News brief­ing: Ex­elix­is rolls the dice with 2 ADC deals tied to $35M cash up­fronts; A rare an­tibi­ot­ic win for promi­nent­ly-backed Spero

Pe­ter Lamb

Catal­ent’s Red­wood Bio­science sub­sidiary is tak­ing the lead role in de­vel­op­ing AD­Cs for Ex­elix­is $EX­EL. In one of 2 deals an­nounced this morn­ing, Ex­elix­is is turn­ing to Catal­ent to do the dis­cov­ery work on the AD­Cs, which will em­ploy their SMARTag site-spe­cif­ic bio­con­ju­ga­tion plat­form tech­nol­o­gy us­ing an­ti­bod­ies out of the biotech’s pipeline.

Catal­ent gets $10 mil­lion up­front to trig­ger the deal, with Ex­elix­is hold­ing world­wide de­vel­op­ment rights on any­thing it choos­es.

In a sep­a­rate ADC de­vel­op­ment deal, Ex­elix­is is turn­ing to NBE-Ther­a­peu­tics for an­oth­er pact that could steer more prod­uct can­di­dates its way. In this deal Ex­elix­is is pay­ing $25 mil­lion up­front to get a 2-year al­liance un­der­way.

“Ex­elix­is is pur­su­ing both in­ter­nal drug dis­cov­ery and ex­ter­nal busi­ness de­vel­op­ment ap­proach­es to build a pipeline with the po­ten­tial to make a dif­fer­ence for pa­tients with can­cer,” said Pe­ter Lamb, the CSO at Ex­elix­is. – John Car­roll

Spero her­alds Phase III an­tibi­ot­ic suc­cess

Back in the days when in­vestors thought there was still good busi­ness to be made in an­tibi­otics, Spero raised a fair bit of cap­i­tal: a $30 mil­lion Se­ries A and B led by At­las Ven­tures, a $51.7 mil­lion Se­ries C led by GV, and a $77 mil­lion IPO. In 2018, they re­ceived an up to $54 mil­lion con­tract with BAR­DA too.

The mar­ket for an­tibi­otics has since soured, but that cash has al­lowed Spero to get through Phase III with its lead drug. And on Tues­day they an­nounced pos­i­tive re­sults, show­ing in a 1,372-per­son study that their oral an­tibi­ot­ic tebipen­em was non-in­fe­ri­or to the ap­proved IV an­tibi­ot­ic er­tapen­em in treat­ing pa­tients with com­pli­cat­ed uri­nary tract in­fec­tions and acute pyelonephri­tis.

Ankit Ma­hade­via

The drug, said tri­al in­ves­ti­ga­tor Kei­th Kaye, will give cU­TI pa­tients a new oral op­tion af­ter evolv­ing mi­cro­bi­ot­ic re­sis­tance had left them with on­ly the IV drug.

“Due to the in­creas­ing preva­lence of an­tibi­ot­ic-re­sis­tant bac­te­ria, many pa­tients with cU­TI now re­ceive in­tra­venous an­tibi­otics as their on­ly avail­able treat­ment op­tion,” Kaye, who is al­so di­rec­tor of re­search in the di­vi­sion of in­fec­tious dis­eases at the Uni­ver­si­ty of Michi­gan Med­ical School, said in a state­ment. “The much-an­tic­i­pat­ed da­ta from this head-to-head com­par­i­son against an IV stan­dard-of-care car­bapen­em an­tibi­ot­ic sug­gest that in many in­stances oral, out­pa­tient treat­ment of these com­pli­cat­ed bac­te­r­i­al in­fec­tions is a vi­able op­tion.”

Spero CEO Ankit Ma­hade­via said it would be the first oral cU­TI drug ap­proved in 26 years. The com­pa­ny said it plans to start a rolling NDA and com­plete it by the sec­ond quar­ter of 2021.

An ap­proval would be a ma­jor boon to any biotech, but when it comes to an­tibi­otics, reg­u­la­to­ry suc­cess doesn’t nec­es­sar­i­ly trans­late in­to com­mer­cial suc­cess. Melin­ta and Achaoe­gen are well proof of that.  — Ja­son Mast

A UK biotech bro­kers an in­ter­con­ti­nen­tal AI deal

A UK-based biotech is buy­ing out­right a soft­ware de­vel­op­er in Brook­lyn, NY, in or­der to bring ar­ti­fi­cial in­tel­li­gence to its di­ag­nos­tics tools.

APIS As­say Tech­nolo­gies an­nounced the ac­qui­si­tion of Beoge­nomics on Fri­day, hop­ing to use da­ta-min­ing process­es to iden­ti­fy bio­mark­er tar­gets in on­col­o­gy, as well as in­flam­ma­to­ry, au­toim­mune and in­fec­tious dis­eases. The tech­nol­o­gy from Beoge­nomics, which has been de­vel­op­ing both on-prem and se­cure cloud-based da­ta analy­sis so­lu­tions, will help sup­port the launch of a new pro­pri­etary ser­vice line. APIS main­ly works in R&D and di­ag­nos­tics, de­vel­op­ing new tests for the pre­dic­tion, pre­ven­tion, and di­ag­no­sis of dis­ease from dis­cov­ery to reg­u­la­to­ry ap­proval.

The com­pa­ny’s busi­ness mod­el fo­cus­es on three as­pects: bio­mark­er di­ag­nos­tics de­vel­op­ment, mol­e­c­u­lar di­ag­nos­tic con­tract de­vel­op­ment, and ap­plied bioin­for­mat­ics. — Max Gel­man

NIH hands out $9.4. M con­tract for re­search on dif­fer­ent virus

In­travacc, a Dutch vac­cines com­pa­ny, land­ed an up to $9.4 mil­lion con­tract from NI­AID to de­vel­op a vac­cine for en­terovirus D68, a res­pi­ra­to­ry virus that can cause paral­y­sis and has be­come in­creas­ing­ly com­mon in Amer­i­ca, Eu­rope and Asia over the last few years.

The small biotech, which al­so has pro­grams for RSV, gon­or­rhea and of course Covid-19, will de­vel­op an in­ac­ti­vat­ed virus vac­cine in Vero cells. The con­tract is for ear­ly prod­uct se­lec­tion through Phase I. — Ja­son Mast

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.

News brief­ing: Gilead com­pletes $21B buy­out of Im­munomedics; In­nate re­ceives $50M mile­stone pay­ment from As­traZeneca

Gilead’s $21 billion mega-acquisition of Immunomedics is now officially complete, the companies announced Friday morning.

The full merger process took a little over a month, with Gilead and Immunomedics signing an agreement on Sept. 13. Gilead acquired all outstanding stock of Immunomedics for $88 per share, a 108% premium on the previous day’s closing price.

Gilead’s big prize was Trodelvy, approved in July for the treatment of metastatic triple-negative breast cancer. The drug also impressed at last month’s ESMO conference, reducing the risk of death by 52% in a Phase III study.

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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