Next-gen CAR-T, TCR play­er Au­to­lus gains $80M for clin­i­cal tri­al work

Mar­tin Pule

Au­to­lus has gone back to the well to draw up an $80 mil­lion C round de­signed to push the next-gen CAR-T play­er through a key test for its three lead pro­grams.

While look­ing to even­tu­al­ly leapfrog the lead­ing pi­o­neers like No­var­tis, which achieved the first OK for CAR-T just months ago, Au­to­lus has its sights set on es­tab­lish­ing proof-of-con­cept da­ta on three pro­grams: AU­TO2 in mul­ti­ple myelo­ma, AU­TO3 in dif­fuse large B cell lym­phoma and pe­di­atric acute lym­phoblas­tic leukemia and AU­TO4 in T-cell lym­phoma.

The first CAR-Ts have es­tab­lished some jaw-drop­ping re­sults in blood can­cers, but sol­id tu­mors re­main a big chal­lenge. Au­to­lus is one of a num­ber of up­start biotechs that think bet­ter tech­nol­o­gy — like its pat­tern recog­ni­tion tech — can make for a much bet­ter CAR-T or T cell re­cep­tor ther­a­py per­son­al­ized for each pa­tient. These new cell ther­a­pies, they be­lieve, will al­low the field to start treat­ing sol­id tu­mors while al­so im­prov­ing new stan­dards of care in hema­to­log­i­cal ma­lig­nan­cies.

It’s a big bet, with lots at stake as on­col­o­gy re­mains the sin­gle biggest field in biotech for VCs in­vest­ing in R&D.

Chris­t­ian Itin

Cor­morant As­set Man­age­ment, Nex­tech In­vest and oth­er new in­vestors joined found­ing in­vestor Syn­cona, Wood­ford In­vest­ment Man­age­ment and Ar­ix Bio­science in the round.

Au­to­lus was spun out of the lab of Mar­tin Pule at Uni­ver­si­ty Col­lege Lon­don. Years ago Pule got a chance to help with some of the pi­o­neer­ing re­search go­ing in­to reengi­neer­ing T cells in­to can­cer ther­a­pies at Mal­colm Bren­ner’s lab at Bay­lor Uni­ver­si­ty in Texas. And now the three-year-old com­pa­ny has raised a to­tal of $185 mil­lion to test what it hopes will be a safer ap­proach to au­tol­o­gous T cell ther­a­pies (which are ex­tract­ed from pa­tients, en­gi­neered and then in­ject­ed) for hema­to­log­i­cal and sol­id tu­mors.

CEO Chris­t­ian Itin — who ran Mi­cromet up un­til its sale — had this to say:

Since our in­cep­tion three years ago, Au­to­lus has made sub­stan­tial progress with two dual tar­get­ing pro­grams in three clin­i­cal stud­ies, a nov­el pro­gram for T-cell lym­phoma’s clin­ic ready and a unique suite of cell pro­gram­ming tech­nolo­gies es­tab­lished for use in haema­to­log­i­cal and sol­id can­cers. With the new fi­nanc­ing we are well on our way to build­ing a pre­mier ful­ly in­te­grat­ed On­col­o­gy Com­pa­ny that har­ness­es the unique pow­er of T cells to com­bat can­cer.

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.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

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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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

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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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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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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)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

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.