The gam­ma delta T cell gam­bit in­spires a small Lon­don biotech start­up with big ideas

If you run through the whole gamut of cell ther­a­pies be­ing worked on in can­cer re­search these days, gam­ma delta T cells aren’t like­ly to fig­ure promi­nent­ly in your re­view. But for years now Adri­an Hay­day, who runs labs at The Fran­cis Crick In­sti­tute and King’s Col­lege Lon­don, has been fas­ci­nat­ed by their un­usu­al abil­i­ty to pen­e­trate in­to tis­sue, mak­ing them po­ten­tial ther­a­peu­tic can­di­dates.

And now, with the ex­plo­sion of im­muno-on­col­o­gy re­search work, some mar­quee re­search play­ers have set out to take Hay­day’s work — along with con­tri­bu­tions by Oliv­er Nuss­baumer — in­to the clin­ic, seed­ing a start­up which will now nav­i­gate its way through about 18 months of pre­clin­i­cal work iden­ti­fy­ing a lead pro­gram that can be tak­en in­to a hu­man study.

The start­up, ap­pro­pri­ate­ly dubbed Gam­maDelta Ther­a­peu­tics, is be­ing helmed by Raj Mehta from Can­cer Re­search Tech­nol­o­gy, who’s tak­ing a break from his busi­ness de­vel­op­ment role to act as the in­ter­im CEO of a small band of staffers, in league with Hay­day’s big lab, to start piec­ing to­geth­er all the ear­ly-stage work need­ed to get their work to the thresh­old of Phase I. CRT, along with King’s Col­lege and The Crick, are pro­vid­ing as­sis­tance. Tim Haines, the man­ag­ing part­ner at Abing­worth’s Lon­don of­fice, is con­tribut­ing seed cash and in­cu­bat­ing the com­pa­ny.

What’s the big idea? It’s very sim­ple.

Gam­ma delta T cells “have the po­ten­tial to in­vade tis­sue and be bet­ter at in­vad­ing tu­mors,” Mehta tells me. And that makes it a po­ten­tial ground­break­er in all the im­muno-on­col­o­gy work now go­ing on glob­al­ly.

Where the check­point ther­a­pies like Keytru­da and Op­di­vo re­quire an en­vi­ron­ment with a heavy mu­ta­tion load to be ef­fec­tive, gam­ma delta cells – at least in the pre­clin­i­cal work — don’t. And where CAR-Ts — T cells which have been reengi­neered with chimeric anti­gen re­cep­tors — have proved promis­ing ini­tial­ly in blood can­cers, it’s been a chal­lenge get­ting them in­to tu­mors. (And, yes, there’s a lot of work be­ing done to fix that.)

Gam­ma delta cells, though, have the es­sen­tial prop­er­ties to get in­side tu­mors to do their work. Al­so, these cells ev­i­dent­ly aren’t heav­i­ly in­flu­enced by reg­u­la­to­ry T cells, mak­ing them good can­di­dates for sol­id tu­mors with high con­cen­tra­tions of Tregs.

One of the biggest chal­lenges faced by the fledg­ling biotech, says Mehta, will be fig­ur­ing out the CMC side of things. These ther­a­pies won’t be very valu­able if they aren’t po­tent, durable and fair­ly straight­for­ward to make. But the team al­so has a big ad­van­tage: Lon­don has emerged as a glob­al hub for cell man­u­fac­tur­ing, mak­ing their job some­what eas­i­er on that score.

The em­pha­sis here is on the col­lab­o­ra­tion among the re­search in­sti­tutes, with the ven­ture back­ing from Haines’ ven­ture group. They’re not say­ing how much it is cost­ing at this point, but chances are it’s not the kind of fig­ure that would leap out at you with all the big num­bers be­ing thrown around biotech these days.

Mehta is fa­mil­iar with at least two oth­er Eu­ro­pean com­pa­nies that have been op­er­at­ing in this field. Lym­phact in Por­tu­gal is one. And there’s al­so Gade­ta, a Dutch biotech which just raised 7 mil­lion eu­ros in a round led by Medicxi Ven­tures. Gade­ta has been us­ing gam­ma delta T cell re­cep­tors to reengi­neer the more com­mon type of T cells.

Gam­maDelta has a dis­tance to trav­el be­fore it gets close to putting any­thing in­to Phase III. But in the in­tense I/O field right now, it will like­ly start at­tract­ing im­me­di­ate at­ten­tion from some key play­ers.

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

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Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Josh Bilenker, Endpoints JPM 2020

Josh Bilenker and Jeff En­gel­man bun­dle a moth­er lode of cash for their stealthy start­up, at­tract­ing a who's who of biotech in­vestors

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Late last week the pair filed a Form D for their new biotech Treeline Biosciences outlining a $212 million raise for their new company — which Bilenker founded around the time he ejected from his top position at Eli Lilly’s oncology group.

Their plan is to top out the raise at $220 million, but with Bilenker’s list of marquee investors on board for his latest creation, that won’t be much of a stretch.

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Cynthia Butitta (L) and Joe Jimenez

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

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Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.