US Senate Passes $2 Trillion Bill to Blunt Coronavirus Pandemic’s Economic Impact, as Households and Businesses Gasp for Relief
March 26, 2020 – (Washington Post) – The bill would create a $500B lending program for businesses, cities, and states, and establish a $367B employee retention fund for small businesses.
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What It’s Like to Go Into the Lab at a Biopharma Company During the Coronavirus Pandemic
March 26, 2020 – (STAT News) – Twenty-one states have now ordered their residents to stay home. Those orders cover the three major life sciences hubs in the US – California, Massachusetts, and New Jersey – but generally include exceptions for biopharma employees to leave their homes to perform work duties that are deemed essential.
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European Parliament to Vote on €37 Billion Crisis Response to the Coronavirus
March 25, 2020 – (European Parliament) – EU countries are due to return almost €8B in unused pre-financing for 2019, so the European Commission is proposing that they keep that money for new projects mitigating the effects of the coronavirus crisis. That could be supplemented by about €29B in EU co-financing, for a total of €37B that could be deployed in investments across the EU.
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As US FDA Settles Into Teleworking, Will Application Reviews Be Affected?
March 24, 2020 – (Pink Sheet – Subscription Only) – Former FDA assessors and managers said that the work of clearing applications is mostly able to continue through telework. Meetings and travel-related tasks such as facility inspections stand the best chance of slowing FDA productivity.
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France To Fast-Track COVID-19 Clinical Trial Applications
March 24, 2020 – (Pink Sheet – Subscription Only) – The French medicines regulator ANSM has asked drug sponsors to prioritize clinical trials of potential therapies for COVID-19 and is putting in place new procedures to speed up the approval of such studies. For ongoing trials, ANSM has published advice on its website to help sponsors when deciding whether to conduct studies and to allow them to amend the trial where necessary.
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AlloVir Expands Its Research Collaboration With Baylor College of Medicine to Discover and Develop Allogeneic, Off-the-Shelf, Virus-Specific T-Cell Therapies for COVID-19
March 23, 2020 – (AlloVir) – AlloVir aims to develop a therapy for coronavirus that can be used as a stand-alone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR106, which is designed to address other devastating and life-threatening community-acquired respiratory viruses.
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As COVID-19 Spreads, Disruptions to Clinical Trial and Drug Development Accelerate
March 23, 2020 – (STAT News) – Two significant challenges to conducting clinical trials in the current environment have emerged: Missing or delayed data collection from ongoing clinical trials, particularly at hospital sites overwhelmed by COVID-19 cases; and difficulties getting new clinical trials up and running because patients are reluctant to enroll or unable to visit hospitals.
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VC Shop Syncona Warns of Company Trial Delays as COVID-19 Pandemic Deepens
March 23, 2020 – (Fierce Biotech) – Syncona’s portfolio includes a series of early- to midstage companies from cancer cell therapy companies Autolus, Quell Therapeutics and Achilles Therapeutics to gene therapy biotechs Freeline, Gyroscope Therapeutics and SwanBio Therapeutics.
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BARDA Designates Athersys’s Cell Therapy “Highly Relevant” for COVID-19
March 20, 2020 – (BioSpace) – MultiStem, a cell therapy in development at Athersys, was recently designated “Highly Relevant” as a Potential Therapy for COVID-19 by BARDA. It has the potential make a significant improvement in patients’ lives and in the use of resources needed to treat COVID-19 and other respiratory conditions.
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EMA Offers Guidance on Conducting Trials During the COVID-19 Pandemic
March 20, 2020 – (Regulatory Focus) – Specific measures that sponsors may want to consider, according to the guidance, include the conversion of physical patient visits into phone or video visits, a temporary halt of a trial at some or all trial sites, the suspension or slowing down of recruitment of new trial participants, the extension of the duration of the trial, and/or the postponement of trials or activation of sites that have not yet been initiated.
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An Updated Guide to the Coronavirus Drugs and Vaccines in Development
March 19, 2020 – (STAT News) – STAT News released a guide to some of the most talked-about efforts to treat or prevent coronavirus infection, with details on the science, history, and timeline for each endeavor.
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Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials
March 18, 2020 – (FDA) – The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19. Although the impact of COVID-19 on trials will vary depending on many factors, the FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.
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Castle Creek Biosciences Announces $75M Investment to Advance Development of Multiple Gene Therapy Candidates for Rare Diseases
March 25, 2020 – (Castle Creek Biosciences) – The company plans to use the funding to advance and expand its gene therapy pipeline, led by the Phase 3 clinical development of FCX-007 for the treatment of RDEB. It will also use the funding to expand its current good manufacturing practices infrastructure located in the greater Philadelphia region.
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Redpin Therapeutics Secures Initial Closing of $15.5M in Series A Financing
March 25, 2020 – (Redpin Therapeutics) – The proceeds will enable Redpin to further progress the development of its groundbreaking ultra-potent ion channel based chemogenetics platform to address disorders associated with neural circuit dysfunction including epilepsy, neuropathic pain, and Parkinson’s disease.
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Avectas and Vycellix Announce Collaboration to Advance Next-Generation Solutions for the Optimized Manufacture of Cell & Gene Therapies
March 24, 2020 – (Avectas) – Avectas and Vycellix announced that the companies have entered into a collaboration agreement to develop proprietary approaches for cell-based immunotherapeutic products.
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MaxCyte and Allogene Therapeutics Sign Clinical and Commercial License Agreement to Enable the Advancement of Allogeneic CAR-T Therapies
March 24, 2020 – (MaxCyte) – Under the terms of the agreement, Allogene gains rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform to develop and advance its AlloCAR T candidates through to commercialization. In return, MaxCyte will receive undisclosed development, approval and commercial milestones in addition to other licensing fees.
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Triumvira Immunologics and Lonza Announce Collaboration to Develop Innovative Point-of-Care Manufacturing for TAC T-Cell Therapeutic Targeting Solid Tumors
March 24, 2020 – (Triumvira Immunologics) – The collaboration, aimed at the development of Triumvira's TAC01-HER2 T-cell therapy for treating solid tumors, will leverage Lonza's expertise in process development and the usage of its proprietary Cocoon Platform.
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Codexis Signs Strategic Collaboration and License Agreement with Takeda to Advance Novel Gene Therapies for Rare Genetic Disorders
March 23, 2020 – (Codexis) – Codexis announced a strategic collaboration and license agreement with Takeda for the research and development of novel gene therapies for certain disease indications, including the treatment of lysosomal storage disorders and blood factor deficiencies. Codexis is eligible to receive an upfront payment as well as milestone payments and royalties.
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IASO Biotherapeutics Raises $60M in Series B Financing led by GL Ventures to Advance Cell Therapies for Cancer Care
March 23, 2020 – (IASO Biotherapeutics) – The funding will go toward expanding the company’s product pipeline, promoting the progress of current projects, improving the technology of fully human antibody development platform, expanding cooperation with leading international research and development institutions, and accelerating the construction of commercial facilities.
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Thermo Fisher Scientific Continues Investments to Accelerate Biopharma Commercialization
March 23, 2020 – (Thermo Fisher) – Thermo Fisher Scientific is investing more than $475M in new capabilities and capacity in 2020 to help customers meet increasing demand for new biologics, cell and gene therapies, and drug products.
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European Medicines Agency Grants Orphan Drug Designation to AlloVir’s Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy
March 26, 2020 – (AlloVir) – In addition to Orphan Drug Designation, Viralym-M has been granted PRIME designation from the EMA and RMAT designation from the US FDA.
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uniQure Announces Achievement of Target Patient Dosing in HOPE-B Pivotal Trial of AMT-061 in Hemophilia B
March 26, 2020 – (uniQure) – In total, 54 patients have received the one-time dose of etranacogene dezaparvovec. The company expects top-line data from the Phase 3 trial before the end of 2020, which will be used to support a BLA submission in 2021.
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Prevail Therapeutics Receives US FDA Fast Track Designation for PR006 to Slow the Progression of Frontotemporal Dementia with a GRN Mutation
March 24, 2020 – (Prevail Therapeutics) – The US FDA has granted Fast Track Designation for the company’s experimental gene therapy program, PR006, to slow the progression of frontotemporal dementia with a GRN mutation. Prevail announced an active IND for the Phase 1/2 clinical trial of PR006 for the treatment of FTD-GRN earlier this month.
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Zolgensma Data Shows Rapid, Significant, Clinically Meaningful Benefit in SMA Now Up to 5 Years Post-Dosing
March 24, 2020 – (AveXis, a Novartis Company) – Interim data continue to show patients achieved age-appropriate motor milestones when treated with Zolgensma presymptomatically. Most patients (7/8) with two copies of SMN2 who achieved the ability to sit independently did so within the window of normal development. AveXis also presented data demonstrating a clinically meaningful response in older patients with SMA Type 2.
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Bone Therapeutics Receives Clinical Trial Application Approval for Next Clinical Studies of Its Two Lead Candidates
March 23, 2020 – (Bone Therapeutics) – The company will initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows.
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Biostage Announces IND Approval from FDA for Its Lead Product Candidate Cellspan Esophageal Implant
March 20, 2020 – (Biostage) – Biostage announced that the US FDA has approved the company's IND for the Cellspan Esophageal Implant to treat patients with end-stage esophageal disease. The FDA notified the company that it removed the clinical hold and that the company may proceed with its study.
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ImStem Biotechnology Announces FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for IMS001 for the Treatment of Multiple Sclerosis
March 20, 2020 – (ImStem Biotechnology) – The company plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.
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Old Human Cells Rejuvenated With Stem Cell Technology
March 24, 2020 – (Stanford University) – Researchers found that elderly mice regained youthful strength after their existing muscle stem cells were subjected to the rejuvenating protein treatment and transplanted back into their bodies.
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CAR Macrophages Go Beyond T Cells to Fight Solid Tumors
March 23, 2020 – (Penn Medicine) – The research team showed that when the viral vector is inserted, not only do these engineered macrophages express the CAR, they also transform into highly inflammatory cells. This transformation allows macrophages to resist being co-opted by tumors.
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Immunotherapy Using ‘Young Cells’ Offers Promising Option Against Cancer
March 19, 2020 – (Washington University in St. Louis) – A new study suggests that natural killer cells appear to be more effective the earlier they are in development, opening the door to the possibility of an immunotherapy that would not utilize cells from the patient or a matched donor. Instead, they could be developed from existing supplies of what are called human pluripotent stem cells.
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Manager, Clinical Quality
Abeona Therapeutics – Cleveland, OH
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Head of Clinical Pharmacology
Magenta Therapeutics – Cambridge, MA
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