With the ink barely dry on its recent private financing, and only slightly drier on its initial big venture capital funding round, a company developing so-called “off-the-shelf” CAR-T therapies has already filed to go public.
South San Francisco, California-based Allogene Therapeutics said Friday that it had filed an S-1 with the Securities and Exchange Commission to make a $100 million initial public offering on the NASDAQ. The company would use the ticker symbol “ALLO.” Goldman Sachs, J.P. Morgan, Cowen and Co. and Jefferies are underwriting the effort.
On Sept. 7, the company said it raised a $120 million private financing from several funds. Allogene was launched in April with a $300 million Series A funding round. Shortly before Allogene’s $120 million raise, liquid biopsy firm Guardant Health also filed for a $100 million IPO.
The CEO and executive chairman are respectively David Chang and Arie Belldegrun, who also founded Kite Pharma. Kite’s CAR-T therapy Yescarta (axicabtagene ciloleucel) was approved last year for diffuse large B-cell lymphoma, before Gilead Sciences acquired the company for $11.9 billion. Yescarta – along with rival Novartis’ Kymriah (tisagenlecleucel) – is an autologous CAR-T made with patients’ own cells, whereas “off-the-shelf” allogeneic CAR-Ts are made using donor cells.
The lead product in Allogene’s pipeline is UCART19, which it in-licensed from Pfizer. Pfizer had licensed the allogeneic CAR-T from French drugmakers Cellectis and Servier, the latter of which still holds ex-US rights to it. The company’s other pipeline products are in preclinical testing, and it anticipates filing Investigational New Drug applications to enter two of them – one for non-Hodgkin’s lymphomas and one for multiple myeloma – into clinical trials next year.
UCART19 is in Phase I clinical trials in children and adults with acute lymphoblastic leukemia, both of which started under Servier’s sponsorship in 2016, according to the ClinicalTrials.gov database. Data on 18 patients from both trials was presented at the European Hematology Association’s annual meeting in June, showing that of the 16 evaluable for a response, 13 achieved a complete response – meaning their tumors went away – while 12 of those achieved minimal residual disease negativity, meaning no evidence of ALL cells in the bone marrow, according to the S-1 filing. One patient in each study developed Grade 1 graft-versus-host disease on the skin, meaning an immune response to the CAR-T, but both patients recovered, according to the filing and EHA conference abstracts for the pediatric and adult trials.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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