Rahul Singhvi, Resilience CEO

Re­silience nets an­oth­er deal, this time with bil­lion­aire’s can­cer re­search cen­ter

Re­silience is hav­ing a fun week. Fresh off a $625 mil­lion Se­ries D and the launch of a joint ven­ture with MD An­der­son, the bio­man­u­fac­tur­er Re­silience has inked an­oth­er part­ner­ship with an in­flu­en­tial can­cer cen­ter.

Sean Park­er

Bil­lion­aire Nap­ster founder Sean Park­er’s Park­er In­sti­tute for Can­cer Im­munother­a­py (PI­CI) and Re­silience on Wednes­day cracked open a five-year strate­gic al­liance to de­vel­op and man­u­fac­ture can­cer ther­a­pies gen­er­at­ed from PI­CI’s net­work of im­munother­a­py re­search cen­ters.

The deal aims for PI­CI and Re­silience to bring nov­el cell and gene ther­a­pies to mar­ket through the cre­ation and in­cu­ba­tion of new com­pa­nies with a com­mit­ment of up to $50 mil­lion in fund­ing. The deal will lever­age tech­nolo­gies from across the PI­CI Net­work and have di­rect ac­cess to Re­silience’s bio­man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties.

“This strate­gic al­liance is rep­re­sen­ta­tive of the trans­for­ma­tive growth un­der­way at PI­CI as we take our vi­sion to the next lev­el with new com­pa­ny in­vest­ments and in­cu­ba­tion,” Park­er said in a state­ment.

The agree­ment will see Re­silience al­so col­lab­o­rat­ing with PI­CI in­ves­ti­ga­tors on chal­lenges re­lat­ed to bio­man­u­fac­tur­ing and nov­el treat­ment modal­i­ties. Re­silience will al­so serve as PI­CI’s first val­ued man­u­fac­tur­ing part­ner for com­plex modal­i­ties. It will al­so work with PI­CI-af­fil­i­at­ed part­ners.

Re­silience and PI­CI will es­tab­lish a joint steer­ing com­mit­tee to ap­prove in­vest­ments and new com­pa­ny op­por­tu­ni­ties, mon­i­tor and track the progress of al­liance port­fo­lio com­pa­nies, and iden­ti­fy chal­lenge fo­cus ar­eas, among oth­er du­ties.

This is not PI­CI’s first for­ay in­to forg­ing deals as it has pre­vi­ous­ly worked with biotechs like Xyphos Bio­sciences to de­vel­op a CAR-T ther­a­py. The or­ga­ni­za­tion has a slew of part­ner­ships and deals with com­pa­nies, uni­ver­si­ties and re­search or­ga­ni­za­tions since its found­ing in 2016.

Re­silience in the mean­time is rid­ing high on its new round of in­vest­ment to fur­ther its mis­sion of be­com­ing the “Fox­conn” of biotech, which was in­tend­ed to be used to build out more deals, po­ten­tial ac­qui­si­tions and R&D ex­pan­sion.

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.

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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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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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.

Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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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.

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.

Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.