Con­stel­la­tion joins the mega-round club with $100M raise and plans to pur­sue can­cer stud­ies

Af­ter keep­ing a fair­ly low pro­file for the past few years, Con­stel­la­tion Phar­ma­ceu­ti­cals is step­ping in­to the spot­light this morn­ing, join­ing the megaround club in biotech with a broad­ened syn­di­cate of crossover in­vestors that fits the pro­file for com­pa­nies groom­ing them­selves for an IPO.

Adding in a $48 mil­lion round the com­pa­ny brought in at the end of 2016 — but didn’t spot­light — along with a $100 mil­lion round to­day, CEO Ji­gar Raythatha tells me that the com­pa­ny has now raised a to­tal of $280 mil­lion since launch­ing 10 years ago. And the sto­ry the com­pa­ny is telling now cen­ters con­sid­er­ably on a pair of ear­ly-stage can­cer stud­ies.

The biotech start­ed a Phase Ib/II study of CPI-1205, an EZH2 in­hibitor com­bined with Yer­voy, that they hope will high­light their po­ten­tial in epi­ge­net­ics, di­al­ing down gene ex­pres­sion in can­cer path­ways to en­hance im­muno-on­col­o­gy drugs that have be­come all the rage these days.  The same drug is al­so in an ear­ly study to see if it can boost the ef­fec­tive­ness of Zyti­ga and Xtan­di in prostate can­cer. And their BET drug is look­ing for proof-of-con­cept da­ta for myelofi­bro­sis.

Kei­th Dionne

Raythatha stepped in to take the helm of the Third Rock start­up a year ago af­ter a stint on the BD side of things at Jounce. He took the place of Kei­th Dionne, who went to Third Rock as an en­tre­pre­neur-in-res­i­dence in­cu­bat­ing new biotechs not long af­ter Genen­tech dropped a buy­out op­tion.

The new CEO says there are no “firm plans” for go­ing pub­lic, some­thing that the pre­vi­ous team dis­cussed sev­er­al years ago, but the syn­di­cate that has now pumped in $100 mil­lion for the 10-year-old com­pa­ny brings along the kind of fi­nan­cial mus­cle need­ed to boost a com­pa­ny up to the pub­lic stage.

New in­vestors in­clude Cor­morant As­set Man­age­ment, Deer­field Man­age­ment, Fi­deli­ty Man­age­ment and Re­search Com­pa­ny, Hill­house Cap­i­tal, NS In­vest­ment, Or­biMed, Sirona Cap­i­tal, and Ven­rock Health­care Part­ners. Cur­rent in­vestors: The Col­umn Group, Third Rock Ven­tures, Ven­rock, SROne, Uni­ver­si­ty of Cal­i­for­nia In­vest­ment Of­fice, Top­spin Part­ners, and Cas­din Cap­i­tal.

Pol­ish­ing their I/O cre­den­tials al­so fits the pic­ture of a biotech look­ing to go pub­lic. And Con­stel­la­tion has been a long time mak­ing clin­i­cal plans.

“As you em­bark on var­i­ous busi­ness ven­tures there are twists and turns, and cer­tain­ly we’ve had out share,” the CEO tells me. When he came on board in ear­ly 2017, he adds, there was some need to think through the biotech’s strate­gic po­si­tion­ing, and re­or­ga­nize the team run­ning the com­pa­ny. Now he says he has plen­ty of time to think through things like an IPO.

What kind of an op­er­at­ing run­way does $100 mil­lion get you these days?

Raythatha isn’t say­ing. 

A decade in at Con­stel­la­tion, you still just get a peek at what’s go­ing on be­hind the big cur­tain.

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.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

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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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.