Te­va calls off CGRP drug dis­cov­ery and de­vel­op­ment pact, re­turns pre­clin­i­cal as­set to So­sei

A strug­gling Te­va has pulled out of a CGRP mi­graine drug dis­cov­ery and de­vel­op­ment pact with the G pro­tein cou­pled re­cep­tor ex­perts at So­sei, just as the lead can­di­date looks ready to start clin­i­cal de­vel­op­ment.

Mal­colm Weir

That re­turns the world­wide rights to HTL0022562 to So­sei’s UK sub­sidiary Hep­tares Ther­a­peu­tics, which plans to re­view the pro­grams be­fore up­dat­ing the time frame of the drug’s en­try in­to Phase I clin­i­cal tri­als, orig­i­nal­ly ex­pect­ed in late 2018. Te­va — which at­trib­uted the move to­day to its on­go­ing repri­or­i­ti­za­tion ef­fort on the pipeline — is al­so hand­ing over all the pre­clin­i­cal da­ta it gen­er­at­ed, as well as all li­cens­ing rights re­lat­ing to any CGRP an­tag­o­nist pro­grams cov­ered by the ini­tial agree­ment.

The ex-part­ners inked the agree­ment back in 2015, lay­ing down $10 mil­lion up­front and $400 mil­lion in mile­stones. Then CSO Michael Hay­den said small-mol­e­cule CGRP an­tag­o­nists are “high­ly com­ple­men­tary” to TEV-48125, or fre­manezum­ab, an an­ti-CGRP an­ti­body.

But now Hay­den is gone, and Te­va hit a road­block last month with fre­manezum­ab when its man­u­fac­tur­er ran in­to is­sues with the FDA. A de­layed launch would put Te­va be­hind some se­ri­ous­ly com­pet­i­tive ri­vals, in­clud­ing both big phar­ma (Am­gen/No­var­tis, Eli Lil­ly) and small biotechs like Alder.

So­sei, mean­while, seems up­beat about the prospect of the drug now back in its hands. Here’s So­sei’s chief R&D of­fi­cer and Hep­tares co-founder, Mal­colm Weir:

Thanks to this ex­cel­lent work by the com­bined teams un­der the al­liance, and fol­low­ing the re­turn of the as­sets, we are now well po­si­tioned to rapid­ly progress HTL0022562 in­to the clin­ic as part of our whol­ly-owned pipeline. HTL0022562 has very in­ter­est­ing and dif­fer­en­ti­at­ed prop­er­ties com­pared to oth­er small mol­e­cule and an­ti­body an­tag­o­nists, and we look for­ward to con­tin­u­ing its de­vel­op­ment.

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.

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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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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