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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine -- so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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