On June 12, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company, reported it has entered into a placement agency agreement for the purchase and sale of 3,753,558 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $1.065 per share (or $1.064 per pre-funded warrant in lieu thereof) (Press release, TONIX Pharmaceuticals, JUN 12, 2024, View Source [SID1234644288]). The closing of the public offering is expected to take place on or about June 13, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. 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 acting as 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 base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained 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 June 12, 2024 Sibylla Biotech and The University of Texas MD Anderson Cancer Center reported a strategic collaboration agreement to discover and develop novel small-molecule cancer therapies known as Folding Interfering Degraders (FIDs), which disrupt the proper folding of target proteins and lead to their degradation (Press release, Sibylla Biotech, JUN 12, 2024, View Source [SID1234644287]).

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Under the agreement, Sibylla and MD Anderson will jointly conduct discovery and development work from target identification through drug candidate nomination on selected proteins, with the potential to continue further pre-clinical and clinical development. The collaboration brings together Sibylla’s Pharmacological Protein Inactivation by Folding Intermediates Targeting (PPI-FIT) technology with the drug development expertise and capabilities of MD Anderson’s Therapeutics Discovery division.

"The Sibylla team is committed to expanding the applications of our PPI-FIT technology and FIDs to provide new treatment options for hard-to-treat indications. This collaboration builds upon the progress we have achieved to date and the applicability of our technology and know-how," said Lidia Pieri, PhD, MBA, Co-Founder and Chief Executive Officer of Sibylla Biotech. "We value the opportunity to work with MD Anderson’s team of drug development experts in order to foster our vision of treating patients with high unmet medical need."

Sibylla’s proprietary PPI-FIT technology is used to discover and develop FIDs, small molecules that induce the degradation of target proteins by interfering with the folding pathway. Notably, PPI-FIT can be applied to target proteins currently considered "undruggable" due to the absence of suitable pockets in their native state.

"Folding interfering degraders represent an exciting new modality to target key cancer drivers, and we look forward to opportunities to advance compelling candidates forward as novel therapeutic options," said Tim Heffernan, Ph.D., vice president and head of Therapeutics Discovery at MD Anderson. "By aligning Sibylla’s innovative PPI-FIT technology with our drug development engine, we hope to create impactful new medicines that will expand options for patients in need of more effective therapies."

By uniting scientists, clinicians and drug development experts together within MD Anderson, the institution’s Therapeutics Discovery division is designed to eliminate the bottlenecks slowing traditional drug discovery. Seamless integration with MD Anderson physicians allows Therapeutics Discovery to develop impactful cancer therapies inspired directly by patient needs and clinical insights.

Once a drug candidate is nominated, Sibylla and MD Anderson may consider further drug development, translational, and clinical activities to advance the candidate to patients in need.

On June 12, 2024 Race Oncology reported that the United States Food and Drug Administration (FDA) has extended Orphan Drug Designation (ODD) to our proprietary formulation of bisantrene, RC220, for acute myeloid leukemia (Press release, Race Oncology, JUN 12, 2024, View Source [SID1234644285]).

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Race CEO Dr Daniel Tillett spoke with Proactive about this significant announcement and the commercial advantage that the ODD will bring to bisantrene.

On Prelude therapeutics presented its corporate presentation (Presentation, Prelude Therapeutics, JUN 12, 2024, View Source [SID1234644283]).

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On June 12, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a data update from its ongoing VERSATILE-002 Phase 2 clinical trial (Press release, PDS Biotechnology, JUN 12, 2024, View Source [SID1234644282]). VERSATILE-002 is evaluating Versamune HPV + KEYTRUDA (pembrolizumab) in patients with HPV16-positive head and neck squamous cell cancer ("HNSCC").

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The Kaplan-Meier analysis described below captures the survival data for immune checkpoint inhibitor ("ICI") naïve patients from the ongoing VERSATILE-002 Phase 2 clinical trial. All patients whose data are reported in the Kaplan-Meier analysis are properly censored to confirm their follow-up and survival status.

Based on a data cut as of May 17, 2024, the updated survival data for the cohort of ICI naïve patients after an additional follow-up of approximately 6 months in the VERSATILE-02 Phase 2 clinical trial with a total of 53 enrolled patients was as follows:

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mOS is 30 months, consistent with data presented at the Company’s Key Opinion Leader event on May 9, 2024, which was based on a data cut as of November 30, 2023.

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27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.

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The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of the patients continue to be followed for survival.

Full data from the May 17, 2024 data cut are expected to be announced in Q3 2024.

Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech stated, "In recurrent and/or metastatic HNSCC objective response rate and progression-free survival have generally not translated into increased survival, and under current standards of care survival rates are well established to be less than 18 months. We believe that our VERSATILE-002 clinical trial and triple combination trial provide us with the critical survival information needed to effectively design the statistical primary endpoint in our planned Phase 3 trial".

The Company continues to advance its clinical strategy, which consists of a three arm registrational trial in first line treatment of HPV16-positive recurrent/metastatic HNSCC. The planned trial has two active arms: the double combination of Versamune HPV + pembrolizumab, and the triple combination of Versamune HPV + PDS01ADC + pembrolizumab. PDS01ADC is the Company’s tumor-targeted IL-12-fused antibody-drug conjugate ("ADC"), which has shown promise in ongoing Phase 2 clinical trials including a Phase 2 clinical trial of Versamune HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.