Zan­tac pulled off shelves due to can­cer scare; The end of the road for Mo­tif Bio

GSK is re­call­ing its heart­burn med­i­cine Zan­tac, sold gener­i­cal­ly as ran­i­ti­dine, from all mar­kets af­ter the FDA found it con­tains “‘un­ac­cept­able’ lev­els of prob­a­ble can­cer-caus­ing im­pu­ri­ty.” The drug is one of sev­er­al blood pres­sure and heart fail­ure med­ica­tions that have been pulled off the sheves since last year due to con­cerns about car­cino­genic ma­te­r­i­al in­tro­duced in the man­u­fac­tur­ing process. Four Zan­tac pre­scrip­tion-on­ly med­i­cines are in­volved: a syrup, an in­jec­tion and tablets of 150 and 300 mil­ligram (mg) dosages. But the over-the-counter ver­sions, which are pro­duced by a dif­fer­ent com­pa­ny, would not be af­fect­ed, ac­cord­ing to the UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­tion Agency.

→ 2019 has not been kind to Mo­tif Bio, who was plan­ning to launch and roll­out its drug iclaprim, but was halt­ed by a Feb­ru­ary com­plete re­sponse let­ter from the FDA that sent its stock crash­ing in­to pen­ny stock ter­ri­to­ry. The com­pa­ny is now wav­ing the white flag af­ter hear­ing back from a meet­ing with the FDA. The short an­swer: they will need years and loads of cash — that they don’t have — in or­der to com­plete a tri­al. CEO Gra­ham Lums­den had this to say: “We now have con­fir­ma­tion of what will be re­quired to progress iclaprim to­wards a po­ten­tial ap­proval. The Com­pa­ny is work­ing hard to find a part­ner or oth­er en­ti­ty to com­plete the HABP/VABP Phase III tri­al, com­mer­cialise iclaprim and en­sure the best out­come for share­hold­ers in Mo­tif Bio.”

→ While Themis, backed by its part­ner Mer­ck, was gear­ing up for a Phase III tri­al of its chikun­gun­ya vac­cine last month, Emer­gent BioSo­lu­tions leapfrogged ahead with the an­nounce­ment that its chikun­gun­ya virus (CHIKV) virus-like par­ti­cle (VLP) vac­cine can­di­date has been grant­ed EMA PRIME des­ig­na­tion. The vac­cine is in­tend­ed to pre­vent the dis­ease caused by the chikun­gun­ya virus in­fec­tion, an ill­ness that spreads through mos­qui­to bites.  No vac­cine or treat­ment is cur­rent­ly avail­able.

→ Cit­ing “ad­verse mar­ket con­di­tions,” ADC Ther­a­peu­tics took an un­ex­pect­ed U-turn at the NYSE last week, but that hasn’t stopped the com­pa­ny from ink­ing a col­lab­o­ra­tion with can­cer-fo­cused Avac­ta Group. Un­der the agree­ment, Avac­ta will pro­vide Af­firmer drug con­ju­gates to be used against three undis­closed can­cer tar­gets. It will al­so pro­vide these to ADC to aim its pro­pri­etary cy­to­tox­ic war­heads (PBDs) at the site of the tu­mor.

→ With larg­er phar­ma com­pa­nies turn­ing to more lu­cra­tive prospects, small­er com­pa­nies like MGB Bio­phar­ma have tak­en up most of the work in com­bat­ting the ever­grow­ing threat of an­tibi­ot­ic re­sis­tance. MGB re­vealed a Phase IIa clin­i­cal tri­al up­date of its bac­te­ri­ci­dal an­tibi­ot­ic, MGB-BP-3, for the treat­ment of clostrid­i­um dif­fi­cile-as­so­ci­at­ed dis­ease (CDAD) — an in­fec­tion of the large in­tes­tine that is the most fre­quent cause of di­ar­rhea in hos­pi­tals and care homes.

The com­pa­ny says that “the first co­hort of pa­tients has now com­plet­ed treat­ment with the low­est dose and re­sults in­di­cate high ef­fi­ca­cy and good tol­er­a­bil­i­ty of MGB-BP-3.” They’ve be­gun re­cruit­ment for the next co­hort, with topline re­sults from both Cana­da and the US an­tic­i­pat­ed in ear­ly 2020.

On­coSec, a late-stage in­tra­tu­moral im­muno-on­col­o­gy com­pa­ny, an­nounced an in­vest­ment and op­tion deal with Grand Decade, a sub­sidiary of Chi­na Grand Phar­ma­ceu­ti­cal (CGP). CGP and its af­fil­i­ate Sir­tex will in­vest $30 mil­lion in On­coSec. In ex­change, CGP and Sir­tex will re­ceive a con­trol­ling share in On­coSec. The deal gives GCP an ex­clu­sive li­cense to On­coSec’s cur­rent and fu­ture prod­ucts and sets a min­i­mum for price-per-share should CGP seek to ac­quire the rest of the com­pa­ny with­in the next year.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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News brief­ing: Eli Lil­ly com­pletes $1B+ Pre­vail buy­out; El­zon­ris ap­proved in Eu­rope for adults

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.