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SBI Pharmaceuticals and TAGCyx announces the research and development collaboration of inovative cancer therapy

On November 25, 2020 SBI Pharmaceuticals and TAGCyx biotechnologies reported entering into a research and develop collaboration to develop innovative products in the field of cancer treatment (Press release, TAGCyx Biotechnologies, NOV 25, 2020, View Source [SID1234625951]).

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SBI Pharmaceuticals is specialized in the application of 5-ALA (5-aminolevulinic acid) and is dedicated to provide innovation for a wide range of health applications in the healthcare and health food field in order to help improve the health and quality of human life all over the world.

TAGCyx has invented artificial nucleic acid base-pair technology that enables to produce high affinity and selective DNA aptamers "Xenoligo".

By combining SBI Pharmaceuticals’ technology and TAGCyx’s Xenoligo, both companies intend to develop novel technologies in oncology arena.

As part of the joint research and development, TAGCyx will receive research and development funds, multiple milestones at certain steps during the development as well as sales related royalties accordingly.

(*1) 5-aminolevulinic acid (5-ALA): An amino acid produced in mitochondria. It is an important substance that serves as a functional molecule related to energy production in the form of heme and cytochromes, and its productivity is known to decrease with age. 5-ALA is contained in food such as shochu lees, red wine and Asian ginseng. It is also known as a material forming chloroplasts in plants.

Alpha1H Patent granted in Europe

On November 25, 2020 Hamlet Pharma AB reported its successfully secured patent protection in Europe for its lead clinical candidate, Alpha1H (Press release, HAMLET Pharma, NOV 25, 2020, View Source;utm_medium=rss&utm_campaign=alpha1h-patent-granted-in-europe [SID1234574599]). This protection is granted as European patent number EP 3618848 B1, which will remain valid until May 14, 2038.

Alpha1H is currently used in clinical trials in patients with bladder cancer. With this patent, Hamlet Pharma AB continues to expand it’s intellectual property portfolio in areas where its key products show benefit. Following this success at the European Patent Office, where the claims of EP 3618848 B1 were readily accepted for grant, Hamlet Pharma AB plans to seek equivalent protection in further key countries around the world.

"This demonstrates the uniqueness of the innovation and the opportunities Alpha1H may offer cancer patients" says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.

"Alpha1H is our lead drug candidate and this is an important milestone to secure long-term protection in Europe" says Mats Persson, CEO of Hamlet Pharma Ltd.

F-star Therapeutics Announces Clearance of
Clinical Trial Application for FS222

On November 25, 2020 F-star Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, reported the authorization of the Clinical Trial Application (CTA) in Spain for the initiation of a Phase 1, open label, first-in-human clinical study of FS222 (Press release, F-star, NOV 25, 2020, View Source [SID1234574523]). FS222 is a potentially best-in-class bispecific antibody targeting CD137 (4-1BB) and PD-L1.

FS222 has a natural antibody structure and a unique tetravalent bispecific mechanism of action. It has the potential to overcome cancer resistance by combining PD-L1 blockade with tumor-targeted, potent CD137 agonism. Most patients do not respond or have a short duration of response to currently approved immune checkpoint inhibitors such as PD-1 or PD-L1 antibodies. In preclinical studies, FS222-mediated PD-L1 blockade that synergized with conditional CD137 agonism stimulated lymphocyte activation and showed antitumor responses beyond that achieved with PD-L1 inhibition alone. FS222 is Fcg receptor null and was well tolerated in preclinical toxicology studies using animal models.

Dr. Louis Kayitalire, CMO of F-star said: "With this CTA authorization we are excited to bring this novel immunotherapy into the clinic for patients with cancer. We are eager to investigate its safety and potential differentiated benefit in partnership with immuno-oncology leaders in Spain. As our third wholly-owned bispecific to enter the clinic, we believe that F-star’s novel platform technology can be the answer that so many patients have been waiting for."

Lixte Biotechnology Holdings, Inc. Announces Pricing of $5,700,000 Public Offering; Uplisting to Nasdaq Capital Market and Reverse Stock Split

On November 25, 2020 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT)("Lixte" or the "Company"), reported the pricing of its underwritten public offering of 1,200,000 units of securities at an offering price of $4.75 per unit (Press release, Lixte Biotechnology, NOV 25, 2020, View Source [SID1234571844]). Each unit is immediately separable into one share of common stock and one warrant to purchase one share of common stock and will be issued separately. The warrants underlying the units are immediately exercisable for one share of common stock at an exercise price of $5.70 and expire 5 years from the date of issuance.

The Company’s common stock and warrants will begin trading on the Nasdaq Capital Market on November 25, 2020, under the symbols "LIXT" and "LIXTW," respectively. In connection with the offering, the Company effectuated a reverse split of its issued and outstanding common stock at a ratio of 1-for-6. The reverse stock split became effective at 4:00 p.m., Eastern Time, on Thursday, November 19, 2020. The share numbers and pricing information in this release are adjusted to reflect the impact of the reverse stock split.

The Company has granted the underwriters a 45-day option to purchase up to 180,000 additional shares of the Company’s common stock and/or up to 180,000 additional warrants to purchase shares of the Company’s common stock, or any combination thereof, to cover overallotments, if any. The offering is expected to close on or about November 30, 2020, subject to customary closing conditions.

The Company expects to receive gross proceeds of $5.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses and before any exercise of the underwriters’ overallotment option. The Company intends to use the net proceeds to fund its planned clinical trials, manufacturing its product candidate, maintain and extend its patent portfolio, retention of contract research organizations, development of a form of its primary compound, LB-100 for oral administration, and for working capital and other general corporate purposes.

WestPark Capital, Inc. and WallachBeth Capital, LLC are acting as the joint book-running managers for the offering.

This offering is being made pursuant to an effective registration statement on Form S-1 (No. 333-248588) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 24, 2020. A final prospectus describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, via the SEC’s website at www.sec.gov or from: WestPark Capital, Inc. – Attention: Jason Stern, 1900 Avenue of the Stars, 3rd Floor, Los Angeles, CA 90077 or by Email: [email protected] or by telephone at (310) 203-2919.

Source: Lixte Biotechnology Holdings, Inc. November 25, 2020 08:30 ET

This press 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 that state or jurisdiction.

Entry into a Material Definitive Agreement

On November 25, 2020, Inspyr Therapeutics, Inc. (the "Company") entered into a conversion price adjustment agreement (the "Agreement") with Sabby Healthcare Master Fund, Ltd. and Sabby Volatility Warrant Master Fund, Ltd. (collectively, "Sabby") (Filing, 8-K, Inspyr Therapeutics, NOV 25, 2020, View Source [SID1234571843]). Pursuant to the Agreement, approximately $2,383,150 in outstanding senior convertible debentures (the "Debentures") held by Sabby were amended such that their conversion prices into common stock ("Common Stock") of the Company are equal to the lesser of (i) $0.33 and (ii) 85% of the lowest volume-weighted average price during the five trading days immediately prior to the date of conversion.