Choon-Peng Ng, ImmunoScape CEO

TCR up­start gets fresh fund­ing as it looks to charge to­ward the clin­ic

While sev­er­al com­pa­nies have been find­ing suc­cess in the TCR-T cell ther­a­py space — with In­tel­lia hav­ing its treat­ment ac­cept­ed by the FDA last year — an­oth­er com­pa­ny is us­ing ma­chine learn­ing to get in on the ac­tion and find a can­di­date to bring to­ward the clin­ic.

Im­munoScape, a biotech based in Sin­ga­pore and Cal­i­for­nia, has raised $14 mil­lion in a fresh round of fi­nanc­ing. The com­pa­ny it­self was found­ed in 2016 as a spin­out from the Sin­ga­pore-based Agency for Sci­ence, Tech­nol­o­gy and Re­search, set­ting up its US op­er­a­tions in San Diego in 2020.

In an in­ter­view with End­points News, Im­munoScape CEO Choon-Peng Ng said the up­start is fo­cused on the dis­cov­ery and even­tu­al de­vel­op­ment of TCR-T cell ther­a­pies in the on­col­o­gy space, with a fo­cus on sol­id tu­mors. Im­munoScape us­es a ma­chine learn­ing-based tech­nol­o­gy plat­form that an­a­lyzes da­ta from its lab to in­ves­ti­gate and even­tu­al­ly de­vel­op TCR-T cell ther­a­pies.

While the com­pa­ny has not un­veiled the de­tails of its ther­a­pies just yet, Ng not­ed that it does have some tar­gets iden­ti­fied and is cen­ter­ing on treat­ments re­lat­ed to breast can­cer, prostate and lung can­cer. He said that Im­munoScape will choose its as­sets and in­sert them in­to the pipeline by the end of the year, with the biotech plan­ning to have an IND filed by 2024.

The $14 mil­lion raise will be go­ing to­ward ex­pe­dit­ing de­vel­op­ment ef­forts and get­ting a can­di­date clos­er to the clin­ic. To date, Im­munoScape has man­aged to raise $41 mil­lion in to­tal through oth­er fundrais­ing ef­forts, in­clud­ing $14 mil­lion last year. Ng said that he would not rule out any fu­ture fund­ing, and while he does rec­og­nize that the IPO can be tough to nav­i­gate cur­rent­ly, he said that the com­pa­ny will be keep­ing its eye on the mar­ket.

As for the im­me­di­ate fu­ture, Peng Ng told End­points that, apart from pur­su­ing its IND, they will al­so be hop­ing to part­ner with oth­er groups and com­pa­nies that may have an in­ter­est to de­vel­op its as­sets.

“At the end of the day, (it’s) ful­fill­ing the mis­sion in bring­ing as many of these nov­el ther­a­peu­tics to the clin­ic. And we rec­og­nize that we are a small team, and we want to do the best we can for what we can man­age,” he said.

Ng al­so not­ed that Im­munoScape is sep­a­rat­ing it­self from the pack due to its ma­chine learn­ing tech­nol­o­gy that can dis­cov­er tar­gets at scale and screen hun­dreds of epi­topes. Al­so, by dis­cov­er­ing nat­u­ral­ly oc­cur­ring TCR anti­gens, Ng be­lieves that this will give the com­pa­ny’s ther­a­pies a more pos­i­tive safe­ty pro­file.

Anzu Part­ners led the round, with Am­gen Ven­tures and Sin­ga­pore-based ED­BI al­so par­tic­i­pat­ing.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.