On June 16, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or the "Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported the closing of an underwritten offering for gross proceeds of approximately $3.5 million to a single healthcare focused investor prior to deducting underwriting discounts and commissions and offering expenses (Press release, Coeptis Pharmaceuticals, JUN 16, 2023, View Source [SID1234632761]).

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The offering was comprised of (i) 2,150,000 shares of common stock, (ii) 1,350,000 pre-funded warrants, (iii) 3,062,500 Series A Warrants with an exercise price of $1.65 per share and a term of five years following the initial exercise date, and (iv) 3,062,500 Series B Warrants with an exercise price of $1.65 per share and a term of five years following the initial exercise date. The warrants issued in this offering are fixed priced and do not contain any variable pricing, resets or price based anti-dilution features. The pre-funded warrant is exercisable at $0.0001.

Ladenburg Thalmann & Co. Inc. acted as sole book-running manager in connection with this offering.

The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-269782), which was declared effective by the United States Securities and Exchange Commission ("SEC") on June 13, 2023 and related MEF registration statements on Form S-1 that was filed with the SEC on June 13, 2023 and June 14, 2023.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering is being made solely by means of a prospectus. A final prospectus relating to this offering was filed by Coeptis with the SEC on June 15, 2023. Copies of the final prospectus can be obtained at the SEC’s website at View Source or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

On June 16, 2023 TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, reported that the FDA has granted clearance for the clinical trial of TGI-6, its groundbreaking bispecific antibody (Press release, TG Immunopharma, JUN 16, 2023, View Source [SID1234632757]). TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling potent anti-tumor responses. The antibody demonstrates exceptional anti-tumor activity, favorable safety profiles, and remarkable druggability.

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TGI-6’s TAA is highly expressed in various solid tumors, including colorectal cancer, breast cancer, hepatocellular carcinoma, gastric cancer, ovarian cancer, pancreatic cancer, and more. This makes TGI-6 a promising candidate for the treatment of a wide range of solid tumors. Preclinical studies have shown outstanding potential, with TGI-6 inducing complete tumor regression in animal models of colorectal cancer following a single administration. Importantly, TGI-6 is designed to maintain high cytotoxic activity while minimizing the risk of cytokine release syndrome (CRS).

"We are thrilled to receive FDA clearance for the clinical trial of TGI-6," said Professor Zhigang Tian, founder of TGI and member of the Chinese Academy of Engineering and the Academia Europaea. "TGI-6 has demonstrated superior anti-tumor activity and safety in preclinical studies. We have great confidence in its potential as a novel therapy for solid tumors."

With this significant milestone, TGI is actively seeking global partners to collaborate on the development, clinical trials, and eventual commercialization of TGI-6. By partnering with pharmaceutical and biotechnology companies, TGI aims to leverage their expertise in clinical development and market access, expediting the availability of TGI-6 for patients worldwide.

TGI remains steadfast in its mission to revolutionize cancer treatment through innovative immunotherapies. With FDA clearance for the clinical trial of TGI-6, the company is poised to advance the development of precise therapies for solid tumors. Interested parties are invited to explore partnership opportunities and join TGI in their pursuit of delivering novel treatment options that improve patient outcomes.

On June 16, 2023 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), reported that Cantex Pharmaceuticals, Inc. recently obtained an exclusive worldwide license from Georgetown University for intellectual property related to the potential use of azeliragon to treat, prevent or alleviate cancer treatment-related cognitive decline (Press release, vTv Therapeutics, JUN 16, 2023, View Source [SID1234632755]). Azeliragon, a small molecule receptor for advanced glycation end products (RAGE) inhibitor, was originally discovered by vTv and studied as a potential treatment for Alzheimer’s disease. Prior to licensing azeliragon to Cantex, vTv produced a substantial body of clinical data supporting the safety and tolerability of azeliragon, as well as preclinical data demonstrating the potential therapeutic benefit of vTv’s RAGE antagonists on several diseases, including cancer and diabetic complications.

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"We once again extend our congratulations to our partners at Cantex on the continued strengthening of their IP estate for azeliragon. Already protected by a robust composition of matter patent and a variety of regulatory exclusivities, azeliragon has broad therapeutic potential which, if realized, could result in sizeable commercial opportunities in oncology and multiple other indications in which RAGE is implicated," said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. "We look forward to the results of Cantex’s collaboration with Georgetown, which will provide greater visibility into the potential of azeliragon to alleviate cognitive decline caused by chemotherapy."

About Azeliragon
Azeliragon is an orally administered small molecule drug, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was originally under development for Alzheimer’s disease by vTv Therapeutics from whom Cantex licensed it. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex is also developing azeliragon for the treatment of brain metastasis, metastatic pancreatic cancer, glioblastoma, and neoadjuvant therapy of breast cancer. In addition, a phase 2/3 trial is currently enrolling hospitalized COVID-19 patients, evaluating the efficacy of azeliragon in the prevention of acute kidney injury.

On June 16, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported clinical data of AUTO4 (Phase 1/2 LibrA T1 study), a TRBC1-targeting CAR T cell therapy in relapsed/refractory TRBC1-Positive Peripheral T-Cell Lymphoma (PTCL) at the International Conference on Malignant Lymphoma (ICML) being held June 13 to 17, 2023 in Lugano, Switzerland (Press release, Autolus, JUN 16, 2023, View Source [SID1234632754]). PTCL is a rare and heterogeneous form of non-Hodgkin lymphoma.

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The LibrA T1 trial is a single arm, open label, multi-center, Phase 1/2 study evaluating the safety and efficacy of AUTO4, a single dose intravenous CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1-positive selected PTCL. At the cutoff date of April 28, 2023, 19 patients were enrolled into the study and 13 were dosed. Using manufacturing process A, 10 patients were dosed. Using manufacturing process B, 3 additional patients were dosed very recently. Overall, the treatment was well tolerated with no dose limiting toxicities. In Process A, at the highest dose tested (450 x 106 cell dose), 4 out of 4 patients achieved a response with 2 out of 4 remaining in ongoing complete metabolic response (CMR) at 15 and 18-months post-dose, respectively. Presence of CAR T cells in the lymph nodes of patients suggest fast homing of CAR T cells to the tumor site, despite absence in the blood. Efficacy data from Process B was not provided given median follow up is <3 months.

"There are limited options for patients with PTCL, so new treatments for this aggressive malignancy are desperately needed," said Dr. Kate Cwynarski, Chief Investigator, UCLH, London. "The LibrA T1 study of AUTO4 is a novel approach using a CAR T cell designed to selectively target and eliminate T cells that include the malignant clone which harbors the TRBC1 receptor, while preserving the T cell compartment with the TRBC2 receptor which helps to maintain immune-competence. AUTO4 is well tolerated and the data to date in this early phase study are very promising."

"AUTO4, with its unique targeting mechanism, represents an opportunity for advanced programmed T cell therapies that will make a difference in patients who traditionally suffer from severe immunosuppression as a result of current therapeutic options," said Dr. Edgar Braendle, Chief Development Officer of Autolus. "This is a trial with a small number of patients, but with all 4 patients at the highest dose in the study achieving a response and 2 out of the 4 remaining in a complete metabolic response beyond 12 months, AUTO4 shows potential to provide a novel therapy option for PTCL patients."

Oral Presentation

Title: First in Human Study of AUTO4, a TRBC1-Targetting CAR T Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma

Abstract No: 044 – Link to Abstract
Session: Peripheral T-cell Lymphomas
Session Date and Time: Thursday, June 15, 2023, 4.30 – 4.45pm CET

Presenting Author: Dr Kate Cwynarski, Consultant Haematologist University College London Hospitals (UCLH)

On June 16, 2023 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with other life science companies to develop and commercialize innovative products in the United States, reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the Maxim Group Healthcare Virtual Conference on Tuesday, June 20, 2023 at 3:30 pm Eastern Time (Press release, Tracon Pharmaceuticals, JUN 16, 2023, View Source [SID1234632753]).

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