Adap­ti­m­mune shares boost­ed by new signs of suc­cess with TCR cell ther­a­py

Rafael Ama­do

One of the big biotech stock movers Thurs­day was Adap­ti­m­mune, a UK-based biotech that saw its shares gy­rate up about 25% af­ter the com­pa­ny tout­ed fresh ev­i­dence that its TCR cell ther­a­py tech showed ear­ly signs of work­ing in a sec­ond sol­id tu­mor in­di­ca­tion.

In what’s be­come a rou­tine prac­tice in im­muno-on­col­o­gy, Adap­ti­m­mune $ADAP made hay from the first glimpse of da­ta from the first four pa­tients treat­ed with its NY-ESO SPEAR T-cells for myx­oid/round cell li­posar­co­ma, or MR­CLS.

Re­searchers tracked two con­firmed and one un­con­firmed par­tial tu­mor re­spons­es in the first group, with the fourth pa­tient sta­ble.

By it­self, that may not look like much, but it was ac­tu­al hu­man da­ta to in­di­cate that their plat­form ap­proach to sol­id tu­mors — a tough hur­dle in cell ther­a­pies — has re­al po­ten­tial across mul­ti­ple tu­mors.

Adap­ti­m­mune R&D chief Rafael Ama­do put it like this:

Al­though MR­CLS is a soft tis­sue sar­co­ma which com­mon­ly ex­press­es NY-ESO, there are fun­da­men­tal dif­fer­ences in its clin­i­cal course, nat­ur­al his­to­ry, mol­e­c­u­lar sig­na­ture, and re­spon­sive­ness to stan­dard treat­ments that make it dis­tinct from syn­ovial sar­co­ma. As we ex­pect da­ta from our oth­er tri­als with our whol­ly owned as­sets through­out 2018, these re­sults in a sec­ond sol­id tu­mor strength­en our con­vic­tion that our pipeline of unique TCRs will be ca­pa­ble of ad­dress­ing mul­ti­ple sol­id tu­mors.

Glax­o­SmithK­line $GSK is in the process of bring­ing this pro­gram in-house af­ter pick­ing up its op­tion in a deal that could be worth $61 mil­lion to Adap­ti­m­mune just through the tran­si­tion phase.

This TCR tech re­volves around reengi­neer­ing T-cell re­cep­tors so that they can rec­og­nize can­cer pro­teins, trig­ger­ing an as­sault on sol­id and liq­uid tu­mors. GSK’s move is part of a new of­fen­sive on the on­col­o­gy front as CEO Em­ma Walm­s­ley looks to re­vive a mori­bund R&D group.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

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In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

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Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

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In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

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Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

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Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.