Unleashing the Anti-CTLA-4 therapy by enhancing the Therapeutic index

On July 7, 2023 Adagene presented its corporate presentation (Presentation, Adagene, JUL 7, 2023, View Source [SID1234633105]).

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Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On July 7, 2023 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents’ fees and other offering expenses (Press release, Abeona Therapeutics, JUL 7, 2023, View Source [SID1234633104]).

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"Our existing institutional investors have shown their confidence in Abeona by participating in this registered direct offering without discounts or warrant coverage," said Vish Seshadri, Chief Executive Officer of Abeona. "We have been very encouraged by the favorable feedback and insights from healthcare professionals, patient communities, payors and hospital administrators based on the results of EB-101 in clinical trials, and we are positioned to launch EB-101 in the U.S. without depending on a partner. The $25 million offering allows us to now start preparing for the commercialization of EB-101 and aim for a timely launch upon potential BLA approval in the first half of 2024, while also extending our cash runway well into the fourth quarter of 2024."

Abeona will use the net proceeds from the offering primarily to fund preparations for commercialization of its product candidate EB-101, as well as for working capital and general corporate purposes. Based on EB-101’s Rare Pediatric Disease designation, Abeona expects to qualify to receive a priority review voucher (PRV) upon Biologics License Application (BLA) approval and subject to final determination by the FDA. The PRV can be used to receive an expedited review process of a subsequent marketing application for a different product or sold to another company to create additional capital.

The Company sold 3,284,407 shares of its common stock (and, in lieu of common stock for certain investors, pre-funded warrants to purchase 2,919,140 shares of its common stock) at an offering price of $4.03 per share (or $4.0299 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant). The pre-funded warrants are immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full.

The offering was led by Nantahala Capital Management, LLC and included participation by Adage Capital Partners LP and two other existing investors.

Cantor Fitzgerald & Co. acted as the sole lead-placement agent for the offering. A.G.P./Alliance Global Partners acted as the co-placement agent for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. The prospectus supplement and the accompanying prospectus that form a part of the registration statement have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by e-mail at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security 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.

New Dose Escalation in Phase I Clinical Trial
of Oncolytic Virotherapy CHECKvacc

On July 7, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno oncology company, reported that City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles, has confirmed the Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc (HOV3, CF33-hNIS-anti-PDL1), will proceed to the fourth dose cohort (Press release, Imugene, JUL 7, 2023, View Source [SID1234633091]).

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The Protocol Management Team agreed CHECKvacc to be safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after review of all safety and tolerability data for the first 3 cohorts dosed with CHECKvacc as monotherapy. City of Hope will proceed with opening the fourth CHECKvacc Phase 1 cohort.

The first-in-human, Phase 1, single-centre, dose escalation study of CHECKvacc is recruiting patients with triple negative breast cancer (TNBC). The purpose of the study is to evaluate the safety and initial evidence of efficacy of intra-tumoural administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The current trial design will involve a dose escalation, followed by an expansion to 12 patients at the final dose, which will be the recommended phase 2 dose (RP2D). The trial is anticipated to run for 24 months and is funded from existing budgets and resources.

The clinical trial is titled "A Phase I Study of Intratumoral Administration of CF33-hNIS antiPDL1 in Patients with Advanced or Metastatic Triple Negative Breast Cancer". The Principal Investigator leading the trial is Dr Jamie Rand MD, PhD.

Imugene MD & CEO Leslie Chong said "We are pleased with the results that we have seen so far with no observed toxicity with early encouraging results in oncolytic virus infection and replication in the TNBC tumours. We look forward to continuing this study and reporting to the market of its progress."

CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field.

Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.

Full study details can also be found on clinical trials.gov under study ID: NCT05081492.

REGiMMUNE Signed Underwriting Contract with HuaNan Securities

On July 6, 2023 REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, reported Hua Nan Securities as the lead underwriter for its upcoming initial public offering (IPO) in Taiwan (Press release, REGimmune, JUL 6, 2023, View Source [SID1234642232]). The IPO is anticipated to take place in 2025, signifying an important milestone in REGiMMUNE’s expansion and entry into the Taiwanese financial market.

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REGiMMUNE Limited’s core technology stems from Riken, a renowned national research institute based in Japan. Our main area of concentration revolves around pioneering immunotherapies that regulate regulatory T cells, also known as Tregs. In 2006, we were founded in Japan, and subsequently REGiMMUNE group has reorganized its Taiwanese entity, REGiMMUNE Limited, to become the holding company for the entire group, and now owns 100% of REGiMMUNE Corporation, its Japanese subsidiary, and REGiMMUNE Inc, its U.S. subsidiary. Our company’s fundamental philosophy, "From Care to Cure for Immune Disorders," highlights our commitment to not only the care of immune diseases but also their cure.

REGiMMUNE Limited provides innovative therapeutic solutions to patients with autoimmune diseases and cancer through its reVax technology platform and antibody drugs. The lead program, RGI-2001, has the potential to be a first-in-class small molecule drug for preventing acute graft-versus-host disease (aGvHD), a fatal complication of allogeneic hematopoietic stem cell transplantation that results in rejection, by enhancing current therapeutic approaches with a novel mechanism. RGI-2001 was selected for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2022 and is planned to be submitted to the FDA for Phase III IND and begin discussions on Fast Track Designation and Breakthrough Therapy Designation, which will be awarded to breakthrough drugs. In the final quarter of 2023, with clinical trials scheduled to commence in the third quarter of 2024.

In March 2023, a licensing agreement regarding RGI-2001 was signed between REGiMMUNE and SanFu Biotech, which is a subsidiary of SanFu Chemical Group. This agreement grants SanFu Biotech the exclusive rights to develop and commercialize RGI-2001 in Asia. SanFu Biotech is considered a valuable strategic partner by REGiMMUNE in the Asian market due to their extensive resources in the biotechnology and biomedical sectors, as well as its exceptional innovative strategies. REGiMMUNE is excited to collaborate with SanFu Biotech to accelerate the progress of RGI-2001 in this significant market.

Taiwan’s biomedical sector boasts a robust clinical trial infrastructure, favorable access to capital markets, extensive research and development capabilities, and a vast human biological database. With steadfast government backing, Taiwan has established itself as a leader in Asia’s biotechnology and medical sector. REGiMMUNE is committed to harnessing Japan’s proficiency in fundamental research and Taiwan’s complete industrial ecosystem in applied research and development to maximize the commercial potential of fundamental research and foster mutually beneficial business opportunities. We are thrilled to partner with Taiwan’s biotech industry to explore the global market and aspire to become the first Japanese novel drug research firm to be listed in Taiwan and embody Taiwan-Japan collaboration in the biotech field, with the support of the officers and colleagues at all levels in Hua Nan Securities.

Simcha Therapeutics Announces First Patient Dosed in Phase 1/2 Study Evaluating ST-067 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Various Solid Tumors

On July 6, 2023 Simcha Therapeutics ("Simcha"), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, reported that the first patient has been dosed in a Phase 1/2 clinical trial of ST-067, Simcha’s decoy resistant IL-18 agent, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors (Press release, Simcha Therapeutics, JUL 6, 2023, View Source [SID1234633098]).

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The Phase 1/2 open-label, dose-escalation study is evaluating ST-067 in combination with pembrolizumab in a variety of solid tumors (NCT04787042). The objective of the study is to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (R2PD) and preliminary activity of ST-067 in combination with pembrolizumab. Secondary endpoints include assessment of safety, pharmacokinetics, pharmacodynamics and immunogenicity.

"We have observed encouraging anti-tumor activity in preclinical studies combining our decoy-resistant IL-18 with PD-1 inhibitors, and we look forward to now studying this combination in the clinic," said Sanuj Ravindran, M.D., CEO of Simcha Therapeutics. "KEYTRUDA has become the standard of care for many cancer patients, and we believe adding ST-067 could further improve clinical outcomes. This combination has the potential to become a powerful new therapeutic option for patients and physicians."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ST-067

ST-067 is the first "decoy-resistant" variant of IL-18, designed to be impervious to the decoy receptor IL-18BP, which blocks IL-18 from interacting with its receptor. ST-067 has been shown in preclinical studies to maintain strong immune stimulation in the tumor microenvironment and is currently in Phase 1/2 clinical development as both a monotherapy and in combination with KEYTRUDA (pembrolizumab).