Peter Blume-Jensen, Acrivon Therapeutics CEO

Can a small band of bio­phar­ma play­ers suc­ceed where Eli Lil­ly failed? They’re tak­ing a shot

Eli Lil­ly didn’t try to spin any­thing about the mid-stage da­ta they got on their CHK1/CHK2 drug prex­as­ert­ib for ovar­i­an can­cer pa­tients. The drug failed to move the di­al in a sig­nif­i­cant fash­ion and they un­cer­e­mo­ni­ous­ly swept it right out of the pipeline a lit­tle more than 2 years ago.

Usu­al­ly, that would have been it, an­oth­er once-promis­ing drug that didn’t make the cut. We see it reg­u­lar­ly. But a small group of biotech play­ers has come to­geth­er to take an­oth­er crack at a piv­otal play on this drug. And they be­lieve they have the key to mak­ing a suc­cess of it.

Jes­per Olsen

They’re launch­ing their new biotech — Acrivon Ther­a­peu­tics, with ops in the Boston area and Lund, Swe­den — af­ter forg­ing an in-li­cens­ing deal for prex­as­ert­ib, swap­ping eq­ui­ty for Lil­ly’s rights to the drug. And they are show­cas­ing a new com­pan­ion di­ag­nos­tics plat­form tech­nol­o­gy with a big goal: us­ing pro­teomics to tri­an­gu­late a va­ri­ety of drug mech­a­nisms to the ac­tive dis­ease-dri­ving process­es of can­cer in pa­tients.

“We be­lieve it’s the next wave of pre­ci­sion med­i­cine. We have worked on ge­net­ics and us­ing ge­net­ics-based med­i­cines for 20 years and they work great when they do work,” CEO Pe­ter Blume-Jensen tells me. “But they are lim­it­ed. Ge­net­ic al­ter­ations most of­ten do not tell you ex­act­ly what’s go­ing on with the tar­get … We are try­ing to more di­rect­ly to mea­sure what are the dis­ease-dri­ving mech­a­nisms in the tu­mor.”

Blume-Jensen says they’ve iden­ti­fied 3 bio­mark­ers — he’s not of­fer­ing de­tails yet — that al­low them to iden­ti­fy the pa­tients most like­ly to re­spond to the treat­ment, bank­ing on the monother­a­py re­spons­es that Lil­ly has tracked to point them to a nar­row mar­ket niche where the drug can more re­li­ably work. And they be­lieve they have found 2 oth­er tu­mor types that can al­so work — which rounds out the bas­ket study that is now be­ing set up as they pur­sue the FDA’s ac­cel­er­at­ed ap­proval path­way.

Kristi­na Mas­son

It’s not a big play, at least not yet. Blume-Jensen says they’ve raised a lit­tle more than $20 mil­lion for the com­pa­ny, with more talks un­der­way with a syn­di­cate that in­cludes Chione, NEA, and Alexan­dria Ven­ture In­vest­ments. He and his in­vestors filed a Form D ear­li­er this year out­lin­ing a $15.5 mil­lion raise.

The com­pa­ny co-founder is Kristi­na Mas­son, who leads and runs the sub­sidiary out of Medicon Vil­lage, in Lund, Swe­den.

Jes­per Olsen, a pro­fes­sor at the No­vo-Nordisk Foun­da­tion Pro­tein In­sti­tute in Copen­hagen and an ex­pert in phos­pho­pro­teomics, is the aca­d­e­m­ic co-founder. The rough­ly 20-mem­ber team is led by Blume-Jensen, who’s worked in a va­ri­ety of roles in bio­phar­ma R&D, along with CMO Er­ick Gamelin and oth­ers.

They’re al­so not plan­ning on be­ing a one-hit biotech. Acrivon has al­so been build­ing a “pro­pri­etary pipeline of struc­ture-based drug pro­grams tar­get­ing crit­i­cal nodes in the DDR and cell cy­cle reg­u­la­tion.”

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.