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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Nkarta CEO Paul Hastings at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Nkar­ta un­der­scores safe­ty of CAR-NK, boasts ear­ly re­spons­es

The first generation of personalized CAR-T therapies made big waves in the treatment of lymphoma for their stunning efficacy. Nkarta is hoping its off-the-shelf natural killer cell approach will stand out on safety — while keeping some of those impressive numbers on responses.

In a new update from its Phase I dose escalation study, the South San Francisco-based biotech reported that seven out of 10 patients treated with the highest doses of its NK cell therapy, NKX019, achieved a complete response, translating to a complete response rate of 70%.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.