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Moderna to Present at the 42nd Annual J.P. Morgan Healthcare Conference

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.

Moleculin Announces Pricing of $4.5 Million Registered Direct Offering and Concurrent Private Placement Priced At-the-Market

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.

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.

Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

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]).

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).

Akoya to Participate at 42nd Annual J.P. Morgan Healthcare Conference

On December 20, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will be participating in the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Akoya Biosciences, DEC 20, 2023, View Source [SID1234638726]).

Brian McKelligon, CEO, is scheduled to present on Wednesday, January 10th, 2024 at 3:45 p.m. PT.

A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

TRACON Pharmaceuticals Provides Positive Update on Ongoing ENVASARC Pivotal Phase 2 Trial

On December 20, 2023 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the ongoing pivotal Phase 2 ENVASARC trial has enrolled more than 70 of the 80 planned patients in Cohort C of single agent envafolimab treatment at a dose of 600 mg subQ every three weeks (Press release, Tracon Pharmaceuticals, DEC 20, 2023, View Source [SID1234638725]).

Additional safety and efficacy data were reviewed for 46 patients enrolled into cohort C who were the subject of the September independent data monitoring committee (IDMC) review. At that time, patients had completed a minimum of 12 weeks of efficacy evaluations and the objective response rate (ORR) was 13% by investigator review and 8.7% by blinded independent central review (BICR). Since then, an additional patient has achieved an objective response by investigator review, which increased the ORR by investigator review to 15%. The most recent objective response has not yet been confirmed by BICR and the patient remains on treatment. Median duration of response by BICR remains greater than six months. In addition, envafolimab remains well tolerated and grade > 3 related toxicity has not been reported to date.

"We continue to believe that these data position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS based on the ORR and tolerability data to date," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "ENVASARC enrollment continues to be brisk, reflecting the high unmet need that exists for these patients."

Updated safety and efficacy data are expected in 1Q 2024, including in the more than 20 patients enrolled following the September IDMC review who will have had a minimum of 12 weeks of efficacy evaluations (two CT scans) at that time.

The primary endpoint of the ENVASARC study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for envafolimab for patients with soft tissue sarcoma and fast track designation from the FDA for envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. ENVASARC is enrolling patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. In Cohort C, a total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.