F-star Therapeutics Announces Release of Phase 1


– FS118 is well tolerated at all dose levels with no serious adverse events related to FS118 therapy

– New mechanism showing an increase in peripheral immune cells and LAG-3 excretion

– 54.8% disease control rate in patients resistant to PD-L1 at doses > 1 mg/kg, including partial response in anaplastic thyroid cancer

– Other ongoing studies in acquired resistance squamous cell carcinoma of the head and neck and naïve non-small cell lung cancer and diffuse B-cell lymphoma

CAMBRIDGE, U.K. and CAMBRIDGE, Mass., Nov. 07, 2022 (GLOBE NEWSWIRE) — F-star Therapeutics, Inc. (NASDAQ: FSTX) (“F-star” or the “Company”), a pioneering biopharmaceutical company bispecific antibodies for immunotherapy so that more people with cancer can live longer and better lives, today announced the publication of safety and efficacy results from the Phase 1 trial of FS118 in patients with advanced cancer resistant to PD-L1 in Clinical cancer researcha journal of the American Association for Cancer Research.

“Phase 1 data published in Clinical cancer research demonstrate that FS118 has the potential to overcome cancer immune resistance given the prolonged pharmacodynamic activity,” said Louis Kayitalire, Chief Medical Officer of F-star. “We are delighted to see that FS118 was well tolerated, and in this population of heavily pretreated patients with acquired PD-L1 resistance, a partial response was achieved and a disease control rate of 54.8% . We look forward to generating additional data and leveraging our bispecific approach to deliver therapies to patients with advanced cancer. »

FS118 is a first-in-class tetravalent bispecific antibody that binds to LAG-3 and PD-L1, resulting in reversal of immune suppression. The Phase 1 trial is the first-in-human study of FS118 that is evaluating forty-three patients with locally advanced/metastatic cancer with a median of three prior treatments and at least one anti-PD-L1 therapy. Patients received intravenous monotherapy of FS118 weekly with an accelerated dose titration design (800 µg to 0.3 mg/kg) followed by a 3+3 escalating dose extension (1 mg/kg to 20 mg/ kg). Weekly dosing was well tolerated with no dose limiting toxicity (DLT) and no serious adverse event (SEA) related to FS118. The recommended phase 2 dose of FS118 has been established at 10 mg/kg per week. Pharmacodynamic activity was prolonged throughout administration, as demonstrated by increased and sustained levels of soluble LAG-3 and peripheral effector cells. A disease control rate (DCR) of 54.8% was observed in patients receiving 1 mg/kg or more who had acquired resistance to PD-L1-targeted therapy.

The article is titled “A First-in-Human Phase 1 Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in PD-L1-Resistant Advanced Cancer Patients.” and is available online at https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-1449/710483/A-Phase-1-first-in-human-study- de-FS118-a The lead author of the publication was Timothy A. Yap, University of Texas MD Anderson Cancer Center.

About FS118

F-star’s FS118 is a dual checkpoint inhibitor targeting PD-L1 and LAG-3 that results in LAG-3 excretion and receptor downregulation, via bispecific activity. It is one of a range of dual-antagonist bispecific formats that are being explored in clinical development, each with the potential to elicit a unique biological activity that may result in different clinical outcomes. The unique pharmacology of FS118 potentially offers a longer lasting response in patients. In the Phase 1 clinical trial, FS118 was well tolerated with no serious treatment-related adverse events and no dose-limiting toxicity up to 20 mg/kg.

About F-star Therapeutics, Inc.:

F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering bispecific immunotherapy so that more people with cancer can live longer and live better. F-star is committed to working towards a future free of cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. The company has four second-generation immuno-oncology therapies in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property portfolio. F-star has over 500 issued patents and pending patent applications relating to its platform technology and product pipeline. The company has attracted several biopharmaceutical partnerships targeting significant unmet needs in several therapeutic areas, including oncology, immunology and CNS. For more information, visit our website and follow us on LinkedIn and Twitter.

Additional information and where to find it:

This communication is neither a recommendation nor an offer to buy or a solicitation of an offer to sell shares of F-star common stock or any other securities. On July 7, 2022, Sino Biopharmaceutical Limited, invoX Biopharm Limited and its direct subsidiary Fennec Acquisition Incorporated filed with the SEC a statement of tender offer on Schedule TO, including an offer to purchase, a letter of and other related documents, and on July 7, 2022, F-star filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC. The offer to purchase common shares of F-star is made only pursuant to the offer to purchase, the letter of transmittal and other related documents filed as part of the schedule TO. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ BOTH THE PUBLIC OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING THE OFFERING OF THEIR COMMON SHARES, INCLUDING THE TERMS AND CONDITIONS OF THE PUBLIC OFFER. Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to information agent for the tender offer, which is Innisfree M&A Incorporated. Investors may also obtain, free of charge, documents filed or furnished to the SEC by F-star in the “SEC Filings” section of F-star’s website at https://investors.f-star.com /.

Forward-looking statements:

Certain statements contained in this communication relating to matters that are not historical facts are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as PSLRA. . These include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including regarding the expected timing of our transaction with invoX Pharma. You are warned not to place undue reliance on it. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. F-star undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In some cases, you can identify forward-looking statements by words such as “expects”, “believes”, “plans”, “anticipates”, “projects”, “future”, “intends”, ” may”, “shall”, “should”, “could”, “estimate”, “predict”, “potential”, “continue”, “guidance” or the negative form of these terms or other comparable terms, which refer to to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on our expectations and involve risks and uncertainties; therefore, actual results may differ materially from those expressed or implied by the statements due to a number of factors, including, but not limited to, the satisfaction of the conditions to closing of the proposed transaction, including, but not limited to, obtaining regulatory approvals, the risk of litigation and/or related actions regarding the proposed transaction, F-star’s cash balances, the ability of F -star to remain listed on the Nasdaq capital market, F-star’s status as a clinical-stage immuno-oncologist company and its need for substantial additional funding in order to complete the development and commercialization of its products candidates, which F-star may experience delays in completing, or ultimately be unable to complete, the development and commercialization of its product candidates, which F-star’s clinical trials may not demonstrate adequately the safety and efficacy of its product candidates, that the preclinical development of the drugs is uncertain and that some of F-star’s product candidates may never proceed to clinical trials, that the results of preclinical studies and early clinical trials may not be predictive of the results of later clinical trials, that F-star relies on patents and other intellectual property rights to protect its product candidates, and the enforcement, defense and maintenance of these rights can be difficult and expensive, and that F-star faces significant competition in its drug discovery and development efforts.

New factors appear from time to time and it is not possible for us to predict all of these factors, or to assess the impact of each of these factors on the business or the extent to which any one factor, or combination of factors , can lead to actual results. differ materially from those contained in the forward-looking statements. These risks are discussed in more detail in F-star’s annual report on Form 10-K, quarterly reports on Form 10-Q and other filings from time to time with the SEC. The forward-looking statements included in this communication are based on information available to F-star as of the date of this communication. F-star undertakes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For more information, please contact:

For investor inquiries:

John Fraunces

Relationship Manager, Life Sciences Advisors

+1 917-355-2395

[email protected]


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