InterVenn Biosciences Announces Start of Enrollment in Colonoscopy Study

On August 2, 2022 InterVenn Biosciences, a clinical technology company leveraging glycoproteomics to transform the future of healthcare, reported the start of enrollment in its prospective cohort study for early detection of colorectal cancer and adenomas (Press release, InterVenn Biosciences, AUG 2, 2022, View Source [SID1234617300]). This confirmatory Noninvasive Identification of Colorectal Cancer and Adenomas in Early Stages – better known as the NICE Study – is intended to validate InterVenn’s platform to detect early colorectal cancers and precancerous adenomas with a high degree of accuracy from a groundbreaking low volume of blood.

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"InterVenn Biosciences was established with the mission that no one should ever be blindsided by disease. Early detection is critical for fulfilling this promise to significantly improve patient outcome and survival," said Tillman Pearce, Chief Medical Officer of InterVenn Biosciences. "The initiation of recruitment in our prospective NICE Study is a significant step forward for InterVenn to demonstrate that our platform has clinical utility to enable and accelerate detection of CRC at earlier stages than conventionally possible today with other methods."

The NICE Study represents the next phase in InterVenn’s advancement toward improving cancer screening, building on the pilot data that the company presented at the ASCO (Free ASCO Whitepaper) healthcare conference in early June. The pilot data demonstrated positive results for the InterVenn perspectIV platform measuring glycosylation of circulating plasma proteins, detecting early CRC and precancerous advanced adenomas with high sensitivity from a low volume of peripheral blood (typically ~100uL).

The multicenter NICE observational study (NCT05445570) is enrolling participants prior to a colonoscopy across major gastroenterology centers, such as Borland Groover, Louisiana Research Center, Paragon Rx Clinical, East View Medical Research, and Blue Ridge Medical Research. This study will support current and future discovery as well as generate clinical evidence for InterVenn’s oncology portfolio developed on InterVenn’s perspectIV platform.

"As a premier G.I. practice, Borland Groover is deeply committed to fighting colon cancer with all available tools and is excited to be part of this trial," said Borland Groover Principal Investigator, Bharat Misra, MD. "While colonoscopy is the gold standard for Colorectal Cancer (CRC) screening, many patients are reluctant to have this procedure. A blood-based screening test is more appealing to our patients who are reluctant to getting screened via colonoscopy and is the future of colon cancer screening."

InterVenn’s oncology program includes a series of liquid biopsy-based assays that InterVenn develops to address a variety of cancers. InterVenn is building a robust pipeline of liquid biopsy tests to unlock the untapped, rich layer of biology called the glycoproteome, which is, in simple terms, the entire set of sugars on proteins. Because of the essential roles glycoproteins play in physiological functions, the glycoproteome has the potential to be highly significant for real-time clinical decision-making.

Validation from the NICE Study will bring InterVenn’s innovation to colorectal cancer screening, which can potentially help prevent and treat the disease in the future. With approximately 110MM people considered average risk for colorectal cancer in the United States, the US market size for colorectal cancer screening represents a potential $18 billion annual market opportunity.

For more information about the NICE Study for CRC, please contact [email protected]

Orca Bio Announces the Precision-T Phase 3 Study is Open and Enrolling Patients at Transplant Centers Across the U.S.

On August 2, 2022 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported Precision-T, its pivotal Phase 3 study, is open, enrolling and treating patients at clinical trial sites including Stanford Health Care, City of Hope, Winship Cancer Institute of Emory University, Sarah Cannon Research Institute, Ronald Reagan UCLA Medical Center and Oregon Health & Science University (Press release, Orca Bio, AUG 2, 2022, View Source [SID1234617299]). Precision-T is expected to enroll approximately 174 patients at more than 20 transplant centers across the U.S.

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Precision-T (NCT05316701) is a randomized, open-label multi-center study that is evaluating the safety and efficacy of Orca Bio’s lead investigational high-precision cell therapy, Orca-T, compared to standard of care allogeneic hematopoietic stem cell transplant (standard allo-HSCT). Orca Bio received guidance from the Food and Drug Administration on the design of Precision-T, which will evaluate Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

"By precision engineering the donor graft, we aim to create a cell therapy that retains the benefits of transplant without serious complications like graft versus host disease and disease relapse," said Robert Negrin, M.D., professor of medicine at the Stanford School of Medicine. "This has been demonstrated by the recent results of the Phase 1b/2 single-arm trials with Orca-T, and we are pleased to be evaluating this novel cell therapy in a randomized Phase 3 clinical trial."

The primary endpoint of the Precision-T study is the rate of moderate-to-severe chronic GvHD-free survival. The secondary endpoints are graft-versus-host-disease and relapse-free survival (GRFS), moderate-to-severe chronic GvHD and relapse-free survival. The randomized Phase 3 trial is being conducted concurrently with Orca Bio’s ongoing single-arm Phase 1b trial of Orca-T.

"The Precision-T study is an important step forward for patients battling deadly blood cancers like AML and ALL, which are often aggressive and for which standard allo-HSCT treatment carries significant risks," said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. "We are pleased to collaborate with these clinical trial centers and the broader blood cancer community to advance this study with the ultimate goal of delivering a safe and effective therapy to the patients who need it."

Orca-T is a first-in-class high-precision cell therapy that combines purified cells from a matched donor. It is designed to replace a patient’s diseased blood and immune system with a healthy one while lowering the risk of developing GvHD and other life-threatening transplant-related side effects. Almost 200 patients have been treated to date with Orca-T in single-arm trials with extremely encouraging results, which were recently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

More information about the Precision-T study can be found at www.precisiontstudy.com or www.clinicaltrials.gov.

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

Aura Biosciences to Participate at the 2022 BTIG Biotechnology Conference

On August 2, 2022 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that Elisabet de los Pinos, PhD, Chief Executive Officer, and Julie Feder, Chief Financial Officer, of Aura will participate in a fireside chat at the 2022 Hybrid BTIG Biotechnology Conference on Monday, August 8, 2022, at 9:00 a.m. ET (Press release, Aura Biosciences, AUG 2, 2022, View Source [SID1234617298]).

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Y-mAbs to Announce Second Quarter 2022 Financial and Operating Results on August 8, 2022

On August 2, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the quarter that ended June 30, 2022, on Monday, August 8, 2022, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, AUG 2, 2022, View Source [SID1234617297]). The announcement will be followed by a conference call and webcast with the investment community on Tuesday, August 9, 2022, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and Interim CEO; Bo Kruse, Chief Financial Officer; and Sue Smith, Chief Commerical Officer.

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Agenus to Participate at BTIG Biotechnology Conference

On August 2, 2022 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported the Company will attend the BTIG Biotechnology Conference (Press release, Agenus, AUG 2, 2022, View Source [SID1234617296]). Agenus will participate virtually and host one-on-one meetings with investors following its second quarter 2022 corporate update on the morning of August 9.

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