Bris­tol-My­ers Squibb brings Op­di­vo to a joint im­muno-on­col­o­gy pro­gram with Nek­tar’s new T cell am­pli­fi­er

Six years ago, when Steve Dober­stein took over as chief sci­en­tif­ic of­fi­cer at Nek­tar Ther­a­peu­tics, he set up a new bi­o­log­ics re­search group with an eye to ex­pand­ing on the biotech’s base of small mol­e­cules. The very first project they would un­der­take went on to be­come NK­TR-214, a pre­clin­i­cal bi­o­log­ic that the com­pa­ny be­lieves can play a role in im­muno-on­col­o­gy.

Steve Dober­stein

To­day, Nek­tar is pulling the wraps off a deal to col­lab­o­rate with Bris­tol-My­ers Squibbs’ I/O all­stars in R&D to see how their ex­per­i­men­tal drug match­es up with Op­di­vo, one of the lead­ers in the first wave of check­point in­hi­bi­tion.

“The com­bi­na­tion of the two med­ica­tions makes a tremen­dous amount of sense to me,” says Dober­stein. The same goes for Bris­tol-My­ers.

It’s easy to see why Bris­tol-My­ers would be in­ter­est­ed enough to foot half the costs of the up­com­ing work. Nek­tar has been run­ning an­i­mal stud­ies that demon­strat­ed their drug’s abil­i­ty to spur im­mune T cells to di­vide and ac­ti­vate, amp­ing up an im­mune re­sponse. Check­points dis­man­tle a can­cer cell’s de­fense sys­tem, leav­ing them vul­ner­a­ble to an at­tack. The syn­er­gies are ob­vi­ous. With the right check­point, which Bris­tol-My­ers feels it has, Nek­tar’s work has the po­ten­tial to “make cold tu­mors hot,” in Dober­stein’s words.

The work at Nek­tar cen­ters around a grow­ing un­der­stand of the role of the IL-2 path­way, says Dober­stein. If you hit the wrong IL-2 re­cep­tor, says the CSO, you’ll wind up trig­ger­ing reg­u­la­to­ry T cells, which sup­press the im­mune sys­tem. Hit the CD122 re­cep­tors, though, and you’ll amp up a T cell at­tack.

The plan now is to wrap up an on­go­ing safe­ty study, with some 30 sub­jects, and then branch out in­to 5 dif­fer­ent tu­mor types and 7 dif­fer­ent in­di­ca­tions, with a va­ri­ety of small ex­pan­sion stud­ies in each in the sec­ond half of 2017 to see if they can have an im­pact. Dober­stein sees po­ten­tial in all of them, though he doubts that they’ll hit on the full slate.

This is not your av­er­age col­lab­o­ra­tion sto­ry. There are no big biobucks in­volved. Every­body is hang­ing on to their rights. No one is plan­ning to con­quer block­buster mar­kets quite yet. But it is the kind of 50/50 ven­ture that Nek­tar likes for its first for­ay in­to the clin­ic. And it puts them at the same ta­ble as some of the best in the check­point busi­ness.

A joint steer­ing com­mit­tee is di­rect­ing the work, with plen­ty of in­put from BMS and Nek­tar in how things are done. Af­ter the first round, they can talk again about any piv­otal plans.

Im­muno-on­col­o­gy projects have been ex­plod­ing around the globe in re­cent months, and there’s some po­ten­tial here to do some­thing unique.

It’s a great place to start.

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.

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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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

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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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.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.