borrower’s common stock or a combination of cash and the Borrower’s common stock.

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Following full repayment of all principal and interest under the April 2024 Promissory Note, the Borrower will make the Required Payments first towards accrued and unpaid interest under the September 2024 Promissory Note and then towards the remaining principal balance payable under the September 2024 Promissory Note.

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If the aggregate unpaid principal outstanding under the April 2024 Promissory Note and the September 2024 Promissory Note and all accrued and unpaid interest thereon is repaid in cash on or before December 31, 2024, then the total principal balance under the September 2024 Promissory Note that will be payable by the Borrower in satisfaction of its obligations under the September 2024 Promissory Note will be reduced from $5,000,000 to $3,500,000.