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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.