On July 8, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor (Press release, Adicet Bio, JUL 8, 2024, View Source [SID1234644726]).

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"We are pleased that ADI-270, our first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumors, has been granted Fast Track Designation by the FDA," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "ccRCC is the most common type of kidney cancer, and this significant milestone underscores our commitment to advancing innovative treatments to these patients as quickly as possible."

Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

About ADI-270

ADI-270 is an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. ADI-270 is engineered with a third-generation CAR designed to target CD70 using its natural receptor, CD27, as the binding moiety and is further armored with a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII) to provide functional resilience to the immunosuppressive tumor microenvironment. ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination. These properties of ADI-270 combined with the potent tumor infiltration demonstrated with gamma delta 1 T cells aim to improve clinical responses of RCC patients and other patients with CD70+ tumors.

On July 8, 2024 Bracco and Blue Earth Diagnostics Ltd, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported the appointment of Marco Campione as its new Chief Executive Officer (CEO), reporting to Bracco Imaging CEO Fulvio Renoldi Bracco (Press release, Blue Earth Diagnostics, JUL 8, 2024, View Source [SID1234644725]). Mr. Campione also joins the Blue Earth Diagnostics Ltd Board of Directors and will serve as Vice Chair of the Blue Earth Diagnostics Inc. Board of Directors. Dr. David Gauden, a co-founder of Blue Earth Diagnostics and with the Company since 2014, assumes the role of full-time CEO of Bracco subsidiary Blue Earth Therapeutics. The changes reflect a carefully planned strategy to drive continued growth, development and opportunity for both companies and Bracco.

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"I congratulate Marco Campione on this CEO appointment and we look forward to drawing upon his strategic, operational and broad general business expertise as we increase our global leadership throughout the diagnostic radiopharmaceutical industry," said Fulvio Renoldi Bracco, CEO of Bracco Imaging. "Marco joins the Bracco Group at a transformative point in our evolution, as the company matures, broadens its horizons globally and expands its commercial presence."

Mr. Renoldi continued, "I also want to take this opportunity to recognize the many contributions of David Gauden in advancing the success of Blue Earth Diagnostics, and I wish him the best of success in now leading Blue Earth Therapeutics as its full-time CEO."

"I am excited and honored to assume the role of CEO at Blue Earth Diagnostics," said Mr. Campione. "The Company is a recognized leader throughout the nuclear medicine and oncology communities, having a strong reputation grounded in successful innovation, execution and dedicated service on behalf of patient health. I look forward to applying my experience towards expanding availability of the Company’s PET imaging products for prostate cancer, advancing its development programs in PET neuro-oncology and solid tumors, and in exploring additional opportunities and collaborations."

Marco Campione brings more than 25 years of experience from GE HealthCare, where he most recently served as Executive Director and Global Head of Contrast Media, General Manager Pharmaceutical Diagnostics North America and President GE HealthCare Inc.

On July 8, 2024 Arcus Biosciences, Inc. (NYSE:RCUS) and Taiho Pharmaceutical Co., Ltd. ("Taiho") reported that Taiho exercised its option for quemliclustat (International Nonproprietary Name; development code: AB680), an investigational small molecule CD73 inhibitor, in Japan and certain other territories in Asia (excluding mainland China) (Press release, Taiho, JUL 8, 2024, View Source [SID1234644724]). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017. This is the fourth option exercise by Taiho to an Arcus program.

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In exchange for the exclusive license of quemliclustat, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.

Quemliclustat is an investigational small molecule CD73 inhibitor. In 2024, Arcus plans to initiate the global, registrational Phase 3 study PRISM-1, comparing quemliclustat plus chemotherapy to chemotherapy alone as a treatment for patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Advancement to a Phase 3 study is based on overall survival results observed in the Phase 1b ARC-8 study that were presented earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium.

Through this collaboration, Taiho will further support the development and potential commercialization of quemliclustat and will operationalize the PRISM-1 study in Japan as part of its mission to deliver innovative drugs to patients and medical professionals.

About Quemliclustat

Quemliclustat is an investigational small molecule CD73 inhibitor. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types. Quemliclustat has been shown to block the production of adenosine. Once the immunosuppressive effects of adenosine are removed, activation of antitumor immune cells may be restored, resulting in cancer cell death.

In addition to the planned registrational Phase 3 study PRISM-1 by Arcus, quemliclustat is being co-developed by Arcus and Gilead Sciences in combination with other molecules within the companies’ portfolios with chemotherapy, including Phase 2 studies in lung and upper gastrointestinal cancers. Quemliclustat is an investigational medicine and is not approved for use globally.

About Taiho and Arcus Agreement

Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to a total of four programs in Japan and certain other territories in Asia (excluding mainland China): (1) quemliclustat, CD73 inhibitor program, announced today; (2) etrumadenant, a dual A2a/b adenosine receptor antagonist program in 2018; (3) zimberelimab, the anti-PD-1 program in 2019; and 4) domvanalimab and AB308, both the anti-TIGIT program in 2021.

For other territories in the world, Gilead obtained the rights to commercialize in the U.S. and to co-promote with Arcus, and Gilead has exclusive rights to develop and commercialize outside the U.S.

On July 8, 2024 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on next-generation antibody therapeutics, reported that PMC-309, VISTA-targeting immuno-oncology program, received safety approval for the first dose cohort (0.2mg/kg) in Phase 1a/b clinical trial for patients with advanced or metastatic solid tumors in Australia (Press release, PharmAbcine, JUL 8, 2024, View Source [SID1234644723]). The second dose cohort (0.5mg/kg) is currently ongoing.

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The first dose cohort (0.2mg/kg) of PMC-309 was initially administered in January 2024 and received safety approval in April 2024. Currently, the second dose cohort (0.5mg/kg) has been administered to two patients, with the third patient scheduled to receive treatment soon.

PMC-309 is an IgG1 monoclonal antibody specifically binding to VISTA on immunosuppressive cells, demonstrating excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 offers a differentiated mechanism of action, contributing to anti-cancer effects through the activation of T cells, monocytes, and the proliferation of M1 macrophages.

This open-label Phase 1a/b clinical trial involves a total of 67 patients and comprises two phases: Phase 1a and Phase 1b. Phase 1a includes PMC-309 monotherapy and combination therapy with KEYTRUDA (pembrolizumab) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Phase 1b will evaluate the safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA at the RP2D. The clinical trial is being conducted at four institutions in Australia.

Dr. Jin-San Yoo, Chief Executive Officer of PharmAbcine Australia Pty, the Australian subsidiary of PharmAbcine Inc., stated, "It has been 10 years since the first generation of immuno-oncology drugs entered the market. During this time, these drugs have been administered to numerous cancer patients. While some patients have benefited, many have developed resistance, and others have passed away. The need for next-generation immuno-oncology drugs is critical. The confirmation of the safety of the first dose cohort of PMC-309 is just the beginning of this trial. We look forward to gradually verifying the safety and efficacy of PMC-309 through the planned higher dose cohorts. We are also preparing for the combination trial of PMC-309 with KEYTRUDA in collaboration with MSD without any delays."

He added, "We are committed to providing new treatment options to patients suffering from the limitations of first-generation immuno-oncology drugs."

For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT05957081.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On July 8, 2024 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported the addition of the University of Pittsburgh Medical Center (UPMC) Department of Dermatology in Pittsburgh, PA as a clinical trial site for its lead product candidate, PH-762 (Press release, Phio Pharmaceuticals, JUL 8, 2024, View Source [SID1234644721]).

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The Phase 1b study recently received a positive safety recommendation from the Safety Monitoring Committee to escalate the dose in the next phase of the study. The clinical trial is currently enrolling patients for the 2nd cohort.

The UPMC Department of Dermatology joins four other sites engaged in the clinical study: The George Washington University-Medical Faculty Associates in Washington, D.C; Banner MD Anderson Cancer Center in Gilbert, Arizona; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio.

"We are excited to conduct our study with these five clinical sites, all of whom have a very keen interest in immuno-oncology and are leading centers in skin cancer," said Robert Bitterman, CEO of Phio Pharmaceuticals.

PH-762 is an INTASYL compound that silences PD-1, a protein that inhibits T cells’ ability to kill cancer cells. The Phase 1b trial is a non-comparative study of neoadjuvant monotherapy using PH-762 in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. The study is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.

More information about this clinical trial is available at clinicaltrials.gov (identifier: NCT06014086).