On February 8 2022 Cytovation AS, a clinical stage immuneoncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, reported that it is has entered into collaboration with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to advance the development of CyPep-1 for the treatment of this orphan disease alongside the Company’s cancer development program (Press release, Cytovation, FEB 8, 2022, View Source;utm_medium=rss&utm_campaign=cytovation-collaborates-with-recurrent-respiratory-papillomatosis-foundation-to-expand-its-clinical-investigations-of-cypep-1-into-rare-neoplastic-disease [SID1234607956]).

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Recurrent Respiratory Papillomatosis (RRP) is a rare neoplastic disease that is characterized by the growth of benign tumors in the respiratory tract caused by the human papilloma virus (HPV). Although they primarily occur in the larynx on and around the vocal cords, these growths may spread downward and affect the trachea, bronchi, and occasionally the lungs. Historic estimates from the RRP Taskforce have indicated an incidence among children of about 4.3 per 100,000 and among adults of about 1.8 per 100,000. Currently there are no approved treatments for RRP.

The collaboration will enable Cytovation to draw upon RRPF’s extensive knowledge and network in preparation for a Phase I/II study to be initiated in 2H 2022.

Kim McClellan, RRPF President, commented: "We are delighted to be combining our expertise with Cytovation’s to help investigate CyPep-1 in RRP. For people with rare diseases like RRP, new clinical studies can help advance our understanding of the condition and potentially address the significant unmet needs faced by patients every day. We believe CyPep-1 has great potential and we’re excited to test its efficacy in this difficult condition."

"The opportunity for CyPep-1 in this rare disease indication highlights its broad potential not just across solid cancer types, but also across neoplastic diseases in general," added Lars Prestegarden, MD, PhD, CEO of Cytovation. "We are very pleased to enter this new collaboration with RRPF, which will extend our clinical development plan with CyPep-1 beyond studies targeting cancers – both as a monotherapy and in combination with checkpoint inhibitors – into non-cancer neoplastic rare diseases. We look forward to working with RRPF and to initiating clinical studies in RRP later in 2022."

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target tumor cells. CyPep-1 eliminates these cells by forming pores in the plasma membrane, releasing antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

On February 8, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that its wholly owned subsidiary, Solta Medical Corporation ("Solta"), has publicly filed a registration statement on Form S-1 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering ("IPO") of Solta’s common shares (Press release, Bausch Health, FEB 8, 2022, View Source [SID1234607944]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. Solta has applied to list its common shares on the Nasdaq Global Select Market under the symbol "SLTA."

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Bausch Health has completed all internal procedural steps and is fully prepared to launch both the Solta and Bausch + Lomb Corporation IPOs, subject to receipt of regulatory, stock exchange and other approvals. The Company is actively monitoring market conditions to determine the paths forward.

Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. Citigroup, Guggenheim Securities, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

The proposed offering will be made only by means of a prospectus, which forms a part of the Registration Statement. Copies of the Registration Statement and the preliminary prospectus included therein relating to the proposed offering, when available, may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, N.Y. 10282, by telephone at 866-471-2526 or by email at [email protected] or Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, N.Y. 10014.

The Registration Statement relating to the proposed offering has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

This news release does not constitute an offer to sell or the 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. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. These securities are not being offered to the public in any Canadian jurisdiction and any sales into Canada, if any, will be made in compliance with available exemptions from the Canadian prospectus requirements and only through securities dealers appropriately registered in the jurisdictions of Canada in which sales would be made.

On February 8, 2022 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, reported the publication of preclinical data for HMBD-002, a novel anti-VISTA antibody therapeutic, in the Journal for ImmunoTherapy of Cancer, a peer-reviewed journal of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Hummingbird Bioscience, FEB 8, 2022, View Source [SID1234607937]).

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The publication highlights how HMBD-002, an IgG4 isotype anti-VISTA neutralizing antibody rationally developed with Hummingbird Bioscience’s Rational Antibody Discovery (RAD) platform, binds specifically and with high affinity to a binding site distinct from other published VISTA antibodies, and significantly inhibits tumor growth in syngeneic and humanized murine models of cancer. The data demonstrate that HMBD-002 inhibits VISTA binding to key partners, including VSIG3, to release suppression of T cell activity, and that HMBD-002 treatment results in remodeling of the tumor microenvironment in murine models towards an anti-tumor phenotype.

"We believe that VISTA has not been adequately drugged to date due to its complex biology that has complicated the discovery and testing of therapeutics that could achieve effective VISTA inhibition without causing unacceptable toxicity," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "Our preclinical data strongly supports that our differentiated anti-VISTA antibody HMBD-002, the development of which was uniquely enabled by our Rational Antibody Discovery platform, has potential as an important new therapy that may address VISTA-mediated immunosuppression across a broad range of tumors."

The publication, titled ‘Rationally targeted anti-VISTA antibody that blockades the C-C’ loop region can reverse VISTA immune suppression and remodel the immune microenvironment to potently inhibit tumor growth in an Fc independent manner’, can be accessed online.

HMBD-002 is currently being developed for patients with VISTA-expressing cancers, including triple-negative breast cancer and non-small cell lung cancer. The Phase 1 clinical trial NCT05082610 is open and enrolling.

About HMBD-002

HMBD-002 is an investigational IgG4 anti-VISTA antagonist antibody produced by our RAD platform to target the region where VISTA interacts with binding partners that have been shown to play an important role in modulating T cell activity, potentially unlocking the immune system to attack cancer cells. Due to complex biology, VISTA has not been adequately drugged to date. We believe HMBD-002 is the first Fc-independent anti-VISTA antibody designed to bind a computationally predicted functional epitope distinct from the epitopes of other known anti-VISTA antibodies in development. In the Company’s preclinical studies, HMBD-002 demonstrated potent anti-tumor activity both as monotherapy and in combination with pembrolizumab, in multiple syngeneic and humanized mouse models of cancers. HMBD-002 is being developed for various VISTA-expressing cancers, both as a monotherapy and in combination with pembrolizumab. The development of HMBD-002 is supported in part by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT, DP190027).

On February 8, 2022 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that it will host a conference call and webcast on Wednesday, February 16, 2022 at 5:00 p.m. EST to provide an update on the Company’s clinical programs, manufacturing processes and pipeline (Press release, Marker Therapeutics, FEB 8, 2022, View Source [SID1234607910]).

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The webcast will be accessible in the Investors section of the Company’s website at WWW.MARKERTHERAPEUTICS.COM. Individuals can participate in the conference call by dialing 877-869-3847 (domestic) or 201-689-8261 (international) and referring to the "Marker Therapeutics Clinical Program Update Call."

The archived webcast will be available for replay on the Marker website following the event.

On February 8, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the closing of its initial public offering of 9,487,500 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 1,237,500 additional shares of its common stock, at a public offering price of $15.00 per share (Press release, Arcellx, FEB 8, 2022, View Source [SID1234607896]). The aggregate gross proceeds from the offering were $142.3 million, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx. All of the shares of common stock were offered by Arcellx. Arcellx’s common stock began trading on the Nasdaq Global Select Market on February 4, 2022, under the ticker symbol "ACLX."

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BofA Securities, SVB Leerink, Barclays and William Blair acted as joint book-running managers for the offering.

A registration statement relating to the offering has been filed with the Securities and Exchange Commission and became effective on February 3, 2022. The offering was made only by means of a prospectus, copies of which may be obtained from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected] or by telephone at (888) 603-5847; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687, or by email at [email protected]. Copies of the final prospectus related to the offering are available at www.sec.gov.

This press release shall not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or jurisdiction.