Nu­clear scare to fu­el an­ti-ra­di­a­tion drug sales? PTx buys ex-Sanofi drug just in case

Part­ner Ther­a­peu­tics (PTx), a Boston start­up formed last week by a pair of Mer­ri­mack and Ser­agon ex­ec­u­tives, has made its first move: it’s ac­quired an ex-Sanofi can­cer drug with hopes that the FDA will OK it for ra­di­a­tion poi­son­ing. Like… the kind from an atom­ic bomb or a nu­clear plant dis­as­ter.

Bob Mul­roy

Seems like a rare and un­com­mon event to tar­get, but founder and CEO Bob Mul­roy says it’s best to be pre­pared.

“You would hope you’d nev­er need a drug like this for this kind of in­ci­dent,” Mul­roy told The Boston Globe. “But I think that, should an in­ci­dent like that oc­cur, be­ing pre­pared for it is a very im­por­tant thing.”

The Globe and oth­ers are posit­ing that in­sults slung be­tween Pres­i­dent Trump and North Ko­re­an leader Kim Jong Un are fu­el­ing fears of nu­clear war, lead­ing to de­mand from peo­ple and gov­ern­ments to stock­pile ra­di­a­tion sick­ness drugs.

The med­i­cine is called Leukine, and it’s cur­rent­ly ap­proved to treat acute myeloid leukemia pa­tients fight­ing in­fec­tions af­ter un­der­go­ing bone mar­row trans­plants. But da­ta pre­sent­ed at the 2016 Amer­i­can So­ci­ety of Hema­tol­ogy meet­ing showed Leukine’s abil­i­ty to boost sur­vival in mon­keys ex­posed to ra­di­a­tion if in­ject­ed 48 hours af­ter ex­po­sure. That’s in­ter­est­ing, con­sid­er­ing Am­gen’s ra­di­a­tion sick­ness drugs Ne­u­pogen and Neu­las­ta must be in­ject­ed al­most im­me­di­ate­ly af­ter ex­po­sure to ra­di­a­tion for it to work.

De­ba­sish Roy­chowd­hury

As part of the as­set ac­qui­si­tion deal, PTx al­so got a ded­i­cat­ed bi­o­log­ics man­u­fac­tur­ing fa­cil­i­ty in Lyn­nwood, Wash­ing­ton. The lo­ca­tion will serve as the core man­u­fac­tur­ing and sup­ply chain cen­ter for PTx’s op­er­a­tions, the com­pa­ny said in a state­ment.

An sBLA for the drug was filed in Sep­tem­ber 2017. The ap­pli­ca­tion WAS grant­ed pri­or­i­ty re­view and has a PDU­FA da­ta of March 29, 2018.

While ra­di­a­tion poi­son­ing in the con­text of nu­clear war is cer­tain­ly the most eye-pop­ping ap­pli­ca­tion, PTx has plen­ty of oth­er plans for Leukine’s de­vel­op­ment.

Leukine has shown promise in com­bo stud­ies with Yer­voy (ip­il­i­mum­ab) against melanoma. A 250-pa­tient, ran­dom­ized Phase II study in re­frac­to­ry melanoma in com­bi­na­tion with Yer­voy demon­strat­ed an im­prove­ment in sur­vival over Yer­voy alone, Part­ner says. Leukine is cur­rent­ly in a Phase III tri­al in front-line melanoma in com­bi­na­tion with Yer­voy and Op­di­vo (nivolum­ab).

Leukine is even a hope­ful for Alzheimer’s dis­ease.

“In con­trast to oth­er ap­proved growth fac­tors that stim­u­late one cell type, Leukine’s abil­i­ty to stim­u­late a broad­er va­ri­ety of cells, en­dows it with unique clin­i­cal po­ten­tial to ad­dress se­ri­ous med­ical needs across hema­to­log­ic dis­eases and can­cer as well as in­fec­tious, neu­ro­log­i­cal and pul­monary dis­or­ders,” said De­ba­sish Roy­chowd­hury, CMO at PTx and for­mer Ser­agon CMO, in a state­ment.

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.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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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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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.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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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.