Potential COVID-19 cell therapy treatments in development

Microscope and coronavirus illustration

July 27, 2020

By Peter Winter

Potential COVID-19 cell therapy treatments in development

Taming the immune response

Racheli Ofir, vice president of research and intellectual property at Haifa, Israel-based Pluristem Therapeutics Inc., described during the webinar the company’s PLX cells that are available off-the-shelf and, once commercialized, can be manufactured in large-scale quantities. They are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages and may prevent or reverse the dangerous overactivation of the immune system.

The company has started enrollment in its U.S. phase II study of PLX cells for the treatment of severe COVID-19 complicated by ARDS. The 140-patient study is evaluating the efficacy and safety of intramuscular injections of PLX-PAD with the primary endpoint being the number of ventilator-free days during the main 28-day study period. Safety and survival follow-up will be conducted at weeks eight, 26 and 52.

In May, Melbourne, Australia-based Mesoblast Ltd. said it dosed the first patients in a 300-patient U.S. phase II/III trial of its allogeneic cellular medicine, remestemcel-L, in COVID-19-infected patients with moderate to severe ARDS on ventilator support. The trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo (1-to-1) on top of maximal care. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.

The study followed initial promising results from use of remestemcel-L in patients with moderate to severe COVID-19 ARDS under an emergency IND application or expanded access protocol at the Mount Sinai Hospital in New York.

Houston-based Hope Biosciences Inc.’s adipose-derived mesenchymal stem cells (HB-adMSCs) are being studied in a phase II trial that is expected to enroll 110 hospitalized patients into two separate arms. Participants taking hydroxychloroquine and azithromycin will be randomized into a placebo or treatment group and patients not on that regimen will also be randomized into a placebo or treatment group. Those receiving treatment will receive four doses of 100 million HB-adMSCs over a 10-day period. Results of the study are expected in April next year.

In the pipeline

Some of the other therapies that have entered clinical trials include Lattice Biologics Ltd., of Belgrade, Mont., which reported it plans to evaluate its amniotic fluid concentrate, Amnioboost, in patients with ARDS. The company said it believes the fluid to have immunomodulatory properties to counteract the inflammatory processes implicated in several diseases by down-regulating production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

To help fund the study, the company entered an agreement with Alumina Partners (Ontario) Ltd. for a commitment of up to CA$6 million (US$4.49 million) in an at-will offering facility. Over a two-year period, the company has the right to draw down on the facility, at any time, at its sole election, in equity private placement tranches of up to CA$1 million.

Celltex Therapeutics Inc., of Houston, received FDA approval to proceed with its IND trial, a phase II study that will evaluate the safety and prophylactic efficacy of autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) against COVID-19. Celltex will enroll 200 patients in the study who have never been infected by COVID-19, half of which will receive intravenous infusions of AdMSCs while the other 100 will receive placebo treatments. The primary objective is to evaluate overall safety of AdMSCs, and the secondary objective is to demonstrate the efficacy of AdMSCs as a prophylactic medicine for those at a high risk of contracting the virus.

In April, Salt Lake City-based Predictive Biotech, a wholly owned subsidiary of Predictive Technology Group, submitted an emergency use authorization application with the FDA for the immediate use of mesenchymal stem cells derived from umbilical cord tissue (UC-MSCs) for the treatment of ARDS. The proposed IND clinical trial will utilize Predictive’s Corecyte product, derived from umbilical cord tissue to assess the efficacy as an add-on therapy to standard treatment of patients with severe ARDS, secondary to COVID-19.

개발중인 잠재적 COVID-19 세포 요법 치료 

？ 2020 년 7 월 27 일

피터 윈터

세포 요법에 중점을 둔 바이오 제약 회사는 COVID-19 사례에서 사망률을 높이는 데 크게 기여한 것으로 보이는 급성 호흡 곤란 증후군 (ARDS)을 치료할 수있는 유망한 임상 시험 결과를보고했습니다. ARM의 과학 및 산업 담당 이사 인 Michael Lehmicke는이 주제에 관한 ARM (Allener for Reenerative Medicine) 웹 세미나에서 개발자가 중간 엽 줄기 세포 (MSC) 및 기타 간질 세포를 이용하여 COVID-19로 인한 ARDS를 치료하고 있다고 언급했습니다. 현재 진행중인 임상 시험의 수는 전임상 단계에서 더 많이 증가하고 있습니다.

클리블랜드 소재 Athersys Inc.의 웨비나 참가자 인 에릭 젠킨스 (Eric Jenkins) 수석 의료 책임자이자 임상 운영 책임자 인이 회사는 멀티 스템 후보를 사용하여 회사의 작업을 설명했습니다. 이 회사는 중증에서 중증의 ARDS 환자를 치료하기 위해 최대 400 명의 COVID-19 환자를 등록 할 수있는 대규모의 중요한 MACOVIA II / III 연구를 시작했습니다.

작년 초, 영국과 미국에서 회사와 폐 중환자 센터에 의해 완료된 탐색 II 상 시험 결과에 따르면 ARDS 환자가 처음 며칠 내에 정맥 주사 멀티 스템을 한 번 주입 한 것으로 나타났습니다. 28 일의 임상 평가 기간 동안 인공 호흡시 사망률, 폐 기능 개선, 인공 호흡기없는 일수 및 ICU가없는 날이 크게 증가했으며 1 년에 걸친 삶의 질과 회복의 의미있는 결과가 의미있게 향상되었습니다. Gil Van Bokkelen, Athersys 회장 및 CEO

최신 연구의 첫 번째 집단은 단일 용량 치료군으로, 두 가지 용량의 Multistem 수준의 안전성을 평가합니다. 그것이 잘 견디면, 연구는 해당 환자 집단의 효능, 안전성 및 내약성을 추가로 평가하도록 설계되었습니다. 본 연구의 1 차 효능 종점은 멀티 스템 및 위약 치료 그룹 중에서 28 일까지 인공 호흡기없는 날 수를 비교할 것이다.

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