Article by Catherine Shaffer @ Precision Medicine Online
NEW YORK – Triumvira Immunologics on Monday said it began dosing patients in a Phase I/II trial or an autologous T-cell antigen coupler (TAC) therapy, TAC101-CLDN18.2, targeting claudin 18.2 (CLDN18.2)-positive solid tumors.
At the same time, in an effort to optimize finite resources, the Austin, Texas-based company has paused clinical development of its HER2-targeted TAC agent, TAC 100-HER1 (formerly TAC01-HER2), and is focusing instead on the CLDN18.2 program, said Robert Williamson, Triumvira’s president and chief operating officer.
BioSpace News Editor Greg Slabodkin gives his takeaways from this year’s J.P. Morgan Healthcare Conference. After a challenging 2023, the biopharma industry appears to be turning a corner, with excitement about an improved outlook for the sector. Certain areas in particular stood out, including cell and gene therapy, artificial intelligence (AI), neuroscience and GLP1. At the same time, attendees acknowledged several challenges that lay ahead, including policy considerations such as the ramifications of the Inflation Reduction Act on drug development.
“It’s not all downhill from here—significant hurdles still face the biopharma industry—but the sector feels invigorated to take on the challenge,” Slabodkin wrote. “Let the journey begin!”
Takeda Touts Promise of Latest Narcolepsy Candidate
Saftey issues may have quashed the development of Takeda’s earlier orexin candidate, but Elena Koundourakis says the company “bounced back big time.” Koundourakis, who leads the company’s orexin franchise, told BioSpace that the company quickly shifted its focus from the previous orexin candidate, TAK-994, to its latest orexin product, TAK-816, and will soon have results to share from an ongoing Phase II trial. “It has the potential to serve [an] unmet need in several indications,” Koundourakis said.
Executive Summary
The private US/Canadian firm is taking a singular approach to T-cell therapy to tackle both solid and liquid tumors and hopes to have early data to back up its novel technology this year. An IPO could follow.
The CAR T sector has been under the regulatory microscope since the FDA announced in late November 2023 that it was investigating 20 reports of T cell lymphoma in patients who had previously received CAR-T therapies. However, at least one cell therapy oncology company is not concerned.
At the 42nd J.P. Morgan Healthcare Conference, Triumvira Immunologics President and Chief Operating Officer Rob Williamson told BioSpace that internal discussions and those with other analysts and oncology-based cell therapy companies indicate the investigation is not a “big deal.” He was also adamant that it would not affect Triumvira and its business.
“(For) these patients, the risk-benefit is significantly in favor of the therapy,” Williamson said.
That is not to say that the CAR T industry has not had some rough times recently or that everything is sailing along smoothly.
“I think cell therapy within biotech is still in the penalty box,” Williamson said. He said cell therapy companies may continue to be seen less favorably than other biotechs during the next year, except for those who can differentiate themselves in showing value, good efficacy data or by targeting unmet needs. He said he is hopeful that cell therapy can get out of this penalty box, “but it’s a very crowded space.”
The last year has demonstrated that a sound financing strategy and compelling company narrative are essential to securing funding – it’s become more important than ever that investors are excited before taking the plunge. Given the current economic environment that is causing challenges in biopharma, how should companies be approaching funding in 2024?
Listen to this discussion on different kinds of funding options available, how companies can optimize their chances to secure funding and how they should be assessing VCs in addition to alternative partners – particularly if your company will be seeking funding at JPM this January. Our host and guests also discuss current challenges, how to weather adversity, and what investment trends are anticipated for next year.
First-in-human phase 0 imaging studies are also known as microdosing proof-of-concept studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of phase 0 studies include the administration of single subtherapeutic doses of the study drug to typically a small number of subjects to gather preliminary human in vivo data on pharmacokinetics, pharmacodynamics, and the target. They enable go/no-go decisions to be based on relevant human models instead of relying on animal data, which can be unpredictive and vary between species. A phase 0 study gives no data on safety or efficacy to cause any therapeutic effect and less risk to human toxicity (USFDA, CDER Guidance, August 2018).
The recent advancements and the great potential of Theranostics technology has allowed the utilization of radioimmune conjugates for diagnosis and treating various diseases in humans. To this end, the use of radiopharmaceutical drugs in phase 0 human studies and prior to early-phase human clinical trials are poised to become more mainstream and strategic regulatory guidance toward rapid, safer, cheaper, and more informed developmental decision in 2024 and beyond. GBI Biomanufacturing is a U.S.-based CDMO with about 20 years of experience and expertise in the radioimmune conjugate (and bioconjugation) arena.
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One-on-one with medical innovators
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us for a new conversation.
By no means should cyborgs be disparaged—even if they are very small. For instance, the cellular cyborgs that serve as living drugs should be accorded the utmost respect. The U.S. Food and Drug Administration (FDA) certainly thinks so. Since 2017, the agency has approved multiple cellular cyborgs—more commonly known as chimeric antigen receptor (CAR) T-cell therapies—for various blood cancers.
In these therapies, the patient’s own T cells are collected and genetically engineered so that they produce an artificial protein—the CAR—that will target specific antigens found on cancer cells. Once the cells are engineered, they are infused back into the patient.
Unlike the all-but-unstoppable cyborgs of science fiction, CAR T cells are, well, stoppable. For example, they have struggled against solid tumors. Consequently, some therapeutic developers have been exploring alternatives to CAR T cells. One such company is Alloplex Biotherapeutics. It claims to have a highly differentiated, nonengineered, cellular therapy platform with potentially broad antitumor activity across multiple tumor types.
This year’s predictions on the biopharma financing and funding environment are more optimistic than they were last year, with the persistent caveat of macroeconomic uncertainty, plus unresolved litigation on policy issues such as the Inflation Reduction Act. With deal activity increasing and the promise of novel product approvals in key therapeutic areas next year, however, small biotechs and (some) Big Pharmas appear poised to steer the industry into calmer waters. Business model creativity will become increasingly mandatory for companies marketing expensive products for small patient populations and larger population drugs in categories like obesity and CNS disorders.
From BioPharma Reporter
Triumvira Immunologics, a Texas-based clinical-stage company developing T cell therapeutics to treat patients with solid tumors, has announced that the first patient has been dosed in its phase 2 trial to treat gastric cancer.
