On May 31, 2022 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 that the Biologics License Application ("BLA") for OMBLASTYS (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration ("FDA") (Press release, Y-mAbs Therapeutics, MAY 31, 2022, View Source [SID1234615273]). The FDA set an action date of November 30, 2022, under the Prescription Drug User Fee Act ("PDUFA"). The Agency also indicated in the BLA filing communication letter that it is planning to hold an advisory committee meeting in October 2022 to discuss the application.

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!

"We believe that the FDA’s acceptance of our OMBLASTYS BLA for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS, if approved by the FDA, can address a significant unmet medical need for children with CNS/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists, potentially adding a second rare disease product to our commercial portfolio and without any significant further investment in our existing commercial infrastructure. Further, OMBLASTYS has a Rare Pediatric Disease Designation which, if approved, will provide Y-mAbs with a Priority Review Voucher, our second PRV, which would further strengthen our financial position as we would seek to monetize the OMBLASTYS PRV," stated Thomas Gad, Founder, President and Interim CEO. "We look forward to working with the Agency to bring OMBLASTYS to the appropriate patients. We are excited to move forward and plan for a seamless commercial launch of OMBLASTYS, if approved by the FDA."

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 interests in the compound and in Y-mAbs.

On May 31, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published online in The Lancet Oncology suggest that the company’s Immunoscore Immune Checkpoint (IC) assay may identify patients with metastatic colorectal cancer (mCRC) who are likely to benefit from the addition of immune checkpoint inhibitor (ICI) therapy to standard first-line treatment (Press release, Veracyte, MAY 31, 2022, View Source [SID1234615272]). The findings are from the randomized, controlled, phase II AtezoTRIBE trial, a multicenter Italian clinical study, sponsored by GONO Foundation.

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 vast majority of mCRC tumors (approximately 95 percent) have a proficient DNA mismatch repair (pMMR) system and are microsatellite stable. These tumors have low immunogenicity and do not derive benefit from immune checkpoint inhibitors. Previous research suggests that the FOLFOXIRI and bevacizumab combination enhances immunogenicity in pMMR mCRC. In the current study, researchers found a modest benefit of the experimental treatment regimen in this subgroup.

"AtezoTRIBE is the first to show that the addition of the PD-L1 inhibitor atezolizumab to standard first-line treatment (FOLFOXIRI plus bevacizumab) improved progression-free survival in patients with previously untreated mCRC," said Chiara Cremolini, M.D., Ph.D., principal investigator of the trial and oncologist at the Pisa University Hospital in Italy.

Additionally, post-hoc statistical analyses designed to evaluate the association of immune-related biomarkers with treatment outcomes found a meaningful correlation between a "high" Immunoscore IC result and response to the experimental treatment regimen (p=0·003).

"To our knowledge, Immunoscore IC is the first biomarker with potential predictive value in selecting patients with pMMR metastatic colorectal cancer who are likely to benefit from the use of immune checkpoint inhibitors," said Carlotta Antoniotti, M.D., oncologist at the Pisa University Hospital and lead author of the new paper. "These findings must be confirmed in further prospective studies, but are encouraging as a means of addressing a significant unmet need."

"These findings are exciting, as they suggest new potential avenues for the use of the Immunoscore IC assay in identifying patients with metastatic colorectal cancer who may benefit from ICIs," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "We believe the assay could help companies developing ICIs by enabling them to better identify appropriate patients for clinical trials."

About Immunoscore IC

Immunoscore IC is a novel assay designed to help predict a patient’s response to immune checkpoint inhibitors. The assay measures the densities of PD-L1+ and CD8+ cells, as well as the proximity among these cells, on a single tissue section using imaging tools, and then produces a risk score based on a proprietary algorithm. The Immunoscore IC assay is available as a clinical research service for biopharmaceutical companies and is part of the Immunoscore family of assays. These assays measure the immune reaction in and around the tumor and help to determine drugs’ mechanisms of action and their impact on the tumor microenvironment (TME). The Immunoscore Colon Cancer test is available clinically and analyzes T lymphocyte infiltration at the tumor site to help guide treatment decisions in localized colon cancer.

On May 31, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics, will present a corporate overview and participate in investor meetings at the upcoming Jefferies Healthcare Conference being held in New York on June 8 – 10, 2022 (Press release, VBL Therapeutics, MAY 31, 2022, View Source [SID1234615270]).

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!

Jefferies Healthcare Conference
Date: Wednesday, June 8th, 2022
Time: 3:00 p.m. ET
Format: Corporate Overview
Webcast Link

A replay of the webcast will be available following the presentation for 90 days on the Events and Presentations page of the Investors section on the Company’s website at www.vblrx.com.

On May 31, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-101 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) (Press release, TScan Therapeutics, MAY 31, 2022, View Source [SID1234615269]). The target of TSC-101 is the minor histocompatibility antigen HA-2, which is a lineage-specific antigen expressed on blood cells. TScan believes that TSC-101 is the first clinical program to target the HA-2 antigen. As previously announced, TScan’s IND for TSC-100, which targets the minor histocompatibility antigen HA-1, was cleared by the FDA in January 2022. TSC-100 and TSC-101 are designed to address different subsets of patients undergoing allogeneic HCT.

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!

Study start-up activities are now ongoing for all three arms of TScan’s umbrella Phase 1 clinical trial, which includes active treatment arms for TSC-100, TSC-101, as well as a control arm using current standard-of-care for HCT patients. TScan expects to enroll the first patient in the middle of the year.

"This marks TScan’s second IND clearance in our leukemia program. Our TCRs against both HA-1 and HA-2 antigens are aimed at reducing the risk of relapse following HCT, thereby enabling increased use of more tolerable conditioning regimens to allow more leukemia patients to be cured by transplantation," said David Southwell, President and Chief Executive Officer. "With the FDA clearance of TSC-101, we will now proceed with all components of our planned multi-arm Phase 1 clinical trial, with preliminary data from all three arms of the trial expected by the end of 2022."

"We look forward to fully opening the Phase 1 umbrella trial for our leukemia program," said Gavin MacBeath, Chief Scientific Officer. "The trial will include patients positive for either the HA-1 or HA-2 antigens, with remaining patients receiving standard-of-care in the control arm. Importantly, the INDs for TSC-100 and TSC-101 were based on our proprietary T-Integrate cell engineering platform, which includes our advanced non-viral vector and our in-house GMP manufacturing capabilities. We will use this same platform to develop enhanced TCR-T cell therapies for our solid tumor program, with IND filings beginning later this year."

Primary endpoints in TScan’s HCT trial include safety and dose-finding, and secondary and exploratory endpoints include relapse rate versus standard-of-care as well as quantitative biological readouts including minimal residual disease and kinetics of donor chimerism.

On May 31, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that it has appointed Marshelle Smith Warren, M.D. as Chief Medical Officer (Press release, SQZ Biotech, MAY 31, 2022, View Source [SID1234615267]). Dr. Warren will report to the CEO and lead the company’s clinical development, clinical operations, translational medicine, and regulatory affairs functions.

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!

"Marshelle has tremendous experience in cell-based therapeutic development and will provide complementary expertise as we seek to rapidly advance our clinical programs," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "Her proven leadership, extensive global clinical trial experience, and broad clinical development background will strengthen our ability to execute on our mission to drive patient impact across disease areas."

Dr. Warren brings over 25 years of clinical development industry experience to the company, including a particular focus on viral malignancies and T cell-directing therapeutics. Previously, she was Chief Medical Officer and Senior Vice President of R&D at Viracta Therapeutics, where she led the development of investigational therapeutics for the treatment of Epstein-Barr virus associated lymphoid malignancies. Her prior experience also includes clinical development positions at Allovir, Atara Biotherapeutics, Ionis, Gilead Sciences, Amgen, and AstraZeneca Pharmaceuticals. Dr. Warren has also recently served as a senior advisor on Phase 2 and Phase 3 clinical research programs for investigational T cell therapies targeting cancer, autoimmunity, and viral infections.

"I am very excited to be joining a dedicated team focused on developing a new generation of impactful cell therapies for diseases with significant unmet need," said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. "I look forward to supporting our clinical team and working with my fellow leaders at SQZ to realize the broad potential of our cell therapy platforms to benefit patients around the world."

During her career, Dr. Warren has made significant contributions to approved immunology products including blockbuster Enbrel (rheumatoid arthritis) and Accolate (asthma). She has led the development of successful investigational new

Empowering Cells to Change Livesimg61662729_0.jpg

drug applications for a range of therapeutic types and has overseen regulatory authority negotiations and advisory meetings.

Dr. Warren, who is board certified in internal medicine and clinical immunology, received a BS in biology with honors from Baylor University, and an MD from the University of Nebraska Medical Center College of Medicine. She performed her residency in internal medicine at St. Joseph’s Hospital in Colorado and completed a clinical immunology fellowship at the National Jewish Center for Immunology and Respiratory Medicine.

SQZ Biotechnologies’ cell therapy programs seek to generate activating or tolerizing target-specific immune responses with potential impact across many diseases. The company’s first disease targets include Human Papillomavirus positive solid tumors and celiac disease.