The Parker Institute for Cancer Immunotherapy and Resilience Announce Strategic Alliance to Develop Next-Generation Cancer Therapies

On June 8, 2022 The Parker Institute for Cancer Immunotherapy (PICI), a network of the largest concentration of immuno-oncology (IO) expertise in the world, and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, reported the launch of a five-year strategic alliance to develop next-generation cancer therapies generated from PICI’s network of leading immunotherapy research centers (Press release, Parker Institute for Cancer Immunotherapy, JUN 8, 2022, View Source [SID1234615777]).

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Together, PICI and Resilience aim to bring novel cell and gene therapies to market through the creation and incubation of new companies with a commitment of up to $50 million in funding. These startups will leverage groundbreaking technologies from across the PICI Network and have direct access to Resilience’s biomanufacturing capacity, capability, and know-how.

"This strategic alliance is representative of the transformative growth underway at PICI as we take our vision to the next level with new company investments and incubation," stated Sean Parker, PICI founder and chairman. "Now, in collaboration with Resilience, we are closing the loop with access to critical biological manufacturing that will further accelerate our mission of delivering breakthrough immune therapies to patients and transforming all cancers into curable diseases."

Under the agreement, Resilience will also collaborate with PICI Network investigators on challenges related to biomanufacturing and novel treatment modalities. As PICI’s first valued manufacturing partner for complex modalities Resilience will be well positioned to work with PICI Affiliated Partners (PICI-invested companies, PICI Network Institutions, and Network Investigators) on developing enabling biomanufacturing technology and to lower the barriers for technology access across the PICI network and more broadly within the therapeutic development community.

"By combining our organizations’ capabilities in drug discovery, development and cutting-edge biomanufacturing technologies, we aim to advance a new wave of treatments to patients in need," said Rahul Singhvi, ScD, Chief Executive Officer of Resilience. "This alliance with PICI will demonstrate the power of new business models in finding and advancing cancer therapies."

Resilience and PICI will establish a Joint Steering Committee to approve investments and new company opportunities, monitor and track the progress of alliance portfolio companies, and identify innovation challenge focus areas, among other duties.

"Through this strategic alliance, we have an opportunity to deliver unparalleled access to innovation in cancer immunotherapy and manufacturing across PICI-invested companies and the PICI Network," stated PICI Chief Scientific Officer, John Connolly, PhD. "The combination of PICI’s bench-to-market-to-patient philosophy and Resilience’s end-to-end biomanufacturing solutions support novel idea generation and development, delivering cutting-edge therapeutics to patients with cancer faster."

"By working closely with PICI Network Investigators, we can develop the advanced manufacturing technologies needed to bring cutting-edge therapies to patients that need them," said Rich Stoner, PhD, Chief Scientific Officer, Resilience. "Our goal is to ensure these therapies can be made at the quality and scale required to bring transformative immune therapies to people with cancer."

IDEAYA Biosciences to Present at the 2022 Jefferies Global Healthcare Conference

On June 8, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 2022 Jefferies Global Healthcare Conference (Press release, Ideaya Biosciences, JUN 8, 2022, View Source [SID1234615793]).

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2022 Jefferies Global Healthcare Conference
Wednesday, June 8 at 11:00am ET

Fireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by
Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

CorMedix to Participate at the JMP Securities Life Sciences Conference

On June 8, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that management will be participating in a fireside chat at the JMP Securities Life Sciences Conference being held in New York on June 15 – 16, 2022 (Press release, CorMedix, JUN 8, 2022, View Source [SID1234615923]).

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JMP Securities Life Sciences Conference

Allogene Therapeutics Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to ALLO-501A for Large B Cell Lymphoma

On June 8, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in relapsed/refractory LBCL (Press release, Allogene, JUN 8, 2022, View Source [SID1234616278]). The RMAT designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies.

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"The designation for ALLO-501A supports the patient need for access to an off-the-shelf CAR T product that can be delivered faster, more reliably, and at greater scale," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "Patients who are eligible for autologous CAR T therapy are often faced with treatment delays and manufacturing failures, placing them at risk for disease progression and disease-related complications. We look forward to initiating our pivotal trial on ALLO-501A and making this innovative product candidate readily available to patients."

Results from the ALPHA2 study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2021. Data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients.

ALLO-501A was associated with consistent and manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS).
There were no relapses observed in LBCL CAR T naïve patients who were in a complete response (CR) at six months with the longest ongoing CRs with ALLO-501A at 15+ months.
Nearly all enrolled patients were able to receive therapy with the median time from enrollment to initiation of treatment of two days in ALPHA2.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

Proscia’s Concentriq Dx Attains CE Mark Under IVDR For Use In Primary Diagnosis

On June 8, 2022 Proscia, a leader in digital and computational pathology solutions, reported that its Concentriq Dx platform has been certified under the new In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis (Press release, Proscia, JUN 8, 2022, View Source [SID1234615778]). This certification will enable the company’s continued growth in the European diagnostic pathology market, where it is helping leading laboratories to modernize their routine operations.

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The IVDR certification demonstrates that Concentriq Dx complies with the stronger quality and safety standards that now govern in vitro diagnostic medical devices in the European Union. This new regulatory framework replaces the IVD Directive, under which Concentriq Dx also received a CE mark.

"Proscia’s dedication to quality is unwavering," said Kim Rendon, Director of Regulatory Affairs. "The IVDR certification is a testament to our focus on delivering the safe, efficacious solutions that pathologists need to provide faster, more accurate diagnoses and ultimately improve patient outcomes."

A singular, secure platform, Concentriq Dx* helps shift the standard of care from microscope to image. It combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks. As laboratories increasingly look to unlock new insights with computational solutions, Concentriq Dx is designed to support them in realizing pathology’s AI-enabled future.

Concentriq Dx is the platform of choice for top reference laboratories and health systems in Europe, including LabPON and Uppsala University Hospital. The European geography has seen some of the earliest adopters of digital pathology due to a widespread shortage of pathologists among other systemic challenges in the traditional laboratory model. Rising demand for diagnostic services continues to intensify pressure for digital transformation.

In response, Proscia has established subsidiary entities in Ireland and Spain to further drive its international growth. These entities will enable the company to increasingly scale its operations and continue to support its expanding customer base.

"Since we entered the European market in 2019, we have welcomed leading laboratories onto the Concentriq Dx platform and built a world-class team," said David West, CEO. "We are now better positioned than ever before to accelerate this momentum as we see through our mission of perfecting cancer diagnosis."

Proscia will be exhibiting at next week’s European Congress on Digital Pathology. To learn more about Concentriq Dx and see a demo, visit the company at booth #B09.

*Concentriq Dx is CE-marked under IVDR and is available for primary diagnosis in the US during the COVID-19 public health emergency.