Xilio Therapeutics Announces FDA Clearance of Investigational New Drug Application for XTX202 for the Treatment of Solid Tumors

On October 18, 2021 Xilio Therapeutics, Inc. (Xilio) a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate XTX202, its tumor-selective IL-2 product candidate, as a potential treatment for patients with solid tumors (Press release, Xilio Therapeutics, OCT 18, 2021, View Source [SID1234591462]). XTX202 is designed to localize activity in the tumor microenvironment (TME), with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.

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"We are excited to have received FDA clearance for our IND application for XTX202," said Martin Huber, M.D., president of research and development and chief medical officer of Xilio. "IL-2 has shown potential for long-term, durable complete responses in certain cancers, but life-threatening toxicity has limited its use to a small subset of patients. We have designed XTX202 with the goal of delivering enhanced anti-tumor activity while minimizing the known liabilities of existing IL-2 therapies. We look forward to beginning Phase 1/2 development to evaluate the potential that XTX202 may offer as both a monotherapy and combination agent for patients in need."

Leveraging its proprietary geographically precise solutions (GPS) platform, Xilio designed XTX202 to be activated selectively in the TME, resulting in localized clinical activity without dose-limiting toxicities. In preclinical studies, XTX202 exhibited tumor-selective biological activity and anti-tumor activity comparable to aldesleukin, a high-dose IL-2 therapy, at its maximum tolerated dose, while minimizing the severe toxicity observed with aldesleukin. XTX202 was well-tolerated in non-human primate models up to 10 mg/kg weekly.

Xilio expects to initiate a Phase 1/2 dose-escalation monotherapy trial for XTX202 in patients with solid tumors who have previously received an anti-PD(L)1 treatment regimen in the first quarter of 2022.

Patrys PATDX3 antibody drug conjugate significantly increases survival in animal model

On October 18, 2021 Patrys reported the latest data from its completed proof-of-concept study demonstrating the potential of its full-sized deoxymab antibody, PAT-DX3, to be used as a targeting agent for antibody drug conjugates (ADCs) to deliver anti-cancer drugs to tumour tissue.

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The preclinical study, which was carried out in mice implanted with human breast cancer cells, has shown that animals treated with the PAT-DX3-MMAE conjugate had a statistically significant increase in survival. At the end of the study, 80% of the mice treated with PAT-DX3-MMAE were still alive, compared to zero survival in the untreated control, and only a single survivor in the control antibody group.

ADCs harness the targeting attributes of antibodies to deliver drugs specifically to the sites of disease. Most ADCs are based on antibodies directed against antigens that are specific for a particular tumour, however Patrys’ deoxymabs are attracted to the DNA that is released from dying cells, making it a pan-cancer therapeutic option.

According to Patrys CEO and Managing Director, Dr James Campbell:

"This preclinical study has shown that the affinity our deoxymabs have for DNA is sufficient for them to target the delivery of cancer drugs to tumours where they can inhibit tumour growth and improve survival. We look forward to advancing this program as an adjunct to our planned first in human clinical study of PAT-DX1, which remains on track for late 2022."

Immunocore and Medison Pharma Partner for Future Commercialization of Tebentafusp in Canada, Central Eastern Europe, and Israel

On October 18, 2021 Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, and Medison Pharma Ltd., a global pharma company focused on providing access to highly innovative therapies to patients in international markets, reported an exclusive multi-regional agreement for Medison to help seek regulatory authorization and commercialize Immunocore’s tebentafusp (IMCgp100), for the treatment of patients with metastatic uveal melanoma, in Canada, twenty markets across Central Eastern Europe and Israel (Press release, Immunocore, OCT 18, 2021, View Source [SID1234591447]).

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"Following the acceptances of the Biologics License Application and Marketing Authorization Application for tebentafusp in metastatic uveal melanoma by regulatory agencies in the U.S. and Europe, we are excited to partner with Medison Pharma to increase our potential ability to reach patients with metastatic uveal melanoma in many more countries," said Ralph Torbay, Head of Commercial at Immunocore.

"We are delighted to partner with Immunocore in 22 markets to accelerate the global reach of this breakthrough treatment for metastatic uveal melanoma", said Meir Jakobsohn, Founder and CEO of Medison Pharma. "In our joint commitment to help treat patients suffering from the most challenging diseases, we look forward to leveraging our commercial platform and providing patients in international markets with access to this much needed therapy."

Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the U.S. Food and Drug Administration (FDA) in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). Immunocore’s biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, EMA’s CHMP has accepted Immunocore’s Marketing Authorisation Application.

Repare Therapeutics to Participate at the H.C. Wainwright 2nd Annual Precision Oncology Conference

On October 18, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate in a fireside chat at the H.C. Wainwright 2nd Annual Precision Oncology Conference on Wednesday, October 20, 2021 at 12:30 p.m. Eastern Time (Press release, Repare Therapeutics, OCT 18, 2021, View Source [SID1234591463]).

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A live webcast of the fireside chat can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days.

NantHealth Teams Up with Care Continuity for Patient Navigation and Care Coordination Across the Healthcare Continuum

On October 18, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported an agreement with Care Continuity Inc., a leader in network integrity and care navigation across the care continuum (Press release, NantHealth, OCT 18, 2021, View Source [SID1234591490]). The agreement was formed to improve the management of care logistics for complex, high risk and chronic diseases. The care pathways enabled by this collaboration will support clinicians, patients, and their families across health networks, and help to ensure patients receive equal, high-quality access to treatment. The initial focus is the extension of cancer pathways through Eviti Connect, then adding other high risk and chronic care pathways through NantHealth’s NaviNet payer/provider collaboration platform.

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Health systems, payers and Accountable Care Organizations (ACOs) invest significant resources building care delivery networks, yet too often rely on patient/member self-navigation and ad hoc tools to connect the dots across the various access points. This results in poor outcomes, patient attrition, and ultimately, lost market share.

Care Continuity’s cloud-based provider communication and consultation management platform will leverage NantHealth’s Eviti Connect to guide patients through their healthcare plans step by step. Eviti provides data—including evidence-based standards and therapies—that gives payers and providers confidence to prescribe and reimburse high-quality, high-value cancer care. Care Continuity will connect patients/members with information that helps them navigate from one step of the treatment to the next. Navigation offerings include:

Emergency Discharge Program: Designed to ensure members visiting the emergency department receive timely care from a physician in the payers’ high quality provider network. Navigators will reach out to targeted patients to offer assistance in scheduling their post-discharge follow-on care.
Inpatient Discharge Services: Designed to ensure that members have all required post discharge follow-on care scheduled prior to discharge, are supported in the transition to post-acute services (e.g., rehab, home care), and are provided with subsequent scheduling of physician appointments and handling of the associated care logistics.
High Touch Care Management Support: An experienced concierge team provides a high level of support, helping to enroll members in complex care management programs.
Referrals Workflow: Through more coordinated health networks, primary care givers can refer patients to the highest quality provider in the network and reduce network leakage.
"When it comes to cancer care, there are many overwhelming decision points for the patient and provider," said Ron Louks, Chief Operating Officer at NantHealth. "Health care navigation through our agreement with Care Continuity furthers NantHealth’s commitment to providing our customers with better data and insights while also helping to advocate for equal, quality healthcare for every patient."

"Patients, when most vulnerable, should not be expected to navigate care on their own," said Andrew Thorby, Chief Executive Officer at Care Continuity. "We are honored, as a trusted patient advocate, to partner with NantHealth and leverage actionable insights to ensure members get the essential services they need."