On July 1, 2024 Aptevo Therapeutics Inc., a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported the closing of its previously announced offering of (i) 5,339,806 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 10,679,612 shares of its common stock (the "Common Warrants") at a purchase price of $0.515 per share and associated Common Warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptevo Therapeutics, JUL 1, 2024, View Source [SID1234644632]). Each share of common stock is being offered together with two Common Warrants, each to purchase one share of common stock. The Common Warrants have an exercise price of $0.515 per share, are exercisable upon stockholder approval, and will expire five years following the date stockholder approval.

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Roth Capital Partners acted as placement agent of the offering, with Dawson James Securities, Inc. acted as co-agent. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, were approximately $2.75 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-280226), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on June 28, 2024. The offering was made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected]. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. All offers were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company also amended certain existing warrants that were previously issued in (i) August 2023 to purchase up to 41,239 shares of the Company’s common stock and have exercise price of $27.28 per share, (ii) November 2023 to purchase up to 610,334 shares of the Company’s common stock and have exercise price of $10.252 per share, and (iii) April 2024 to purchase up to 6,666,668 shares of the Company’s common stock and have exercise price of $1.35 per share, whereas effective upon the closing of the offering, such existing warrants have a reduced exercise price of $0.515 per share and shall become exercisable upon stockholder approval.

On July 1, 2024 Vivos Inc. reported the company filed the application for an Investigational Device Exemption ("IDE") (Press release, Vivos, JUL 1, 2024, View Source [SID1234644629]).

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The filing was an amendment, addressing the FDA comments to our previous application (Q211938/S001). Today’s IDE submission marks our first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel Precision Radionuclide Therapy. We are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Our IDE filing contained reports on two complex studies, RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. This current IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, we repeated underlying testing to strengthen our answers with current data. Dr. Korenko stated, "we are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly."

In closing Dr. Korenko stated, "We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic’s Internal Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

Dr. Michael Korenko

Vivos Inc.

Michael K. Korenko, Sc.D.

President & CEO

Email: [email protected]

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On July 1, 2024 Vivesto AB, an oncology-focused research and development company, reported that new positive preclinical efficacy data was obtained further supporting the continued development of the candidate drug Cantrixil for hematological cancer (Press release, Vivesto, JUL 1, 2024, View Source [SID1234644628]). The new in vitro data in hematological cancer cell lines show clear positive effects in combination with other anti-cancer drugs.

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"The results obtained provide essential information about the action of Cantrixil in combination with other anti-cancer drugs and gives good guidance in the continued preclinical evaluation and moving of the program towards clinical studies in hard-to-treat hematological cancer indications. An understanding of the effects of combinations is important since Cantrixil, as almost all other new cancer therapies, would be developed in the clinic and initially used when marketed in combination with other anti-cancer agents," said Erik Kinnman, CEO of Vivesto.

The new preclinical data further strengthens previous positive results with Cantrixil, which has shown strong cytotoxic effects at low doses in cell lines derived from patients with hematological cancers. Furthermore, the data provide guidance to upcoming in vivo experiments, as well as towards clinical development. Specifically, the data adds input to the dosing selection and regime in the planning of the next set of experiments, which will include in vivo hematological cancer models and patient sample testing.

On July 1, 2024 TRACON Pharmaceuticals (NASDAQ: TCON) reported the objective response rate (ORR) by blinded independent central review (BICR) in the fully enrolled ENVASARC pivotal trial in the 82 evaluable patients is 5% (four responders), which is lower than the primary endpoint of the study of 11% ORR by BICR needed to support a biologics license application (BLA) (Press release, Tracon Pharmaceuticals, JUL 1, 2024, View Source [SID1234644627]). As a result, the Company is terminating further development of envafolimab and is focusing entirely on exploring strategic alternatives in the near term that may include, but are not limited to, a merger, reverse merger, acquisition, other business combination, sales of assets, licensing or other strategic transactions involving the Company.

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In pursuit of any potential strategic transaction, TRACON plans to leverage its turnkey in-house Product Development Platform (PDP) utilizing integrated Veeva systems that has been used to conduct more than 15 Phase 1, 2 or 3 oncology trials at more than 120 sites in the U.S. and Europe across more than ten tumor types over 12 years, at a fully burdened cost of less than $100,000 per patient. TRACON offers cost-savings, time savings and enhanced quality of clinical trials using its PDP.

There can be no assurance the exploration of strategic alternatives will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms. To the extent that it cannot complete a strategic transaction, there is no guarantee that the Company will continue as a going concern. TRACON does not expect to disclose developments with respect to this process until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded disclosure is appropriate or legally required.

"We are proud of our execution of the largest trial ever done in the sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma using TRACON’s Product Development Platform," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "While individual patients derived benefit from envafolimab, the response rate by blinded independent central review in the ENVASARC trial of envafolimab as a single agent does not support a BLA. We are therefore discontinuing all of our clinical development activities and intend to take action to immediately reduce cash burn to better position the company for this strategic alternative process. We plan to leverage the value of our PDP in pursuing strategic alternatives."

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. The primary endpoint is ORR by blinded independent central review of nine responses in cohort C of approximately 80 patients with duration of response a key secondary endpoint. The trial was fully enrolled and the primary endpoint was not met. As a result, TRACON discontinued further development of envafolimab.

On July 01, 2024 Syncromune Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for SYNC-T SV-102 therapy, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Syncromune, JUL 1, 2024, View Source [SID1234644626]). SV-102 is part of Syncromune Inc.’s innovative SYNC-T platform, an in situ personalized therapy that uniquely employs a combination multi-target approach to cancer treatment, aiming to improve outcomes and quality of life for patients.

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The Fast Track designation was granted based on the potential of SYNC-T SV-102 therapy to address the significant unmet need in treating patients with mCRPC. This advanced form of prostate cancer affects over 40,000 men in the U.S. alone and is associated with a very poor prognosis. The Fast Track process is designed to facilitate the development and expedite the review of therapies that treat serious conditions and fulfill an unmet medical need, with the goal of getting important new treatments to patients sooner. Fast Track designation provides Syncromune with several key benefits, including more frequent FDA interactions, eligibility for accelerated approval, and priority review.

"The Fast-Track designation for SYNC-T SV-102 therapy signifies another step forward in bringing our potentially groundbreaking therapy to patients who need it most," said Eamonn Hobbs, Chief Executive Officer and co-founder of Syncromune. "This accomplishment builds upon the foundation of positive Phase 1 clinical data and recent IND clearance."

Syncromune’s lead candidate, SYNC-T SV-102, is a platform therapy that combines an in situ vaccine via partial oncolysis of a tumor followed by intratumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumor. This combination is designed to provide both immune stimulation and block immune suppression to activate and proliferate T cells to elicit a systemic anti-tumor response. Interim data from a Phase 1 study of SV-102 in males with mCRPC demonstrated an overall response rate of 85% with a favorable safety profile and tolerability. The Fast-Track designation comes on the heels of clearance of the company’s investigational new drug (IND) application, with studies expected to begin in the US this year.

Charles Link, M.D., Executive Chairman of Syncromune added, "We believe that Fast-Track designation for SYNC-T SV-102 will significantly aid our development goals for this therapy for men with difficult to treat prostate cancer. We look forward to initiating trials at multiple US sites later this year to expand our efforts to develop the SYNC-T SV-102 Therapy."