William Ho, IN8bio CEO

IN8bio's 'off-the-shelf' gam­ma delta T cells stave off re­lapse for high-risk leukemia pa­tients in very ear­ly da­ta cut

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.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.