Bahija Jallal (Source: MedImmune)

Wood­ford who? TCR-fo­cused Im­muno­core sol­diers on with $130M+ B round

Im­muno­core — once a dar­ling of the now-dis­graced Neil Wood­ford — is shak­ing off its past by rais­ing more than $130 mil­lion in a Se­ries B haul.

The Ox­ford­shire, UK-based com­pa­ny, which launched in 2015 to ad­vance its T cell re­cep­tor (TCR) tech­nol­o­gy with a mam­moth $320 mil­lion round, was soon glo­ri­fied with a val­u­a­tion of near­ly $1 bil­lion (£800m). That uni­corn sta­tus proved to be its Achilles heel, trig­ger­ing an ex­o­dus of top man­age­ment in re­cent years as po­ten­tial in­vestors balked at the old val­u­a­tion.

Bahi­ja Jal­lal, for­mer pres­i­dent of the now-de­funct Med­Im­mune unit at As­traZeneca, took over the reins as CEO in ear­ly 2019, promis­ing to steady the ship.

“I be­lieve for what we promised to de­liv­er, the fund­ing is ad­e­quate for that,” Jal­lal told End­points News.

Im­muno­core, which counts Genen­tech, GSK, As­traZeneca, Eli Lil­ly, and the Bill and Melin­da Gates Foun­da­tion as part­ners, has three com­pounds be­ing test­ed in hu­mans (in­clud­ing tebenta­fusp, which is in a piv­otal melanoma study) and plans to shep­herd two more in­to the clin­ic this year, she said.

The new round comes as the in­dus­try’s ap­petite for TCR ther­a­pies is bur­geon­ing. One of the key com­po­nents of the im­mune sys­tem are T cells, which oblit­er­ate aber­rant 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. TCR tech typ­i­cal­ly in­volves reengi­neer­ing T cell re­cep­tors so that they can bet­ter rec­og­nize can­cer pro­teins, spark­ing an as­sault on tu­mors.

Im­muno­core’s in-house TCR tech­nol­o­gy has spawned bis­pecifics de­signed to over­come the lim­i­ta­tions of oth­er im­munol­o­gy agents by com­bin­ing a TCR to tar­get and rec­og­nize can­cer, in­fect­ed or au­toim­mune cells and an ef­fec­tor func­tion to ac­ti­vate (for can­cer and in­fec­tious dis­eases) or sup­press (for au­toim­mune dis­eases) the im­mune sys­tem.

One of the at­trib­ut­es of the tech­nol­o­gy is hav­ing ac­cess to any pro­tein that is processed by the body, in­clud­ing the in­tra­cel­lu­lar pro­teins that can­not be ad­dressed by mon­o­clon­al an­ti­bod­ies, Jal­lal not­ed.

“You see the suc­cess of the check­point in­hibitors in can­cer, but they’re still ad­dress­ing on­ly the anti­gen-spe­cif­ic T cells,” she said. “Our tech­nol­o­gy can bring any T cells and ren­der them, if you will, killer cells to kill the tu­mor cells.”

This B round was led by Gen­er­al At­lantic, with par­tic­i­pa­tion of old stake­hold­ers Eli Lil­ly and RTW In­vest­ments and new in­vestors CCB In­ter­na­tion­al, JDRF T1D Fund, Rock Springs Cap­i­tal, Ter­ra Mag­num Cap­i­tal Part­ners and WuXi AppTec’s Cor­po­rate Ven­ture Fund. The Tele­graph had re­port­ed in Sep­tem­ber that New York-based Gen­er­al At­lantic had com­mit­ted an ini­tial £60 mil­lion to what was shap­ing up to be a £100 mil­lion round.

Jal­lal would not com­ment on a time­line, but said an IPO re­mains one of Im­muno­core’s op­tions go­ing for­ward.

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.

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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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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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.

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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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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

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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