1stOncology™: Cancer Intelligence Service – Page 8824 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Vincerx Pharma Announces FDA Clearance of IND for Phase 1b Study of VIP152 in Chronic Lymphocytic Leukemia and Richter Syndrome

On April 20, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application to initiate a Phase 1b dose escalation study evaluating VIP152, a highly selective PTEFb/CDK9 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter syndrome (RS) (Press release, Vincerx Pharma, APR 20, 2021, View Source [SID1234578246]).

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 IND clearance for VIP152 in CLL is an important milestone for Vincerx, marking our first IND clearance and now second clinical program for what we believe is the most selective CDK9 inhibitor in clinical development," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Preclinical data for VIP152 show highly selective, ATP-independent, inhibition of CDK9 which translates to robust on-target activity across key gene targets. Most importantly, we believe this differentiated profile leads to encouraging early clinical activity, with demonstrated durable single-agent activity in hematologic malignancies and heavily pretreated solid tumors. This new dose-escalation study in CLL and Richter syndrome, expected to initiate before year end, builds upon our planned Phase 1b expansion cohort study in MYC-driven hematologic malignancies and solid tumors, which is on track to begin patient dosing in Q2 2021. We are proud of our rapid progress and look forward to continued execution as we advance VIP152 through our targeted oncology clinical programs to address a broad range of aggressive, resistant cancers."

The Phase 1b dose-escalation study will evaluate VIP152 in patients with relapsed/refractory CLL who have failed a Bruton tyrosine kinase inhibitor (BTKi) and venetoclax. Part 1 of the study will enroll CLL patients treated with ³2 prior regimens including either a BTKi or venetoclax. Part 2 of the study will consist of a CLL Phase 1b expansion which will enroll 20 patients with CLL relapsed/refractory to venetoclax and BTKi, and a RS Phase 1b expansion which will enroll 20 patients with CLL transformed to diffuse large B cell lymphoma (DLBCL) who have relapsed after, or been refractory to, at least 1 prior line of therapy for DLBCL and having MYC overexpression/ amplification/translocation. The Company expects to initiate the Phase 1b dose-escalation study in 2H 2021.

The Phase 1b dose-escalation in CLL and RS builds upon Vincerx’s ongoing first-in-human (FIH) study in patients with advanced cancer. Part 2 of the FIH study is on-track to begin patient dosing in 2Q 2021 and will consist of two expansion arms. Arm 1 will enroll up to 30 patients with relapsed/refractory aggressive lymphoma including DLBCL, transformed follicular lymphoma, or blastoid mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

Veracyte to Release First Quarter 2021 Financial Results on May 10, 2021

On April 20, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its full financial results for the first quarter of 2021 after the close of market on Monday, May 10 (Press release, Veracyte, APR 20, 2021, View Source [SID1234578245]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following conclusion of the live broadcast and will be accessible on the company’s website at View Source

Y-mAbs Provides Regulatory Update on Omburtamab

On April 20, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a regulatory update for omburtamab, which is an investigational, monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system ("CNS") administration (Press release, Y-mAbs Therapeutics, APR 20, 2021, View Source [SID1234578244]). B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.

Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration ("FDA") regarding omburtamab and received requests from the FDA for additional data concerning the granularity of data from our identified historical control groups. In order to agree on a statistical analysis plan ("SAP"), this additional granularity data is being collected and we anticipate submitting it to the FDA by the end of April. An additional Type B meeting has been scheduled for June 1, 2021 to discuss the SAP based on review of the additional data. We continue to be in close dialog with the FDA and maintain our aim of resubmitting the Biologics License Application ("BLA") for omburtamab late in the second quarter or in the third quarter of 2021.

"We believe omburtamab is on track to potentially become the first FDA approved targeted therapy for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, addressing an important unmet medical need, where no standard therapy is currently available," said Thomas Gad, founder, Chairman and President of Y-mAbs.

Dr. Claus Moller, the Company’s Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we continue to work closely with the FDA to resubmit the omburtamab BLA. In addition, we are targeting submission of a Marketing Authorization Application to the European Medicines Agency on April 30, 2021."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interest related to the compound and Y-mAbs.

Amgen’s Bemarituzumab Granted Breakthrough Designation in U.S.

On April 20, 2021 Amgen reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to bemarituzumab for first-line treatment of patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) cancer (Press release, EVERSANA, APR 20, 2021, View Source [SID1234578243]).

The designation was supported by the Phase II FIGHT trial, in which bemarituzumab treatment plus chemotherapy demonstrated clinically significant and substantial improvements in progression-free survival and overall survival in the patient population with at least 10% of tumor cells overexpressing FGFR2b.

"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients."

The designation makes bemarituzumab the second asset in Amgen’s oncology portfolio to receive Breakthrough Therapy Designation in the past six months – following sotorasib.

Minomic enters into collaboration with GloriousMed Biomedical Group, Shanghai, to introduce MiCheck® Prostate into China

On April 20, 2021 GloriousMed Biomedical Group Co., Ltd ("GloriousMed") and Minomic International Ltd ("Minomic") of Australia reported that officially executed the agreement, which formally launched the commercialization of MiCheck Prostate, a prostate cancer early diagnosis product, in mainland China (Press release, Minomic, APR 20, 2021, View Source [SID1234578242]). Finalizing this agreement completes an important step in commercializing MiCheck Prostate in one of the world’s largest healthcare markets. Under the agreement GloriousMed will make an initial investment in Minomic to fund a validation study of MiCheck Prostate using samples sourced from Chinese patients. The agreement also includes an option for GloriousMed to make a further investment of up to US$2.5 Million in Minomic.

GloriousMed is a leading provider of total solutions for precision tumor management in China, and a market leader in precision urological tumor testing, committed to creating an integrated ecological loop for precision treatment of vertical tumor types. Minomic is an Australian medical diagnostic company specializing in the development of diagnostic technologies for solid tumors, including prostate, bladder and pancreatic cancers. MiCheck Prostate, a blood test developed by Minomic over six years, is a rapid, non-invasive, highly specific test with higher sensitivity and specificity than existing PSA screening technologies. The product helps urologists decide whether to subject patients to a puncture biopsy by assessing the risk of aggressive prostate cancer, effectively avoiding unnecessary biopsies.

With the aging of the population, the incidence of prostate cancer in China is increasing. GloriousMed is actively expanding its multi-omics technology platform and introducing the most cutting-edge international technologies and products to promote the development of precise diagnosis and treatment of prostate cancer in China and further assist in the early diagnosis and treatment of prostate cancer. Through the application of MiCheck Prostate in mainland China, it is expected to increase the early diagnosis rate of prostate cancer patients in China and improve their survival quality.

Dr Brad Walsh CEO Minomic, Mrs Jin Ge CEO GloriousMed, Prof Xue Wei, Shanghai Jiaotong University School of Medicine

Minomic’s CEO, Dr Brad Walsh, noted "being able to test MiCheck Prostate on a Chinese population has been an aim of the company for some time. We recognize that to be successful in the China market we must work with a partner with significant local expertise and experience to execute this and are very pleased to partner with one of the leading urology companies in China. Our thanks to the GloriousMed team for making this possible. We are very excited to be working with them as they continue to build their franchise in the urological testing space".

GloriousMed’ CEO, Mrs. Jin Ge, said "We are very pleased to reach this cooperation with Minomic. In the past five years, GloriousMed has devoted itself to the integration of urological tumor diagnosis and treatment. In both independent research and global introduction, we hope to establish the entire urological tumor treatment pathway and diagnostic sequence. With five years of hard work, GloriousMed has become a leader in precision treatment of urological tumors in China, and we also hope to build a more professional product system. MiCheck Prostate is a very competitive product that can bring real value to Chinese prostate cancer patients. GloriousMed has already started to communicate with many clinical experts in China and is ready for future clinical trials to achieve the translation of MiCheck in China as soon as possible.

Prostate cancer has now leaped to the top of malignant tumors of the male genitourinary system in China, said Professor Xue Wei of Renji Hospital, Shanghai Jiaotong University School of Medicine. Due to untimely screening and diagnosis, about half of the newly diagnosed prostate cancer patients in China are at advanced stages. It is evident that early screening, early diagnosis and early treatment of prostate cancer will be the key factor to improve the survival time and quality of life of patients. As we know, PSA test is one of the main tools for prostate cancer screening and diagnosis, but there are certain problems in the specificity of PSA test, leading some patients with elevated PSA to undergo unnecessary prostate puncture biopsy. Minomic has spent 6 years developing a rapid, non-invasive, highly specific blood test: MiCheck Prostate, which has higher sensitivity and specificity than existing PSA screening technologies. The introduction of this technology into China by GloriousMed is expected to improve the current situation of early diagnosis and treatment of prostate cancer in China, help clinicians accurately select patients who do need to undergo puncture biopsy, effectively avoid unnecessary biopsies and reduce patient trauma."