Robin Li, Baidu CEO, at the World Artificial Intelligence Conference (WAIC) in Shanghai, July 9, 2020 (Zhai Huiyong, Imaginechina via AP Images)

As Chi­na's tech gi­ants catch on­to biotech, Baidu plots $2B start­up fo­cused on di­ag­no­sis, AI drug dis­cov­ery

When Chi­na’s biggest search en­gine builder for­ays in­to biotech, ex­pect it to move in large strides.

Baidu is re­port­ed­ly scout­ing around for in­vestors to col­lec­tive­ly put $2 bil­lion be­hind a biotech start­up that would lever­age its ar­ti­fi­cial in­tel­li­gence tech­nolo­gies in dis­ease di­ag­no­sis and drug dis­cov­ery — fol­low­ing in the foot­steps of Amer­i­can tech gi­ants while join­ing its Chi­nese coun­ter­parts in mak­ing health­care in­vest­ments.

The goal is not to be a con­trol­ling share­hold­er, ac­cord­ing to in­sid­ers who told Reuters about the plan. CN­BC lat­er con­firmed the dis­cus­sions, re­port­ing that the start­up will like­ly be a stand­alone com­pa­ny rather than a sub­sidiary.

CEO Robin Li is per­son­al­ly in­volved in the project, sources said, the idea for which first came about six months ago.

Baidu isn’t com­ing in en­tire­ly un­in­formed. Through its ven­ture arm, it has in­vest­ed in AI star­tups such as Atom­wise and In­sil­i­co, as well as di­ag­nos­tic play­er Po­laris Bi­ol­o­gy and T cell ther­a­py de­vel­op­er Root­Path.

At the peak of the coro­n­avirus pan­dem­ic in Chi­na back in Feb­ru­ary, Baidu al­so open-sourced its RNA pre­dic­tion al­go­rithm Lin­ear­Fold in hopes of help­ing front­line re­searchers bet­ter un­der­stand how SARS-CoV-2 is spread­ing. It promised to re­duce over­all analy­sis time from 55 min­utes to 27 sec­onds, or 120 times faster.

Al­though Al­iba­ba and Ten­cent have backed health­care ven­tures, they have his­tor­i­cal­ly fo­cused on telemed­i­cine, med­ical im­age analy­sis, drug dis­tri­b­u­tion and even in­sur­ance, aid­ing R&D on­ly in­di­rect­ly through their tools.

In con­trast, Google par­ent Al­pha­bet has launched a whole sub­sidiary — Ver­i­ly — ded­i­cat­ed to life sci­ence re­search. Google it­self has al­lied with Sanofi in a pact sim­i­lar to what Mi­crosoft inked with No­var­tis, where the tech ti­tans lend their com­pu­ta­tion­al pow­ers to solve the phar­ma gi­ants’ most press­ing chal­lenges.

But the pan­dem­ic has ev­i­dent­ly pushed bio­phar­ma to the top of Chi­nese tech ex­ec­u­tives’ agen­das. Ten­cent launched its own AI drug dis­cov­ery plat­form in Ju­ly called iDrug, and Baidu an­nounced one month lat­er that it will be open­ing up two new labs fo­cused on bio­sta­tis­tics and biosafe­ty.

The yet-to-be-named new start­up is ex­pect­ed to ma­te­ri­al­ize with­in the next three years.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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