On July 8, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the grant of stock options to purchase 108,292 shares of its common stock to seven new employees (Press release, Verastem, JUL 8, 2024, View Source [SID1234644720]). The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employees’ acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to $3.25 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on July 1, 2024. The stock options to purchase 78,292 shares of common stock that were granted to seven new employees will vest at a rate of twenty-five percent (25%) on the one-year anniversary of each employee’s date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date. A stock option to purchase 30,000 shares of common stock granted to one new employee will vest upon the achievement of certain regulatory milestones, provided that the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date.

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On July 8, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company, reported that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof) (Press release, TONIX Pharmaceuticals, JUL 8, 2024, View Source [SID1234644719]). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 registration or qualification under the securities laws of any such state or jurisdiction.

On July 8, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, JUL 8, 2024, View Source [SID1234644717]).

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"We are thrilled to receive ODD from the EMA for the treatment of AML. This designation along with the recently announced strong preliminary Phase 2 data and previous FDA ODD designation reinforces our continued progress and commitment to developing SLS009 as a potential treatment for AML," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We look forward to working closely with the EMA and the FDA to advance SLS009 clinical development and ultimately deliver it to the patients who need it most. To that end, we remain on track to share further data around SLS009 in the third quarter of this year."

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medical Association (EMA) Committee for Orphan Medicinal Products. The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives that include a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization. The treatment must also provide significant benefit to those affected by the condition.

"We are excited to receive this designation from the EMA to complement the earlier FDA’s ODD. The ongoing clinical trial data continues to support significant benefit in patients with AML relapsed after or refractory to venetoclax regimens and the EMA recognizes the significant benefit of SLS009 for patients impacted by AML. Together with EMA’s Protocol Assistance will define a path to an eventual regulatory approval in the European Union and working with the FDA towards a potential approval in the US," said Andrew Elnatan, Vice President of Regulatory Affairs at SELLAS.

The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with aza/ven at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival over 3 months. ASXL1 mutation has been identified as the most promising target mutation based on biology of the mutation and the SLS009 mechanism of action that has been confirmed by the clinical results to date. The trial continues enrollment in two cohorts, both enrolling patients with myelodysplasia-related mutations, one with ASXL1 mutations and the other with myelodysplasia-related mutations other than ASXL1. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

On July 8, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that it will host an investor webcast to provide an update on its RMC-6236 pancreatic ductal adenocarcinoma (PDAC) clinical development program (Press release, Revolution Medicines, JUL 8, 2024, View Source [SID1234644716]). Speakers will include members of Revolution Medicines’ management team, along with Brian M. Wolpin, M.D., M.P.H., professor of medicine at Harvard Medical School, and director of the Gastrointestinal Cancer Center and Robert T. & Judith B. Hale Chair in Pancreatic Cancer at Dana-Farber Cancer Institute.

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The webcast will take place at 8:00 a.m. Eastern Time on Monday, July 15, 2024. To access the live webcast, please visit the "Events & Presentations" page of Revolution Medicines’ website at View Source Additionally, a replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines website for at least 14 days following the event.

On July 8, 2024 PharmaMar (MSE:PHM) reported to have received a notification from the European Commission (EC) informing the Company of its decision to revoke the refusal to grant Marketing Authorization for Aplidin in Multiple Myeloma (Press release, PharmaMar, JUL 8, 2024, View Source [SID1234644715]).

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According to the communication received, the EC has re-evaluated the criteria applied for the participation of experts in the administrative procedure for the Marketing Authorization of Aplidin, as well as the relevant EMA rules governing conflicts of interest, so that they can ensure the objective impartiality of these experts.

Therefore, the EC notes that one of the experts of the Scientific Advisory Group (SAG) involved in the development of a rival product, was allowed to participate in the Marketing Authorization procedure for Aplidin, in accordance with the EMA rules applicable at the time.

Consequently, in order to avoid any doubt as to the objective impartiality of the assessment of the application, the Commission has decided it is appropriate to revoke the decision to refuse Marketing Authorization for Aplidin.

It is also reported that the Commission has forwarded to the EMA the opinions of the Committee for Medicinal Products for Human Use (CHMP), to request the re-evaluation of the application from the time of the onset of the detected procedural irregularity.

The European Commission’s reversal of the decision, which is totally exceptional, is a de facto acknowledgement that PharmaMar did not have all the necessary guarantees in the evaluation process for Aplidin. Now that the registration dossier has been returned to the EMA, the Company will ensure that the procedure is conducted with absolute impartiality and on a level playing field.

History of the lawsuit, 7 years of litigation

PharmaMar filed a lawsuit in October 2018 before the General Court of the European Union against the EC, seeking the annulment of the Commission’s Implementing Decision, by which it denied Marketing Authorization for Aplidin as a treatment for patients with Multiple Myeloma.

The reason for the lawsuit related to the strict conflict-of-interest checks carried out by the experts appointed by the EMA and the correct analysis of the scientific evidence presented by PharmaMar.

In October 2020, the General Court of the European Union upheld PharmaMar’s claim in full, at the extreme end of the conflict of interest, annulling the European Commission’s decision to refuse Marketing Authorization for Aplidin for the treatment of patients with Multiple Myeloma, and ordered the Commission to pay the costs.

In 2021, Estonia and Germany appealed the decision to the EU Court of Justice, although the EC decided not to do it, which could be understood as implicitly accepting the ruling.

In 2023, the Court of Justice of the European Union annulled the judgment of the General Court and referred the case back to the General Court, to rule again on the first ground for annulment urged by PharmaMar in its initial application, and to rule, if it considered it necessary, on the other claims for annulment in its action. That is, to rule not only on the conflict of interest and the breach of the Principle of Objective Impartiality by the EMA, but also on the breach of the Principle of Good Administration, the breach of the Principle of Equal Treatment and incorrect analysis of the scientific evidence presented by PharmaMar, the breach of the obligation to state reasons and the breach of the rights of defense.

The Company has always maintained that, during the evaluation process of its drug, Aplidin for the treatment of Multiple Myeloma, there was a conflict of interest of several members based on numerous objective elements, including the cooperation of one of its members with a Swedish company, XNK Therapeutics AB, developing a rival drug, as well as its participation in the development of other competing drugs.