Linnaeus Therapeutics Announces Expanded Clinical Collaboration with Merck to Include Multiple Additional Cohorts to Evaluate LNS8801 in Combination with KEYTRUDA® in Patients with Advanced Cancer

On June 15, 2021 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that the expansion of its ongoing clinical collaboration with Merck to include multiple additional phase 2 cohorts(Press release, Linnaeus Therapeutics, JUN 16, 2021, View Source [SID1234584073]). Based on promising preliminary safety, pharmacodynamic and efficacy data, this expanded agreement will allow the companies to further evaluate the combination of LNS8801 and Merck’s anti-PD-1 therapy, KEYTRUDA(pembrolizumab) in patients with selected advanced solid tumors.

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LNS8801 is a first-in-class, orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Stimulating GPER rapidly and durably depletes the c-Myc oncoprotein, stops cancers from proliferating, and makes them more visible to the immune system.

Linnaeus and Merck are currently evaluating the combination of LNS8801 and KEYTRUDA in patients who had previously responded to PD-1/L1 therapy but have subsequently progressed on PD-1/L1 inhibitors. Additionally, Linnaeus is currently evaluating LNS8801 as a monotherapy in patients that cannot tolerate PD-1/L1 therapy due to serious immune-related adverse events.

Under the terms of the agreement, Linnaeus will conduct six additional Phase 2 cohorts evaluating the combination of LNS8801 and KEYTRUDA in several indications including NSCLC, head and neck cancer, cutaneous and uveal melanoma, among others.

"We are very pleased to expand our collaboration with Merck, the established leader in cancer immunotherapy, as we advance LNS8801 into Phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "Based on the encouraging signals we have seen so far in the advanced cancer patients treated with the combination of LNS8801 and KEYTRUDA as well as LNS8801 as monotherapy, we are optimistic that the combination of LNS8801 and KEYTRUDA will provide meaningful benefit to this patient population."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LNS8801

LNS8801 is an orally bioavailable and highly specific, potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc oncoprotein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing phase human 1/2a study, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc oncoprotein depletion, and durable clinical benefit in patients with advanced cancer.

Inhibikase Therapeutics Prices Follow-On Public Offering of Common Stock

On June 15, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported that the pricing of an underwritten public offering of 15 million shares of its common stock at a public offering price of $3.00 per share for total gross proceeds of approximately $45 million (the "Offering) before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase(Press release, Inhibikase Therapeutics, JUN 16, 2021, View Source [SID1234584072]). In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to 2.25 million additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 18, 2021, subject to customary closing conditions.

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Inhibikase intends to use the net proceeds from the public offering, together with existing funds, to fund the costs of a Phase 1b extension study for IkT-148009 in Parkinson’s patients and to validate target engagement markers in the central and peripheral nervous system; to fund production of IkT-148009 for Phase 1b and Phase 2 clinical studies and to fund a Phase 2 efficacy trial of IkT-148009 in Parkinson’s patients. This funding will further support the clinical dose calibration study(ies) of IkT-001Pro in healthy subjects to support approval under the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act and to fund drug product production for IkT-001Pro. The balance will support general research and development activities, medicinal chemistry for additional molecules and IND-enabling studies, team building, and other general corporate activities

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering. JonesTrading Institutional Services LLC is acting as the co-manager for the offering.

The offering is being made pursuant to a registration statement on Form S-1 (File No. 333-257032) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected].

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.

ImmunoPrecise Attending the 6th Annual CART-CR Summit

On June 16, 2021 ImmunoPrecise reported that it will be attending The 6th Annual CAR-TCR Summit which returns in 2021 as the industry-leading comprehensive forum with one goal: to engineer a disease-free world(Press release, ImmunoPrecise Antibodies, JUN 16, 2021, View Source [SID1234584070]). At the event, over 150 speakers will lead discussions on many topics from commercial pipeline development to new innovations and approaches. The virtual event will be held from August 30 to September 2.

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Enochian BioSciences Announces $29 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On June 14, 2021 Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, reported that it has entered into a definitive securities purchase agreement with several institutional investors for the issuance and sale of an aggregate of 3,866,667 shares of its common stock at a purchase price of $7.50 per share of common stock a registered direct offering priced at-the-market under Nasdaq rules(Press release, Enochian BioSciences, JUN 16, 2021, View Source [SID1234584069]). The registered direct offering is expected to close on or about June 16, 2021, 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 gross proceeds from the offering are expected to be approximately $29 million before deducting placement agent fees and other offering expenses. Enochian currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The securities described above are being offered pursuant to Enochian’s shelf registration statement on Form S-3 (File No. 333-239837) filed with the Securities and Exchange Commission (the "SEC") on July 13, 2020 and declared effective on July 20, 2020. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the securities being offered in the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any 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.

GT Biopharma to Present at Raymond James Human Health Innovation Conference

On June 16, 2021 GT Biopharma, a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform, reported that it will provide a corporate update at the upcoming Raymond James Human Health Innovation Conference on Tuesday, June 22, 2021 at 11:20 AM ET (Press release, GT Biopharma, JUN 16, 2021, View Source [SID1234584068]).
A live webcast of the event will be available by visiting "Presentations" page in the Investors section of GT Biopharma’s website at www.gtbiopharma.com/news-media/presentations. A replay of the webcast will be archived for 30 days following the presentation.

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