Al­lied with Genen­tech and Pfiz­er on dis­cov­ery deals, pro­tein degra­da­tion crew at Arv­inas looks for $100M IPO ahead of PhI start

The next wave of biotech IPOs is start­ing to swell to­day as the pro­tein degra­da­tion crew at Arv­inas jumps in with a $100 mil­lion of­fer­ing. And once again we’re see­ing a dis­cov­ery com­pa­ny go­ing ear­ly — with their first Phase I pro­gram still out ahead.

Arv­inas gained a con­sid­er­able amount of at­ten­tion for two deals with Genen­tech and Pfiz­er, which we now know came with a rel­a­tive­ly small up­front and big back end num­bers.

John Hous­ton

The big Roche sub­sidiary stepped up first in 2015, then re­jigged their deal in 2017. Genen­tech can tap up to 10 tar­gets in the dis­cov­ery al­liance, which was worth $11 mil­lion to get start­ed and an­oth­er $34.5 mil­lion pay­day to ex­tend last year. And there’s $156 mil­lion in col­lec­tive mile­stones for each tar­get — should it go all the way in­to the mar­ket.

Pfiz­er is in for less. The phar­ma gi­ant hand­ed over $28 mil­lion to get start­ed and com­mit­ted up to $775 mil­lion in de­vel­op­ment and com­mer­cial mile­stones for the pack­age. That an­swers one of the unan­swered ques­tions from Arv­inas’ days as a pri­vate start­up.

Pro­tein degra­da­tion has be­come a hot field in on­col­o­gy, as new com­pa­nies look to do bet­ter than the orig­i­nal set of ther­a­pies that have hit the mar­ket. In Arv­inas’ case, CEO John Hous­ton has been go­ing af­ter prostate can­cer and breast can­cer, with their first Phase I for the lead prostate can­cer ther­a­py lin­ing up for a start in ear­ly 2019.

Craig Crews

Arv­inas is by no means play­ing so­lo in the sec­ond-gen pro­tein degra­da­tion field. Ri­vals to the pro­tein degra­da­tion ti­tle in­clude C4 Ther­a­peu­tics — out of Jay Brad­ner’s lab at Dana Far­ber be­fore he took the helm at NI­BR — and the start­up Kymera. And not sur­pris­ing­ly, Brad­ner — who now runs NI­BR — re­cent­ly forged a close re­la­tion­ship with UC San Fran­cis­co on pro­tein degra­da­tion as well.

They’re look­ing to use an E3 lig­ase to dis­patch tar­get pro­teins through the cell’s nat­ur­al “garbage dis­pos­al” called the ubiq­ui­tin-pro­tea­some sys­tem, knock­ing them en­tire­ly out of the pic­ture and do­ing a much bet­ter job than what you get from mere pro­tein in­hi­bi­tion.

5AM and Canaan have the biggest stakes in the com­pa­ny, at 18.5% each. Craig Crews, who pro­vid­ed the sci­en­tif­ic in­sights from his Yale lab, has 8.9% while RA Cap­i­tal is in for 8%, Or­biMed has 6% and Nex­tech V On­col­o­gy is down for 5%. CEO Hous­ton has a 4.5% batch of stock.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Chris Kim, Liminatus Pharma CEO

A fledg­ling biotech goes SPAC route to bankroll can­cer vac­cine, CAR-T and CD47

A relatively unknown clinical-stage biotech — backed by a Korean lighting company and focused on a cancer vaccine out of a Thomas Jefferson University lab — is headed to Nasdaq via the blank check route.

Liminatus Pharma will get about $316 million in proceeds from the SPAC combination to fund its ongoing Phase IIa study of a cancer vaccine, bring a CAR-T therapy into the clinic and prep a CD47 immune checkpoint inhibitor for human trials, the company said this week.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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