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]

Evogene Financial Results and Earnings Announcement Schedule for the Second Quarter of 2022

On August 2, 2022 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that it will release its financial results for the second quarter of 2022 on Wednesday, August 31, 2022 (Press release, Evogene, AUG 2, 2022, View Source [SID1234617317]).

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On the day of the announcement, Company management will host a conference call to discuss the results at 9:00 AM Eastern time, 4:00 PM Israel time.

To access the conference call, please dial +1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately two hours following the completion of the call. To access the replay, please dial +1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through September 2, 2022, and an archive of the webcast will be available on the webcast link for the following twelve months.

Theratechnologies to Present at the Canaccord Genuity 42nd Annual Growth Conference

On August 2, 2022 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that Paul Levesque, President and Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 42nd Annual Growth Conference on Wednesday, August 10, 2022 at 1:00 p.m. ET (Press release, Theratechnologies, AUG 2, 2022, View Source [SID1234617248]).

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A live webcast of the event can be accessed here and through the investor relations section of the Company’s website under ‘Events’. An archive will also be available for 90 days following the conference.

Heron Therapeutics to Report Second Quarter 2022 Financial Results on Tuesday, August 9, 2022

On August 2, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported that the company will host a conference call and live webcast on Tuesday, August 9, 2022 at 8:30 a.m. ET to report second quarter 2022 financial results and discuss recent business highlights (Press release, Heron Therapeutics, AUG 2, 2022, View Source [SID1234617269]).

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The conference call can be accessed by dialing (646) 307-1963 in the U.S. or (800) 715-9871 internationally. Please provide the operator with the passcode 4215874 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

Lucid Diagnostics’ Laboratory Executes Four New Participating Provider Agreements

On August 2, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid", the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that its wholly-owned CLIA-certified and CAP-accredited laboratory, LucidDx Labs Inc. ("LucidDx Labs"), has entered into participating provider agreements with preferred provider organizations Prime Healthcare, Three Rivers Provider Network, and Galaxy Health Network (the "PPOs"), as well as Alivio Health, a specialized diagnostic laboratory network (Press release, Lucid Diagnostics, AUG 2, 2022, View Source [SID1234617301]).

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The PPOs and Alivio Health collectively provide access to millions of lives through the provider networks they have compiled for their clients, including third-party administrators, insurance companies, self-insured companies, corporations, and government entities, to access. Pursuant to the agreements, persons covered by clients of the PPOs and Alivio will have in-network access to Lucid’s EsoGuard DNA test, the first and only commercially available test capable of serving as a widespread tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk chronic heartburn patients. The agreement provides rates of reimbursement as a percent of charges for services rendered to such covered persons by LucidDx Labs, including performance of the EsoGuard test.

"We are excited to join these provider networks and continue to expand our reach, offering in-network access to EsoGuard esophageal cancer prevention testing to millions of persons covered by their clients and payers," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "Securing broad commercial reimbursement for EsoGuard testing remains one of our most important near-term strategic goals and key value drivers. Our talented and expanding market access team will continue to work tirelessly to secure many more such agreements covering millions more lives."

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing element—the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. A recently updated American College of Gastroenterology clinical practice guideline endorses nonendoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s CLIA-certified, CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing.