Black Di­a­mond dou­bles in val­ue hours in­to Nas­daq de­but, mark­ing hot start to the 2020 IPO run

There are few al­losteric ther­a­pies ap­proved, but in­vestors seem to like the idea — and the lat­est duo to pur­sue it.

Black Di­a­mond Ther­a­peu­tics, the young on­col­o­gy com­pa­ny from Tarce­va vets David Ep­stein and Eliz­a­beth Buck, opened its IPO yes­ter­day at $19 per share. By 11:15 am, it was up to $35 per share. And, with a slight rise in the last min­utes, it closed at $39.48. That’s a 108% in­crease on its open­ing ten­der. They col­lect­ed over $200 mil­lion.  The mar­ket cap dou­bled from around $670 mil­lion to $1.3 bil­lion.

On Fri­day, right on the heels of that quick coup, Ar­cutis Bio­ther­a­peu­tics priced its IPO at $17 — the top of the range. That of­fer­ing raised $159 mil­lion through the sale of 9.4 mil­lion shares. It’s start­ing out with a mar­ket val­ue of $657 mil­lion.

The end-of-week surge sug­gests that de­spite some head­winds in­vestors still want to get in ear­ly on what they deem the most promis­ing com­pa­nies, par­tic­u­lar­ly in on­col­o­gy. That bodes well for the start of the 2020 IPO sea­son and will like­ly in­spire oth­ers to jump in­to the game ear­ly — though there’s no way to pre­dict what will hap­pen down the road. The biotech IPO win­dow has been wide open for 5 years now, mark­ing a very long stretch.

Black Di­a­mond’s first-day gain dwarfed the mean for biotech IPOs. Since the start of 2019, they’ve risen on av­er­age 16% on day one and 60% over­all, ac­cord­ing to Re­nais­sance Cap­i­tal.

Black Di­a­mond had raised mon­ey rapid­ly in the pri­vate mar­kets as well. They were the first com­pa­ny to come out of Ver­sant’s Basel-based in­cu­ba­tor and launched with an ini­tial $20 mil­lion from the ven­ture firm. With­in a month of emerg­ing from stealth mode in De­cem­ber 2018, they an­nounced an $85 mil­lion Se­ries B fund­ing. Less than a year lat­er, they net­ted an­oth­er $85 mil­lion. They then im­me­di­ate­ly filed for an IPO.

Buck and Ep­stein are far from alone in pur­su­ing al­losteric ther­a­pies for can­cer and oth­er dis­eases. No­var­tis has a Phase I pro­gram for an al­losteric SHP2 in­hibitor, Rev­o­lu­tion Med­i­cines — now pur­su­ing its own $100 mil­lion IPO –  has an al­losteric SHP2 it li­censed from Sanofi for $50 mil­lion, and back in 2016, Gilead paid Nim­bus $40o mil­lion for fir­so­co­stat, an al­losteric in­hibitor for NASH. (Which did not per­form well last year).

Black Di­a­mond is be­hind those oth­er pro­grams. They have yet to en­ter the clin­ic.

In­vestors are large­ly bet­ting on their MAP plat­form, which works to map out al­losteric mu­ta­tions across the body. Al­losteric sites are grooves away from a pro­tein’s ac­tive bind­ing site but which can nev­er­the­less af­fect the bind­ing site and the pro­tein’s over­all func­tion. A mu­ta­tion there could af­fect the pro­tein’s func­tion, po­ten­tial­ly dri­ving cer­tain can­cers. Sci­en­tists have long known about these sites, but have strug­gled un­til re­cent­ly to find them.

A com­pa­ny with promis­ing map­ping soft­ware could have a sig­nif­i­cant leg up. An­oth­er biotech try­ing to do that, Hotspot Ther­a­peu­tics, launched in 2018 with a $45 mil­lion Se­ries A.

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.