Lon­car In­vest­ments launch­es Chi­na bio­phar­ma in­dex; La Jol­la prices $100M pub­lic of­fer­ing

→ In a move that high­lights the in­creas­ing fix­a­tion on op­por­tu­ni­ties in Chi­na, a new stock mar­ket in­dex launched this morn­ing to track the per­for­mance of com­pa­nies lead­ing Chi­na’s biotech rise. This new in­dex will go by the sym­bol $LCHI­NA, and it in­cludes stocks on both the Hong Kong Ex­change and the Nas­daq.

Brad Lon­car

Found­ed by Brad Lon­car, an in­de­pen­dent biotech in­vestor, through his com­pa­ny Lon­car In­vest­ments, the in­dex is the sec­ond formed by Lon­car that fol­lows ma­jor trends in biotech. His first in­dex, which de­buted in 2015, is a col­lec­tion of im­munother­a­py stocks un­der the in­dex $LCINDX.

Lon­car says this new in­dex is in re­sponse to mas­sive growth in Chi­na’s glob­al biotech pres­ence, dri­ven in part by re­cent re­forms in Chi­na’s reg­u­la­to­ry body and the rule change al­low­ing biotechs to more eas­i­ly go pub­lic on Hong Kong’s stock ex­change.

“Chi­na’s bio­phar­ma in­dus­try is on the cusp of a true rev­o­lu­tion that has glob­al im­pli­ca­tions,” Lon­car said in a state­ment. “Un­til to­day, no good stock mar­ket in­dex ex­ist­ed as a bench­mark for fol­low­ing this im­por­tant trend.”

LCHI­NA has 32 hold­ings, in­clud­ing Shang­hai Fo­s­un Phar­ma­ceu­ti­cal Group, BeiGene, Gen­script Biotech, Zai Lab, and Hutchi­son Chi­na MediTech.

→ Seek­ing cash to sup­port its new­ly com­mer­cial op­er­a­tion, La Jol­la Phar­ma­ceu­ti­cal Com­pa­ny is look­ing to raise $100 mil­lion in a pub­lic of­fer­ing. Its lead prod­uct, a treat­ment for low blood pres­sure called Gi­apreza, nabbed the last FDA ap­proval of 2017 and was re­cent­ly rolled out in the US. The San Diego-based biotech said the pub­lic of­fer­ing, which sells a to­tal of 3,400,000 shares at $29.50 per share, will sup­port not just the con­tin­ued com­mer­cial­iza­tion of that drug but al­so clin­i­cal tri­als for LJPC-401, cur­rent­ly in Phase II stud­ies for iron over­load. The pro­ceeds will al­so cov­er pre­clin­i­cal de­vel­op­ment work and oth­er ad­min­is­tra­tive ex­pens­es.

Adri­an Gottschalk

→ Pock­ets heavy from a re­cent mega-haul of its own, start­up in­vest­ment ma­chine Flag­ship Pi­o­neer­ing is drop­ping $50 mil­lion in­to Cam­bridge biotech up­start Foghorn Ther­a­peu­tics, a new­ly-formed com­pa­ny ex­plor­ing the chro­matin reg­u­la­to­ry sys­tem’s con­nec­tion to hu­man dis­ease. The up­start was found­ed in 2016 by Flag­ship’s Dou­glas Cole, Ger­ald Crab­tree of the Howard Hugh­es Med­ical In­sti­tute and Stan­ford Uni­ver­si­ty, and Cigall Kadoch, of the Dana-Far­ber Can­cer In­sti­tute, Har­vard Med­ical School and the Broad In­sti­tute. Bio­gen’s for­mer SVP and neu­rode­gen­er­a­tion head Adri­an Gottschalk has signed on as CEO. In a state­ment de­scrib­ing the com­pa­ny’s work, Foghorn likened the chro­matin reg­u­la­tion sys­tem to traf­fic con­trol: “Just as air­ports need an air traf­fic con­trol sys­tem to di­rect which planes move and when, where, and in what or­der, our bod­ies need a sys­tem to con­trol which genes our cells ex­press, and when, where, in what or­der, and what quan­ti­ty.” Gottschalk said the com­pa­ny’s plat­form would be used against can­cer, neu­rol­o­gy, and im­munol­o­gy. “At Foghorn, we en­vi­sion a world where pa­tients can re­gain con­trol of their genes to bat­tle can­cer and oth­er se­ri­ous dis­eases… This is just the be­gin­ning of an en­tire­ly new ap­proach to con­trol­ling gene ex­pres­sion and to bring­ing new med­i­cines to pa­tients with in­tractable dis­eases.”

With con­tri­bu­tion by Am­ber Tong.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.