On July 24, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported that its Canadian Nuclear Research Initiative Health ("CNRI-H") Program application was retained and approved by the Canadian Nuclear Laboratories ("CNL") to accelerate Defence’s radio-immuno-conjugates project (Press release, Defence Therapeutics, JUL 24, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-granted-cnri-h-from-the-canadian-nuclear-laboratories-to-accelerate-the-development-of-its-radio-immuno-conjugates-program [SID1234645036]).

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Defence’s CNRI-H project will focus on the synthesis and evaluation of novel constructs, variations of 111In-AccuTOX-Trastuzumab. The objective is to demonstrate that AccuTOX moiety is an essential modification to conventional 111In-Trastuzumab constructs to evade an endosome entrapment and ensure nuclear localization, where 111In will emit Auger Electrons ("AEs") to kill cancer cells, and providing a synergistic effect by unleashing AccuTOX immune-boosting power. It is expected that these constructs will be lethal to HER2-positive cancer cells specifically and will produce high potency.

Selected AccuTOX constructs, based on stability, solubility, and biochemical properties, will be conjugated to the trastuzumab antibody, followed by radiolabeled with 111In, and then characterized, in vitro and in vivo, for its efficacy in killing cancer. The main goal is to identify the biologically active 111In-AccuTOX-Trastuzumab molecule that will be more potent to treat solid tumor resistant to current HER2-targeting therapy such as therapeutic antibodies (e.g., trastuzumab alone) and antibody-drug conjugate (e.g., Kadcyla).

In summary, the aim of this CNRI-H collaborative project is:

1. To synthesize AccuTOX-Trastuzumab antibody conjugates, radiolabel with 111In, and characterize, including structure and cellular analysis (e.g. identification, drug-antibody ratio, specific activity), stability, and cytotoxic effects, in vitro.

2. To perform animal studies in rodents, in vivo, namely biodistribution, pharmacokinetic profile, and therapeutic potency, using selected 111In-AccuTOX-Trastuzumab constructs.

"We are proud to have this opportunity to collaborate with the Canadian Nuclear Laboratories and to advancing Defence’s radio-immuno-conjugates program for the benefit of the cancer’s patients. The CNL scientific team dedicated to our project is very strong and will definitely accelerate and reinforce Defence’s strength in this renowned and fast-growing radiopharmaceuticals field," said Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.

CNRI-H is a program developed by CNL to further the realization of its mission of contributing to the health of Canadians. Through CNRI-H, CNL provides financial support along with its expertise, experience, capabilities and makes this available and accessible to the healthcare community to advance new life saving radiopharmaceutical solutions. CNRI-H is a turnkey solution that integrates both funding and project execution in one award. The goal of the program is to accelerate the optimization of therapeutic isotopes production and the clinical translation of targeted radiopharmaceuticals for the benefit of Canadians whilst increasing the safety and efficacy of therapies that involve radiopharmaceuticals.

According to Allied Market Research, the global radiopharmaceuticals market was valued at $7.9 billion in 2023, and is projected to reach $21.8 billion by 2033, growing at a CAGR of 10.6% from 2024 to 2033. And according to Straits Research, the global radioligand therapy market size was valued at USD 12.55 billion in 2023, and it is anticipated to reach USD 21.55 billion by 2032 with a CAGR of 4.62%. The use of radioligands to treat specific cancers is a novel method. It delivers radiation to cancer cells with pinpoint accuracy and minimal side effects on healthy cells, resulting in higher treatment efficacy.

On July 24, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported it will host a virtual key opinion leader (KOL) event on Friday, August 2 at 9:00 AM ET featuring J. Randolph Hecht, MD, (Professor, UCLA Gastrointestinal Oncology Program) and Howard Brown (CRC Survivor, Patient and Advocate) who will discuss the unmet need and current treatment landscape for patients with metastatic microsatellite stable colorectal cancer (MSS-CRC) (Press release, Gritstone Bio, JUL 24, 2024, View Source [SID1234645039]).

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Gritstone management will also highlight the development of Gritstone’s personalized neoantigen vaccine program, GRANITE, as a potential treatment for immunologically "cold" tumors including MSS-CRC. Mature progression-free survival data from a randomized Phase 2 study of GRANITE in frontline MSS-CRC are expected in the third quarter of 2024.

A live Q&A session will follow the formal presentations.

About J. Randolph Hecht, MD
J. Randolph Hecht, MD is a Professor of Clinical Medicine in the David Geffen School of Medicine at UCLA School of Medicine. He holds the Carol and Saul Rosenzweig Chair for Cancer Therapies Development and is the Director of the UCLA Gastrointestinal Oncology Program. Dr. Hecht attended medical school at Eastern Virginia Medical School. He took his internal medicine residency at Northwestern and completed fellowships in gastroenterology research at the University of Chicago, and in gastroenterology and medical oncology at UCLA. Dr. Hecht is an internationally known clinical and translational researcher in the field of gastrointestinal cancers. He has published widely on the molecular biology, early detection, and treatment of gastrointestinal malignancies. He has led and is currently directing small trials with new molecules as well as large international randomized trials. Current ongoing research includes preclinical models of therapy with biological agents, early studies with gene therapy vectors and tyrosine kinase inhibitors, and leading phase II and phase III trials with novel agents.

About Howard Brown
Howard Brown is a two-time Stage IV cancer patient, survivor, advocate, technology entrepreneur, husband, dad and avid basketball player. In 1989 at the age of 23, Howard was diagnosed with Stage IVe Non-Hodgkin’s Lymphoma. After failing three chemotherapy regimens, he had an allogeneic (from a donor) bone marrow transplant from his twin sister who was an exact HLA match. That, along with massive chemotherapy and full body radiation saved his life. Twenty-six years after achieving remission, Howard was diagnosed with Stage III Colon Cancer at age fifty via a standard colonoscopy. After two colon resection surgeries, intense chemotherapy and a failed clinical trial he turned metastatic Stage IV and discovered the cancer had spread to his liver, peritoneum, omentum and small bowel. After salvage second line chemotherapy showed some regression (shrinkage), Howard underwent Cytoreduction Surgery (debulking / removal of live and dead cancer cells) with Heated intra-peritoneal chemotherapy (hot chemo wash to kill micro cancer cells– (CRS HIPEC). Howard is currently considered No Evidence of Disease (NED) at this time after 9 consecutive CT scans. He serves as the Board Chair and President of Colontown, an organization that serves over 11,000 patients and caregivers with colorectal cancer. Howard is a proud graduate and past trustee of Babson College, #1 for entrepreneurship, and lives with his family in Birmingham, Michigan.

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).

On July 24, 2024 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported that it awarded inducement grants on July 22, 2024 to its Executive Vice President and Chief Financial Officer, Edward Dulac, under Intellia’s 2024 Inducement Plan as a material inducement to employment (Press release, Intellia, JUL 24, 2024, View Source [SID1234645040]).

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The inducement grants consisted of non-qualified stock options to purchase 96,219 shares of Intellia’s common stock with an exercise price of $25.33 per share, the closing price of Intellia’s common stock as reported by Nasdaq on July 22, 2024, with 33% of the options underlying the option award vesting on the first anniversary of the grant date and the remainder vesting monthly thereafter until fully vested on the third anniversary of the grant date; time-based restricted stock units ("RSUs") for 66,324 shares of Intellia’s common stock, with one-third of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the grant date; performance-based RSUs for 33,162 shares of Intellia’s common stock, with vesting criteria linked directly to Intellia’s total stockholder return over a three-year period compared to the companies comprising the Nasdaq Biotechnology Index at the beginning of the performance period; and performance-based RSUs for 30,000 shares (at target) of Intellia’s common stock, with vesting criteria linked directly to certain development milestones over a three-year period.

All equity vesting is subject to Mr. Dulac’s continued service as an employee of, or other service provider to, Intellia through the applicable vesting dates.

All of the above-described awards were granted outside of Intellia’s stockholder-approved equity incentive plans pursuant to Intellia’s 2024 Inducement Plan, which was adopted by the board of directors in June 2024. The awards were approved by a majority of the independent directors of Intellia’s board of directors as a material inducement to Mr. Dulac’s entering into employment with Intellia in accordance with Nasdaq Listing Rule 5635(c)(4).

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.