Covid-19 roundup: Pfiz­er, Mer­ck start late-stage tri­als for Covid-19 pills; Mer­ck be­gins PhI­II study on post-ex­po­sure treat­ment

Phar­ma gi­ants Pfiz­er and Mer­ck an­nounced to­day that they are mov­ing for­ward with Phase II and III clin­i­cal tri­als for an­tivi­ral treat­ments against Covid-19 — a sig­nif­i­cant mile­stone in the more than year-long bat­tle against the pan­dem­ic.

The drugs rep­re­sent two of the lead­ing ef­forts to treat Covid-19 with a pill, a po­ten­tial break­through giv­en that all doc­tors and hos­pi­tals have avail­able to­day need to be ei­ther in­fused or in­ject­ed – and they have been in short sup­ply. Out­side of the vac­cines, few prod­ucts have been ap­proved to fight the virus and a pill could present the best weapon to treat new­ly in­fect­ed or ex­posed pa­tients be­fore they wind up in a hos­pi­tal.

Pfiz­er an­nounced to­day that the first par­tic­i­pant has been dosed in a piv­otal Phase II/III clin­i­cal tri­al to eval­u­ate the safe­ty and ef­fi­ca­cy of PF-07321332, an ex­per­i­men­tal oral pro­tease in­hibitor de­signed to com­bat the coro­n­avirus.

The pa­tients in that study are non-hos­pi­tal­ized, symp­to­matic adult par­tic­i­pants who have a con­firmed di­ag­no­sis of SARS-CoV-2 in­fec­tion and are not at in­creased risk of pro­gress­ing to se­vere ill­ness.

The ran­dom­ized and dou­ble-blind tri­al will en­roll ap­prox­i­mate­ly 1,140 par­tic­i­pants, who will re­ceive PF- 07321332 with HIV an­ti­retro­vi­ral ri­ton­avir or place­bo oral­ly every 12 hours for five days.

Co-ad­min­is­tra­tion with a low dose of ri­ton­avir is ex­pect­ed to help slow the break­down of PF-07321332, help­ing it re­main in the body for longer pe­ri­ods of time at high­er con­cen­tra­tions, ac­cord­ing to Pfiz­er.

If proven suc­cess­ful, PF-07321332 in con­junc­tion with ri­ton­avir could be yet an­oth­er av­enue to com­bat the coro­n­avirus with­out re­quir­ing hos­pi­tal­iza­tion. — Paul Schloess­er

Mer­ck & part­ner an­nounce Phase III study on post-ex­po­sure Covid treat­ment

Mer­ck and part­ner Ridge­back Bio­ther­a­peu­tics an­nounced to­day the start of Phase III clin­i­cal tri­al MOVe-AHEAD, to eval­u­ate their ex­per­i­men­tal oral an­tivi­ral mol­nupi­ravir as a Covid-19 pre­ven­ta­tive. The glob­al study is en­rolling in­di­vid­u­als who are at least 18 years of age and re­side in the same house­hold as some­one with lab­o­ra­to­ry-con­firmed SARS-CoV-2 in­fec­tion with symp­toms.

“As the pan­dem­ic con­tin­ues to evolve and surges are be­ing re­port­ed in many places around the world, it is im­por­tant that we in­ves­ti­gate new ways to pro­tect in­di­vid­u­als ex­posed to the virus from be­com­ing in­fect­ed with symp­to­matic dis­ease,” said Nick Kart­so­nis, SVP of vac­cines and in­fec­tious dis­eases for Mer­ck Re­search Lab­o­ra­to­ries. “If suc­cess­ful, mol­nupi­ravir could pro­vide an im­por­tant ad­di­tion­al op­tion to­wards re­duc­ing the bur­den of COVID-19 on our com­mu­ni­ties.”

The safe­ty and ef­fi­ca­cy of mol­nupi­ravir is al­so cur­rent­ly be­ing eval­u­at­ed in Part 2 of an­oth­er tri­al known as MOVe-OUT, a glob­al Phase III, ran­dom­ized, place­bo-con­trolled, dou­ble-blind, mul­ti-site study. That study is study­ing mol­nupi­ravir in non-hos­pi­tal­ized adult pa­tients with lab-con­firmed mild to mod­er­ate COVID-19 and at least one risk fac­tor as­so­ci­at­ed with poor dis­ease out­comes. Da­ta from that study is ex­pect­ed by the end of the year. — Paul Schloess­er

Mesoblast takes an­oth­er hit as FDA de­mands ad­di­tion­al tri­al ahead of any EUA re­view

Shares of Mesoblast $MESO tum­bled 12% on Tues­day af­ter the small Aus­tralian biotech re­port­ed that the FDA is de­mand­ing an­oth­er tri­al be­fore the agency will con­sid­er an emer­gency au­tho­riza­tion for their ex­per­i­men­tal drug remestem­cel-L for Covid pa­tients suf­fer­ing from acute res­pi­ra­to­ry dis­tress syn­drome.

A slew of small biotechs have been beaver­ing away, at­tempt­ing to cap­ture the FDA’s at­ten­tion with enough da­ta to gain a cov­et­ed EUA — some­thing that has been the pre­serve of ma­jor play­ers or small­er com­pa­nies tied to the gi­ants.

In Mesoblast’s case, ex­ecs pitched da­ta from a failed tri­al af­ter No­var­tis stepped up with a $1.2 bil­lion deal on their drug — with $25 mil­lion com­ing in an up­front pay­ment. That deal al­so cov­ered the drug’s use for Covid pa­tients.

Soon af­ter the sign­ing with No­var­tis, Mesoblast was forced to con­cede that their an­ti-in­flam­ma­to­ry had failed their Covid tri­al and that in­de­pen­dent mon­i­tors want­ed it cut short due to fu­til­i­ty. Then, months lat­er, they teased out pos­i­tive da­ta from a sub­set of pa­tients and hus­tled that to the FDA.

It wasn’t enough.

Mesoblast has ex­pe­ri­enced a se­ries of set­backs over the course of the past 12 months. The FDA re­ject­ed their ap­pli­ca­tion on remestem­cel-L for acute graft-vs-host dis­ease last fall. A few months lat­er the drug failed a late-stage tri­al for heart fail­ure. And it’s al­so had to con­tend with a red flag from their au­di­tors on their abil­i­ty to con­tin­ue as a go­ing con­cern. — John Car­roll

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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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

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.