On October 26, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL) ("Trillium" or the "Company") reported that its securityholders approved a statutory arrangement with PF Argentum ULC ("PF Argentum") a wholly-owned, indirect subsidiary of Pfizer Inc. (NYSE: PFE) ("Pfizer") at the special meeting of Trillium securityholders (Press release, Trillium Therapeutics, OCT 26, 2021, View Source [SID1234592006]). Pursuant to the arrangement, PF Argentum will acquire all of the issued and outstanding shares and warrants of Trillium, other than Trillium securities owned by Pfizer and its affiliates.

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The special resolution approving the arrangement was approved by: (i) 99.61% of the votes cast by Trillium shareholders voting as a single class present in person or represented by proxy and entitled to vote at the meeting; and (ii) 99.64% of the votes cast by Trillium shareholders and warrant holders, voting as a single class present in person or represented by proxy and entitled to vote at the meeting.

A non-binding resolution approving the compensation that may become payable to certain executive officers of Trillium in connection with the arrangement was also approved by 97.11% of the votes cast by holders of Trillium common shares present in person or represented by proxy at the meeting.

Upon closing of the arrangement, Trillium shareholders other than Pfizer and its affiliates will receive US$18.50 per share in cash subject to any applicable withholdings and other source deductions, and warrant holders will receive, at the holder’s election, (1) a cash payment equal to the amount by which US$18.50 exceeds the exercise price per share of such warrant, subject to applicable withholdings and other source deductions, or (2) a cash payment equal to the Black Scholes value of such warrant (as calculated pursuant to the terms and conditions of the certificate governing such warrant), subject to applicable withholdings and other source deductions.

The arrangement is subject to court and regulatory approvals and clearances, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the transaction is expected to be completed in the fourth quarter of 2021 or the first half of 2022.

On October 25, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data being presented at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting suggest the company’s Decipher Prostate genomic classifier identifies patients with clinically high-risk prostate cancer who may require treatment intensification beyond standard-of-care therapy (Press release, Veracyte, OCT 25, 2021, View Source [SID1234591888]).

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The findings, from a pre-specified analysis of biopsy samples taken from prostate cancer patients with clinically high-risk disease who were enrolled in multiple phase 3, prospective, randomized studies, show that Decipher Prostate test scores are independently associated with distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS) in this patient population. After a median follow up of 11 years, men with disease classified as Decipher high-risk experienced substantially less favorable outcomes compared to men with disease classified as Decipher low-risk.

"Clinically high-risk prostate cancer is a heterogenous disease, and having reliable information about individual patients’ prognoses based on their unique tumor biology can help improve shared decision-making," said Paul L. Nguyen, M.D., of the Dana-Farber Brigham Cancer Center, who presented the data during an ASTRO media briefing today. "The findings we’re sharing at ASTRO are particularly exciting because they are the first to validate use of a gene expression classifier in pre-treatment prostate cancer biopsy samples collected during prospective, randomized clinical trials."

For the analysis, Dr. Nguyen and colleagues obtained Decipher Prostate scores for 265 biopsy samples from the NRG/RTOG 9202, 9413 and 9902 phase 3 randomized trials. After multi-variable analyses adjusting for age, prostate-specific antigen (PSA) levels, Gleason score, cT-stage, trial and randomized treatment arm, researchers found that Decipher Prostate scores were independently associated with distant metastases (HR 1.24), prostate cancer-specific mortality (1.27) and overall survival (1.12). The cumulative incidence of DM at 10 years was 26%, 15% and 6% for men who were Decipher high-risk, intermediate-risk and low-risk, respectively. Among the subset of patients with a Decipher Prostate score >0.85 (within the "high-risk" range of 0.6-1.0), DM was 29% at 5 years and 41% at 10 years.

"This analysis provides the first clinical evidence that the Decipher Prostate classifier can help physicians and patients make critical, personalized treatment decisions in the post-biopsy, clinically high-risk prostate cancer setting," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers. "It adds another important piece to the extensive and growing body of clinical data supporting use of the classifier to help inform treatment decisions across the patient’s prostate cancer journey."

Treatment intensification for men with clinically high-risk prostate cancer and Decipher scores above 0.85 is being studied in the currently enrolling, prospective, phase 3 randomized trial NRG-GU009 (PREDICT-RT), which also studies treatment de-intensification by halving the duration of hormonal therapy in men with Decipher scores 0.85 or less. Along with PREDICT-RT, the Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, phase 3, prospective, randomized controlled clinical trials; 13 phase 2/3 prospective trials; and more than 20 retrospective studies of phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On October 25, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its third quarter 2021 financial results and operational highlights before open of U.S. markets on Wednesday, November 3, 2021 (Press release, Autolus, OCT 25, 2021, View Source [SID1234591904]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm GMT to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 6984737. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 6984737.

On October 25, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, reported it has entered into a clinical trial collaboration agreement with Merck (Press release, Hummingbird Bioscience, OCT 25, 2021, View Source [SID1234591920]).

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Under this collaboration, Hummingbird will evaluate the safety, tolerability, and anti-tumor activity of its novel anti-VISTA antibody, HMBD-002, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and other cancers with high VISTA expression. HMBD-002 is anticipated to enter a Phase 1 clinical trial in 2021.

VISTA is a co-inhibitory immune checkpoint receptor that is involved in suppressing an anti-tumor immune response. Overexpression of VISTA in the immune cells in tumors has also been associated with acquired resistance to other checkpoint therapies, such as anti-PD1 therapies. TNBC and NSCLC were identified as priority indications for clinical investigation based on the unmet need for new treatment options and widespread expression of VISTA in these tumor types. HMBD-002 is the only IgG4 isotype anti-VISTA antibody currently in development. It is precisely engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, and thereby inhibits VISTA by neutralizing its immunosuppressive activity without depleting other VISTA expressing cells that play many important roles in the immune system. Preclinical studies have demonstrated potent anti-tumor activity both as single agent and in combination with PD-1 therapy.

"Our preclinical studies have shown that VISTA in combination with PD-1 therapy can enhance anti-tumor activity. We look forward to initiating clinical trials for HMBD-002 as we aim to develop new treatment options for patients who do not respond to existing therapies," said Piers Ingram, Chief Executive Officer and co-founder of Hummingbird.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system. Preclinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. HMBD-002 has also shown enhanced anti-tumor activity when used in combination with anti-PD-1 therapy. HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor. The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded Hummingbird a US$13.1 million product development grant to advance HMBD-002 into clinical trials.

On October 25, 2021 Silenseed, a Tel Aviv RNAi company, reported that it raised $7.8 million from the Guangzhou Sino-Israel Bio-Industry Investment Fund to start a China JV (Press release, Silenseed, OCT 25, 2021, View Source [SID1234593957]). Silenseed-China will own the rights to develop, market and sell Silenseed’s RNAi products in China. The Israeli company will use the capital to conduct a Phase III trial of its lead candidate, which targets the KRAS oncogene to treat pancreatic cancer. Silenseed’s novel drug delivery platform enables the insertion of RNAi therapeutics directly into solid tumors. GIBF will own a 49% stake in the Silenseed Chinese subsidiary.

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