For­bion leads $62.5M round for neu­ro start­up as ex-Te­va R&D chief takes con­trol; CSL Behring inks gene ther­a­py pact in im­munol­o­gy

For­bion has led a $62.5 mil­lion round for Prile­nia Ther­a­peu­tics to fund two late-stage tri­als in Hunt­ing­ton’s dis­ease and amy­otroph­ic lat­er­al scle­ro­sis. Michael Hay­den, the for­mer Te­va R&D chief who’s been serv­ing as chair­man, will now take over as CEO to over­see the pro­gram for pri­do­pi­dine, which ag­o­nizes the sig­ma-1 re­cep­tor (S1R). Morn­ing­side and Sec­toral As­set Man­age­ment al­so joined, as did Tal­is­man Cap­i­tal Part­ners and Gen­works 2.

→ Aus­tralia’s CSL Behring is team­ing up with Seat­tle Chil­dren’s Re­search In­sti­tute to de­vel­op stem cell gene ther­a­pies for rare pri­ma­ry im­mun­od­e­fi­cien­cy dis­eases, start­ing with Wiskott-Aldrich Syn­drome and X-linked Agam­ma­glob­u­line­mia. They are among 400 pri­ma­ry im­mun­od­e­fi­cien­cy dis­eases, in which the hu­man im­mune sys­tem is dys­func­tion­al. “Ex­pand­ing our gene ther­a­py port­fo­lio in­to an area of im­munol­o­gy well known to CSL ex­em­pli­fies how we are strate­gi­cal­ly grow­ing our ca­pa­bil­i­ties in this strate­gic sci­en­tif­ic plat­form and are col­lab­o­rat­ing with world class in­sti­tu­tions to ac­cess in­no­va­tion with the po­ten­tial to vast­ly im­prove pa­tients’ lives,” not­ed CSL R&D chief Bill Mez­zan­otte.

Hy­loris Phar­ma­ceu­ti­cals, a Bel­gian com­pa­ny ded­i­cat­ed to re­for­mu­lat­ing well-known drugs, is look­ing to tap the pub­lic mar­ket by list­ing on Eu­ronext Brus­sels. “The IPO is ex­pect­ed to pro­vide us with the re­sources need­ed to fi­nance the de­vel­op­ment of our ex­ist­ing port­fo­lio of prod­uct can­di­dates, as well as es­tab­lish a com­mer­cial in­fra­struc­ture in the Unit­ed States for our IV Car­dio­vas­cu­lar port­fo­lio (ex­cl. So­talol IV, which is com­mer­cial­ized through a part­ner), where we will fo­cus on ad­dress­ing pre­scribers in a cost-ef­fi­cient man­ner by con­cen­trat­ing on spe­cial­ized care fa­cil­i­ties such as hos­pi­tals,” CEO Sti­jn Van Rompay said in a state­ment.

GHO Cap­i­tal has put the $1 bil­lion-plus fund it closed at the end of last year to use, buy­ing X-Chem from an af­fil­i­ate of The Car­lyle Group and Hell­man & Fried­man. The com­pa­ny spe­cial­izes in DNA-En­cod­ed Li­brary (DEL)-based dis­cov­ery ser­vices and has li­censed over 70 re­search pro­grams to bio­phar­ma part­ners over the years. Matt Clark, a co-founder and the cur­rent SVP of chem­istry, will re­place Rick Wag­n­er as CEO.

→ Dublin-based Avec­tas has en­list­ed Scott Si­mon’s lab at UC Davis to char­ac­ter­ize cells en­gi­neered on its plat­form, with the goal of in­form­ing the de­vel­op­ment of next-gen cell ther­a­pies. “A ma­jor fo­cus of our group is to un­der­stand how chem­i­cal and me­chan­i­cal forces act­ing on im­mune cells en­able them to lo­cal­ize at sites of in­flam­ma­tion,” Si­mon said in a state­ment. “The part­ner­ship with Avec­tas will help us eval­u­ate how these same forces play a role to de­liv­er­ing mR­NA and pro­teins to im­mune cells and there­by ex­tend their ther­a­peu­tic ap­pli­ca­tions.”

→ Ire­land’s Shorla Phar­ma has closed its Se­ries A at $8.3 mil­lion to ad­vance a slate of drugs for rare, or­phan and pe­di­atric can­cers. Ser­o­ba Life Sci­ences led the round, which fea­tured oth­er lo­cal in­vestors as well as fam­i­ly of­fices in Cana­da.

Chris­t­ian Anger­may­er, founder of the men­tal health and psy­che­delics biotech ATAI, is try­ing to bring the Aus­tralian biotech Bio­nom­ics and its PTSD drug back from the near-dead. Bio­nom­ic’s stock flat­lined to $0.04 af­ter the drug’s fail­ure in a Phase II tri­al, but the com­pa­ny, which has al­so part­nered with Mer­ck on Alzheimer’s, has since re­for­mu­lat­ed the drug, and Anger­may­er is bet­ting it might now work. His firm Ape­iron put down $5 mil­lion and un­der­wrote $15 mil­lion in fund­ing to put the com­pound back in­to tri­als.

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

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

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 of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

News brief­ing: HHS chas­tis­es Eli Lil­ly for end­ing some dis­counts in a pan­dem­ic; Gilead to pay $97 mil­lion to set­tle kick­back al­le­ga­tions

Gilead agreed to pay $97 million to settle allegations that it illegally used a charity to pay thousands of Medicare patients’ co-payments for its pulmonary arterial hypertension drug Letairis.

The US government claimed that between June 2007 and December 2010, Gilead $GILD used the Caring Voice Coalition as a conduit to cover the costs of just its own drug. The alleged behavior goes against the False Claims Act.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.