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Propanc Biopharma Targets Site of First-In-Human Study for PRP at the Peter Mac Cancer Center, Melbourne, Australia

On August 15, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company will target the Peter Mac Cancer Center in Melbourne, Australia, as the site for the First-In-Human (FIH) study for PRP in patients with advanced solid tumors (Press release, Propanc, AUG 15, 2023, View Source [SID1234634429]). Initial discussion held previously with the Clinical Investigator confirmed the remaining development activities to be conducted by the Company prior to filing the clinical trial application for the FIH study. This includes the finished drug product manufacture and validation of the bioanalytical method to analyze the pharmacokinetics (movement of drug within the body) of PRP during the study.

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The Peter Mac Cancer Center is a world leading cancer research, education and treatment center and Australia’s only public health service dedicated to caring for people affected by cancer. They have 3,900 employees, including more than 750 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer. They are well placed to support the Company’s goals for a world first clinical study of PRP, as a long term, proenzyme therapy for the treatment and prevention of metastatic cancer from solid tumors by targeting and eradicating cancer stem cells, free from side effects normally associated with standard treatment approaches.

"We are pleased to have engaged in positive initial discussion with Professor Mark Rosenthal, Director and FIH Clinical Study Investigator at the Peter Mac Cancer Center," said James Nathanielsz, BAS, MEI, Propanc’s Chief Executive Officer. "We are excited about the opportunity to work with a world class facility like Peter Mac, and it was great to see our mutual excitement about a potential world first study for PRP as a new therapeutic approach to treat and prevent metastatic cancer from solid tumors. Our plan is to undertake the FIH study in Australia, given the favorable R&D cashback benefit where we will receive 43% of our R&D expenditure on local activities, as well as approval from the Australian Government for reimbursement some overseas activities as well. We will then plan to undertake subsequent clinical studies in Europe, as the preeminent region behind the USA, where we will undertake a Pre-IND meeting with the US Food and Drug Administration once we have clinical data from our FIH study. Achieving this exciting development stage in the not-too-distant future could prove transformative for the Company, and its shareholders."

Propanc is set to capitalize on favorable government incentives from the Australian government for future product and clinical development of PRP, receiving a 43.5% cash back benefit on all local R&D activities conducted in Australia. Furthermore, a Certificate for Advance Overseas Finding was received from the Board of Innovation and Science Australia to receive up to a 43.5% "cash back" benefit from overseas R&D expenses. Overseas activities to be undertaken include validation of the pharmacokinetics method for PRP and its manufacture of the finished product for the FIH study.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

Precision BioSciences Completes Strategic Transaction with Imugene for Azer-Cel in Cancer

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.

"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.

NANOBIOTIX Announces Expiration of HSR Waiting Period Regarding the Agreement for Worldwide Co-Development and Commercialization of Potential First-in-Class Radioenhancer NBTXR3

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]).

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.

Corporate presentation

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

Clinical Trial Results Support Genetic Testing of All Patients with Prostate Cancer

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]).

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.