On January 26, 2024 AskGene Pharma Inc. reported dosing of the first patient at a participating site in China for the Phase III pivotal trial of ASKB589 (Press release, AskGene Pharmaceuticals, JAN 26, 2024, View Source [SID1234639546]). ASKB589 is a CLDN18.2 targeting antibody that is being tested in combination with CAPOX and a PD-1 inhibitor. This combination therapy is intended for the first-line treatment patients with advanced, recurrent, or metastatic gastric cancer (GC) and gastroesophageal junction (GEJ) cancer in China. This study marks the first pivotal clinical trial for triple combination therapy using an anti-claudin 18.2 antibody alongside a PD-1 inhibitor and chemotherapy, for the initial treatment of G/GEJ cancer patients (NCT04632108).

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Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene, commented: "We are very happy that our pivotal phase 3 program has successfully started in China with the enrollment of the first patient. The promising results of Phase 1/2 study of triple combination suggest that the combination of ASKB589, PD-1 inhibitor, and chemotherapy may be a transformative treatment option for gastric or gastroesophageal junction adenocarcinoma and support exploring the combination in patients with earlier stages of disease. The triple combination represents an innovative approach which aims to leverage the full potential of targeted therapy, immunotherapy and chemotherapies."

The multicenter, randomized, double-blind, standard-of-care controlled Phase 3 trial (NCT06206733) has a planned enrollment of 780 patients. Patients will receive ASKB589 plus tislelizumab and CAPOX or placebo plus tislelizumab and CAPOX on day 1 of each 3-week cycle. The primary endpoint of the trial is progression free survival (PFS), with overall survival (OS), objective response rate (ORR), duration of response (DOR) and safety serving as secondary endpoints.

The latest Phase I/II clinical results presented at ASCO (Free ASCO Whitepaper) GI (the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium) in January 2024 demonstrate an encouraging anti-tumor activity and a manageable safety profile for ASKB589 combination therapy with CAPOX and a PD-1 inhibitor1. Among 45 CLDN18.2 moderate to high patients (determined by a validated proprietary companion diagnostic kit) with measurable disease and at least one post-treatment tumor assessment in the 6 mg/kg dose-expansion phase, 36 (80.0%) patients achieved Partial Response (PR) and 9 (20.0%) achieved Stable Disease as the best overall tumor response per RECISTv1.1. Disease Control Rate (DCR) was 100%.

About ASKG589

ASKB589 is a second generation anti-CLDN18.2 humanized monoclonal antibody with ADCC enhancement. To support the Phase 3 pivotal trial, more than 200 patients have been enrolled into 2 Phase I/II studies, including ASKB589 monotherapy, combination with chemotherapy, and combination with PD-1 inhibitor and chemotherapy. No dose limiting toxicity (DLT) has been observed so far, with monotherapy up to 20 mg/kg, and combination therapy up to 15 mg/kg. A maximum tolerated dose (MTD) has not yet been reached. ASKB589 is intended for treatment of G/GEJ cancer, pancreatic cancer, and additional cancer types which express CLDN18.2.

AskGene has also developed a sensitive and specific CLDN18.2 immunohistochemistry-based companion diagnostic kit, which is used to support ASKB589 Phase III program.

On January 26, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (Nasdaq: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, reported the pricing of an underwritten public offering (the "Public Offering") of 4,912,280 common shares of the Company (the "Common Shares") at a public offering price of US $1.71 per share (Press release, Aptose Biosciences, JAN 26, 2024, View Source [SID1234639544]). Each Common Share will also include a warrant to purchase a Common Share (a "Warrant Share") at a price of $1.71 per Warrant Share. Gross proceeds from the Public Offering, before deducting underwriting discounts and commissions and offering expenses payable by Aptose, are expected to be approximately US $8.4 million. The underwriters have been granted a 30-day option to purchase up to an additional 736,842 Common Shares and/or 736,842 Warrants in the Public Offering, under the same terms and conditions.

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Aptose also announced the pricing of a concurrent $4 million private placement (the "Private Placement") of Common Shares with Hanmi Pharmaceutical, Inc. ("Hanmi"), Seoul, South Korea, representing ownership of 19.97% of the outstanding Common Shares of the Company following the Private Placement. Under the terms of the strategic investment, Hanmi will purchase each Common Share at a price of $1.90, representing an 11% premium over the price of the Common Shares issued in the Public Offering. The Company will also issue Hanmi Warrants to purchase Common Shares at a price of $1.71 per Warrant Share. Upon the closing of the Private Placement, Hanmi will have satisfied its remaining investment obligations under the existing subscription agreement and investor rights agreement (announced September 6, 2023) between Aptose and Hanmi.

The Public Offering is expected to close on or about January 30, 2024, subject to satisfaction of customary closing conditions. The Private Placement is expected to close on or about January 31, 2024, subject to satisfaction of customary closing conditions.

Aptose intends to use the net proceeds of the Public Offering and Private Placement to (i) support clinical trials for tuspetinib; (ii) support manufacture of tuspetinib clinical supplies; and (iii) for working capital and general corporate purposes.

Newbridge Securities Corporation is acting as the sole book-running manager for the Public Offering and as placement agent for the Private Placement.

No Common Shares, Pre-Funded Warrants or Warrants will be offered or sold in Canada as part of the Public Offering or Private Placement. The Public Offering and Private Placement are subject to the approval of the Toronto Stock Exchange ("TSX") and Nasdaq. For the purposes of TSX approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The securities to be sold in the Public Offering are being offered by Aptose pursuant to a registration statement on Form S-1 (File. No. 333-275870), including a base prospectus, that was previously filed by Aptose with the Securities and Exchange Commission ("SEC") and was declared effective on January 25, 2024. The Public Offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. Before you invest, you should read the prospectus supplement and the accompanying prospectus and other documents the Company has filed with the SEC for more complete information about the Company and the Public Offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus supplement may be obtained, once available, by contacting Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected] or by telephone at (877) 447-9625. The securities to be sold to Hanmi have not been registered under the U.S. Securities Act of 1933, as amended, and will be issued in reliance on an exemption from the registration requirements thereof.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Aptose, 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.

On January 26, 2024, Aprea Therapeutics, Inc. (the "Company") reported to have entered into an at the market offering agreement (the "Sales Agreement") with H.C. Wainwright & Co., LLC (the "HCW") (Press release, Aprea, JAN 26, 2024, View Source [SID1234639543]). Under the Sales Agreement, the Company may offer and sell its common stock, par value $0.001 per share ("Common Stock"), from time to time having an aggregate offering price of up to $1.0 million (the "Shares") during the term of the Sales Agreement through or to HCW as sales agent or principal. The Company has filed a prospectus supplement relating to the offer and sale of the Shares pursuant to the Sales Agreement. The offering and sale of the Shares will be made pursuant to the Company’s Registration Statement on Form S-3, filed with the Securities and Exchange Commission (the "SEC") on January 26, 2024. The Shares may be offered only by means of a prospectus forming a part of the Registration Statement. The Company intends to use the net proceeds from the offering, if any, for general corporate purposes, including for preclinical studies and clinical trials and the advancement of our product candidates.

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The Company is not obligated to sell any Shares pursuant to the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, HCW will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations, to sell Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may impose.

Under the Sales Agreement, HCW may sell Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, and the rules and regulations thereunder.

The Sales Agreement may be terminated by either party providing notice, subject to the limitations set forth in the Sales Agreement.

The Company has agreed to pay HCW a commission equal to 3.0% of the gross proceeds from the sales of Shares pursuant to the Sales Agreement and has agreed to provide HCW with customary indemnification and contribution rights.

The foregoing summary of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 hereto and incorporated herein by reference. The Sales Agreement contains representations and warranties that the parties made to, and solely for the benefit of, the other in the context of all of the terms and conditions of the Sales Agreement and in the context of the specific relationship between the parties. The provisions of the Sales Agreement, including the representations and warranties contained therein, are not for the benefit of any party other than the parties to the Sales Agreement and are not intended as a document for investors and the public to obtain factual information about the Company’s current state of affairs. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the SEC.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any Shares under the Sales Agreement, nor shall there be any sale of such Shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On January 25, 2024 Alphamab Oncology (stock code: 9966.HK) and 3DMedicines (stock code: 1244.HK) ("Licensors") reported that we entered into a license agreement with Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (BSE: 532296，NSE: GLENMARK) for the subcutaneous injection PD-L1 antibody drug (R&D code: KN035, generic name: Envafolimab), pursuant to which, Glenmark was granted exclusive licensing interests in clinical development and commercialization of oncology indications in India, Asia Pacific(except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, CIS and Latin America. Glenmark will develop and commercialize KN035 in the Field in the Territory at its own cost and expense.

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Under the License Agreement, Licensors will receive from GSSA (a) a total of up to US$700.8 million of a non-refundable upfront payment and milestones payments subject to the achievement of certain development, regulatory and commercialization milestones, and (b) a single to double digits percentage royalty fee according to the level of net sales of KN035. The Licensors’ respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between Jiangsu Alphamab and 3D Medicines.Jiangsu Alphamab retains its sole right to manufacture KN035 for any purpose within or outside the Territory. 3D Medicines retains the right to develop and commercialize KN035 for any purpose in the field of tumor outside the Territory.

We believe that the cooperation will enable Jiangsu Alphamab to effectively utilize the existing team and resources of Glenmark and establish a favorable market position for KN035 in the Territory rapidly. The implementation of the License Agreement will have a positive impact on the commercialization of KN035 in the Territory.

Dr. Ting Xu, Chairman, and CEO of Alphamab Oncology, remarked, "This collaboration holds significant importance for the continued advancement of Envafolimab. Leveraging Glenmark’s robust development and commercialization capabilities, we are confident that Envafolimab will reach a substantial number of patients in the specified territory, especially in regions where cancer patients face underserved conditions. The notable advantages of Envafolimab in terms of safety, convenience, and compliance position it as a competitive product. We eagerly anticipate a successful collaboration."

Dr. Gong Zhaolong, Chairman and CEO of 3D Medicines, remarked, "We are very pleased that Envolizumab can help more cancer patients. This cooperation is good news for more cancer patients. In a wide range of emerging markets, patients need more convenient and innovative treatments. We will work together to serve more cancer patients and help them live longer and better."

"This marks an important milestone for us at Glenmark, through this transformational deal we get access to the first recombinant humanized single domain antibody against PD-L1 in a SubQ formulation for a wide territory globally. We are excited to take this innovative product across our territory and meaningfully contribute to the spread of immune Oncology treatments to potentially help cancer patients across emerging markets." remarked Glenn Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals Ltd.

About Envafolimab（KN035）

Envafolimab is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology，and co-developed with 3D (Beijing) Medicines since 2016. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.

Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of MSI-H or dMMR advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.

(Press release, Alphamab, JAN 25, 2024, View Source [SID1234657017])

On January 25, 2024, HOOKIPA Pharma Inc. ("HOOKIPA") received written notice (the "Notice") from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (collectively referred to as "Roche") of their decision to terminate the Research Collaboration and License Agreement (the "Collaboration Agreement") among Roche and Hookipa Biotech GmbH ("HOOKIPA GmbH," and together with HOOKIPA, the "Company"), a wholly-owned subsidiary of HOOKIPA, dated October 18, 2022 (Filing, Hoffmann-La Roche, JAN 25, 2024, View Source [SID1234642009]). Roche’s decision to terminate the Collaboration Agreement was made according to Roche’s right to terminate without cause, acknowledging that, to date, HOOKIPA met all go-forward criteria under the Collaboration Agreement.

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The Collaboration Agreement was entered into to (i) grant Roche an exclusive license to research, develop, manufacture and commercialize the Company’s pre-clinical HB-700 cancer program, an arenaviral immunotherapeutic for KRAS-mutated cancers, and (ii) grant Roche an option right to exclusively license for research, development manufacturing and commercialization, a second, novel arenaviral immunotherapeutic program targeting undisclosed cancer antigens.

Pursuant to the terms of the Collaboration Agreement and the Notice, the Collaboration Agreement will be terminated on April 25, 2024. The Company remains eligible for a final milestone payment associated with an IND submission. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and will have full collaboration and licensing rights for the HB-700 program. After the termination of the Collaboration Agreement, and except as disclosed above, there is no other material relationship between the Company and Roche.