Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveX­is team is mov­ing quick­ly in Dal­las.

Three months ago, they launched Taysha with $30 mil­lion in Se­ries A fund­ing and a pipeline of gene ther­a­pies out of UT South­west­ern. Now, they’ve an­nounced an over­sub­scribed $95 mil­lion Se­ries B. And the biotech is de­clin­ing all in­ter­view re­quests on the news, the kind of broad si­lence that can in­di­cate an IPO is in the pipeline.

Biotechs, in­clud­ing those rel­a­tive­ly fresh off launch, have been go­ing pub­lic at a fren­zy since the pan­dem­ic be­gan. In­vestors have showed a will­ing­ness to put up­wards of $200 mil­lion to com­pa­nies that have yet to bring a drug in­to the clin­ic. Still, if Taysha were to go pub­lic in the near fu­ture, it would be per­haps the short­est path from launch to IPO in re­cent biotech mem­o­ry.

Taysha launched in April as the brain­child of for­mer AveX­is CEO Sean Nolan and for­mer AveX­is cor­po­rate strat­e­gy chief RA Ses­sion II, who now serve as Taysha’s chair­man and CEO, re­spec­tive­ly. The idea was to tap in­to a line of AAV9 vec­tor gene ther­a­pies that were be­ing de­vel­oped at UT South­west­ern, par­tic­u­lar­ly from the labs of Steven Gray and Berge Mi­nass­ian. The group al­ready had 50 trans­la­tion­al sci­en­tists at work and a GMP fa­cil­i­ty.

The biotech would take a port­fo­lio ap­proach to gene ther­a­py, akin to the one pur­sued by Bridge­Bio (where Ses­sion had been CBO of gene ther­a­py). They li­censed 15 gene ther­a­pies in epilep­sy, neu­rode­vel­op­ment and neu­rode­gen­er­a­tive dis­or­ders, with an op­tion to li­cense 4 more. The com­pa­ny pur­sued new tech­nolo­gies that can be built on top of AAV9, in­clud­ing bi­cistron­ic plas­mids (a vec­tor with 2 genes in­stead of 1), mi­croR­NA knock­down (a method to in­hib­it the tiny strands of RNA that con­trol gene ex­pres­sion), and re­dos­ing.

When they launched, Taysha said they planned to clin­i­cal stud­ies on a gene ther­a­py for Tay-Sachs dis­ease and then file three more INDs in 2021. De­spite the pan­dem­ic, the com­pa­ny said they are still on track for that plan.

Gene ther­a­py tri­als, of course, can cost a fair bit of cash. And the com­pa­ny said that it hopes to even­tu­al­ly con­struct its own com­mer­cial scale pro­duc­tion site in Dal­las – a prospect that per­haps could come soon­er rather than lat­er.

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.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

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.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

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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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

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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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.