Next-gen T cell play­er TCR2 Ther­a­peu­tics sets stage for $100M-plus IPO as MP­M's Baeuer­le caps pro­lif­ic year

Patrick Baeuer­le

Patrick Baeuer­le has been busy. Right af­ter steer­ing next-gen BiTE com­pa­ny Har­poon Ther­a­peu­tics to­ward an IPO, the MPM part­ner and im­mu­nol­o­gist is shep­herd­ing an­oth­er on­col­o­gy com­pa­ny with pre­clin­i­cal as­sets — TCR2 Ther­a­peu­tics — in­to a pub­lic list­ing. And this time the biotech is look­ing for $100 mil­lion-plus in a mar­ket that’s been on a wild roller coast­er ride.

The im­munother­a­py com­pa­ny is de­vel­op­ing next-gen T-cell drugs for can­cer in an ef­fort to con­front lim­i­ta­tions posed by cur­rent T-cell and CAR-T ther­a­pies in sol­id tu­mors.

Robert Hofmeis­ter

One of the key com­po­nents of the im­mune sys­tem are T cells, which oblit­er­ate can­cer cells by us­ing T cell re­cep­tor (TCR) recog­ni­tion of cell sur­face mark­ers known as anti­gens. When a T cell rec­og­nizes a tu­mor anti­gen via the TCR, it snuffs the ma­lig­nant cell on which it re­sides. Ex­ist­ing T cell ther­a­pies for can­cer, in­clud­ing CAR-T cells and en­gi­neered TCR-T cells, at­tempt to repli­cate this mech­a­nism.

The drug de­vel­op­er’s tech­nol­o­gy — called TRuC-T cells — is de­signed to rec­og­nize and kill can­cer cells by har­ness­ing the TCR sig­nal­ing com­plex, un­like CAR-T for in­stance, which on­ly taps in­to a part of the TCR struc­ture. In con­trast to ex­ist­ing T cell ther­a­pies, the TCR2 tech­nol­o­gy is fash­ioned such that it could be used across pa­tients that ex­press the can­cer sur­face anti­gen ir­re­spec­tive of hu­man leuko­cyte anti­gens (HLA) sub­type, which could po­ten­tial­ly ad­dress a larg­er group of pa­tients.

The com­pa­ny has 5 drugs in its ar­se­nal. Its lead can­di­date — TC-210 — is be­ing de­vel­oped to tar­get mesothe­lin-pos­i­tive sol­id tu­mors. An ap­pli­ca­tion to test the drug in hu­mans was sub­mit­ted in De­cem­ber and the com­pa­ny ex­pects to con­duct a Phase I/II study ear­ly in 2019, and even­tu­al­ly ap­ply for the FDA’s fast track sta­tus. Its sec­ond drug, TC-110, is be­ing eval­u­at­ed for CD19-pos­i­tive B-cell hema­to­log­i­cal ma­lig­nan­cies. An IND is ex­pect­ed to be filed in the sec­ond half of 2019 and the com­pa­ny will al­so seek a fast track des­ig­na­tion for this as­set.  The rest — TC-220, TC-310 and TC-410 — are in ear­li­er stages of pre­clin­i­cal de­vel­op­ment.

Al­fon­so Quin­tás Car­dama

TCRwill have two ex­pe­ri­enced sci­en­tif­ic minds work­ing on their pipeline in the clin­ic: Robert Hofmeis­ter, who de­vel­oped one of the first PD-L1 in­hibitors — Baven­cio — while at EMD Serono, will serve as CSO, while Al­fon­so Quin­tás Car­dama, who was piv­otal in the ap­proval process for one of the two li­censed T cell ther­a­pies for hema­to­log­i­cal ma­lig­nan­cies — No­var­tis’ Kym­ri­ah — will serve as CMO.

The com­pa­ny will be list­ed on the Nas­daq un­der the sym­bol $TCRR, ac­cord­ing to the S-1 post­ed last week. TCRwas found­ed by Baeuer­le, a part­ner at MPM who pre­vi­ous­ly served as CSO at Mi­cromet be­fore it was swal­lowed by Am­gen. Baeuer­le was ush­ered in­to Am­gen — where R&D was then run by Roger Perl­mut­ter — fol­low­ing the buy­out, to help take Mi­cromet’s Blin­cy­to across the fin­ish line.

Mitchell Fin­er

TCR2 al­so worked close­ly with Mitchell Fin­er, an MPM Cap­i­tal ex­ec­u­tive part­ner who has decades of cell ther­a­py man­u­fac­tur­ing ex­pe­ri­ence, in­clud­ing the de­sign of GMP process­es for blue­bird bio and Cell Genesys. Over­all, just un­der half of the 30 com­pa­nies MPM has in­vest­ed in are on­col­o­gy-fo­cused.

So far, TCR2  has raised rough­ly $170 mil­lion from in­vestors, in­clud­ing MPM Cap­i­tal, F2 Ven­tures, Di­men­sions Cap­i­tal, Ar­row­Mark Part­ners, Cathay For­tune Cap­i­tal, Cu­ra­tive Ven­tures, Hill­house Cap­i­tal Group, Mi­rae­As­set Fi­nan­cial Group and Red­mile Group. Pri­or to the IPO, MPM has the biggest hold­ing with a 19.18% stake, and F2 is a run­ner up with a 15.97% stake.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.