PACT Phar­ma bags $75M for neoanti­gen TCR work, man­u­fac­tur­ing; Bay­er grabs ex­per­i­men­tal con­tra­cep­tive from Daré

→ With a new pres­i­dent and chief tech­ni­cal of­fi­cer in place, next-gen T cell ther­a­py play­er PACT Phar­ma has $75 mil­lion in fresh fi­nanc­ing to ex­pand the scope of its nascent clin­i­cal pro­grams and open its own man­u­fac­tur­ing fa­cil­i­ty in South San Fran­cis­co. By iso­lat­ing spe­cif­ic neoanti­gen re­cep­tors in pa­tients that ap­pear to be dri­ving an im­mune re­sponse, PACT promis­es to tack­le some of the tough­est sol­id tu­mors pre­vi­ous­ly im­pen­e­tra­ble to cell ther­a­pies. Vi­da Ven­tures, which has close ties to promi­nent cell ther­a­py biotechs such as Kite and Al­lo­gene, led the Se­ries C round. CTO Tim Moore, who jumped from Kite last Oc­to­ber, will su­per­vise ef­forts to au­to­mate some pro­duc­tion and an­a­lyt­ics process “to re­duce cy­cle time and man­u­fac­tur­ing costs.”

→ Large CRO Charles Riv­er is en­ter­ing a mul­ti-year drug dis­cov­ery col­lab­o­ra­tion with Take­da, fo­cus­ing on four ar­eas the Japan­ese drug­mak­er cham­pi­ons — on­col­o­gy, gas­troen­terol­o­gy, neu­ro­science and rare dis­ease. Un­der the deal, Charles Riv­er gets an undis­closed up­front fee from Take­da, and is el­i­gi­ble to re­ceive de­vel­op­ment pay­ments of up to $50 mil­lion per can­di­date as well as po­ten­tial com­mer­cial mile­stones of up to $120 mil­lion plus roy­al­ties on launched prod­ucts.

Bay­er has inked a li­cens­ing agree­ment with Daré Bio­science for com­mer­cial­iza­tion rights of an in­ves­ti­ga­tion­al hor­mone-free month­ly vagi­nal con­tra­cep­tive, Ovaprene, in the US. San Diego-based Daré will re­ceive an undis­closed up­front and $20 mil­lion if Bay­er de­cides to ex­er­cise its op­tion, plus mile­stones that add up to $310 mil­lion. The biotech ex­pects to launch a piv­otal study in the sec­ond half of 2020.

→ Af­ter tout­ing in­ter­im Phase II re­sults on its lead COPD drug last March, Verona Phar­ma has chalked up an­oth­er win in the next stage. The com­pa­ny re­port­ed pos­i­tive da­ta in the 4-week Phase IIb study eval­u­at­ing neb­u­lized en­sifen­trine (0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg) or place­bo as an add-on treat­ment to tiotropi­um (Spiri­va Respi­mat), a long-act­ing an­ti-mus­carinic (“LAMA”) bron­chodila­tor mar­ket­ed by Boehringer In­gel­heim. The pri­ma­ry end­point was met at all dos­es, with sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in lung func­tion at week 4.

Al­lo­gene and Spring­Works Ther­a­peu­tics — two not­ed star­tups de­vel­op­ing port­fo­lios of drugs flow­ing from Pfiz­er are team­ing up to eval­u­ate Al­lo­gene’s BC­MA Al­lo­CAR T ther­a­py, AL­LO-715, in com­bi­na­tion with Spring­Works’ gam­ma sec­re­tase in­hibitor (GSI), nirogace­s­tat, in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. Un­der the terms of agree­ment, Al­lo­gene will spon­sor and con­duct the Phase I study — which is ex­pect­ed to com­mence in the sec­ond half of 2020.

→ Back in No­vem­ber 2018, Eli Lil­ly showed their faith in NextCure by drop­ping $40 mil­lion in up­front and eq­ui­ty cash. Now, Lil­ly is ter­mi­nat­ing the deal, ef­fec­tive as of March 3, 2020.

→ For his lat­est com­pa­ny cre­ation, Vivek Ra­maswamy is look to serve the peo­ple who serve drug­mak­ers. Loka­vant’s stat­ed goal is to cen­tral­ize da­ta from over 1,000 tri­als “to pow­er a ma­chine learn­ing mod­el that an­tic­i­pates tri­al risk, pro­vides risk mit­i­ga­tion strate­gies, and pre­dicts the im­pact of mit­i­ga­tion strat­e­gy im­ple­men­ta­tion. Rhit Nam­bisan, head of dig­i­tal prod­uct at Roivant, will serve as pres­i­dent. The new com­pa­ny has al­so en­tered its first mul­ti-year en­ter­prise li­cense agree­ment with Parex­el, which re­cent­ly inked a re­al world ev­i­dence pact with an­oth­er Roivant sub­sidiary, Data­vant.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.