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U.S. Department of Defense Awards $5.1 Million to Humanetics Corporation for Continued Development of Radiation Countermeasure

On June 21, 2022 Minneapolis-based Humanetics Corporation (Humanetics) reported that it has entered into a new $5.1 million cooperative research agreement with the U.S. Department of Defense (DOD) to continue advanced development of BIO 300, a medical countermeasure to protect military personnel and first responders from the harm caused by radiation exposure (Press release, Humanetics, JUN 21, 2022, View Source [SID1234616156]).

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The new funding will be used to create, manufacture, and test a new formulation of BIO 300 that can be self-administered using an auto injector. Auto injectors are commonly used by the military to deliver fast-acting drugs such as atropine and naloxone. This new formulation of BIO 300 will complement the existing suite of oral formulations in the Humanetics portfolio that have been tested extensively and are in phase 2 trials. It is envisioned that the DOD would have access to both oral and auto injectable forms of BIO 300, which each have a unique use case.

"With the increasing potential for use of radiological or nuclear weaponry in the current global environment, especially with events in Ukraine, it’s a strategic imperative to protect our armed forces and first responders from radiation exposure and enable them to operate in areas of concern," said Ronald Zenk, President and CEO at Humanetics.

BIO 300’s radioprotective attributes were originally discovered by researchers within the DOD at the Armed Forces Radiobiology Research Institute. The drug was licensed to Humanetics Corporation, which is leading its advanced development toward FDA approval. In parallel to the drug’s development for use as a medical countermeasure, Humanetics is evaluating the drug in clinical trials to determine its potential to reduce the toxic side effects of radiation in cancer patients and to reduce lung damage in COVID-19 long-haulers.

"We are enthused and encouraged by the DOD’s continued investment in the development of BIO 300 as a medical countermeasure," said Zenk. "We see this drug not only providing protection for our warfighters, but also for our embassy personnel around the world and civilian populations who are at risk of radiation exposure from nuclear incidents and, furthermore, to improve the lives of cancer and COVID-19 patients."

PharmaJet Partner, Nykode Therapeutics, Announces Positive Interim Results in HPV+ Cervical Cancer Phase 2 Trial

On June 21, 2022 PharmaJet, a biotech company that has developed a more effective way of administering drugs and biologics with their innovative, needle-free injection technology, reported that its partner, Nykode Therapeutics announced positive interim results from its phase 2 trial of their novel candidate, VB10.16, in combination with checkpoint inhibitor atezolizumab for treating advanced cervical cancer (Press release, Nykode Therapeutics, JUN 21, 2022, View Source [SID1234616155]). The DNA-based therapeutic cancer vaccine is delivered with the PharmaJet needle-free injection technology.

HPV is the cause of 630,000 cases of cancers annually1 and HPV16 is the predominant cause. To address this, Nykode Therapeutics is continuing to advance their cervical cancer program with their therapeutic DNA immunotherapy (VB10.16) targeting malignancies caused by the cancer inducing Human Papillomavirus 16 (HPV16). The PharmaJet Needle-free Injection System is proven to increase vaccine effectiveness and in addition was chosen by Nykode for its convenient ease of use.

The interim results demonstrate evidence of anti-tumor activity in a population of heavily pre-treated patients with late-stage cervical cancer. The majority of patients experienced a clinical benefit, and many had durable responses, indicating that VB10.16 may give a meaningful added clinical benefit compared to the existing standard of care treatment in this setting.

Chris Cappello, President and CEO, PharmaJet, commented, "We are encouraged by the phase 2 clinical trial results, and continued expansion of the Nykode clinical trials using our Needle-free Injection System. The number of disease applications for DNA vaccines and therapeutics using our delivery systems continues to grow. This is another example of how our needle-free systems are helping novel DNA technologies move successfully into early and late-stage clinical trials."

For more information about PharmaJet visit www.pharmajet.com.

Refer to Instructions for Use to ensure safe injections and to review risks.

1 HPV New Zealand project; HPV and Cancer, View Source

Adicet Bio to Present at Upcoming Investor Conferences

On June 21, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported that company management will participate in two upcoming investor conferences in June (Press release, Adicet Bio, JUN 21, 2022, View Source [SID1234616154]).

Details of the events are as follows:

Truist Securities Cell Therapy Symposium, Symposia-cel, June 28, 2022

Chen Schor, President & CEO, will participate in a panel discussion titled, "The Next Cells & Mechanisms to Watch in Oncology" on Tuesday, June 28, 2022, at 11:30 A.M. ET.
Stifel 2022 Virtual Cell Therapy Summit, June 29-30, 2022

Chen Schor, President & CEO, will participate in a panel discussion titled, "Outlining the Potential of New Cell Types and Novel Approaches" on Wednesday, June 29, 2022, at 1:00 P.M. ET.

InnoCare Announces First Patient Dosed in Clinical Trial of Novel SHP2 Allosteric Inhibitor ICP-189 in China

On June 21, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first patient has been dosed in clinical trial of the Company’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189 in China (Press release, InnoCare Pharma, JUN 21, 2022, View Source [SID1234616153]).

ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents.

SHP2 is involved in mediating MAPK signaling pathway and immune checkpoint pathway for the regulation of cellular proliferation and survival. Preclinical studies have shown that ICP-189 has excellent selectivity over other phosphatases and demonstrated significant anti-tumor effects in various xenograft models.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, "ICP-189 has entered into clinical stage in China and the U.S. SHP2 inhibitor has high potential for targeting a variety of solid tumors. We will push forward the clinical development of ICP-189 to provide treatment options for patients in China and around the world."

Novocure Enrolls First Patient in KEYNOTE-B36, a Pilot Study of Tumor Treating Fields Together with KEYTRUDA® for Patients with First-Line Stage III Non-Small Cell Lung Cancer

On June 21, 2022 Novocure (NASDAQ: NVCR) reported the first patient has been enrolled in its phase 2 pilot KEYNOTE-B36 study, conducted in collaboration with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA (Press release, NovoCure, JUN 21, 2022, View Source [SID1234616152]). KEYNOTE-B36 is designed to evaluate the safety and effectiveness of Tumor Treating Fields (TTFields) together with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, for the first-line treatment of locally advanced or metastatic intrathoracic non-small cell lung cancer (NSCLC) that expresses PD-L1 .

"This is an important next step for our thoracic program," said William Doyle, Novocure’s Executive Chairman. "KEYNOTE-B36 represents one of Novocure’s five ongoing clinical trials exploring the potential of Tumor Treating Fields to complement immunotherapy agents. We look forward to continuing our studies in partnership with Merck in hopes of treating many more patients in need."

KEYNOTE-B36 is a single arm, open-label phase 2 pilot study expected to enroll 66 patients. The primary endpoint of the study is objective response rate. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate and frequency and severity of adverse events.

About Non-small Cell Lung Cancer
Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S.

Physicians use different combinations of surgery, radiation therapy and systemic therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy has been the first-line standard of care for locally advanced NSCLC and systemic therapy alone for those with metastatic disease. Certain immune checkpoint inhibitors have recently been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 24,000 patients have been treated with TTFields therapy.

The NovoTTF-200T is an investigational device for the treatment of NSCLC. Safety and efficacy have not been established for this indication.