Category Archives: CAR-T

Veteran analyst Eric Schmidt moves over to biotech as Allogene’s new CFO

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Longtime Cowen analyst Eric Schmidt is joining Arie Belldegrun’s latest CAR-T startup, Allogene, as its chief financial officer.

The announcement comes six weeks after Schmidt confirmed that he was considering a job offer from the company, which is working on off-the-shelf CAR-T therapies.

“Eric is an enormously talented individual with a rare blend of insight into multiple facets of the industry and deep relationships within the financial community. We are very fortunate to have him join the Allogene executive team and look forward to him applying his expertise to our vision for allogeneic cell therapy,” said Allogene CEO and President, David Chang, M.D., Ph.D, in a statement.

Schmidt joined Cowen in 1998, where he served as managing director and senior biotechnology analyst. Though he’s leaving his post at Cowen, he will stay on as a senior advisor to the company.

After creating the first CAR-T for non-Hodgkin lymphoma and selling their company off to Gilead, the former Kite Pharma executives Belldegrun and Chang returned for chapter two—allogeneic, or off-the-shelf CAR-T. They launched the startup in April, with $300 million in series A capital and a suite ofe early-stage allogeneic CAR-T assets, licensed from Cellectis, by way of Pfizer.

Pfizer licensed 16 CAR-T assets from Cellectis in 2014 for $80 million up front and another $185 million per product up for grabs, making the deal potentially worth as much as $2.9 billion. A year later, Pfizer and Servier gained the rights to another CAR-T candidate, UCART19, which has now become Allogene’s lead asset, with phase 2 trials slated to start in 2019.

While Kite and Novartis earned the first approvals for CAR-T treatments in 2017, there remains much room for improvement. Their therapies, Yescarta and Kymriah, are both indicated for blood cancers, with most CAR-Ts seeing limited success in solid tumors. Moreover, CAR-T cells are made by collecting a patient’s T cells, modifying them to better target and destroy cancer and then putting them back into the patient. This makes manufacturing complex and time-consuming. An allogeneic approach uses donor cells, which can be stored and used off the shelf.

“I’ve watched and analyzed dozens of companies as they worked to bring innovative and transformative new therapies to the market,” Schmidt said. “I have greatly admired the team and investors behind Allogene and consider myself very fortunate to be in a position to help make a difference in the lives of patients who are facing cancer.”

SOURCE: www.fiercebiotech.com

Gilead signs $3bn-plus gene-editing deal with Sangamo

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Gilead Sciences has claimed another stake in the emerging cell therapy sector with a $3bn agreement to use Sangamo Biosciences gene-editing platform for new cell-based cancer therapies.

The company seems determined to stay in the forefront of the pharma industry’s push into cell therapies, with the latest deal coming shortly after it acquired CAR-T specialist Kite Pharma for $12bn and almost immediately bolted on another CAR-T tech through the takeover of Cell Design a few weeks later.

Sangamo is getting $150m upfront from Gilead in the deal, which will see Kite claim an exclusive license to use the biotech’s zinc finger nuclease (ZFN) technology to develop up to ten off-the-shelf (allogeneic) as well as autologous CAR-T therapies. It also stands to receive up to $3bn in milestones – $300m per product – as well as tiered royalties on sales.

Kite will be responsible for all development, manufacturing and commercialisation of products under the collaboration, and will be responsible for agreed upon expenses incurred by Sangamo.

Gene-editing techniques are used to modify the cells – either harvested from patients or taken from donor stocks – that are infused into cancer patients in order to mount an immunotherapeutic assault on cancers. The deal with Sangamo means rivals in the CAR-T category such as Novartis, Celgene/Juno and off-the-shelf specialist Cellectis won’t be able to use the ZFN technology in their own gene-editing toolboxes.

ZFN is a gene-editing approach that uses a DNA-cutting nuclease enzyme attached to zinc finger -binding proteins to recognize and edit specific sequences of DNA. Other techniques include CRISPR/Cas9 – used by Novartis and Juno – and Cellectis’ favoured TALENS.

However, according to CEO Sandy Macrae, Sangamo has made significant strides in improving the precision, efficiency and specificity of ZFN, which means the technique now “sets the standard on what therapeutic genome editing should be”.

He said that Kite’s “financial strength and clear determination” to bring new cellular therapies products forward makes it an ideal partner for ZFN in this setting.

Kite highlighted the potential of the technology for developing allogeneic CAR-Ts, which have been put forward as potentially a major advance over autologous therapies, as they should be much quicker and cheaper to deliver – an important consideration given the current debate over the escalating costs of cancer treatment.

“The emergence of gene editing as a tool to edit immune cells holds promise in the development of therapies with potentially improved safety, efficacy and efficiency,” commented Gilead’s CEO John Milligan.

SOURCE: www.pmlive.com/pharma_news