Take­da and Fra­zier team up again to launch a spin­out — this time fo­cused on a late-stage vac­cine

Take­da has plucked a late-stage vac­cine from the pipeline and hand­ed it to a spin­out com­pa­ny — once again turn­ing to some col­leagues at Fra­zier Health­care Part­ners to make the deal work.

The phar­ma gi­ant is spin­ning out its norovirus vac­cine TAK-214 to a start­up called Hill­e­Vax for the last stage of what will like­ly be a con­sid­er­able R&D jour­ney. The world was treat­ed to a record set­ting late-stage pro­gram for Covid-19 vac­cines, but reg­u­lar de­vel­op­ment in the field typ­i­cal­ly take years to see out.

Patrick Heron

Now dubbed HIL-214, the vac­cine has been put through its Phase IIb study, with promis­ing enough re­sults to war­rant a chap­er­one for its own late-stage dri­ve.

The deal comes a lit­tle over 2 years af­ter Take­da and Fra­zier got to­geth­er to launch Phath­om, hand­ing off an acid fight­ing drug called Vono­prazan. Com­ing right on the heels of the Shire buy­out, Take­da was go­ing through the process of pri­or­i­tiz­ing what it need­ed to keep, what it could sell and what re­quired a spin­out to car­ry on.

Now, that process is still in place as Take­da R&D chief Andy Plump con­tin­ues his strat­e­gy of car­ry­ing on with pro­grams in the most ef­fi­cient man­ner pos­si­ble.

In an ear­ly 2020 in­ter­view with End­points News’ Am­ber Tong, Fra­zier’s Patrick Heron spelled out the eco­nom­ics of this kind of deal, and why Take­da fa­vors the gam­bit from time to time.

So we’ve prob­a­bly put to­geth­er around 25 com­pa­nies over the past 8 years. As you’ve in­di­cat­ed, a lot of those com­pa­nies had come from ba­si­cal­ly spin­ning off as­sets and putting them in­to the port­fo­lio like Phath­om and like in Ar­cutis. And I would say that the phar­ma com­pa­nies had be­come more re­cep­tive to that when they see sub­stan­tial val­ue ac­cru­al to them. And it’s pub­lic now, Take­da owns prob­a­bly about $200 mil­lion worth of stock in Phath­om, and so they are ba­si­cal­ly de­riv­ing a lot of eco­nom­ic val­ue from the part­ner­ship, and what they’re al­so fo­cused on is the qual­i­ty of teams we can put around their as­set such that the pro­gram will reach the clin­ic and ben­e­fit pa­tients. One of the ben­e­fits we have of do­ing this strat­e­gy for the past 15 years is that we can demon­strate that we got mul­ti­ple prod­ucts ap­proved and have been be­come broad­ly avail­able in the mar­ket­place and again had a re­al im­pact on true un­met need, dis­eases.

Ra­jeev Venkayya

This deal leaves Take­da fo­cused on its high-pri­or­i­ty dengue vac­cine, a pan­dem­ic ef­fort and a Zi­ka vac­cine part­nered with the US gov­ern­ment.

There are a va­ri­ety of vac­cines in the clin­ic for norovirus — in­clud­ing one from Vaxart — which trig­gers mil­lions of cas­es of acute gas­troen­teri­tis in the US every year with symp­toms that in­clude se­vere ab­dom­i­nal cramp­ing, di­ar­rhea and vom­it­ing.

“Take­da and Fra­zier have a his­to­ry of suc­cess­ful­ly part­ner­ing to­geth­er, and we are con­fi­dent in Hill­e­Vax’s ca­pa­bil­i­ties to progress HIL-214, the most ad­vanced norovirus vac­cine can­di­date in de­vel­op­ment with the po­ten­tial to ad­dress the huge glob­al bur­den of norovirus-as­so­ci­at­ed acute gas­troen­teri­tis,” said Ra­jeev Venkayya, pres­i­dent of Take­da’s glob­al vac­cine busi­ness unit.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.