Achilles Therapeutics raises $120M in Series B round for cancer cell therapy

Stevenage, U.K.-based Achilles Therapeutics said Tuesday that it had raised 100 million pounds – equal to about $120 million – in a Series B round, led by RA Capital Management. Founding investor Syncona participated, along with Forbion, Perceptive Advisors and Redmile Group.

The company said proceeds for the round will be used to launch two clinical trials of its product candidates in non-small cell lung cancer and melanoma. Its pipeline page lists multicenter Phase I/IIa studies for both indications. Both trials are listed also on ClinicalTrials.gov, with the page for the NSCLC study stating it is currently open for recruitment.

Achilles’ approach involves personalized T-cell therapies that target clonal neoantigens, which are protein markers unique to each patient that are present on the surface of cancer cells. The starting material for the products, known as clonal neoantigen T cells – or cNeT – consists of T cells isolated from a tumor sample known as tumor-infiltrating lymphocytes, or TILs.

“The Achilles approach integrates years of multi-disciplinary scientific and clinical knowledge from immuno-oncology, cell therapy and genomics with the goal of creating a TIL-based therapeutic enriched with T cells reacting against clonal neoantigens,” RA Capital Management Derek DiRocco said in a statement. “We believe this approach may represent the optimal way to expand the utility of polyclonal TIL therapy to multiple solid tumor types and has the potential to provide profound clinical benefit for patients living with cancer.”

TILs represent one of multiple kinds of cell therapies currently in development for cancers. Another company developing them is Iovance, which said in July that, per discussions with the Food and Drug Administration, it could use data from its Phase II study of a TIL in cervical cancer to seek the agency’s approval.

Other types of cell therapies include T-cell receptors, or TCRs, and chimeric antigen receptor T-cells, or CAR-T. Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel) are CAR-Ts with FDA approval for blood cells, both targeting the CD19 antigen.

Source. Medcity News, Alaric Dearment, September 4, 2019

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Bayer powers Versant cell therapy startup to $250M round

Versant Ventures’ Century Therapeutics has exited stealth with $250 million to take allogeneic cell therapies into the clinic. Bayer’s VC wing led the investment with the support of Versant and Fujifilm Cellular Dynamics (FCDI).

Century, like other allogeneic cell therapy players, is trying to improve on autologous products that require the administration of a patient’s own cells back to them by creating off-the-shelf alternatives. The potential of allogeneic therapies has attracted a lot of attention—Allogene Therapeutics alone has raised more than $500 million—but Century thinks it can improve on existing approaches.

That belief rests on Century’s use of self-renewing induced pluripotent stem cells (iPSC). Century puts these cells through multiple rounds of cellular engineering to create master cell banks. By expanding and differentiating the cells in these banks into immune effector cells, Century thinks it can supply “vast amounts” of homogeneous off-the-shelf products. Other developers of allogeneic cell therapies work with nonrenewable donor-derived cells.

Versant set Century up last year to build on the research of the biotech’s scientific cofounders, Marcela Maus, M.D., Ph.D., of Harvard Medical School and Hiro Nakauchi, M.D., Ph.D., of Stanford University School of Medicine.

A partnership with Fujifilm subsidiary FCDI followed later in 2018, providing Century with access to an iPSC platform, immune effector cell differentiation protocols and a manufacturing service provider.  

Leaps by Bayer, the VC wing of the German life science company, has committed $215 million to enable Century to build on this platform. With the involvement of Versant and FCDI bringing the size of the round up to $250 million, Century is positioned to move multiple iPSC-derived treatments for blood cancers and solid tumors into human testing.

The pursuit of iPSC-derived cell therapies may take Century into uncharted waters. Maus is among the researchers to previously note the challenges this will entail, telling Cancer Discovery last year that “we don’t have a long safety track record of using pluripotent stem cells clinically, much less genetically manipulated ones.” Other researchers have questioned how companies will convince the FDA that their products are completely free from undifferentiated stem cells. 

Century is well equipped to try to overcome these hurdles. As well as raising $250 million, Century has put together a leadership team with deep experience in immuno-oncology and cell therapies.

Ex-Juno Therapeutics CSO Hyam Levitsky, M.D., has taken up the post of president of R&D at Century. Luis Borges, Ph.D., an ex-Amgen scientist who spent the past two years at Cell Medica, has come on board as CSO. And longtime Celgene and Roche employee Adrienne Farid, Ph.D., has arrived as chief development officer. This team will be led by Lalo Flores, Ph.D., who helped to guide Versant’s Novira Therapeutics to a takeover by Johnson & Johnson in 2015.

Source. FierceBiotech, Nick Paul Taylor, July 1, 2019

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ElevateBio Gets $150M to Grow a Crop of Gene & Cell Therapy Startups

By Frank Vinulan

When a biotech startup is ready to test an experimental therapy it faces a pricey choice: Should it make its drug in-house, or hire a contract manufacturer? The decision is particularly expensive for companies developing complex gene and cell therapies, which need to make large batches of engineered viruses to test their work.

A new Cambridge, MA, company called ElevateBio aims to offer an alternative path.

ElevateBio is building a facility that is intended to manufacture experimental gene and cell therapies for multiple startups, and aims to invest in those companies and help them grow. The company has raised $150 million led by UBS Oncology Impact Fund and F2 Ventures to execute its plan. Co-founder and CEO David Hallal says that the ElevateBio site will be more efficient as a shared resource than it would be if it were owned by a single company.

“We get to build it once and then run multiple companies through it,” he says.

Startups developing chemical drugs often lean on contract manufacturers to make their products. But ElevateBio chief scientific officer Mitch Finer says contractors are too expensive for most cell and gene therapy startups. Gene and cell therapy products involve engineering viruses and filling them with genetic instructions. And for some gene and cell therapies, companies have to extract cells from a patient, modify them in a lab, and infuse them back into the body—a complex and costly process that can take weeks. Finer saw this firsthand as the chief scientific officer of cell and gene therapy developer Bluebird Bio (NASDAQ: BLUE), which built its own manufacturing capabilities. Last year, it reported $448 million in research and development expenses alone.

The need for gene and cell therapy manufacturing expertise has grown considerably as these cutting edge treatments have progressed forward. Multiple gene and cell therapies are now approved in the US and Europe, and many more are in development. The FDA, for instance, could approve the spinal muscular atrophy gene therapy Zolgensma, from Novartis (NYSE: NVS), this month. Others for hemophilia, beta-thalassemia, Duchenne muscular dystrophy, and more could follow.

Biopharma is investing heavily in gene therapy’s future: Roche, Biogen (NASDAQ: BIIB), Johnson & Johnson (NYSE: JNJ), and Pfizer (NYSE: PFE) have all bought gene therapy assets this year. What’s more, two contract manufacturers who specialize in gene and cell therapy work, Paragon Bioservices and Brammer Bio, have both been acquired since March. Upon buying Paragon for $1.2 billion, Catalent (NYSE: CTLT) estimated that the addressable market for gene therapy tools is worth $40 billion, and “is expected to have sustained growth of 25 percent in the medium term.”

ElevateBio is trying to capitalize on this momentum by meeting the manufacturing needs of startups. It is currently building a 100,000 square-foot complex in Waltham, MA, that it calls BaseCamp (pictured above). The site, which is still under construction, will be capable of manufacturing both gene and cell therapies, Finer says. BaseCamp will be able to support several companies, though Hallal wouldn’t say how many it can house at one time. Finer adds that the facilities will meet quality control standards and the requirements of US and European regulations.

But ElevateBio isn’t doing this just to be a contract manufacturer. It will operate as a holding company that invests in nascent cell and gene therapy startups spun out of academia. Hallal says his team is already talking with scientists at universities in the US and abroad about bringing their early gene and cell therapy work into ElevateBio.

ElevateBio’s plan is to nurture these startups until they progress, get more private financing, or go public, Hallal says. Each startup that leaves the nest will clear the way for a new company. The goal is to spark a cycle of gene and cell therapy companies being created, grown, and spun out of the Waltham space, Hallal says.

ElevateBio’s Waltham facility is expected to become fully operational in the second half of next year. But Hallal says startups can start working with the company sooner. Right now, it has lab space in Cambridge.

EcoR1 Capital, Redmile Group, and Samsara BioCapital invested in ElevateBio along with UBS Oncology and F2. Before emerging from stealth, ElevateBio was incubated within MPM Capital, where both Hallal and Finer are executive partners.

Source. Xeconony, Frank Vinulan, May 13, 2019

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