Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An ex­per­i­men­tal drug that promis­es to be the first an­ti-in­fec­tive agent to prove su­pe­ri­or to van­comycin — an an­tibi­ot­ic ap­proved in 1958 — has notched the FDA’s “break­through” sta­tus.

Roger Pomer­antz

Con­tra­Fect said the des­ig­na­tion was based on Phase II da­ta in which exe­ba­case was test­ed against a su­per­bug known as me­thi­cillin-re­sis­tant Staph au­reus, or MR­SA. In a sub­group analy­sis, the clin­i­cal re­spon­der rate at day 14 was 42.8% high­er than that among those treat­ed with stan­dard of care, the com­pa­ny said (p=0.010).

The 21% re­duc­tion in 30-day all-cause mor­tal­i­ty, how­ev­er, was not sta­tis­ti­cal­ly sig­nif­i­cant with p=0.056.

Demon­strat­ing su­pe­ri­or­i­ty marks a first for the MR­SA field, em­pha­sized Roger Pomer­antz, who jumped from Seres to be­come CEO for Con­tra­Fect last April. Al­ler­gan’s Dal­vance, a struc­tur­al rel­a­tive to van­comycin, was ap­proved based on non-in­fe­ri­or­i­ty.

Con­tra­Fect is now con­duct­ing a piv­otal Phase III study to ex­am­ine exe­ba­case’s ef­fi­ca­cy in all in­fec­tions caused by Staph au­reus, in­clud­ing right-sided en­do­cardi­tis.

Cara Cassi­no

“Based on our in­ter­ac­tions with the FDA re­gard­ing stream­lined de­vel­op­ment of exe­ba­case, this sin­gle Phase 3 study, in ad­di­tion to the full pack­age of da­ta gen­er­at­ed to date, may serve as the ba­sis of a Bi­o­log­ics Li­cense Ap­pli­ca­tion for FDA re­view and po­ten­tial ap­proval of exe­ba­case,” CMO Cara Cassi­no said in a state­ment.

MR­SA, which com­pris­es a group of Gram-pos­i­tive bac­te­ria, can cause in­fec­tions in the skin, the heart, the res­pi­ra­to­ry sys­tem, bone and joint, and even the cen­tral ner­vous sys­tem.

Michael Messinger

Tak­ing a page from bac­te­rio­phages — virus­es that in­fect bac­te­ria — Con­tra­Fect’s drug is a cell wall hy­dro­lase en­zyme, or lysin, that in­duces bac­te­r­i­al death by punc­tur­ing the cell wall. Its in­ven­tor, Vin­cent Fis­chet­ti of Rock­e­feller Uni­ver­si­ty, calls it an an­tibi­ot­ic al­ter­na­tive.

The com­pa­ny fore­casts a $700 mil­lion mar­ket for the MR­SA bac­teremia in­di­ca­tion pro­vid­ed that exe­ba­case de­liv­ers in Phase III and gets the su­pe­ri­or­i­ty la­bel, CFO Michael Messinger told End­points News. They are al­so gun­ning for an ex­pand­ed la­bel cov­er­ing all Staph au­reus.

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.

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.

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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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.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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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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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.