Paul Bolno, Wave Life Sciences CEO

Take­da, Wave Life Sci­ences re­vise their $230M R&D col­lab­o­ra­tion, drop­ping dis­cov­ery work

Three years af­ter Take­da paid a hefty down pay­ment on a re­search col­lab with Wave Life Sci­ences, the two part­ners have re­vised the pact.

The Cam­bridge biotech an­nounced a re­vi­sion to its deal with Take­da yes­ter­day — end­ing their al­liance on dis­cov­ery work. As part of the amend­ment, Take­da will pay Wave more than $22 mil­lion for re­search and pre­clin­i­cal ex­pens­es from the col­lab­o­ra­tion.

Back in 2018, Cam­bridge, MA-based Wave en­tered a mega-deal with Take­da. The deal was two-fold: Wave gave Take­da the op­tion to co-de­vel­op and co-com­mer­cial­ize pro­grams in Hunt­ing­ton’s dis­ease, amy­otroph­ic lat­er­al scle­ro­sis (ALS), fron­totem­po­ral de­men­tia, and spin­ocere­bel­lar atax­ia type 3. Take­da al­so had the right to li­cense sev­er­al of Wave’s pre­clin­i­cal pro­grams tar­get­ing CNS dis­or­ders, in­clud­ing Alzheimer’s and Parkin­son’s.

Take­da paid Wave $110 mil­lion up­front and pur­chased $60 mil­lion of Wave’s shares at $54.70 per share, a pre­mi­um of $2 a share at the time. Take­da had al­so agreed to fund at least $60 mil­lion of Wave’s re­search over four years to ad­vance mul­ti­ple pre­clin­i­cal CNS tar­gets — picked by and li­censed to Take­da.

This an­nounce­ment comes sev­er­al months af­ter two of Wave’s ex­per­i­men­tal drug can­di­dates failed in clin­i­cal tri­als on Hunt­ing­ton’s dis­ease.

The change now al­lows Wave to ad­vance their pre­clin­i­cal CNS pro­grams them­selves, or en­ter part­ner­ships in the CNS field out­side of three tar­gets, which are part of the still on­go­ing late-stage col­lab­o­ra­tion be­tween Wave and Take­da: C9orf72, HTT and ATXN3.

The late-stage com­po­nent of the orig­i­nal col­lab­o­ra­tion re­mains the same as the 2018 deal. Take­da still holds the op­tion to co-de­vel­op and co-com­mer­cial­ize CNS ther­a­pies for those tar­gets. If Take­da de­cides to opt in on any of these pro­grams, Wave re­ceives an opt-in pay­ment and would take the lead on man­u­fac­tur­ing and joint clin­i­cal co-de­vel­op­ment ac­tiv­i­ties.

Take­da would then lead joint com­mer­cial ac­tiv­i­ties in the Unit­ed States and all com­mer­cial ac­tiv­i­ties out­side of the US. Glob­al costs and po­ten­tial prof­its would be split even­ly and Wave would be el­i­gi­ble for mile­stones.

Some of those pro­grams are now in on­go­ing clin­i­cal tri­als. One is in a Phase Ib/IIa tri­al for ALS and fron­totem­po­ral de­men­tia, and an­oth­er is in a Phase Ib/IIa tri­al for treat­ing Hunt­ing­ton’s dis­ease.

“This amend­ment stream­lines our ex­ist­ing col­lab­o­ra­tion with Take­da and im­me­di­ate­ly en­ables us to ad­vance or part­ner ear­ly-stage CNS pro­grams, out­side of the C9orf72, HTT, and ATXN3 tar­gets,” said Wave Life Sci­ences pres­i­dent and CEO Paul Bol­no in a pre­pared state­ment. “We look for­ward to con­tin­u­ing the part­ner­ship as we ad­vance our on­go­ing clin­i­cal pro­grams.”

Wave’s cash run­way is ex­pect­ed to last in­to Q2 of 2023, based on its ex­ist­ing cash and cash equiv­a­lents.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

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

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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