Pete Salzmann. Immunovant

Vivek Ra­maswamy en­gi­neers new deal with RTW to take Pe­te Salz­man­n's Im­muno­vant pub­lic

Sev­er­al weeks af­ter pulling out of an IPO for Der­ma­vant, Vivek Ra­maswamy has found a dif­fer­ent route for an­oth­er of his biotechs to go pub­lic.

Vivek Ra­maswamy

Im­muno­vant is merg­ing with Health Sci­ences Ac­qui­si­tions Cor­po­ra­tion, a $115 mil­lion blank check com­pa­ny spon­sored by RTW In­vest­ments and backed by Adage Cap­i­tal, Cor­morant, Even­tide and Per­cep­tive Ad­vi­sors. In ad­di­tion to around $100 mil­lion con­firmed to be in the bank, RTW and Roivant, along­side BVF Part­ners, have put to­geth­er a $35 mil­lion pri­vate “bridge fi­nanc­ing.”

“We be­lieve IMVT-1401 is a unique­ly com­pelling as­set with­in the FcRn drug class, which we ex­pect will be­come a cor­ner­stone ther­a­py for treat­ing many au­to-an­ti­body dri­ven dis­eases,” said Rod­er­ick Wong, the chief in­vest­ment of­fi­cer of RTW, who took charge of HSAC, in a state­ment.

Wong will now step aside from the helm to make room for Im­muno­vant CEO Pe­te Salz­mann to run the com­bined en­ti­ty, of which cur­rent Im­muno­vant share­hold­ers will re­tain 77%. They may be award­ed more shares if the price goes up.

Rod­er­ick Wong RTW

The neona­tal Fc re­cep­tor (FcRn) tar­get is be­lieved to be im­pli­cat­ed in a range of IgG-me­di­at­ed au­toim­mune dis­eases. Im­muno­vant was found­ed last year af­ter li­cens­ing its lead com­pound — a sub­cu­ta­neous in­jec­tion — from South Ko­rea’s HanAll Bio­phar­ma.

Salz­mann, an Eli Lil­ly vet, has steered the drug through a Phase I pro­gram and kicked off Phase IIa tri­als for Graves’ oph­thal­mopa­thy and myas­the­nia gravis, both of which will be fund­ed by the trans­ac­tion. A third IND is planned for warm au­toim­mune he­molyt­ic ane­mia.

Im­muno­vant is the fourth pub­lic com­pa­ny among Roivant’s sub­sidiaries, a group that has grown to 20 — though on­ly 16 have been dis­closed, with the lat­est in­tro­duc­tion of Cy­to­vant. Ra­maswamy, who’s built his Vant em­pire on a web of deals, has man­aged to se­cure siz­able IPOs for Ax­o­vant, My­ovant and Urovant, though all their shares have slide sub­stan­tial­ly since re­spec­tive pub­lic de­buts.

Ex­ecs had orig­i­nal­ly pen­cilled in a $100 mil­lion IPO for Der­ma­vant, but af­ter post­pon­ing that plan once they of­fi­cial­ly with­drew the ap­pli­ca­tion on the same day Roivant an­nounced a sweep­ing $3 bil­lion deal with Sum­it­o­mo Dainip­pon Phar­ma that gives the Japan­ese phar­ma rights to at most 11 Vants (Der­ma­vant was not ex­plic­it­ly named).

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.