On the heels of ma­jor Pfiz­er deal, Arv­inas snags $55M Se­ries C for pro­tein degra­da­tion can­cer pro­grams

Af­ter ink­ing two ma­jor deals with Big Phar­mas tack­ling the in­creas­ing­ly hot path of pro­tein degra­da­tion ear­li­er this year, Yale spin­out Arv­inas has scored a $55 mil­lion round of fund­ing to take two of its can­cer pro­grams through the clin­ic.

The cash came in a Se­ries C round led by on­col­o­gy-fo­cused fund Nex­tech In­vest, which is new to Arv­inas’ line­up of fi­nan­cial back­ers. Oth­er new in­vestors Deer­field Man­age­ment, Hill­house Cap­i­tal and Sirona Cap­i­tal joined the round, along with a slew of re­peats.

John Hous­ton

Arv­inas is a bit of a pi­o­neer in a new modal­i­ty called pro­tein degra­da­tion, an area pick­ing up steam in the in­dus­try. The sci­en­tif­ic con­cept is sim­ple enough. Where pro­tein in­hi­bi­tion has led to some ad­vanced med­i­cines, de­grad­ing pro­teins could prove a much more durable so­lu­tion.

Specif­i­cal­ly, Arv­inas plans to tag cer­tain dis­ease-caus­ing pro­teins for de­struc­tion by re­cruit­ing an E3 lig­ase to the tar­get, there­by send­ing the pro­tein to the cell’s nat­ur­al “garbage dis­pos­al” called the ubiq­ui­tin-pro­tea­some sys­tem.

Arv­inas’ CEO John Hous­ton tells me the plat­form, in the­o­ry, could be wide­ly ap­plic­a­ble to sev­er­al dis­eases.

“We’re not lim­it­ed by dis­ease area, as al­most any dis­ease with a cell you want to de­grade could be tar­get­ed,” Hous­ton said.

Hous­ton says Arv­inas was the first to take the con­cept be­yond acad­e­mia, but the sci­ence has since gained pop­u­lar­i­ty, with com­pa­nies like C4 Ther­a­peu­tics and Kymera jump­ing on board. Even ma­jor phar­mas like Cel­gene, Take­da, GSK and No­var­tis have ef­forts in the space.

In Jan­u­ary, Arv­inas scored a dis­cov­ery deal with Pfiz­er to hunt for a slate of small mol­e­cules that can de­grade pro­teins. Al­though the com­pa­nies were sparse on de­tails of the deal (in­clud­ing up­front pay­ment amounts and tar­gets), we do know the over­all pack­et of mile­stones adds up to $830 mil­lion for un­bri­dled suc­cess.

Arv­inas has signed two oth­er ma­jor al­liances with mar­quee phar­mas, ink­ing deals with Genen­tech and Mer­ck ear­li­er. And Genen­tech came back last No­vem­ber to dou­ble down on that re­la­tion­ship, push­ing the mile­stones up to $650 mil­lion.

This new round of in­vest­ment cap­i­tal will take Arv­inas’ new­ly ap­point­ed pro­grams —  which tar­get the an­dro­gen and es­tro­gen re­cep­tors for prostate and breast can­cers — through the clin­ic, the com­pa­ny said.

“This past year has been ex­cit­ing for us with two clin­i­cal can­di­date nom­i­na­tions, the ex­pan­sion of our col­lab­o­ra­tion with Genen­tech and the an­nounce­ment of a new col­lab­o­ra­tion with Pfiz­er,” Hous­ton said. “With this ad­di­tion­al fi­nan­cial sup­port from ex­ist­ing and new in­vestors who be­lieve in our in­no­v­a­tive pro­tein degra­da­tion plat­form, we will con­tin­ue ex­e­cut­ing on our strat­e­gy of pro­gress­ing our lead pro­grams to the clin­ic, ex­pand­ing the use of the plat­form out­side of on­col­o­gy, and tack­ling un­drug­gable tar­gets.”

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.