On January 18, 2024 AskGene Pharma Inc. reported encouraging clinical results for ASKB589, an anti-CLDN18.2 antibody, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium (ASCO-GI 2024) in San Francisco on January 18-20, 2024 (Press release, AskGene Pharmaceuticals, JAN 18, 2024, View Source [SID1234639323]).

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The results were from clinical trial NCT05632939, a Phase Ib/II, two-part, dose escalation and expansion study to evaluate the safety, tolerability, and anti-tumor activities of ASKB589 in combination with chemotherapy (CAPOX) and a PD-1 inhibitor as a first-Line treatment in patients with locally advanced, relapsed and metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma. As of December 20, 2023, a total of 62 patients with positive CLDN18.2 expression were dosed Q3W with ASKB589 combined with CAPOX and PD-1 inhibitor: 9 patients received ASKB589 at 6 mg/kg (n=3) and 10 mg/kg (n=6) in the dose escalation and 53 patients at 6 mg/kg in the dose expansion. Most of the enrolled patients had moderate to high CLDN18.2 expression (83.9%) and PD-L1 CPS ³1 (59.7%).

ASKB589 was safe and tolerated at both 6 and 10 mg/kg. No dose-limiting toxicity was observed, and maximum tolerated dose (MTD) was not identified during the escalation phase of the study. Most adverse events (AEs) were of mild severity (grade 1 or 2). The most common AEs were hypoalbuminemia (77.4%), nausea (66.1%), anemia (56.5%), neutrophil count decreased (54.8%), and vomiting (51.6%). No patients discontinued the treatment due to AEs.

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 and 9 (20.0%) achieved stable disease as the best overall tumor response per RECISTv1.1. Disease control rate was 100%. As of the cutoff date, 41(77.3%) out of the 53 patients in the dose expansion group were still on treatment.

In summary, ASKB589 plus CAPOX and PD-1 inhibitor as a first-line treatment in patients with G/GEJ cancer demonstrated good safety and tolerability. Adding a PD-1 inhibitor to ASKB589 plus CAPOX in patients with moderate to high CLDN18.2 expression resulted in encouraging anti-tumor activities with deep and durable responses. Based on the interim results of this study, NMPA greenlighted the Phase 3 study of ASKB589 in combination with CAPOX and PD-1 inhibitor as a first-line treatment in CLDN18.2 moderate to high (≥40% 2+/3+ staining) patients with advanced G/GEJ cancer in China.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene, commented: "Claudin 18.2 has recently been validated as a new molecular target that demonstrates clinical benefit for patients with gastric and gastroesophageal cancer. Our study shows that triple combination of ASKB589, chemotherapy, and PD-1 inhibitor can be administered safely in patients and results in a very high rate of deep and durable responses, as well as a 100% disease control rate. We have initiated the registrational trial and expect to enroll the first patient soon".

Presentation Details

Title: A Phase Ib/II Study of ASKB589 (Anti-CLDN18.2 Monoclonal Antibody) in Combination with CAPOX and PD-1 Inhibitor as a First-Line Treatment of Locally Advanced, Relapsed and Metastatic G/GEJ Cancer (NCT05632939)
Principle Investigator: Dr. Lin Shen, Peking University Cancer Hospital
Presenter: Dr. Zhi Peng, Peking University Cancer Hospital
Abstract #: 317
Poster #: E17
About NCT05632939

The NCT04632108 study is a Phase Ib/II, two-part, dose escalation and expansion study to evaluate the safety, tolerability, and anti-tumor activities of ASKB589 in combination with chemotherapy (CAPOX) and a PD-1 inhibitor as a first-Line treatment in patients with locally advanced, relapsed and metastatic G/GEJ cancer. The study includes ASKB589 dose escalation (6 and 10 mg/kg) and expansion study of ASKB589 (6 mg/kg) combined with CAPOX and PD-1 inhibitor. Patients with positive CLDN18.2 expression (any tumor cell with ≥1+ membrane staining) determined by the central lab have been enrolled.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting CLDN 18.2. The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to CLDN18.2-expressing cancer cells. ASKB589 is intended for treatment of G/GEJ cancer, pancreatic cancer, and additional cancer types which express CLDN18.2.

On January 18, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that the US FDA have cleared Amplia’s IND application for a trial of Amplia’s best-in-class focal adhesion kinase (FAK) inhibitor narmafotinib in pancreatic cancer (Press release, Amplia Therapeutics, JAN 18, 2024, View Source [SID1234639295]). The proposed trial will explore the safety, tolerability and efficacy of a combination of narmafotinib with the chemotherapy regime FOLFIRINOX.

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The company is currently undertaking a Phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, gemcitabine and Abraxane, in advanced pancreatic patients in Australia and South Korea. In contrast, the IND application reviewed by the US Food and Drug Administration (FDA) supports the use of narmafotinib in combination with a different chemotherapy called FOLFIRINOX (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer.

The IND document is an extensive dossier that details all preclinical and clinical data amassed to date for narmafotinib, along with complete CMC (chemistry, manufacturing and controls) information. The final document comprised more than 10,000 pages and represented a major undertaking by the company over the previous months.

Amplia CEO and MD Dr Chris Burns commented: "Clearance of the IND by the US FDA is a significant step forward for the Company. We will now start planning the combination trial of narmafotinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor. FOLFIRINOX is the preferred treatment for pancreatic patients in the USA and most of Europe, and therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On January 17, 2024, Alector, Inc. (the "Company") entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co. (the "Underwriter"), relating to the issuance and sale (the "Offering") of 10,869,566 shares of the Company’s common stock, par value $0.0001 per share, at a price per share of $6.57 to be paid by the Underwriter (the "Underwritten Shares") (Filing, Alector, JAN 17, 2024, View Source [SID1234640081]). The Company also granted the Underwriter an option exercisable for 30 days from the date of the Underwriting Agreement to purchase up to an additional 1,630,434 shares of common stock (together with the Underwritten Shares, the "Shares"). All of the Shares in the Offering are being sold by the Company.

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The gross proceeds from the Offering are expected to be approximately $75 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and assuming no exercise of the Underwriter’s option to purchase additional shares. The Offering is expected to close on January 19, 2024, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties, and termination provisions. The representations, warranties, and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by such parties.

The Offering is being made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-270126) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "Commission") on May 1, 2023, and a related prospectus and prospectus supplement, each as filed with the Commission.

The above summary of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation relating to the shares of common stock being offered pursuant to the Underwriting Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On January 17, 2024 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the pricing of an underwritten public offering of 15,925,000 ordinary shares at a public offering price of $11.00 per share (Press release, Immatics, JAN 17, 2024, View Source [SID1234639331]). The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be approximately $175 million. The offering is expected to close on January 22, 2024, subject to customary closing conditions. In addition, Immatics has granted the underwriters a 30-day option to purchase up to 2,388,750 additional shares at the public offering price, less the underwriting discount.

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Jefferies, BofA Securities and Leerink Partners are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on August 9, 2021. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 821-7388, email: Prospectus_Department@Jefferies.com;
BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, telephone: (800) 294-1322, email: dg.prospectus_requests@bofa.com;
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: syndicate@leerink.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

On January 17, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the pricing of an underwritten public offering of 10,869,566 shares of its common stock for total gross proceeds of $75 million before deducting underwriting discounts and commissions and estimated offering expenses payable by Alector (Press release, Alector, JAN 17, 2024, View Source [SID1234639322]). The offering is expected to close on January 19, 2024, subject to satisfaction of customary closing conditions. All of the shares in the offering are being sold by Alector.

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Alector has granted the underwriter a 30-day option to purchase up to an additional 1,630,434 shares of its common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions.

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333- 270126) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC") on May 1, 2023. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by e-mail at prospectus@cantor.com.

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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.