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.

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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."

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.

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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.

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.

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On November 25, 2020 Novavax Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported that it will participate in two upcoming investor conferences (Press release, Novavax, NOV 25, 2020, View Source [SID1234571791]). Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion in each conference.

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Piper Sandler 32nd Annual Virtual Healthcare Conference
Panel
Date:
Tuesday, December 1, 2020
Time: 10:00 a.m. Eastern Time (ET)
Panel title: The Road Ahead for COVID-19 Vaccines: What We Know and Questions Still to Be Answered into 2021
Moderators: Edward A. Tenthoff and Yasmeen Rahimi, Ph.D.
NVAX Panelist: Gregory M. Glenn, M.D., President of Research and Development, Novavax
Additional panelists: Moderna, Inc., Arcturus Therapeutics Holdings, Inc. and Altimmune, Inc.
This event is open to Piper Sandler clients

Conference
Event:
Participants: Fireside chat
Stanley C. Erck, President and Chief Executive Officer, and Dr. Glenn
Webcast:
A replay of the recorded fireside session is available through the events page of the Company’s website at ir.novavax.com for 90 days.

Event:
Date:

Investor meetings
Wednesday, December 2, 2020
Evercore ISI 3rd Annual HealthCONx Conference
Date: Thursday, December 3, 2020
Time: 2:15 p.m. Eastern Time (ET)
Participation: Fireside chat and investor meetings
Live webcast: www.novavax.com, "Investors"/ "Events"

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

On November 25, 2020 UniSA researchers reported are partnering with Spanish pharmaceutical company Almirall through its open innovation platform, AlmirallShare, to further the development of new ways of treating common skin cancers (Press release, University of South Australia, NOV 25, 2020, View Source [SID1234571779]).

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UniSA researchers from its Future Industries Institute, Professor Tarl Prow and Dr Miko Yamada, will be working in collaboration with others to further their research into the causes and potential treatments for one of the most common forms of skin cancer, squamous cell carcinoma.

The research will help to unpack the molecular mechanism underlying this type of skin cancer and modulate its development with the novel use of an off-patent topical drug, proved effective in clinical trials funded by the Skin Cancer College of Australasia conducted by the UniSA FII team.

Prof Prow says joining forces with Almirall could be a game changer.

"This this collaboration will allow us to establish synergies between different groups to further our commitment to fighting skin cancer," Prof Prow says.

"By pairing our deep knowledge of a common type of skin tumor with Almirall’s leading expertise in medical dermatology we could reimagine the treatment options for people with skin carcinoma.

"This group has a strong commitment to fight skin cancer and has developed innovative technologies with clinical applications and enhanced delivery of topical drugs.

"Our team is excited to be working with them on such a significant project."

Launched in 2017, AlmirallShare aims to facilitate collaborations in dermatological research and accelerate the generation of new treatments for skin conditions, by putting together the science and creativity of experts around the world with Almirall’s own expertise.

To date more than 400 research proposals have been received and globally, 900 scientific researchers have joined the group.

Australia leads the world in incidence of skin cancer with 33.6 adults in every 100,000 affected.