Cell therapy weekly: RMAT designation for BK-induced hemorrhagic cystitis therapy

This week: New collaboration will target vision loss and two new offices for CTI

Jun 13, 2019
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The news highlights:

RMAT designation for BK-induced hemorrhagic cystitis therapy
Allele and Alpine BioTherapeutics will collaborate on iPSC-derived therapy for retinal disease
Two new offices for CTI

RMAT designation for BK-induced hemorrhagic cystitis therapy

Viralym-M, developed by AlloVir (TX, USA) has been granted Regenerative Medicine Advanced Therapy (RMAT) by FDA. Viralym-M is an allogeneic T-cell therapy that can be used off-the-shelf for the treatment of hemorrhagic cystitis (HC) caused by BK virus in adults and children following allogeneic hematopoietic stem cell transplantation (HSCT). HC caused by BK virus occurs in 8%-25% of pediatric patients and 7%-54% of adult patients, and is associated with significant morbidity and increase mortality. There are currently no approved treatments.

David Hallal, Chief Executive Officer of AlloVir, commented: “Viralym-M is specifically designed to restore natural T-cell immunity in immunocompromised patients, helping to fight or prevent severe and life-threatening virus-associated diseases such as hemorrhagic cystitis until the patient’s own immune system kicks back in. We are on track to initiate Phase 3 studies for Viralym-M and to advance ALVR106, AlloVir’s second allogeneic, off-the-shelf multi-respiratory virus specific T-cell therapy, into the clinic over the next 12 months…we look forward to working closely with the FDA as we continue to develop Viralym-M for these patients, who currently lack effective treatment options.”

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Allele and Alpine BioTherapeutics will collaborate on iPSC-derived therapy for retinal disease

Allele Biotechnology and Pharmaceuticals, Inc. and Alpine BioTherapeutics Corporation (both CA, USA) will partner to develop an iPSC-derived cell therapy to treat retinal diseases. The collaboration will leverage Allele’s cGMP facility and mRNA-based technology for generating and differentiating footprint-free iPSCs, and Alpine’s patented, robust stem cell differentiation technique whist is claimed to be “the most efficient process known in the manufactured retinal cell category”.

"This collaboration with Allele Biotechnology provides us a clear path forward for clinical use of our technology. There are only a handful of clinical grade iPSC lines available in the world and we are fortunate that we will now have access to one of the best. Moreover, the support of Allele’s cell scientists and cGMP experts will be of great advantage to enable us to move to IND and into clinical trials quickly,” said Jack J. Zhao, CEO of Alpine BioTherapeutics.

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Two new offices for CTI

CTI Clinical Trial and Consulting Services (CTI; KY, USA)) has announced the opening of two new offices in Dallas (TX, USA) and San Diego (CA, USA). CTI, a full-service contract research organization, revealed earlier this year that they were expanding into Raleigh (NC, USA) and San Francisco (CA, US). The expansions will bring CTI closer to local medical centers.

"We are thrilled to expand our workforce in Dallas and San Diego," remarked Timothy J. Schroeder, Founder and CEO. "Both locations are rich with talent, and we look forward to the opportunities that will come from becoming a part of those communities. We have a very long history of successful collaborations in both areas with leading academic centers and emerging biotechnology companies and are excited to expand our team in both cities."

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For more weekly cell therapy news, read previous editions of the cell therapy weekly.

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