On August 15, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based in vivo gene editing therapies, reported completion of a strategic transaction with Imugene Limited (ASX: IMU) for global rights to Azercabtagene Zapreleucel (azer-cel), Precision’s lead allogeneic CAR T candidate, for cancer (Press release, Precision Biosciences, AUG 15, 2023, View Source [SID1234634428]). Imugene will assume ongoing clinical execution for azer-cel in the large B-cell lymphoma (LBCL) population who have relapsed following autologous CAR T treatment. The license also includes an option to develop up to three other cancer research programs in the future.

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"We are excited to reach this key inflection point for Precision BioSciences with the achievement of three milestones – first, the completion of a global deal with Imugene for azer-cel in cancer; second, the extension of our expected cash operating runway to greater than two years; and third, our pivot to focus exclusively on in vivo gene editing," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "We are very pleased to partner with Imugene as they plan to leverage azer-cel’s clinical data package and recent regulatory feedback to continue its path toward a pivotal trial in LBCL and potentially help patients in dire need. Our commercial and scientific interests are closely aligned, and we believe Precision’s allogeneic CAR T technology can complement the novel oncology approaches being pursued by Imugene, especially its OnCARlytics platform for solid tumors."

"After an extensive review of the allogeneic CAR T landscape, we are excited to progress what we believe is the most advanced allogeneic CAR T program – azer-cel, which has regulatory feedback and a broad data set. This is an important opportunity to develop a much-needed treatment for the growing number of lymphoma patients who have relapsed following CAR T treatment and is complementary to our pipeline, which is designed to unleash the immune system to fight cancer, including our OnCARlytics program," said Leslie Chong, Chief Executive Officer and Managing Director at Imugene Limited.

In exchange for global rights to azer-cel for cancer, as well as Precision BioSciences’ CAR T infrastructure and its experienced cell therapy teams, Precision will receive upfront economics valued at $21 million (all figures in USD) consisting of cash and equity. In addition, Precision is eligible for an $8 million near-term payment in cash and equity upon successful completion of the phase 1b dosing in the CAR T relapsed LBCL patient population. For azer-cel, Precision is eligible to receive up to $198 million in additional milestone payments and double-digit royalties on net sales. For each additional research program selected by Imugene, Precision is eligible for up to $145 million in milestone payments and tiered royalties on net sales.

Precision’s PBCAR19B stealth cell and its CAR T assets targeting multiple myeloma, as well as all rights to non-oncology indications for azer-cel, remain available for development through partnership only.

Corporate & Financial Update

As a result of this transaction, Precision expects to reduce its annual operating spend by approximately $20 million from the current base case and has right-sized the company to operate as a single platform company focused on in vivo gene editing. Upfront cash from this transaction, reduced CAR T operating expenses, and continued fiscal discipline are expected to extend Precision’s cash runway through the third quarter of 2025.

"As we pivot our full attention and resources to leveraging the core features of ARCUS for differentiated in vivo gene editing programs, we are prepared to capitalize on the utility of ARCUS to produce a profound impact on diseases in the liver and beyond, including those that are best suited for gene insertion or excision of large defective gene sequences. We look forward to providing additional updates about our in vivo gene editing progress at our upcoming R&D event on September 12, 2023," added Mr. Amoroso.

On August 15, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 for its previously announced (July 10, 2023) global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV ("Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTXR3 (Press release, Nanobiotix, AUG 15, 2023, View Source [SID1234634427]).

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With the expiration of the HSR waiting period, the transaction has become effective, and as such, Nanobiotix is eligible to receive payment of the $30 million upfront cash licensing fee.

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).