On September 29, 2023 Akeso (9926.HK) reported that its subsidiary, Akeso Pharma, will collaborate with RemeGen (Yantai) Co., Ltd. (688331.SH/09995.HK) to advance the development of Akeso’s globally first PD-1/CTLA-4 bispecific antibody, cadonilimab (trade name: 开坦尼), and RemeGen’s first domestically developed antibody-drug conjugate (ADC) injection, Disitamab Vedotin (trade name: 爱地希) in combination therapy (Press release, Akeso Biopharma, SEP 29, 2023, View Source [SID1234635551]). The collaboration will also initiate a phase II clinical study for gastric cancer.

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Cadonilimab is a human tetravalent bispecific IgG1 antibody with symmetric IgG-single-chain variable fragment (scFv) structure that targets both PD-1 and CTLA-4. It has shown higher affinity for tumor-infiltrating lymphocytes (TILs) than for surrounding tissues in the tumor microenvironment (TME). With Fc-null design, cadonilimab contributes to better safety compared to combination of anti-PD-1 and anti-CTLA-4 antibodies while fully exerting the synergistic anti-tumor effects of inhibiting PD-1 and CTLA-4 immune checkpoints.

Cadonilimab has shown excellent anti-tumor efficacy in clinical trials for various solid tumors. According to the two-year follow-up data presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, cadonilimab demonstrated a high overall response rate and long-term survival benefit in the first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma in the entire population (regardless of PD-L1 expression). The study results also indicate that cadonilimab has the potential to overcome the limited efficacy of immunotherapy in populations with low PD-L1 expression or negative PD-L1 expression, making it a superior immunotherapeutic option for patients with advanced gastric cancer.

爱地希 (Disitamab Vedotin) utilizes a novel, highly affinity, and better internalization effect humanized antibody, Disitamab Vedotin monoclonal antibody, combined with advanced linker and small molecule cytotoxic drugs. It demonstrates specific targeting abilities, exceptional efficacy, and excellent safety profiles. The study results have been presented at major domestic and international conferences such as the ASCO (Free ASCO Whitepaper) Annual Meeting.

The 2023 version of the Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Gastric Cancer, announced in April this year, recommends Disitamab Vedotin as a preferred third-line treatment for HER2-positive (IHC3+ or 2+) advanced gastric cancer, upgrading its recommendation level from "Grade II Recommendation" to "Grade I Recommendation."

Multiple preclinical studies have demonstrated the synergistic and enhanced efficacy of immune checkpoint inhibitors in combination with ADC drugs. The combination therapy of cadonilimab and Disitamab Vedotin has a solid theoretical basis and may achieve synergistic efficacy in anti-tumor treatment, potentially bringing a new generation of more efficient and safer combination therapy for cancer patients.

Currently, Akeso is fully committed to advancing the exploration of cadonilimab as a cornerstone cancer treatment by developing more combination therapies. This includes not only the development of combination therapies with the Akeso’s self-developed innovative product pipeline but also the development of combination therapies with new molecules and mechanisms within the industry that have excellent clinical value potential, in order to fully tap into the clinical value of cadonilimab.

On September 29, 2023 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, reported the pricing of an underwritten public offering of (i) 7,394,363 shares of common stock (or common stock equivalents in lieu thereof) and (ii) accompanying common warrants to purchase up to an aggregate of 7,394,363 shares of common stock (Press release, Synlogic, SEP 29, 2023, View Source [SID1234635550]). The combined effective offering price to the public of each share of common stock (or pre-funded warrant) and accompanying warrant is $2.84. The accompanying warrants will have an exercise price of $3.408 per share, will be exercisable immediately, and will expire five years from the initial exercise date. All of the securities are being offered by Synlogic, Inc. The Company expects to receive total gross proceeds of approximately $21.0 million, before deducting underwriting discounts, commissions and offering expenses. The offering is expected to close on or about October 3, 2023, subject to satisfaction of customary closing conditions.

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Chardan is acting as sole book-running manager for the offering.

The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-274421), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 28, 2023. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Chardan Capital Markets, LLC, 17 State Street, Suite 2130, New York, New York 10004, at (646) 465-9000, or by email at [email protected].

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.

On September 29, 2023 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will host a conference call and live webcast to share topline results from the pivotal AUGMENT-101 trial in patients with relapsed/refractory KMT2Ar acute leukemia on Monday, October 2, 2023 at 8:00 a.m. ET (Press release, Syndax, SEP 29, 2023, View Source [SID1234635549]).

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The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

Conference ID: SNDX0923
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: https://www.veracast.com/webcasts/syndax/events/Kwl396.cfm

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

On September 29, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies (Press release, Regeneron, SEP 29, 2023, View Source [SID1234635547]). The target action date for the FDA decision is March 31, 2024. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

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The BLA was supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2). Results from these studies investigating odronextamab in both FL and DLBCL were last presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

The FDA previously granted odronextamab Orphan Drug Designation and Fast Track Designation for FL and DLBCL. In August, the European Medicines Agency accepted for review a Marketing Authorization Application for odronextamab for the treatment of adult patients with R/R FL or R/R DLBCL who have progressed after at least two prior systemic therapies.

FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing subtype, and although many patients are responsive to initial treatment, approximately 20% are expected to relapse within two years and have shorter remissions with each successive line of therapy. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). As these blood cancers progress, they become increasingly hard to treat, especially in the third-line setting and beyond, leaving patients with few treatment options.

Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About the Odronextamab Clinical Program
ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy, including an expansion cohort evaluating DLBCL patients who had progressed on CAR-T therapy (post-CAR-T). ELM-2 is an ongoing, open-label, multicenter pivotal Phase 2 trial investigating odronextamab in 375 patients across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint of ELM-2 is objective response rate according to the Lugano Classification, and secondary endpoints include complete response, progression-free survival, overall survival, duration of response, disease control rate, safety and quality of life.

Regeneron is also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other B-NHLs, representing one of the largest clinical programs in lymphoma.

On September 29, 2023 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company advancing novel multi-targeted therapies for use as single agents and in combination, reported that it has entered into a definitive agreement for the purchase and sale in a registered direct offering of an aggregate of 3,157,895 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $1.90 per share (or common stock equivalent in lieu thereof) (Press release, Portage Biotech, SEP 29, 2023, View Source [SID1234635546]). The Company has also agreed to issue in a concurrent private placement unregistered series A warrants to purchase up to an aggregate of 3,157,895 shares of common stock, series B warrants to purchase up to an aggregate of 3,157,895 shares of common stock and series C warrants to purchase up to an aggregate of 3,157,895 shares of common stock. The closing of the offering is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The series A warrants will have an exercise price of $1.90 per share, will become exercisable immediately upon issuance and have a term of eighteen months from the date of issuance, the series B warrants will have an exercise price of $2.26 per share, will become exercisable immediately upon issuance and have a term of three years from the date of issuance and the series C warrants will have an exercise price of $2.26 per share, will become exercisable immediately upon issuance and have a term of five years from the date of issuance.

The gross proceeds to the Company from the offering are expected to be approximately $6.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for clinical development, general corporate and working capital purposes.

The securities described above (excluding the unregistered warrants and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-253468) that was originally filed with the Securities and Exchange Commission (the "SEC") on February 24, 2021 and became effective on March 8, 2021. The offering of such securities in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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