Ex-Al­ler­gan CEO David Py­ott backs a biotech start­up along­side Take­da, PhI tri­al set to launch

David Py­ott has a new gig to add to his post-Al­ler­gan CV. Py­ott and Take­da co-led a $13 mil­lion start­up round for Bion­iz, an Irvine, CA-based de­vel­op­er which just had its first IND ap­proved.

David Py­ott

Bion­iz is build­ing a pep­tide plat­form based on block­ing par­tic­u­lar cy­tokines that can trig­ger dis­ease. It has two lead pro­grams, BNZ-1 and BNZ-2, with two com­plete­ly dif­fer­ent dis­ease tar­gets. BNZ-1 is aimed at HTLV-1 As­so­ci­at­ed Myelopa­thy (HAM), an or­phan dis­ease, and for cer­tain T-cell leukemias. The pre­clin­i­cal BNZ-2 tar­gets cy­tokines IL15/IL21 for celi­ac dis­ease and oth­er im­muno-in­flam­ma­to­ry dis­or­ders in the GI tract.

Py­ott is tak­ing the chair­man’s post for him­self while Na­zli Az­i­mi takes the CEO’s role. Az­i­mi worked on cy­tokine re­search at the NIH and lat­er moved on to the fac­ul­ty of the pres­ti­gious Fred Hutchin­son Can­cer Re­search Cen­ter, where she spe­cial­ized in the her­pes virus.

The high-pro­file Py­ott blazed a wide trail for him­self dur­ing the 17 years he helmed Al­ler­gan. But his am­bi­tions to con­tin­ue to grow the com­pa­ny ran in­to a hos­tile bid from Valeant. In the end, Brent Saun­ders ap­peared as the white knight in that deal, grab­bing the com­pa­ny and in­te­grat­ing it in­to his own glob­al net­work.

Small is now big in bio­phar­ma. Like a num­ber of ex-CEOs, Py­ott is find­ing plen­ty of op­por­tu­ni­ties to work with biotech star­tups. Ex-Gen­zyme CEO Hen­ri Ter­meer is a key play­er in the Boston/Cam­bridge start­up hub, while ex-Sanofi CEO Chris Viehbach­er is run­ning an in­vest­ment group, and ex-Pfiz­er CEO Jeff Kindler runs his own shop.

Joe Kiani and Co­ta Cap­i­tal con­tributed to the round for Bion­iz.

Bion­iz’s Az­i­mi had this to say in a state­ment this morn­ing:

This fi­nanc­ing is an im­por­tant step need­ed to dri­ve the de­vel­op­ment of new po­ten­tial treat­ments for pa­tients af­fect­ed by very se­ri­ous cy­tokine-dri­ven dis­eases. The ac­cep­tance of the BNZ-1 IND is a great ac­com­plish­ment by our team and we are ex­cit­ed to col­lab­o­rate with the NIH on the clin­i­cal ad­vance­ment of this pro­gram.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Luisa Salter-Cid, Pioneering Medicines CSO (Credit: Bristol Myers Squibb via Twitter)

Luisa Salter-Cid joins long­time Bris­tol My­ers col­lab­o­ra­tor Paul Bion­di at Flag­ship's new drug brew­ery

Paul Biondi is gaining a familiar research chief at his corner of Flagship Pioneering.

The ambitious VC — famous for bold platform plays such as Moderna — said Luisa Salter-Cid is joining Pioneering Medicines as CSO, with the mandate of leveraging the platforms of various Flagship portfolio companies to conceive new treatments.

The two had crossed paths at Bristol Myers Squibb, where Biondi brought in a series of new drugs throughout his prolific business development stretch while Salter-Cid worked her way up the ladder to become head of immunology, small molecule immuno-oncology and genomics discovery.

Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Money is flying for companies promising to revolutionize the way clinical trials are conducted. Leaps by Bayer is the latest to get behind one of these players, leading a $200 million venture round for Huma Therapeutics and its digital “hospital at home” tech.

London-based Huma unveiled a $130 million Series C on Wednesday, which it will use to expand its digital platform in the US, Asia and the Middle East. As part of the round, the company can exercise another $70 million commitment later on.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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