For­mer No­vo chair­man Göran An­do joins the board as Tes­sa bags $50M in ad­di­tion­al fund­ing

As Tes­sa Ther­a­peu­tics preps a piv­otal late-stage tri­al read­out and ramps up clin­i­cal ac­tiv­i­ty for ear­ly-stage as­sets, it will be joined by a high pro­file board mem­ber as well as new in­vestors who just in­fused $50 mil­lion in­to the com­pa­ny.

Göran An­do

Göran An­do, the re­cent chair­man of No­vo Nordisk, is now an in­de­pen­dent di­rec­tor at Tes­sa. He joins a team that now has a whop­ping to­tal of $130 mil­lion to steer its virus-spe­cif­ic T cell tech­nol­o­gy-based prod­ucts to the mar­ket, in­clud­ing an $80 mil­lion raise from a sig­nif­i­cant group of Asian in­vestors an­nounced four months ago. Lead­ing that well-heeled pack was Temasek, the sov­er­eign wealth fund of Sin­ga­pore, where Tes­sa is based.

An­do was the CEO of Cell­tech be­fore it was ac­quired by UCB, and pri­or to that had served in R&D roles at Bris­tol-My­ers Squibb and Phar­ma­cia. Hav­ing sat on nu­mer­ous biotech boards, An­do says he’s drawn to Tes­sa’s unique ap­proach to T cell ther­a­py, “one of the most ex­cit­ing ar­eas in the health­care sec­tor to­day.”

Han Chong Toh

Root­ed in re­search work CSO John Con­nol­ly and CMO Han Chong Toh — of Bay­lor and the Na­tion­al Can­cer Cen­tre Sin­ga­pore, re­spec­tive­ly — Tes­sa adapts T cells to go af­ter vi­ral­ly-as­so­ci­at­ed tu­mors like cer­vi­cal and head and neck can­cer. That ap­proach, which promis­es to go be­yond some of the ground­break­ing suc­cess­es that CAR-T treat­ments have had in blood can­cers in­to sol­id tu­mors, has at­tract­ed a part­ner­ship with Park­er In­sti­tute for Can­cer Im­munother­a­py.

“Ob­vi­ous­ly there’s a lot of press and clin­i­cal da­ta and ex­cite­ment around CAR-T,” Fred Rams­dell, the vice pres­i­dent for re­search at the Park­er In­sti­tute, told End­points News at the time. “That’s great and won­der­ful. What Tes­sa is do­ing is a lot dif­fer­ent.”

John Con­nol­ly

A Phase III tri­al tar­get­ing Ep­stein-Barr Virus pos­i­tive na­sopha­ryn­geal can­cer is on­go­ing in the US and four Asian coun­tries, a pro­gram that came up with ex­cel­lent PhII da­ta when com­pared to his­tor­i­cal re­sults: two- and three-year sur­vival rates at 62.9% and 37.1%.

With the new round of fund­ing (the in­vestors were not dis­closed), the biotech will have plen­ty of cash to steer an HPV pro­gram for cer­vi­cal can­cer and oropha­ryn­geal can­cer in­to Phase II in 2019. Tes­sa has al­so been lin­ing up new tech on on­colyt­ic virus­es and chimeric anti­gen re­cep­tors for its next-gen work, which would bring them in­to liv­er and lung can­cers.

“Com­bined with the ad­di­tion­al fund­ing we have raised by ex­pand­ing our re­cent fund­ing round, I feel that we are now at a key mo­ment in our jour­ney as an im­por­tant play­er in the de­vel­op­ment of cel­lu­lar im­munother­a­py, and we are de­light­ed that Dr. An­do is join­ing us at this ex­cit­ing stage,” said CEO An­drew Khoo in a state­ment.

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.

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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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.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

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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