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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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