With eyes set on the future of cell therapy, researchers are looking to leverage a growing menagerie of immune cells to engineer a better generation of tumor fighters. One type showing early promise is gamma delta T cells, and now another biotech in that space is trotting out promising — if limited — results.
Three acute myeloid leukemia patients dosed with IN8bio’s off-the-shelf gamma delta T cells remained in remission after a stem cell transplant as long as 20 months after receiving their cells, offering an early vote of confidence for the small biotech’s approach, the company said Thursday.
The three patients were still in remission at 20 months, 18 months and around six months after dosing, IN8bio said. About 50% of patients with post-transplant, high-risk AML relapse within the first year, the company said in a release.
Gamma delta T cells are the latest in drug developers’ efforts to engineer members of the innate immune system to fight stubborn cancers without the onerous safety profile of current-generation T cell therapies. Off-the-shelf, or allogeneic, therapies are engineered from donor cells rather than autologous therapies, which are derived from a patient’s own.
Because this program, dubbed INB-100, relies on donor cells, IN8bio is keeping a close eye on graft-versus-host disease, and the early results look promising. There were no treatment-related Grade 3 events or higher, including serious cases of GVHD 100 days after infusion, and no cytokine release syndrome or neurotoxicity events were reported.
Gamma delta T cells, rare cells that bridge the gap in function between the innate and adaptive immune system, have earned researchers’ interest due to their regulatory and cancer-fighting properties as well as a lack of alpha and beta T cell receptors, which drive GVHD, potentially cracking open more promise as allogeneic therapies. Promising data cuts like these have only helped drive even more investment into this space.
Earlier this month, Adicet, another player here, rolled out early data showing its own off-the-shelf candidate AD-001 posted two complete responses across four patients in an early Phase I study testing the drug in patients with heavily pretreated B cell non-Hodgkin’s lymphoma. Adicet engineered AD-001 with a CD20-targeting chimeric antigen receptor (CAR) onto donor cells.
At a low dose of 30 million cells, one patient posted a complete response with another seeing a partial response, which Adicet described as a ‘near CR.’ A third evaluable patient progressed and two other patients in the low-dose arm of the study dropped out before the 28-day mark.
Unlike IN8bio, which genetically modifies donors’ cells to be resistant to chemotherapy, Adicet doesn’t genetically engineer, cutting away the potential for unwanted mutagenesis, which may have sidelined allo cell therapy player Allogene’s lead program earlier this year.
Acepodia, meanwhile, has plans to file an IND for its own CD20-targeting CAR gamma delta T cell later this month. And in October, Takeda acquired GammaDelta Therapeutics, which is developing what it calls allogeneic variable delta 1 (VD1) gamma delta T cells that entered the clinic this summer.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Eli Lilly, Gilead, Thermo Fisher and other industry groups and nonprofits like BIO and USP are seeking some slight changes and more clarity from the International Council of Harmonisation on its new guidance related to continuous manufacturing.
The guidance, known as Q13, focuses on continuous manufacturing and its potential to lower manufacturing costs and reduce the physical footprint of manufacturing facilities compared to traditional batch manufacturing, according to USP. Continuous manufacturing also may improve quality control, lower the variability in manufactured products, and provide enhanced flexibility in production quantity and utilization of manufacturing lines.
Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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For the first time, Biogen released details Thursday on how it intends to prove that its by turns celebrated and maligned drug Aduhelm can actually slow the decline of patients with Alzheimer’s, as required by the FDA.
The biotech said it will launch a global 1,300-person trial next May that will randomize early-stage Alzheimer’s patients to receive either Aduhelm or placebo. It will probably take about four years for the trial to generate results, the company said, pushing a final answer to 2026.
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Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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https://endpts.com/in8bios-off-the-shelf-gamma-delta-t-cells-stave-off-relapse-for-high-risk-leukemia-patients-in-very-early-data-cut/
