On December 20, 2023 BioCity Biopharma reported dosing of the first patient in a Phase Ib/II clinical trial of its anti-TIM-3 monoclonal antibody (mAb) BC3402 in combination with IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC) in China (Press release, Biocity Biopharmaceutics, DEC 20, 2023, View Source [SID1234638732]). The study is being conducted at Zhongshan Hospital with Prof. Jia Fan as the principal investigator. Dr. Fan is a world-renowned liver cancer surgeon, member of the Chinese Academy of Sciences, and president of Zhongshan Hospital.

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Liver cancers are highly prevalent in China, with 410,000 newly diagnosed patients (appx. 50% of all new cases worldwide) and responsible for 390,000 deaths annually. Among liver cancers, 90% are HCC. The unmet medical need for impactful novel treatments are significant for HCC treatments in China in which the 5-year survival rate for subjects with advanced disease is about 7%.

Based on previous research, TIM-3 is highly expressed by HCC, lung, and other cancers that are resistant to monoclonal antibodies targeting immune checkpoints, particularly PD-1 and PD-L1. Simultaneous inhibition of PD-1/PD-L1 and TIM-3 prevents T cell exhaustion and promotes tumor killing. Synergy has been observed with the combination of BC3402 and anti-PD-1/CTLA-4 treatment in pre-clinical and translational studies. In addition, encouraging clinical outcomes have been reported in clinical trials with other anti-TIM-3 antibodies in combination with anti-PD1/L-1 antibodies.

BioCity and AstraZeneca will work closely with the investigators to advance this clinical study. It is hoped that this trial will help demonstrate the potential clinical benefit of BC3402 in combination with durvalumab for the management of advanced HCC.

About BC3402

BC3402 is a potential best-in-class anti-TIM-3 mAb that binds to multiple TIM-3 epitopes and has a higher binding affinity than other anti-TIM-3 mAbs in development. BC3402 has been demonstrated to efficiently block the binding of CEACAM1, PtdSer and Gal-9 to TIM-3, alleviating the inhibitory effects of Tregs, and restoring IL-2 production by T cells. Moreover, BC3402 has shown synergistic anti-cancer activity with mAbs targeting PD-1 and CTLA-4, which are important clinical targets for liver cancer.

BC3402 has completed a phase I clinical study in advanced solid tumors showing a favorable safety profile and antitumor activity. Multiple phase Ib/II clinical studies are on-going with BC3402 in combination with other agents in solid tumors as well as hematological malignances.

On December 20, 2023 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, reported that data from an investigator sponsored trial (IST) evaluating botensilimab (BOT, multifunctional CTLA-4 immune activator) in combination with balstilimab (BAL, PD-1 antibody) in neoadjuvant colorectal cancer (CRC) will be presented at the upcoming ASCO (Free ASCO Whitepaper)-GI Meeting, to be held January 18 – 20, 2024 in San Francisco, CA (Press release, Agenus, DEC 20, 2023, View Source [SID1234638731]). The IST is led by Pashtoon Kasi, M.D., who was recruited to Weill Cornell Medicine as an associate professor of medicine and is a member of its Sandra and Edward Meyer Cancer Center. Dr. Kasi is also an oncologist at NewYork Presbyterian/Weill Cornell Medical Center.

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Presentation Details:

Abstract Title: Neoadjuvant botensilimab plus balstilimab in resectable mismatch repair proficient and deficient colorectal cancer: NEST-1 clinical trial (NCT05571293)
Abstract Number: 117
Presenting Author: Pashtoon Kasi, M.D., M.S., Director of Colon Cancer Research at Weill Cornell Medicine/NewYork Presbyterian Hospital, and Director of Liquid Biopsy Research, Englander Institute of Precision Medicine, Sarah and Edward Meyer Center
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Presentation Date and Time: 1/20/2024, 6:30am – 7:55am PST

Complete abstracts will be released on Tuesday, January 16, 2024 at 5:00pm EST. Data presented at the conference will be available to view in the publications section of the Agenus website (View Source) following the ASCO (Free ASCO Whitepaper)-GI Meeting.

About Botensilimab

Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 750 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

On December 20, 2023 Moderna, Inc. (Nasdaq:MRNA), reported that Jamey Mock, Chief Financial Officer, will present at the 42nd annual J.P. Morgan Healthcare Conference on Monday, January 8th at 6:45 p.m. ET / 3:45 p.m. PT (Press release, Moderna Therapeutics, DEC 20, 2023, View Source [SID1234638730]).

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A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for at least 30 days following the presentation.

On December 20, 2023 Moleculin Biotech, Inc. (NASDAQ: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor and certain of the Company’s executive officers and directors to purchase 7,044,836 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Moleculin, DEC 20, 2023, View Source [SID1234638728]). In a concurrent private placement, the Company also agreed to issue unregistered warrants to purchase up to an aggregate of 14,089,672 shares of common stock. The combined effective offering price for each share of common stock (or pre-funded warrant in lieu thereof) and accompanying warrants is $0.64 for the institutional investor, and $0.69 for the executive officers and directors. The warrants will have an exercise price of $0.64 per share, expire five years from the date of stockholder approval and will become exercisable beginning on the effective date of stockholder approval for the shares issuable upon the exercise of the warrants.

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The gross proceeds to the Company from the registered direct offering and concurrent private placement are estimated to be approximately $4.5 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company. The offering is expected to close on or about December 26, 2023, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock (or pre-funded warrants in lieu thereof) are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256627), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 11, 2021. The offering of shares of common stock (or pre-funded warrants in lieu thereof) will be made only by means of a prospectus supplement that forms a part of such registration statement. The warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were 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 have not been registered under the Act or applicable state securities laws.

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. A prospectus supplement relating to the shares of common stock and pre-funded warrants will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3500.

On December 20, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported constructive feedback has been received from the Paul-Ehrlich-Institut ("PEI"), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha ("efti") for first line treatment of metastatic non-small cell lung cancer (NSCLC) (Press release, Immutep, DEC 20, 2023, View Source [SID1234638727]).

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The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Also, the PEI acknowledged the good safety profile of efti in combination with anti-PD-1 therapy.

Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and the potential patient population as defined by level of PD-L1 expression. Additional interactions with the U.S. Food and Drug Administration (FDA), other local European regulators, as well as with other stakeholders and potential partners are ongoing. Immutep plans to announce its final trial design for TACTI-004 in Q1 of CY2024.

Immutep CEO, Marc Voigt, commented: "We appreciate the valuable feedback from the PEI and look forward to additional discussions with other regulatory agencies in the coming months. Immutep is uniquely positioned to address multiple patient populations within non-small cell lung cancer as defined by their level of PD-L1 expression, including high, low, and negative expressors, with either efti combined with anti-PD-1 therapy or a triple combination approach including chemotherapy. Our confidence in efti’s ability in this important indication stems from the mature data in the large TACTI-002 Phase II trial, and the emerging data from the triple combination INSIGHT-003 study."

About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).