FDA side­swipes Ne­oleukin with clin­i­cal hold on lead im­munother­a­py can­di­date, sends shares plum­met­ing

Nat­ur­al killer and CD8 T cells for on­col­o­gy have been a hotbed of in­vest­ment in re­cent years, with some Big Phar­ma play­ers dab­bling in the ef­fort. A small­er com­peti­tor, Seat­tle’s Ne­oleukin Ther­a­peu­tics, hoped to give its IL-2 in­no­va­tor a shot at boost­ing those cells with­out the tox­i­c­i­ty con­cerns, but the FDA had oth­er ideas.

The FDA has placed a clin­i­cal hold on Ne­oleukin’s IND ap­pli­ca­tion for NL-201, a de no­vo cy­tokine re­cep­tor ag­o­nist for IL-2 and IL-15, which it hoped to test in ex­pand­ing CD8 T cells and nat­ur­al killer cells for use in on­co­log­ic ther­a­peu­tic ar­eas, the com­pa­ny said Fri­day.

The FDA re­quired Ne­oleukin to come up with a new as­say for the ther­a­py that would more ac­cu­rate­ly mea­sure the amount of pro­tein be­ing ad­min­is­tered to pa­tients in a pos­si­ble Phase I tri­al and en­sure the cor­rect dos­ing and ad­min­is­tra­tion of the drug, Ne­oleukin said. The FDA al­so posed “ad­di­tion­al ques­tions” to the biotech un­con­nect­ed to the hold that were not dis­closed in a re­lease.

Jonathan Drach­man

“We will work dili­gent­ly to ad­dress the FDA’s ques­tions as quick­ly as pos­si­ble,” CEO Jonathan Drach­man said in a state­ment. “We be­lieve that we will be able to de­vel­op the re­quest­ed as­say and re­spond with­in the next sev­er­al months. While we do not have a de­fin­i­tive time­line as to when we will be able to ob­tain clear­ance to pro­ceed, we look for­ward to work­ing with the FDA to sat­is­fy their re­quests.”

On the heels of the news, Ne­oleukin $NLTX was trad­ing down 18% be­fore the bell Fri­day at around $12.97.

Ne­oleukin, which launched with re­search out of the Uni­ver­si­ty of Wash­ing­ton in Jan­u­ary 2019, looked to shake up the IL-2 space by stim­u­lat­ing the ex­pan­sion of tu­mor fight­ing cells while side­step­ping pro­tein re­cep­tor CD25, which has been tied to tox­i­c­i­ty con­cerns.

In Au­gust 2019, the com­pa­ny went pub­lic af­ter a re­verse merg­er with Aquinox Phar­ma­ceu­ti­cals, which took a 61.42% stake in the new com­pa­ny in ex­change for $65 mil­lion in cap­i­tal for Ne­oleukin.

As part of that merg­er, Drach­man as­sumed the CEO role as David Main stepped away, mark­ing a new be­gin­ning for the team. Drach­man brought on VP ap­pointees Daniel Sil­va, Umut Ulge and Carl Walkey to con­tin­ue their work in re­search, trans­la­tion­al med­i­cine and cor­po­rate de­vel­op­ment, re­spec­tive­ly.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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News brief­ing: Five pub­lic biotechs, over 2 days, raise $883M from fresh of­fer­ings; Bel­gian biotech ex­pands Se­ries B fund­ing

The wave of biotech IPOs we’ve been seeing in the last few days underscores that the public markets remain one of the key channels for fresh investments in drug R&D. And that trend was in full view this week as a slate of biotechs nailed down hundreds of millions of dollars in fresh funds.

One of the big winners of the week is Editas $EDIT, which nailed $231 million to back its pioneering work on a gene editing platform. The biotech sold 3.5 million shares at $66 each.

With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.