Cell therapy weekly: FDA approves Phase I trial of cryopreserved, cord blood-derived, T-regulatory cells for COVID-19-associated ARDS

Written by RegMedNet

This week: Orgenesis (MD, USA) and the Edith Wolfson Medical Center (Tel Aviv, Israel) announce their collaboration over a clinical study to validate Orgenesis’ novel cell culturing system for generating tumor infiltrating lymphocytes, AgeX Therapeutics (CA, USA) and ImStem Biotechnology (CT, USA) sign a non-binding letter of intent regarding an investigational MSC product being considered for COVID-19-associated ARDS and more.

The news highlights:

 

FDA approves Phase I trial of cryopreserved, cord blood-derived T-regulatory cells for COVID-19-associated ARDS

Cellenkos® Inc. (TX, USA) has announced it has received US FDA clearance to initiate a double-blinded, placebo-controlled, Phase I clinical trial to assess the safety and preliminary efficacy of CK0802 – an off-the-shelf, cord blood-derived, allogeneic T-regulatory cell product – in hospitalized patients with COVID-19-associated acute respiratory distress syndrome (ARDS).

Elizabeth Read, Chief Technology Officer at Cellenkos Inc., commented: “We appreciate FDA’s expedited review of our plans to evaluate CK0802 in critically ill, intubated patients suffering from ARDS, a deadly complication of COVID-19…In the forthcoming Phase I randomized trial, CK0802 will be assessed for both toxicity and 28-day treatment success, as co-primary outcomes.”

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Collaboration over clinical study to validate novel cell culturing system for generating tumor infiltrating lymphocytes

Orgenesis (MD, USA) has announced a collaboration with the Edith Wolfson Medical Center (Tel Aviv, Israel) over a clinical study to leverage and validate Orgenesis’ proprietary POCare Technologies, including a novel, automated cell culturing system for generating and expanding tumor infiltrating lymphocytes for use in T-cell therapies.

Ronen Brenner, Head of the Oncology Division at the Edith Wolfson Medical Center, stated: “We look forward to collaborating with Orgenesis on this important clinical trial to advance and validate this breakthrough Orgenesis proprietary [tumor infiltrating lymphocytes] technology, with the joint goal of reducing manufacturing costs and bringing new, cell and gene therapy products to cancer patients worldwide.”

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Companies sign non-binding letter of intent regarding investigational MSC product being considered for COVID-19-associated ARDS

AgeX Therapeutics (AgeX; CA, USA) and ImStem Biotechnology (ImStem; CT, USA) have signed a non-binding letter of intent regarding IMS001 – an investigational, mesenchymal stem cell (MSC)-based product currently being investigated for multiple sclerosis under an Investigational New Drug application – for ARDS resulting from both COVID-19 and non-COVID-19 causes. Under the agreement, ImStem will obtain a non-exclusive license to utilize stem cells from one of AgeX’s human embryonic stem cell lines to develop IMS001 for potential use in ARDS.

Nafees Malik, COO of AgeX, explained: “We feel privileged to be part of a global effort to combat COVID-19…Decades of pioneering work with human embryonic stem cells means this technology is now at a point where it may play a role in the development of a cell-based approach to combating COVID-19. We are very excited by the prospect of expanding our relationship with ImStem to include COVID-19 and ARDS.”

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Partnership to progress allogeneic MSC therapy for critical limb ischemia resulting from Buerger’s disease

Stempeutics Research (Bangalore, India) and Novumcella (Tokyo, Japan) have announced their signing of a development cooperation agreement regarding progressing Stempeucel® onto the Japanese market. Stempeucel – an allogeneic MSC-based product – received conditional manufacturing and marketing approval for the treatment of critical limb ischemia due to Buerger’s disease from the Drugs Controller General of India (New Delhi, India) in 2017. Under this new agreement, with the intention of commercializing Stempeucel for the same indication in Japan, Stempeutics Research will receive regulatory support from Novumcella to obtain Pharmaceuticals and Medical Devices Agency (Tokyo, Japan) approval for the conduct of a bridge investigation for Stempeucel and will fund the costs of this study.

Yasuyuki Kusuhara, Founder & CEO of Novumcella, commented: “We are happy to partner with Stempeutics since its product Stempeucel® is already validated in multiple clinical trials in India for Buerger’s Disease and also the product has been patented in Japan. Data from Indian clinical trials will be useful for getting bridge study approval in Japan.”

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