On May 10, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapies to transform the lives of patients with cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, F-star, MAY 10, 2022, View Source [SID1234614110]).

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"This year is one of the most important years in F-star’s history, with data readouts expected across all four of our clinical programs, expansion of our partnering activities, and continued development of our organization," said Eliot Forster, CEO of F-star Therapeutics, Inc. "During the quarter, we increased the number of clinical sites for FS118 and FS120 by expanding beyond the US into the EU. We have also further advanced our understanding of the differentiated mechanism of FS118 in modulating LAG-3 cell surface expression. F-star continues to execute and create value for shareholders by advancing our programs and enabling our partners to develop next-generation bispecific therapeutics by leveraging the power of our discovery platform."

First Quarter 2022 and Recent Highlights:

Patients dosed in FS120 and FS118 trials in Europe, adding to the ongoing clinical activities in the US.
Appointment of James Sandy as Chief Development Officer: Mr. Sandy brings over 35 years of experience in the pharmaceutical and biotechnology industries. James brings valuable additional expertise to the team in accelerating cancer treatment programs through early and late-stage development that will greatly benefit our clinical development strategy.
FS118 poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting demonstrating a novel LAG-3 reduction and shedding mechanism: Data revealed that the tetravalent and unique structure of FS118 plays a critical role in evoking LAG-3 shedding and cell surface reduction by tumor-infiltrating lymphocytes (TILs), enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade.
Fourth licensing option exercised by Merck KGaA, Darmstadt, Germany: Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will be responsible for all future development and commercialization costs of the bispecific program and will pay future success-based milestones and royalties on any net sales resulting from programs covered by the agreement.
IP portfolio expansion with the issuance of U.S. patent further protecting FS118: United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors. U.S. Patent No. 11,214,620 is entitled "Binding Molecules Binding PD-L1 and LAG-3" and is expected to provide F-star with exclusivity for FS118 out to at least August 2038.
Participation in investor conferences: The management team participated in four investor conferences in the first quarter.
Anticipated 2022 Program Milestones:

A clinical efficacy readout of FS118 in PD-1 acquired resistance head and neck cancer patients who have failed checkpoint therapies.
Clinical update on FS222 Phase 1 trial.
Clinical update on the Phase 1 trial of FS120 and initiation of the combination with Merck’s pembrolizumab.
Clinical update of the dose-escalation study of SB 11285.
First-Quarter 2022 Financial Update

Cash Position
Cash and cash equivalents were $68.8 million as of March 31, 2022, compared to $78.5 million at December 31, 2021.

Research & Development Expense
Research & Development (R&D) expenses were $8.0 million for the quarter ended March 31, 2022, compared to $7.1 million for the corresponding quarter in 2021. This increase of $0.9 million in R&D expense is primarily due to increased CRO costs as more patients are enrolled in clinical studies, increased R&D staff related costs primarily to support clinical operations, offset by a reduction in manufacturing costs.

General & Administrative Expense
General & Administrative (G&A) expenses were $5.7 million for the quarter ended March 31, 2022, compared to $6.4 million for the first quarter 2021. The $0.7 million decrease is primarily due to a decrease in stock compensation expense, and legal and professional costs due to costs incurred in the comparative period for work in relation to the share exchange transaction with Spring Bank Pharmaceuticals. These decreases were offset by increases in facilities-related costs and information technology costs.

Net Loss Attributable to Common Shareholders
Net loss attributable to common shareholders was $12.1 million or $0.57 per share, for the quarter ended March 31, 2022, as compared to a net loss of $9.7 million or $1.07 per share for the quarter ended March 31, 2021.

Conference Call and Webcast

F-star will host a conference call today, May 10, 2022, at 9:00 a.m. EDT.

To access the call, participants may join via a live webcast on the Investors & News section of the F-star Therapeutics website, under Events and Presentations. To join by phone, participants may dial the following numbers at least 10 minutes prior to the start of the call:

A replay of the conference call will be available for 90 days from the call and may be accessed in the Investor & News/Events and Presentations section of the F-star Therapeutics website.

On May 10, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, will present at the upcoming H.C. Wainwright Global Investment Conference (Press release, ImmunoGen, MAY 10, 2022, View Source [SID1234614126]). The presentation will be available on May 24, 2022 at 7:00am ET.

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A webcast of the presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the webcast, a replay will be available at the same location.

On May 10, 2022 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on May 10th, 2022, that its phase IIb study in prostate cancer, BRaVac, has reached "Database Lock" (Press release, RhoVac, MAY 10, 2022, View Source [SID1234614143]). This means that all data from the trial is now finally reported, cleaned and "locked" in the data base. The next step will be analysis to produce the results. As previously stated, RhoVac anticipates having its primary results no later than at the beginning of June.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after local curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. Patient recruitment was conducted in six European countries (Finland, Sweden, Denmark, the United Kingdom, Belgium and Germany) and in the United States. Recruitment ended in September 2021, when 180 patients had been included. The objective of the study is to show that onilcamotide can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted and no unexpected adverse reactions have been identified, confirming the anticipated safety of the drug. Now, the study has reached "Database Lock" with only a few weeks to go until the primary results are known. All results, including subgroup analyses, will be available in the summer.

CEO, Anders Månsson, comments: "BRaVac started at the end of 2019, and much of the study has been run in pandemic conditions, which it has taken extraordinary efforts to overcome. We are happy to conclude that we have overcome all obstacles, that our intermediary safety reviews have all been positive, and now, after database lock, we await with excitement and anticipation what the primary results will bring in terms of efficacy."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 10-05-2022 20:50 CET.

On May 10, 2022 Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported that it has successfully produced all batches of personalized cancer immunotherapies for all patients enrolled in the Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma (Press release, Evaxion Biotech, MAY 10, 2022, View Source [SID1234614175]).

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Birgitte Rønø, Chief Scientific Officer of Evaxion, said: "I am extremely proud that the team behind EVX-02 has shown that this complex production chain is feasible and that we can provide truly unique, personalized DNA vaccines within a critical time window. And we are delighted that we mastered all steps in the production process. Every cancer is unique, as is every immune system, and this is why we create cancer therapies that are one size fits one – and only one."

She continues: "With the release of the final batch, we confirmed our manufacturing process, which we believe will allow us to progress our DNA cancer immunotherapy programs into larger global trials to explore the clinical benefits of the compounds further. We have again demonstrated our capabilities to timely deliver personalized cancer treatment tailored to the unique cancer profile of every patient in a clinical trial."

The production process of the personalized drug product consists of multiple steps. The sequencing of the tumor DNA is followed by AI-powered identification of the most promising therapeutic targets developed by Evaxion’s proprietary PIONEERTM technology. This leads to designing the personalized multi-target vaccine drug product, which is then manufactured, released to the clinical sites, and administered to the patient.

This is the second time Evaxion has conducted a clinical trial with personalized cancer immunotherapy, having previously used a peptide-based treatment.

About EVX-02

Our EVX-02 program (NCT04455503) treats adjuvant melanoma patients with our patented DNA-based immunotherapy in combination with standard of care. The patients are fully resected before the trial, meaning that their tumors have been successfully removed (surgically). In the study, the focus of the therapy is to prevent disease relapse. The EVX-02 program is a multicenter study conducted in Australia. There are currently 16 patients enrolled in the trial.

On May 10, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER) IMA401 for patients with recurrent and/or refractory solid tumors (Press release, Immatics, MAY 10, 2022, View Source [SID1234614047]). IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipeline targeting an HLA-A*02-presented peptide derived from both MAGEA4 and MAGEA8. TCER IMA401 will be developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial.

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The primary objectives of the clinical trial (NCT#05359445) are to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for IMA401 in biomarker-positive (HLA-A*02:01 and MAGEA4/8) patients with recurrent and/or refractory solid tumors. Secondary objectives are to characterize safety and tolerability, evaluate initial anti-tumor activity and assess pharmacokinetics of IMA401. The Phase 1 trial consists of a dose-escalation (Phase 1a) portion that will be followed by a dose-expansion (Phase 1b) portion to treat patients at the recommended dose level. The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients.

"IMA401 is the first TCER candidate from our TCR Bispecifics pipeline entering clinical development, and expands our clinical portfolio with an exciting new TCR-based immunotherapy approach that can be supplied off-the-shelf compared to autologous cell therapies," said Cedrik Britten, Chief Medical Officer at Immatics. "Our innovative TCER format leads to an extended-half-life and incorporates novel binding-moieties that are designed to maximize efficacy while minimizing toxicities in patients. Our TCER IMA401 could treat a range of solid tumors and therefore meet currently unmet needs of a broad patient population. This is best achieved with a strong pharma partner which we have found in Bristol Myers Squibb."

Immatics entered into a global exclusive license agreement with Bristol Myers Squibb in December 2021 for the IMA401 program under which both companies will collaborate to advance the program through clinical development.

Immatics’ TCR Bispecific pipeline includes a second TCER product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023. Immatics’ TCER pipeline is further strengthened by additional innovative TCER program(s), IMA40X, in preclinical development.

About IMA401
IMA401 is Immatics’ most advanced TCER molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT and is presented at a 5-fold higher copy number per tumor cell than a MAGEA4 peptide targeted in other clinical trials. Following preclinical proof-of-concept data, including complete remissions of transplanted human-derived tumors in xenograft mouse models, the Phase 1 trial investigates IMA401 in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma (sqNSCLC), small cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

About TCER
Immatics’ half-life extended TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack the cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER are "off-the-shelf" biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and provide the opportunity to reach a large patient population without the need of specialized medical centers.