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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

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Carson Block. Muddy Waters via YouTube

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