Compass Therapeutics Announces Proposed Public Offering of Common Stock and Uplisting to Nasdaq Capital Market

On November 1, 2021 Compass Therapeutics, Inc. (the "Company"), a clinical stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported that it intends to offer and sell shares of common stock in an underwritten public offering (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594048]). All of the shares of common stock are being offered by the Company. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate shares of common stock offered in the public offering at the public offering price, less the underwriting discount. In connection with the offering, the Company also announced that its common stock has been approved for listing on the Nasdaq Capital Market under the symbol "CMPX", subject to the pricing of the public offering on the terms proposed.

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The offering is subject to customary closing conditions. The Company intends to use the net proceeds from the public offering, together with its existing cash and cash equivalents, (i) to secure the listing of its common stock on the Nasdaq Capital Market, (ii) for funding of ongoing operations including clinical trials for its existing programs, which may change based on clinical and preclinical results and (iii) for general corporate purposes.

SVB Leerink is serving as the book-running manager for the proposed offering.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-257821) that was declared effective by the Securities and Exchange Commission on July 20, 2021. A preliminary and final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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 these securities in jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200301

On November 1, 2021 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200301 (Press release, HiFiBiO Therapeutics, NOV 1, 2021, View Source [SID1234594087]). HFB200301 is a first-in-class monoclonal agonist antibody designed to promote an antitumor response by stimulating both innate and adaptive immune systems through TNFR2 in solid tumors identified through HiFiBiO’s Drug Intelligent Science (DISTM) platform.

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"The FDA’s clearance of our IND for HFB200301 is an important milestone for HiFiBiO as it further demonstrates the power of our single cell-powered DIS platform to identify and develop novel therapeutics. This milestone also signifies our transition to a clinical stage company," said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. "The FDA’s clearance brings us one step closer toward achieving our mission of delivering novel therapeutics that improve treatment options for cancer patients"

"We were excited to discover that our TNFR2 clinical candidate not only stimulated effector CD4 and CD8 T cells, but also activated NK cells to drive anti-tumor activity" shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. "HFB200301 has shown strong in vivo efficacy alone and combined with anti-PD-1 at doses well tolerated in mice and NHPs."

"The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts in selected solid tumors identified through HiFiBiO DISTM platform. The company is also exploring a potential combination with checkpoint inhibitor therapy", said Luigi Manenti, M.D., CMO of HiFiBiO Therapeutics. "We remain committed to further developing novel immune therapies for patients with cancer and autoimmune diseases."

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select patients who may benefit the most from HFB200301 treatment.

Exact Sciences to participate in November investor conferences

On November 1, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, NOV 1, 2021, View Source [SID1234594015]).

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Jefferies London Healthcare Conference
Fireside Chat on Tuesday, November 16, 2021 at 10:40 a.m. ET

Stifel Virtual Healthcare Conference
Fireside Chat on Tuesday, November 16, 2021 at 3:20 p.m. ET

Evercore ISI HealthCONx Virtual Conference
Fireside Chat on Tuesday, November 30, 2021 at 11:20 a.m. ET
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Mustang Bio Awarded NIH Grant For MB-106 CD20-Targeted CAR T Cell Therapy for Treatment of B-cell non-Hodgkin Lymphomas

On November 1, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has been awarded a grant of approximately $2 million from the National Cancer Institute of the National Institutes of Health ("NIH") (Press release, Mustang Bio, NOV 1, 2021, View Source [SID1234594032]). This two-year award will partially fund the Phase 1, Open Label, Multicenter Trial to Assess the Safety, Tolerability and Efficacy of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") or chronic lymphocytic leukemia ("CLL").

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In addition, the Office for Human Research Protections has approved Federalwide Assurance ("FWA") for Mustang’s research. FWA is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The NIH grant and FWA validate our scientific efforts as we continue to advance the development of MB-106. This grant will contribute to Mustang’s evaluation of MB-106 in clinical trials with the hope to bring this therapeutic treatment to patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia."

Research is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA265616. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHL and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.

BioNTech to Present New Clinical Data from First-in-Class CAR-T Program BNT211 in Late-breaking Session at 36th SITC Annual Meeting

On November 1, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation (Press release, BioNTech, NOV 1, 2021, View Source [SID1234594067]). The presentation is scheduled for the late-breaking abstract poster session at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held both in person and virtually from November 10 – 14, 2021.

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"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial (NCT04503278) to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Poster Details:

Program: BNT211
Poster Title: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Abstract Number: 958
Presenter: Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany
Date & Time: Friday, November 12, 2021; 12.25 – 12.40 pm ET