On August 15, 2023 Lava therapeutics presented its corporate presentation (Presentation, Lava Therapeutics, AUG 15, 2023, View Source [SID1234634426]).

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On August 15, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported findings from its PROCLAIM trial, published in European Urology Oncology, showing that almost half of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants (PGVs) could be missing out on genetics-informed care due to restrictive criteria for genetic testing (Press release, Invitae, AUG 15, 2023, View Source [SID1234634425]).

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In this prospective, observational study, nearly 1,000 men with prostate cancer unselected for family history of cancer, age at diagnosis or stage of disease, underwent germline genetic testing of 84 cancer predisposition genes under the care of urologists across the U.S., primarily in community clinics. In this study, 51% of patients with prostate cancer met National Comprehensive Cancer Network (NCCN) guidelines and 49% did not. The diagnostic yield of germline genetic testing between these two patient groups was compared.

"Real world evidence suggests that less than 15% of prostate cancer patients who could benefit from genetics-informed care undergo genetic testing, in part due to complicated and prohibitive testing guidelines," said Neal Shore, M.D., F.A.C.S., from the Carolina Urologic Research Center in Myrtle Beach, South Carolina, and the principal investigator of the study. "We found no statistically significant difference in the diagnostic yield of PGVs between those who met NCCN guidelines and those who did not, suggesting there are a significant number of patients with PGVs, many of which are targets for precision therapies, who are being missed when adhering to current NCCN guidelines for genetic testing."

Among nearly 1,000 patients (median age at diagnosis was 65 years), 65% had low-or intermediate-risk disease. A total of 77 PGVs in 17 genes were identified in 7.7% of the cohort. No significant difference was found in the prevalence of PGVs (8.8%) among the 51% of patients who met 2019 NCCN prostate criteria versus the remaining 49% who did not (6.6%), indicating that these criteria would miss 41.9% of patients with PGVs.

The data show nearly 80% of men with PGVs had potentially clinically actionable variants, including those in genes with eligibility for approved precision therapies or clinical treatment trials. When stratified by self-reported ethnicity, non-white (predominantly Black) men who were out-of-criteria had a higher number of PGVs than those who were in-criteria, suggesting current criteria disproportionately disadvantage historically underrepresented populations from obtaining critical genetic information. This disparity is particularly disturbing given Black men with prostate cancer are known to present with more aggressive disease.

"According to the American Cancer Society, prostate cancer is the second most common cancer in American men. Considering how common this diagnosis is, it’s critical that individuals are offered the proper screenings and access to necessary preventive measures to assess their risk and detect cancer as early as possible," said W. Michael Korn, M.D., chief medical officer for oncology at Invitae. "Through this study, we are seeing how genetic testing can play a vital role in understanding a prostate cancer diagnosis, as it can inform different types of treatment that might work best for a patient’s individual needs."

The findings support broadening the current guidelines and offering germline genetic testing to all patients with prostate cancer. This could change the standard of medical care for these patients, expanding access to precision therapies, clinical trial treatments and enhanced screening.

On August 15, 2023 Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, reported the closing of a $30 million financing round (Press release, Instylla, AUG 15, 2023, View Source [SID1234634424]). This financing round was led by new investor, Delos Capital, with continued participation from the investor syndicate of Excelestar Ventures, Ascension Ventures, Catalyst Health Ventures, Amed Ventures, Sparta Group, and Incept, LLC. The funds from this financing are anticipated to see Instylla through the ongoing prospective clinical trials and early commercialization.

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"At Instylla, we are executing two large pivotal clinical trials in North America in pursuit of our two initial indications for the embolization of hypervascular tumors and peripheral arterial bleeds. The funds will allow us to complete the clinical trials and prepare for the commercialization of Embrace HES. We are excited to have Delos Capital join our strong group of healthcare investors who share our values," said Amar Sawhney, CEO of Instylla, Inc. and Managing Director of Incept, LLC.

The Instylla HES Hypervascular Tumor Pivotal Study is currently enrolling patients in the US and Canada to evaluate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared with standard of care transcatheter arterial embolization or transcatheter arterial chemoembolization for the vascular occlusion of hypervascular tumors. The "HALT" Study was recently launched in the US and is continuing to enroll patients to study the safety and effectiveness of Embrace HES for the embolization of arterial bleeding in solid organs and peripheral arteries.

As part of this round of financing, Henry Chen, Managing Partner, Delos Capital has joined the Instylla Board of Directors. "Instylla has demonstrated impressive progress, having already advanced its next-generation liquid embolic technology to human clinical studies. We are honored and thrilled to support Instylla as it continues developing breakthrough solutions that will meaningfully improve patient outcomes," said Henry Chen.

About Embrace Hydrogel Embolic System:
Embrace HES is an investigational device intended to be used to embolize hypervascular tumors in vessels ≤ 5 mm or peripheral arterial bleeds in vessels ≤ 6 mm. Embrace HES consists of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during embolization. The Embrace HES embolization uses no organic solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG).

On August 15, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and co-founder, will participate in a fireside chat at the H.C. Wainwright Immune Cell Engager Virtual Conference on Thursday, August 17, 2023 at 2:00 pm ET (Press release, In8bio, AUG 15, 2023, View Source [SID1234634423]).

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The H.C. Wainwright presentation will be available live and as a replay on IN8bio’s website at https://bit.ly/3F1WEaQ.

On August 15, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, and Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, reported an agreement pursuant to which Gritstone bio, Inc. will have a multi-year option for a non-exclusive license under Genevant’s LNP technology on a pathogen-by-pathogen basis to develop and commercialize self-amplifying RNA (samRNA) vaccines (Press release, Gritstone Bio, AUG 15, 2023, View Source [SID1234634422]).

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"Our previous collaborations with Genevant have demonstrated the powerful potential of combining the strengths of two technology leaders, and we are pleased to expand our relationship with this new agreement," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone bio. "With the established complementarity between our samRNA technology and Genevant’s LNP technology, evident in clinical datasets in both oncology and infectious disease, we are now even better positioned to capitalize on the emergence of RNA vaccines and therapeutics to address a broader array of infectious diseases."

"The key role that LNP technology has played and can continue to play in the emergence of important medical advances has been a focus of Genevant scientists for over two decades," said Pete Lutwyche, Ph.D., President and Chief Executive Officer, Genevant Sciences Corporation. "As leaders in the field, we are thrilled to build upon our relationship with Gritstone to pursue new and better approaches to combat infectious disease."

Under the terms of the agreement, Genevant is eligible to receive from Gritstone option maintenance and exercise fees in the single digit millions, up to $136 million in contingent milestone payments per product, subject to increase for multi-pathogen products and in other specified circumstances, and royalties ranging from the mid to high single digits on future product sales. If Gritstone outlicenses an applicable infectious disease program, in lieu of certain of these payments, Genevant may be entitled to a percentage of amounts that Gritstone receives from its sublicensee.