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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Paul Hudson, Sanofi CEO (Photographer: Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

Sanofi chief executive Paul Hudson told investors earlier this year that the Big Pharma was going to emphasize its sales kingpin Dupixent moving forward.

He wasn’t joking — the megablockbuster drug and sales king, recording just shy of $2 billion in sales this past quarter, has now officially secured its fifth indication from the FDA.

Sanofi and Regeneron, who jointly work on Dupixent development and commercialization, announced the new development on Thursday, saying that the FDA gave the all-clear to Dupixent to treat patients with prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch — and also visualized by hard, extremely itchy bumps known as nodules that form on the skin. The FDA noted in its announcement that it is the agency’s first approval for the disease.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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