On June 20, 2021 Complete Omics reported a collaboration with ErVaccine Technologies, a pharmaceutical company headquartered in Lyon, Rhone-Alpes, France, on a neoantigen validation and quantification project (Press release, ErVaccine, JUN 20, 2021, View Source [SID1234629618]).

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Ervaccine Technologies a developer of next-generation cancer vaccines that targets endogenous retroviruses. Complete Omics is proud to work with ErVaccine to leverage our Valid-NEO platform for personalized cancer therapeutics.

On June 18, 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 the closing of its previously announced underwritten public offering of 15 million shares of its common stock at a price to the public of $3.00 per share (Press release, Inhibikase Therapeutics, JUN 18, 2021, View Source [SID1234584139]). The gross proceeds to Inhibikase from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase, were $45 million. Inhibikase has granted the underwriters a 45-day option to purchase up to an additional 2,250,000 shares of common stock, at the public offering price less discounts and commissions.

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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., acted as sole book-running manager for the offering. JonesTrading Institutional Services LLC acted as the co-manager for the offering.

The offering was 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. A final prospectus related to the offering has been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus relating to this offering may be obtained 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.

On June 17, 2021 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899)(Press release, BioNTech, JUN 18, 2021, View Source [SID1234584122]). The study is evaluating the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech.

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The BNT111-01 trial which is being conducted in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in Spain, Germany, Italy and Poland as well as in the United Kingdom, the United States and Australia. The open-label randomized trial evaluates the efficacy, tolerability, and safety of BNT111 in combination with Libtayo, an anti-PD-1 monoclonal antibody, being co-developed by Regeneron and Sanofi. The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone. The primary endpoint is the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single agent arms, duration of response, and safety. The first patient has been dosed in the EU. BioNTech retains global commercial rights to BNT111.

"Our vision is to harness the power of the immune system against cancer and infectious diseases. We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. We must not forget, that cancer is also a global health threat, even worse than the current pandemic," said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech. "BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. With the start of patient treatment in our Phase 2 trial, we are encouraged to continue on our initial path to realize the potential of mRNA vaccines for cancer patients."

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation. More than 90% of melanomas in patients express at least one of the four tumor-associated antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE). BNT111 is one of the most advanced of five clinical-stage FixVac product candidates within BioNTech’s development pipeline.

This Phase 2 clinical trial is based on previous results from the Phase 1 Lipo-MERIT dose escalation trial (NCT02410733) that demonstrated a favorable safety profile in 89 patients with advanced melanoma. In addition, efficacy analysis of the Lipo-MERIT study in a subset of 42 metastatic melanoma patients previously treated with a checkpoint-inhibitor (CPI) showed that BNT111 mediated durable responses both as a single agent and in combination with anti-PD-1 antibodies and that durable objective responses by BNT111 were associated with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells. These results were published in Nature in July 2020.

The Company also plans to start randomized Phase 2 trials with mRNA vaccine product candidates in two additional programs in 2021 (FixVac: BNT113 and iNeST: BNT122). As part of its development strategy, BioNTech aims to rapidly advance its broad oncology pipeline and expects to bring additional candidates into late-stage clinical development and towards market entry within the next five years.

About FixVac
BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature the Company’s proprietary RNA-lipoplex delivery formulation which is designed to enhance stability and translation of the mRNA cargo as well as specifically target dendritic cells. Thus, the vaccine candidate aims to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.

On June 18, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX), a clinical stage biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 3,503,311 shares of its common stock, including 456,953 shares sold pursuant to the underwriters’ exercise in full of their "green shoe" option to purchase additional shares, at a price to the public of $37.75 per share (Press release, Protagonist, JUN 18, 2021, View Source [SID1234584140]). Aggregate gross proceeds to Protagonist from the offering were approximately $132.2 million, before deducting underwriting discounts and commissions and offering expenses.

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J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler acted as joint book-running managers for the offering. JMP Securities LLC and H.C. Wainwright & Co., LLC acted as co-lead managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

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.

On June 17, 2021 Cleveland BioLabs, Inc. (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, announced that its registration statement on SEC Form S-4 (the "Registration Statement") filed with U.S. Securities and Exchange Commission (the "SEC") in connection with its previously reported merger with Cytocom Inc. ("Cytocom") was declared effective by the SEC on June 10, 2021(Press release, Cytocom, JUN 18, 2021, https://www.cytocom.com/2021/06/18/cleveland-biolabs-inc-and-cytocom-announce-registration-statement-and-proxy-statement-for-previously-announced-merger-declared-effective-by-sec/ [SID1234584123]). Cytocom is a leading biopharmaceutical company creating next-generation immune therapies that deliver immune homeostasis.

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A special meeting of the Cleveland BioLabs stockholders to approve the proposals related to the merger (the "Special Meeting") will be held virtually. Details of the meeting are as follows:

Date:

Tuesday, July 6, 2021

Time:

10:00 a.m. ET

Registration:

www.virtualshareholdermeeting.com/CBLI2021SM

The Registration Statement includes a definitive proxy statement and a prospectus. Notice of the Special Meeting and the definitive proxy statement/prospectus was mailed to stockholders of the Company as of June 9, 2021.

ubsequent to the closing of the merger, the new combined company will be named "Cytocom Inc.", and its common stock is expected to trade on the Nasdaq Capital Market under the symbol "CYTO". The closing of the merger, which is expected to occur during the third quarter of 2021, is subject to approval by Cleveland BioLabs’ stockholders, the approval of the application for listing of the combined company’s stock on the Nasdaq Capital Market and the satisfaction of other customary closing conditions.