Tri­umvi­ra snags $55M Se­ries A to guide TAC tech­nol­o­gy to the clin­ic

Tri­umvi­ra Im­muno­log­ics wants to bring its T-cell anti­gen cou­pler (TAC) tech­nol­o­gy to the clin­ic ear­ly next year, and it plans on rid­ing a $55 mil­lion Se­ries A to get there.

Paul Lam­mers

The Austin, TX-based biotech an­nounced the com­ple­tion of its fi­nanc­ing round on Thurs­day. And now pres­i­dent and CEO Paul Lam­mers says it’s “all hands on deck” to sub­mit an IND for the com­pa­ny’s HER2-di­rect­ed TAC for sol­id tu­mor pa­tients. Lam­mers hopes the TAC will be ready for hu­man test­ing in late Q1 of 2021.

The fund­ing “will give us a nice run­way to do a lot of fun stuff,” he said. The CEO helmed Mir­na Ther­a­peu­tics un­til a re­verse merg­er with Syn­log­ic in 2017.

Leaps by Bay­er and North­pond Ven­tures led the Se­ries A, and Ocean­pine Cap­i­tal, Vi­va Biotech Hold­ings, Bloom Bur­ton, and the Cen­tre for Com­mer­cial­iza­tion of Can­cer Im­munother­a­py joined in.

The com­pa­ny’s TAC tech is de­signed to ac­ti­vate can­cer-fight­ing T cells “in a nat­ur­al fash­ion,” Lam­mers said. “We tru­ly think that a nat­ur­al ac­ti­va­tion of the T cell is a step for­ward in T-cell ther­a­py, and that’s re­al­ly what we’re try­ing to ac­com­plish with our TAC T cell.”

When not in con­tact with can­cer cells, TAC T cells are to­tal­ly in­ac­tive — as op­posed to CAR-T cells which may be­come ex­haust­ed, Lam­mers said. Plus, the CEO said the TAC tech­nol­o­gy could be safer than cur­rent treat­ments.

“Be­cause of the risk of tox­i­c­i­ties, in fact, it’s on­ly a lim­it­ed num­ber of pa­tients that are el­i­gi­ble to re­ceive these kinds of CAR-T ther­a­pies to be­gin with. If we can ex­pand that pop­u­la­tion with a safer en­gi­neered T cell, that would be fan­tas­tic,” he said.

It’ll all come down to the hu­man stud­ies, which will ini­tial­ly in­clude a va­ri­ety of par­tic­i­pants, in­clud­ing gas­tric, ovar­i­an and breast can­cer pa­tients.

Juer­gen Eck­hardt

Tri­umvi­ra will al­so use Se­ries A fund­ing to de­vel­op its al­lo­gene­ic TAC, for which it hopes to sub­mit an IND at the end of next year. In No­vem­ber, the com­pa­ny re­ceived fast-track des­ig­na­tion from the FDA for its TAC01-CD19 as a po­ten­tial third-line ther­a­py for pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL). The com­pa­ny was set to be­gin a Phase I/II study by the end of 2019, but then the Covid-19 pan­dem­ic struck.

For now, Tri­umvi­ra is putting its CD19 TAC on the back burn­er to fo­cus on its sol­id tu­mors TAC.

“Sol­id tu­mors is where we think our biggest val­ue propo­si­tion is for in­vestors and for the com­pa­ny, and that’s re­al­ly some­thing that we’d like to ex­pand in the com­ing years,” Lam­mers said.

Juer­gen Eck­hardt, head of Leaps by Bay­er, said Tri­umvi­ra’s pipeline brings forth a “unique op­por­tu­ni­ty in the de­vel­op­ment of next-gen­er­a­tion cell ther­a­pies that promise to ad­dress pre­vi­ous­ly in­cur­able can­cers.” He and VP of ven­ture in­vest­ments Jak Knowles will join the biotech’s board of di­rec­tors.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Marc de Garidel, CinCor Pharma CEO (Eric Piermont/AFP via Getty Images)

Fol­low­ing the re­cent play­book, Cin­Cor rais­es $225M on back of pos­i­tive PhII read­out

On Monday, CinCor Pharma drummed up positive Phase II data for its hypertension drug baxdrostat, following it later that day with a public offering — as many other public biotechs with positive readouts have done with astounding frequency in the lukewarm market conditions.

The size of that raise? $225 million, CinCor said today in a press release. The biotech had originally proposed its public offering at six million shares, but said it was upsized to 7.5 million.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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