Bil­lion­aire-backed Park­er In­sti­tute tack­les the Holy Grail of can­cer R&D — with a vir­tu­al un­known

Up un­til about 6 months ago, Fred Rams­dell, the vice pres­i­dent for re­search at the Park­er In­sti­tute for Can­cer Im­munother­a­py, had nev­er heard of Tes­sa Ther­a­peu­tics. But he and some of the top can­cer re­searchers as­so­ci­at­ed with the Park­er In­sti­tute’s far flung net­work of in­ves­ti­ga­tors have been mak­ing up for lost time.

Fred Rams­dell

The Park­er In­sti­tute — fund­ed by tech mogul Sean Park­er — is an­nounc­ing Mon­day that it is mak­ing a leap in­to next-gen adop­tive cell ther­a­pies for can­cer, join­ing with Sin­ga­pore-based Tes­sa. Their new biotech al­ly is now en­gaged in a Phase III tri­al that hopes to open a new chap­ter in the field, look­ing to share the spot­light with the lead­ers which have dom­i­nat­ed the im­munother­a­py are­na so far. And the part­ners have some big plans for the fu­ture.

“Ob­vi­ous­ly there’s a lot of press and clin­i­cal da­ta and ex­cite­ment around CAR-T,” says Rams­dell, the vice pres­i­dent for re­search at the Park­er In­sti­tute. “That’s great and won­der­ful. What Tes­sa is do­ing is a lot dif­fer­ent.”

In­stead of ex­tract­ing T cells and reengi­neer­ing them to hunt down and kill can­cer cells, a CAR-T ap­proach that re­quires ag­gres­sive man­age­ment of some se­vere re­ac­tions but with some re­mark­able re­sults for liq­uid can­cers, Tes­sa takes blood and ex­pands and adapts virus-spe­cif­ic T cells to tar­get vi­ral­ly-as­so­ci­at­ed tu­mors like cer­vi­cal and head and neck can­cer, swarm­ing the cells.

“As much as its tech­no­log­i­cal as­pect, it’s al­so a philo­soph­i­cal align­ment,” Rams­dell adds about the al­liance. “They have a very good sci­en­tif­ic un­der­pin­ning. They know what they’re do­ing; very well round­ed….You nev­er know, but it looks re­al­ly quite good.”

In this new col­lab­o­ra­tion, star im­munother­a­py spe­cial­ists like Phil Green­berg at the Fred Hutch and Crys­tal Mack­all of Stan­ford are be­ing brought in to work with Tes­sa’s re­search team, head­ed by Chief Sci­en­tif­ic Of­fi­cer John Con­nol­ly and CMO Han Chong Toh, the deputy di­rec­tor of the Na­tion­al Can­cer Cen­tre Sin­ga­pore and one of the top can­cer in­ves­ti­ga­tors in the re­gion. Oth­er in­ves­ti­ga­tors in the Park­er net­work can al­so pitch ideas on ad­vanc­ing the work, pos­si­bly even get­ting fund­ing for small proof-of-con­cept stud­ies to test their no­tions.

“In any col­lab­o­ra­tion,” says Rams­dell, “we can be the hub of that wheel and bring the dif­fer­ent ap­proach­es to­geth­er.”

That fits in per­fect­ly with Tes­sa’s strat­e­gy, Con­nol­ly tells me. The vet­er­an Bay­lor Col­lege of Med­i­cine in­ves­ti­ga­tor ran in­to Han Chong Toh — who had been at the Cen­ter for Cell and Gene Ther­a­py at Bay­lor Col­lege of Med­i­cine work­ing un­der found­ing di­rec­tor Mal­colm Bren­ner — af­ter he moved to Sin­ga­pore in 2010 to set up a lab.

John Con­nol­ly

Tes­sa’s Phase III will read out in 2018, says Con­nol­ly, giv­ing them a piv­otal chance to demon­strate how they can trans­form B cells with the Ep­stein-Barr virus, mov­ing be­yond ran­dom ac­ti­va­tion of T cells with chimeric anti­gen re­cep­tors to a po­ten­tial­ly much more tar­get­ed cell ther­a­py de­signed to con­tin­u­al­ly hunt down and kill spe­cif­ic can­cer cells. The HPV pro­gram can do the same for head and neck and oth­er can­cers. And when you start to mar­ry this ap­proach with oth­er im­munother­a­pies, you can start to vi­su­al­ize Tes­sa’s goal: elim­i­nat­ing sol­id tu­mors, the Holy Grail of cell ther­a­py.

Con­nol­ly and Han Chong Toh are di­rect­ing the late-stage pro­gram, sanc­tioned with the FDA’s fast track and or­phan drug des­ig­na­tions, which is be­ing con­duct­ed in 5 coun­tries with 29 sites.

Rams­dell was at­tract­ed by an ap­proach that should avoid off­site tox­i­c­i­ty. And with the nat­ur­al sig­nal­ing in­volved, he al­so be­lieves you’re more like­ly to cre­ate mem­o­ry cells that can keep up the at­tack — promis­ing a durable re­sponse.

“Tes­sa (with a base of IP in-li­censed from Bay­lor Col­lege of Med­i­cine) adds their own se­cret sauce of cy­tokines that ac­ti­vate in a par­tic­u­lar way for good killing and dura­bil­i­ty,” notes Rams­dell, help­ing avoid the risk of burn­ing the cells out, which hap­pens when you mul­ti­ply their num­bers.

The ear­ly re­sults “showed beau­ti­ful sur­vival da­ta,” says Con­nol­ly, which helped at­tract a line­up of fam­i­ly of­fices and high net worth in­vestors to back a biotech that now has a staff of about 130.

Tes­sa turned up at AS­CO in ear­ly June with Phase II da­ta on 35 pa­tients with rare cas­es of Stage 4c na­sopha­ryn­geal car­ci­no­ma, or NPC, as­so­ci­at­ed with Ep­stein-Barr virus. Their con­clu­sion:

The 2- and 3-year over­all sur­vival rates were 62.9% and 37.1% re­spec­tive­ly, which rep­re­sent the best re­port­ed sur­vival out­come for first-line treat­ment of ad­vanced NPC when com­pared to his­tor­i­cal clin­i­cal tri­als.

Tes­sa added that it has bio­mark­ers to iden­ti­fy which pa­tients are like­ly to ben­e­fit, the kind of strat­e­gy that the FDA prefers.

‘We’re very in­ter­est­ed in mov­ing CAR-T to next-gen as well, putting pay­loads in­to CAR-T, etcetera, etcetera,” says Rams­dell. “The par­al­lel here is that as you move in­to sol­id tu­mors, Tes­sa is more ad­vanced tech­ni­cal­ly, con­cep­tu­al­ly and philo­soph­i­cal­ly.”

Just a few months ago Tes­sa launched a col­lab­o­ra­tion with Rochester, MN-based Vyr­i­ad, which has clin­i­cal-stage on­colyt­ic virus­es that in­fect and de­stroy can­cer cells, but al­so use anti­gens to flag an im­mune sys­tem at­tack (one of a group of next-gen on­colyt­ics com­pa­nies look­ing to do T-Vec bet­ter. Tes­sa sees it as a match of syn­er­gis­tic tech­nolo­gies for fight­ing can­cer.

In March Tes­sa al­so bought out an­oth­er Sin­ga­pore start­up, Eu­chloe, which has been work­ing on a slate of an­ti­bod­ies, in­clud­ing PD-1, as well as chimeric anti­gen re­cep­tor tech­nolo­gies for next-gen CARs.

Tes­sa may just be still in the ear­ly stages of its de­but on the glob­al biotech scene. But with Asian biotechs tak­ing a more cen­tral role in drug de­vel­op­ment, it could al­ready be on the verge of do­ing some­thing big.

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.

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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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