Cy­to­Dyn tries to squeeze pos­i­tive news out of a failed Covid-19 study — and shares take a beat­ing

Cy­to­Dyn re­al­ly, re­al­ly want­ed to put its best foot for­ward.

So much so that, af­ter sit­ting on un­blind­ed Phase IIb/III da­ta on leron­limab in Covid-19 for two weeks pend­ing reg­u­la­to­ry dis­cus­sions, the biotech is­sued six press re­leas­es over the week­end, each of­fer­ing a lit­tle more in­for­ma­tion or re­fin­ing what was pre­vi­ous­ly dis­closed.

In one of them, Cy­to­Dyn ac­knowl­edged that leron­limab — an an­ti-CCR5 an­ti­body that had al­ready been turned away at the FDA’s doorsteps once — had failed the pri­ma­ry end­point of low­er­ing all-cause mor­tal­i­ty at Day 28, as the re­sult was not sta­tis­ti­cal­ly sig­nif­i­cant. At best, ex­ecs im­plied, they would need to col­lect fur­ther clin­i­cal da­ta to be ready for reg­u­la­to­ry re­views.

Shares $CY­DY slid 20.99% to $3.20 once the stock mar­ket opened on Mon­day.

That’s not what they chose to high­light, though.

Rather, Cy­to­Dyn zoomed in on a sub­group that ac­count­ed for 62 out of 384 pa­tients en­rolled in the CD12 tri­al and de­clared a sur­vival ben­e­fit. Where­as the tri­al in­volved se­vere to crit­i­cal­ly ill pa­tients, the com­pa­ny found that me­chan­i­cal­ly ven­ti­lat­ed crit­i­cal­ly ill pa­tients saw a 24% re­duc­tion in all cause-mor­tal­i­ty be­tween the leron­limab and place­bo arms, with­out break­ing down the num­ber of deaths in ei­ther group.

Nad­er Pourhas­san

“We be­lieve these re­sults are the best re­sults ever achieved for this pop­u­la­tion in a Phase 3 clin­i­cal tri­al,” CEO Nad­er Pourhas­san boast­ed in one of the state­ments.

Fur­ther mas­sag­ing the da­ta, ex­ecs point­ed out that there were more over-65 pa­tients tak­ing leron­limab than place­bo — lead­ing them to con­duct a post hoc “age ad­just­ment” analy­sis and de­duce “(s)ta­tis­ti­cal­ly sig­nif­i­cant re­sults (p-val­ue = 0.0319)” for the pri­ma­ry end­point “in par­tic­i­pants re­ceiv­ing leron­limab + ‘com­mon­ly used COVID-19 treat­ments’ com­pared to par­tic­i­pants who re­ceived ‘com­mon­ly used COVID-19 treat­ments’ alone in the place­bo group in the over­all mod­i­fied in­tent-to-treat (‘mITT’) pop­u­la­tion.”

Not that it helped with the main out­come mea­sure:

When age ad­just­ment was con­duct­ed, the pri­ma­ry end­point was much clos­er to sta­tis­ti­cal­ly sig­nif­i­cant val­ue. Of note, the re­duc­tion of mor­tal­i­ty in this pop­u­la­tion of 65 years and younger leron­limab arm had more than 30% less mor­tal­i­ty than place­bo and 9% less mor­tal­i­ty in par­tic­i­pants over 65.

But Cy­to­Dyn claimed it’s got­ten reg­u­la­tors on board with the sub­group hy­poth­e­sis: The UK’s MHRA is ap­par­ent­ly will­ing to ac­cept da­ta from the open-la­bel ex­ten­sion of the study, which has en­rolled 45 so far. The US agency is ask­ing for da­ta from 140 more pa­tients in the crit­i­cal­ly ill pop­u­la­tion, with the new pri­ma­ry end­point of length of hos­pi­tal stay (ac­cord­ing to Cy­to­Dyn, leron­limab had short­ened time to re­cov­ery by 6 days among these pa­tients com­pared to place­bo plus stan­dard of care on­ly, with a p-val­ue of 0.005). In Cana­da, the com­pa­ny will ap­ply to start sell­ing the drug while clin­i­cal tri­als con­tin­ue — with un­clear prospects.

Some of the un­cer­tain­ty may be an­swered af­ter Cy­to­Dyn re­leas­es de­tailed re­sults on the tri­al, which it is plan­ning to do lat­er to­day. Or at the in­vestor we­b­cast sched­uled right be­fore it.

There’s just one caveat: It will be a “lis­ten on­ly” we­b­cast — in­vestors can sub­mit their ques­tions on­line.

Nad­er Pourhas­san (Pho­to by Jeff Kravitz/Film­Mag­ic for Cy­to­Dyn’s Pro)

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.

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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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.

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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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.

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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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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