DB­V's peanut al­ler­gy patch is fi­nal­ly un­der FDA re­view; Rit­ter swal­lows bit­ter pill to ex­plore strate­gic al­ter­na­tives

→ DBV Tech­nolo­gies $DB­VT, which with­drew its ap­pli­ca­tion to mar­ket its peanut al­ler­gy patch late last year, es­sen­tial­ly en­abling ri­val Aim­mune $AIMT to leapfrog it, on Fri­day an­nounced that the FDA has ac­cept­ed its lat­est BLA fil­ing. The agency is ex­pect­ed to make its de­ci­sion by Au­gust 5 — but will host an ad­vi­so­ry pan­el meet­ing to dis­cuss the im­munother­a­py.

Rit­ter Phar­ma­ceu­ti­cals $RT­TR did its best to make lemon­ade with the lemons it was dealt — by vault­ing its lac­tose in­tol­er­ance ther­a­py to­ward a con­fir­ma­to­ry tri­al, de­spite miss­ing the main goal in the pre­ced­ing Phase II/III study. Last month, the com­pa­ny re­port­ed its ther­a­py, RP-G28, failed not on­ly to se­cure a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment ver­sus place­bo in re­duc­ing lac­tose in­tol­er­ance symp­toms, but pa­tients in the place­bo group ac­tu­al­ly did bet­ter than the drug arm. Now, the LA-based com­pa­ny has ap­point­ed a fi­nan­cial ad­vi­sor to ex­plore strate­gic al­ter­na­tives.

As­traZeneca-part­nered French biotech, In­nate Phar­ma, which an­nounced plans for a US IPO worth up to $100 mil­lion a few weeks ago, said to­day that it plans to is­sue and sell about 10.7 mil­lion in an of­fer­ing, to de­vel­op their lead prod­uct, mon­al­izum­ab; fund their mid-stage tri­al of IPH4102 for pa­tients with Sézary syn­drome, MF and PT­CL; and the phase I/II de­vel­op­ment of IPH5401 for sol­id tu­mors, in­clud­ing NSCLC and HCC.

→ The FDA has green­light­ed Pfenex’s ap­pli­ca­tion to mar­ket PF708 to treat os­teo­poro­sis in cer­tain pa­tients at high risk of frac­ture. The ther­a­peu­tic is sim­i­lar to Am­gen’s $AMGN block­buster For­teo, which is made us­ing a type of parathy­roid hor­mone called teri­paratide.

Al­though the FDA plans to des­ig­nate cer­tain prod­ucts like in­sulins and hor­mones from drugs to bi­o­log­ics next year, teri­paratide is not on that list. There­fore, Pfenex sub­mit­ted a 505(b)(2) New Drug Ap­pli­ca­tion for PF708 rather than an ab­bre­vi­at­ed Bi­o­log­ics Li­cense Ap­pli­ca­tion. “We be­lieve PF708 has the po­ten­tial to sig­nif­i­cant­ly en­hance pa­tient ac­cess to an im­por­tant ther­a­py as a cost-ef­fec­tive al­ter­na­tive to For­teo, which had $1.6 bil­lion in glob­al sales in 2018,” said Eef Schim­melpen­nink, CEO of Pfenex. Pfenex is al­so con­duct­ing a sep­a­rate study with the goal of get­ting PF708 des­ig­nat­ed as ther­a­peu­ti­cal­ly equiv­a­lent to For­teo.

Adap­tive Phage Ther­a­peu­tics (APT), a com­pa­ny fo­cused on the de­vel­op­ment of ther­a­pies to com­bat the rise of mul­ti-drug re­sis­tant (MDR) path­o­gen­ic bac­te­ria, has closed its over­sub­scribed, non-bro­kered fi­nanc­ing — rais­ing about $7 mil­lion in pro­ceeds. In­vestors in­clud­ed Alexan­dria Ven­ture In­vest­ments. The com­pa­ny said that pro­ceeds will be used to­wards the sup­port of Phase II clin­i­cal stud­ies for its Phage­Bank ther­a­py for an­tibi­ot­ic-re­sis­tant bac­te­r­i­al in­fec­tions.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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