Antengene Announces HREC Approval in Australia for the Phase I Trial of the Small Molecule CD73 Inhibitor ATG-037

On February 6, 2022 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that ATG-037 has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I STAMINA trial, a first-in-human study of ATG-037 in patients with locally advanced or metastatic solid tumors (Press release, Antengene, FEB 6, 2022, View Source [SID1234607771]). The primary objective of the study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with an immune checkpoint inhibitor (CPI), to determine the appropriate dose for Phase II studies, and to assess preliminary signal of activity; the secondary objective is to characterize the pharmacology of ATG-037.

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ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 generates adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 has demonstrated promising preclinical efficacy as a monotherapy and in combination with CPIs and chemotherapy agents. In preclinical studies, the compound has demonstrated to overcome the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound will have a broad therapeutic window.

Kevin Lynch, M.D., Chief Medical Officer of Antengene commented, "Developing novel molecules that can make a clinical difference in cancer is of paramount importance to Antengene. Preclinical toxicology data suggests that ATG-037 will have a broad therapeutic window and further preclinical data suggests the potential for differentiated characteristics compared to other CD73 inhibitors."

Dr. Lynch continued, "While we remain very interested to explore the drug as a monotherapy, combination therapy of ATG-037 with CPIs and chemotherapies could enable synergistic improvements in tumor response for patients with advanced and metastatic cancers. ATG-037 also has the potential to be used in combination with several agents in the Antengene pipeline including ATG-101, a proprietary PD-L1/4-1BB bispecific antibody, demonstrating the in-house combinatory potential of our pipeline programs. I’m very excited about the start of the clinical program and look forward to next steps with ATG-037."

Aptamer Science, contract development and production of ApDC anti-cancer drug with China’s Kai Liying

On February 4, 2022 Aptamer Science reported on the 4th that it signed a contract development and manufacturing (CDMO) contract with China’s Cailaing (Asymchem) for ‘AST-201’, an aptamer drug conjugate (ApDC)-based anticancer treatment (Press release, Aptamer Sciences, FEB 4, 2022, View Source;idx=171 [SID1234641605]).

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According to this contract, Aptamer Science has established a basis for mass production and stable supply of AST-201 clinical trial material.

AST-201 is an ApDC-based targeted treatment that internalizes the anticancer drug ‘gemcitabine’ in the form of a prodrug within the anticancer target aptamer structure. A specific aptamer was applied to the ‘GPC3’ protein, a tumor biomarker.

Accordingly, it is expected to minimize the systemic side effects of gemcitabine and maximize the target-specific anticancer effect. Additionally, it is believed that gemcitabine can be internalized within the aptamer to overcome the tumor’s anticancer drug resistance mechanism.

In addition, it is said to have the property of effectively overcoming the toxic side effects of antibody drug conjugate (ADC) treatments. Aptamers have a relatively short half-life in the blood compared to antibodies, so they have high tumor selectivity and tissue penetration while minimizing systemic exposure to the drug.

An Aptamer Science official said, "The process for clinical trials of ApDC-based anti-cancer treatments is proceeding smoothly," and added, "We will strive to quickly advance to the clinical development stage through collaboration with Kai-Laying."

Athebio Enters Research Agreement with REGENXBIO

On February 4, 2022 Athebio AG, an innovation leader in the discovery and design of designed ankyrin repeat proteins (DARPins), reported that it has entered a research agreement with REGENXBIO Inc., a clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy, to develop novel, targeted, adeno-associated virus (AAV) vectors that combine Athebio’s proprietary Athebody DARPin Platform and REGENXBIO’s NAV Technology Platform (Press release, AtheBio, FEB 4, 2022, View Source [SID1234638736]).

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Under the terms of the agreement, Athebio will provide select Athebody DARPins from its proprietary library to REGENXBIO, which intends to utilize the DARPins as elements of novel AAV vectors targeted to an undisclosed, cell-specific receptor. REGENXBIO may option the selected Athebody DARPins for a commercial license for development of potential gene therapy candidates. In exchange, Athebio will receive an undisclosed upfront payment, research funding fees, and has the potential to receive milestones, as well as royalties on net sales.

"As a leader in the field of AAV-mediated gene therapy, REGENXBIO perfectly matches with Athebio’s pioneering mindset," said Patrik Forrer, one of the inventors of the DARPin technology and CEO and Chairman at Athebio. "Our mission is to make our proprietary Athebody DARPin Platform accessible to our partners, and provide them with tailor-made binding domains and access to our in-depth repeat protein expertise. The small size, excellent intracellular expression, and high specificity make Athebody DARPins excellent candidates to enable novel, targeted AAV vectors."

Entry into a Material Definitive Agreement

On February 4, 2022, Nuvectis Pharma, Inc. (the "Company"), reported that entered into an Underwriting Agreement (the "Underwriting Agreement") with H.C. Wainwright & Co., LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, Nuvectis Pharma, FEB 4, 2022, View Source [SID1234607776]). Pursuant to the Underwriting Agreement, the Company agreed to sell in an underwritten offering (the "Offering") an aggregate of 3,200,000 shares (the "Shares") of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), at an offering price of $5.00 per share, for gross proceeds of $16,000,000, less underwriting discounts and commissions and offering expenses. The Shares are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-260099), initially filed with the Securities and Exchange Commission (the "Commission") on October 6, 2021, as amended, and declared effective on February 4, 2022. The Company subsequently filed a registration statement on Form S-1MEF (File No. 333-262512) pursuant to Rule 462(b) under the Securities Act of 1933, as amended, which was effective immediately upon filing.

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The closing of the Offering is subject to satisfaction of customary closing conditions set forth in the Underwriting Agreement and is expected to occur on or about February 8, 2022.

The summary of the Underwriting Agreement set forth above does not purport to be complete and is subject to and qualified in its entirety by reference to the text of the Underwriting Agreement, a form of which is filed herewith as Exhibit 1.1. The Underwriting Agreement includes customary representations, warranties, closing conditions and covenants by the Company and the Underwriters.

Nuvectis Pharma, Inc. Announces Pricing of $16,000,000 Upsized Initial Public Offering of Common Stock

On February 4, 2022 Nuvectis Pharma, Inc. (Nasdaq: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of innovative precision medicines for serious conditions of unmet medical need in oncology, reported the pricing of its initial public offering of 3,200,000 shares of common stock at a public offering price of $5.00 per share, for gross proceeds of $16,000,000, before deducting underwriting discounts and commissions and offering expenses (Press release, Nuvectis Pharma, FEB 4, 2022, View Source [SID1234607770]). In addition, the Company has granted the underwriter a 30-day option to purchase additional 480,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

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H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The Company intends to use the proceeds to fund the Phase 1/2 development of NXP800, the IND-enabling studies of NXP900, to continue development and sponsored research related to its current product candidates or any future product candidate, hiring of additional personnel, capital expenditures, costs of operating as a public company, and other general corporate purposes.

Nuvectis’ shares of common stock are expected to begin trading on the Nasdaq Capital Market today under the symbol "NVCT." The offering is expected to close on or about February 8, 2022, subject to the satisfaction of customary closing conditions.

The shares of common stock described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-260099) previously filed with the Securities and Exchange Commission ("SEC") and became effective on February 4, 2022 and an additional registration statement on Form S-1 filed pursuant to Rule 462(b) which became automatically effective on February 4, 2022. This offering is being made only by means of a prospectus. Electronic copies of the final prospectus, when available, may be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or by email at [email protected]. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.