Tiny hep B drug com­bo study touts po­ten­tial of a ‘func­tion­al cure’ at lit­tle-known Replicor

A small, large­ly un­known biotech in Cana­da is re­port­ing some re­mark­able re­sults from a tiny proof-of-con­cept study for a new hep B com­bo.

Re­port­ing at the Amer­i­can As­so­ci­a­tion for the Study of Liv­er Dis­ease meet­ing in Wash­ing­ton, DC, in­ves­ti­ga­tors for the Mon­tre­al-based Replicor say that they tracked a per­sis­tent func­tion­al cure for 4 of the hand­ful of pa­tients be­ing treat­ed with a com­bi­na­tion ther­a­py. And 8 of 10 pa­tients have achieved what they term “func­tion­al con­trol” over the dis­ease.

An­drew Vail­lant, Replicor

The com­bo match­es an in-house drug dubbed REP 2139 with teno­fovir diso­prox­il fu­marate and pe­gy­lat­ed in­ter­fer­on al­pha 2a. With­out the pro­pri­etary drug, the re­searchers say that pa­tients can ex­pect a 10% re­sponse. And they’re now set­ting the stage for a big­ger tri­al to put their drug to a more am­bi­tious test.

Their de­f­i­n­i­tion of func­tion­al con­trol was the re­duc­tion of he­pati­tis B sur­face anti­gens to less than one IU/mL and vi­ral DNA lev­els of less than 10 IU/mL. This was an open-la­bel study with no con­trol arm.

Not much has been re­port­ed about this pri­vate biotech com­pa­ny, in­clud­ing any de­tails on how it’s been fi­nanced since it was found­ed in 2009.

Replicor CSO An­drew Vail­lant had this to say in a pre­pared state­ment:

The ad­di­tion of REP 2139’s unique abil­i­ty to clear cir­cu­lat­ing HB­sAg im­proves this out­come in a strik­ing fash­ion, achiev­ing func­tion­al con­trol in 80% of pa­tients not on­ly dur­ing treat­ment but per­sist­ing af­ter treat­ment is with­drawn. Equal­ly im­por­tant is the nor­mal­iza­tion of liv­er func­tion dur­ing fol­low-up in all these pa­tients, even those with sig­nif­i­cant­ly el­e­vat­ed liv­er en­zymes at the start of ther­a­py.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Seat­tle Ge­net­ic­s' Astel­las-part­nered ADC nails con­fir­ma­to­ry PhI­II in urothe­lial can­cer

Nine months after Seattle Genetics nabbed an accelerated approval for its Astellas-partnered antibody-drug conjugate Padcev, the partners said the therapy has nailed a confirmatory Phase III, proving its worth in locally advanced or metastatic urothelial cancer.

Padcev, which has widely been tapped as a potential blockbuster, scored improvements in both overall survival and progression-free survival compared to chemotherapy, causing a 30% reduction in risk of death (p = 0.001) and 39% reduction in risk of disease progression or death (p<0.00001).

Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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Stéphane Bancel, Moderna CEO

UP­DAT­ED: 'The biggest in­flec­tion point ever': On R&D day, Mod­er­na CEO Stéphane Ban­cel dou­bles down on vac­cines and lays out a vi­sion for a '40, 50'-drug biotech

The stakes have always been different for Moderna. They didn’t invest more in the Covid-19 vaccine race than Pfizer, Sanofi or AstraZeneca, and they didn’t have more to lose than Novavax — a $100 million biotech that became a $7 billion company virtually overnight. But they had considerably more to gain than anyone.

Born with grand ambitions and the checkbook to match, Moderna spent its first decade of life attracting as many critics of its vision to remake drug development as it did backers. But the pandemic presented a twin opportunity: to prove its technology on a global stage and to give a still-young biotech billions in annual revenue years before anticipated.

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Steve Hurly, Lava CEO

La­va breaks pro­longed si­lence with an $83M Se­ries C and two I/O pro­grams set for the clin­ic

Lava debuted in May of 2018 with $18.9 million, a platform built around something called gamma delta cells and a plan, apparently, of saying nothing else for the next two years. They never announced a program and they did not issue another press release for the next 20 months.

In May, though, the Dutch-American biotech announced a partnership on cancer bispecifics with J&J. And today, CEO Steve Hurly is ready to talk about what they’ve been working on for the last two years in Utrecht and Philadelphia – as well as the $83 million they raised from Novo, Sanofi and others to bring that work into the clinic next year.