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Halozyme To Host First Quarter 2021 Financial Results Webcast And Conference Call

On April 20, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will webcast its Quarterly Update Conference Call for the first quarter 2021 on Monday, May 10 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, APR 20, 2021, View Source [SID1234578247]). On the same date, Halozyme will release financial results for the first quarter ended March 31, 2021 following the close of trading.

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To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 1584694.

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]).

"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.