On July 24, 2024 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported that the American Medical Association (AMA) has granted a PLA code for the PurISTSM pancreatic cancer test (Press release, GeneCentric Therapeutics, JUL 24, 2024, View Source [SID1234645075]). PurIST is commercially available under a collaboration agreement with Tempus AI, Inc. (NASDAQ: TEM) and run on its xR platform. The PurIST PLA code is the first CPT code created to describe an algorithm-only analysis from previously sequenced, LDT, transcriptomic (RNA) data and represents a meaningful step toward reimbursement for AI-enabled algorithms.

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"Receipt of a PurIST-specific PLA test code further supports the significance of GeneCentric’s pipeline of next-generation AI-derived tests," said Michael Milburn, PhD, President and CEO of GeneCentric Therapeutics. "This is a key step toward reimbursement and successful commercialization for PurIST, and we’re excited about the importance of this test in guiding first-line treatments for pancreatic cancer patients."

Pancreatic cancer has one of the highest mortality rates among all major cancers, and there has been limited availability of validated diagnostic tests or biomarkers to guide first-line treatment selection. The PurIST test classifies the tumors of patients with unresectable stage III or stage IV pancreatic ductal adenocarcinoma (PDAC) as either a basal or classical subtype and can help guide first-line therapy.

About the PurIST Test

PurIST identifies the molecular subtype of patients with unresectable stage III or stage IV PDAC and classifies patients with PDAC into either a basal or classical subtype and may help inform first-line therapy management. Tempus and GeneCentric recently completed a new clinical validation study demonstrating that PurIST can be used to help predict overall survival of classical patients between standard-of-care first-line therapies, FOLFIRINOX and gemcitabine nab-paclitaxel. The PurIST test is available for ordering as part of the on-line Tempus HUB or via paper requisition forms for orders in the United States. Providers and patients can learn more about the PurIST test on the Tempus website.

About Pancreatic Cancer

Pancreatic cancer is the 10th most commonly diagnosed cancer in the U.S. and the 12th most common cancer worldwide. The National Cancer Institute estimates there will be over 64,440 new cases and more than 51,750 deaths in the U.S. alone in 2024, making it the third-leading cause of cancer-related deaths in the U.S. with one of the highest mortality rates of all major cancers. More than 90% of pancreatic cancers are pancreatic ductal adenocarcinoma (PDAC), and the 5-year overall survival for resectable/borderline-resectable and non-resectable PDAC is approximately 20% and 1-3%, respectively. The three main treatments for PDAC are surgical resection (if diagnosed early), radiation therapy and chemotherapy. For resectable tumors, surgical resection is provided with curative intent, however, for non-resectable tumors, chemotherapy such as FOLFIRINOX or gemcitabine with nab-paclitaxel is often used.

On July 24, 2024 Dren Bio, Inc. ("Dren Bio" or the "Company"), a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, reported that it has entered into a strategic collaboration with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS) (Press release, Dren Bio, JUL 24, 2024, View Source [SID1234645074]). The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform.

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"Our agreement with Dren Bio is a promising opportunity to discover novel bispecific antibody therapies for cancer, building on our longstanding expertise in immuno-oncology science at Novartis," said Shiva Malek, Ph.D., Global Head of Oncology for Biomedical Research at Novartis. "We’re excited to collaborate to bring forward new therapeutic options for patients living with cancer, complementing our strategic efforts across a wide range of modalities, including targeted therapies, biologics, radioligand therapies and CAR-Ts."

"We are thrilled to establish this new collaboration with Novartis, a global leader in oncology," said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. "Combining the proven capabilities of Novartis in oncology drug development with Dren Bio’s novel platform could enable the advancement of important new therapies for patients."

Amit Mehta, Ph.D., Chief Operating Officer and Chief Business Officer of Dren Bio, added, "Dren Bio’s Targeted Myeloid Engager and Phagocytosis Platform is designed to deplete various disease-causing agents and has led to a rich and diverse pipeline. This collaboration will benefit from Novartis’ impressive track record of developing novel medicines and help further expand the reach of our platform."

Under the terms of the agreement, Dren Bio will receive a total upfront consideration of $150 million from Novartis, which includes a $25 million equity investment in the Company. Dren Bio is also eligible to receive up to $2.85 billion in additional cash payments upon achieving certain preclinical, clinical, regulatory, and commercial milestones, as well as tiered royalties on future net sales of any commercialized products resulting from the collaboration. Dren Bio and Novartis will collaborate to advance selected targeted myeloid engager programs in oncology through clinical candidate selection, at which point Novartis will assume full responsibility for all remaining development, manufacturing, regulatory, and commercialization activities.

The agreement is subject to customary closing conditions including regulatory clearance.

On July 24, 2024 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage oncology-focused immunotherapy company developing cancer vaccines and antibody drug conjugate (ADC) therapeutic candidates, reported positive data from a Phase 1 clinical trial of OST-HER2 in patients with HER2-expressing solid tumors in breast cancer and other cancers (Press release, OS Therapies, JUL 24, 2024, View Source [SID1234645073]). Additionally, the Company announced positive preclinical efficacy data for OST-HER2 in multiple models of breast cancer.

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The FDA has granted Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for OST-HER2 in Osteosarcoma. OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with osteosarcoma and other solid tumors. The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T cells that can eliminate or slow potential micrometastases that can grow into recurrent osteosarcoma and other solid tumors, including breast cancer. T cell responses home in on HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent osteosarcoma in the United States.

A total of twelve (12) patients with a history of HER2 positive cancer were enrolled in the Phase 1b clinical study, comprised of ten (10) patients with breast cancer, one (1) patient with esophageal cancer and one (1) patient with GE junction cancer. OST-HER2 was determined to be safe and well tolerated in patients with HER2-expressing solid tumors, including at the dose currently being used in the Company’s ongoing Phase 2b clinical trial in recurrent, resected osteosarcoma (AOST-2121, NCT04974008). The Company previously announced positive AOST-2121 interim data and is now in active discussions with the US FDA regarding a Breakthrough Therapy (BTD) designation application submitted for OST-HER2 based on the interim results. The Company is focused on approval for OST-HER2 in osteosarcoma, and thereafter plans to expand development into breast cancer and other HER2 expressing cancers such as esophageal cancer and colorectal cancer.

In addition, the Company announced positive data from multiple preclinical models of breast cancer. The key data for OST-HER2 include:

78% reduction in tumor size (3mm for OST-HER2 treated vs. 14mm for control arm) in FVB/N HER2 transgenic mouse model of breast cancer treatment at day 75
33% prevention of breast cancer in OST-HER2 treated mice vs. 0% prevention of breast cancer in FVB/N HER2 transgenic model of breast cancer prevention at week 50
20% reduction of tumor size for OST-HER2 plus HER2-targeted antibody vs. HER2-targeted antibody alone Tg tumor regression model of breast cancer at day 42
65% reduction cellular concentration of metastatic cells for OST-HER2-treated mice compared with controls in brain metastasis model of primary breast cancer

On July 24, 2024 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC), reported the grant of an inducement equity award to Ron Cooper, the Company’s newly-appointed Chief Executive Officer (Press release, enGene, JUL 24, 2024, View Source [SID1234645072]).

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The inducement award consists of a non-qualified stock option to purchase 1,250,000 of the Company’s common shares. The option has an exercise price of $8.81 per share, which is equal to the closing price of the Company’s common shares on July 22, 2024, the date of grant. The stock option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the grant date and the remainder vesting in equal amounts monthly for three years thereafter, subject to Mr. Cooper’s continued service as an employee of, or other service provider to, the Company through the applicable vesting dates.

The stock option was granted by the Company’s independent Compensation Committee of the Board of Directors as an inducement material to Mr. Cooper entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). While the stock option was granted outside of the Company’s Amended and Restated enGene Holdings Inc. 2023 Incentive Equity Plan, it will have terms and conditions consistent with those set forth under the Plan.

On July 24, 2024 Inimmune, a clinical stage biotech company focused on the development of novel immunotherapies, vaccines, and vaccine adjuvants reported the dosing of the first patient in its Phase 1 single ascending dose study of INI-4001 in patients with advanced solid tumors (Press release, Inimmune, JUL 24, 2024, View Source [SID1234645071]).

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This is an open-label, multiple-ascending dose, two-part dose ranging and cohort expansion study of INI-4001 in patients with advanced solid tumors. This first-in-human trial of INI-4001, Inimmune’s proprietary TLR7/8 agonist in a nanoparticle delivery system, will consist of two parts. In Phase 1a, single dose escalation cohorts receiving monotherapy INI-4001 will determine PK, safety, and tolerability. This is followed by Phase 1b where patients who have progressed or have stable disease after 3 cycles of INI-4001 will be allowed to receive concurrent administration of an anti-PD-1 or anti-PD-L1 immunotherapy plus INI-4001.

In pre-clinical studies, INI-4001 was efficacious both as a monotherapy and in combination with anti-PD-1 checkpoint therapy in syngeneic murine tumors (LLC, MC38 and B16F10). Additionally, INI-4001 has been shown to induce production of the cytokine IFNα and activation of antigen presenting cells, leading to downstream T cell activation in vivo. INI-4001 may prove to be an ideal combination agent with checkpoint inhibitors given that a minority of patients currently benefit from checkpoint inhibitor monotherapy.

Inimmune’s CEO, Alan Joslyn, said "We are very excited that INI-4001 clinical trials have commenced, as this marks an important milestone for our company and oncology patients. INI-4001 either as monotherapy or in combination with checkpoint therapy can potentially provide physicians a new therapeutic option in their treatment toolbox."

Inimmune’s trial of INI-4001 is being conducted in Australia and is expected to be complete by the end of 2025. Additional information can be found at clinicaltrials.gov (NCT06302426).