Pfiz­er and Lil­ly's tanezum­ab large­ly makes the ef­fi­ca­cy cut in sec­ond PhI­II study, but safe­ty is­sues con­tin­ue to blight an­ti-NGF drug

Stark safe­ty is­sues in the field of an­ti-NGF pain drugs have led a num­ber of high pro­file drug­mak­ers to press pause on de­vel­op­ment, re­duce dos­es or aban­don their ef­forts al­to­geth­er. On Tues­day, Lil­ly and Pfiz­er’s of­fer­ing — tanezum­ab — large­ly passed muster in terms of ef­fi­ca­cy in pa­tients with os­teoarthri­tis (OA) pain in a late-stage study, but was un­able to shake off that safe­ty is­sue — trig­ger­ing ag­gres­sive os­teoarthri­tis in a small per­cent­age of pa­tients.

The Phase III 849-pa­tient tri­al test­ed two dos­es of tanezum­ab (2.5 mg and 5 mg) against a place­bo in mod­er­ate-to-se­vere pa­tients that suf­fered symp­toms de­spite treat­ment or in­tol­er­ance to at least three dif­fer­ent class­es of anal­gesics, and on av­er­age had OA for more than six years. Pa­tients giv­en the high­er dose met all three co-pri­ma­ry goals ver­sus the place­bo at 24 weeks: a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in pain, phys­i­cal func­tion and over­all OA as­sess­ment. Al­though those on the low­er dose met the first two end­points, the 2.5 mg dose failed to spur a sta­tis­ti­cal dif­fer­ence in over­all OA as­sess­ment against the place­bo.

Mean­while, a num­ber of safe­ty is­sues emerged, akin to the re­sults of a pre­vi­ous Phase III study re­port­ed last Oc­to­ber that eval­u­at­ed the use of the drug for 16 weeks. In the new tri­al, rapid­ly pro­gres­sive os­teoarthri­tis was ob­served in 2.1% of tanezum­ab-treat­ed pa­tients, while no such events were ob­served in the place­bo arm.

There was al­so one event of os­teonecro­sis (a loss of blood to the bone that caus­es the bone to die) and one event of sub­chon­dral in­suf­fi­cien­cy frac­ture (a slow­ly heal­ing frac­ture of the bone sit­u­at­ed im­me­di­ate­ly be­low the car­ti­lage of a joint) ob­served in pa­tients treat­ed with the drug, and once again no such events were re­port­ed in pa­tients who got the place­bo, the com­pa­nies said, adding that de­tailed da­ta would be pre­sent­ed at a fu­ture med­ical meet­ing.

Years ago, the promise of an­ti-nerve growth fac­tor an­ti­bod­ies in­spired an­a­lysts to project multi­bil­lion-dol­lar mar­kets for the class of drugs. But a slew of safe­ty is­sues forced the FDA to im­pose clin­i­cal holds on keen­ly watched drugs af­ter re­ports of pa­tients blow­ing their joints out — some have spec­u­lat­ed that the drugs al­most work too well, dulling pain and thus help­ing pa­tients be­come more ac­tive, but al­so ac­cel­er­at­ing the pace of car­ti­lage de­te­ri­o­ra­tion at the joints.

Nonethe­less, such safe­ty set­backs forced Pfiz­er $PFE to cut back on tanezum­ab dos­es, al­though it did not de­ter Lil­ly $LLY from pour­ing as much as $1.8 bil­lion to buy in­to the drug. Te­va $TE­VA and Re­gen­eron $REGN too were com­pelled to trim down their dose of an­ti-NGF drug fas­inum­ab af­ter sim­i­lar con­cerns, while drug­mak­ers such as J&J $JNJ , As­traZeneca $AZN and Ab­b­Vie $AB­BV washed their hands of their an­ti-NGF of­fer­ings.

Tanezum­ab is be­ing test­ed in a slate of Phase III tri­als, out­side of the two whose re­sults have been al­ready re­port­ed. Piv­otal da­ta in pa­tients with chron­ic low­er back pain are ex­pect­ed lat­er this year, and da­ta from pa­tients with can­cer pain due to bone metas­tases are al­so in­com­ing.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist partnered with Novartis, the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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