On October 25, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that Company management will participate in a fireside chat and one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, AC Bioscience, OCT 25, 2021, View Source [SID1234591903]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the fireside chat, Prof. Andrea Pfeifer, CEO, AC Immune SA, will discuss the Company’s corporate strategy while highlighting its precision medicine approach, clinical stage vaccine programs in neurodegenerative diseases, and data from the Lauriet Phase 2 trial evaluating semorinemab in mild-to-moderate Alzheimer’s disease.

The fireside chat will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. A replay of the fireside chat will also be available on the Events Page of AC Immune’s website following the conference’s conclusion.

On October 25, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Juventas Cell Therapy Ltd. ("Juventas") has completed a Series C financing round through which it raised more than RMB410 million (approximately $63 million (USD)) (Press release, CASI Pharmaceuticals, OCT 25, 2021, View Source [SID1234591919]). Juventas states that the funds will be used to pursue a new drug application in China and launch implementation of a commercialization and international research and development plan for CNCT19.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CASI shares global co-commercial and profit-sharing rights with Juventas and indirectly owns a 12.0098% equity stake in Juventas on a fully diluted basis following completion of the Series C financing round. The Juventas’ financing was led by CICC Capital.

Dr. Wei-Wu He, CEO and Chairman of CASI comments: "CASI, through its commercialization of Evomela in China, has built a robust commercial team in the hematology-oncology market. Juventas is a leading cell therapy innovator in China. The collaboration between CASI and Juventas will speed up the adoption of CAR-T therapy in China, helping thousands of patients in need of this breakthrough therapy."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.