Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is pay­ing out a $25 mil­lion up­front for the rights to sell Turn­ing Point Ther­a­peu­tics’ lead drug re­potrec­tinib in Greater Chi­na. The San Diego-based biotech is al­so in line for up to $151 mil­lion in mile­stones, along with mid-to-high teen roy­al­ties. Zai plans to add sites to the Phase II tri­al of the drug, which is de­signed to treat ROS1-pos­i­tive ad­vanced NSCLC in pa­tients who were not pre­vi­ous­ly treat­ed with a TKI.

Xen­cor and Atre­ca forged a col­lab­o­ra­tion and li­cense deal to re­search, de­vel­op and com­mer­cial­ize T cell en­gag­ing bis­pe­cif­ic an­ti­bod­ies as po­ten­tial ther­a­peu­tics in on­col­o­gy. Atre­ca will pro­vide an­ti­bod­ies against nov­el tu­mor tar­gets while Xen­cor en­gi­neers XmAb bis­pe­cif­ic an­ti­bod­ies that al­so bind to the CD3 re­cep­tor on T cells: “Up to two joint pro­grams will be mu­tu­al­ly se­lect­ed for fur­ther de­vel­op­ment and com­mer­cial­iza­tion, with each part­ner shar­ing 50 per­cent of costs and prof­its. Each com­pa­ny will lead de­vel­op­ment, reg­u­la­to­ry and com­mer­cial­iza­tion ac­tiv­i­ties for one of the joint pro­grams. In ad­di­tion, the agree­ment al­lows for each part­ner to pur­sue up to two pro­grams in­de­pen­dent­ly, with a mid- to high-sin­gle dig­it per­cent roy­al­ty payable on net sales. Atre­ca and Xen­cor be­gan work­ing to­geth­er in 2019 un­der a ma­te­r­i­al trans­fer agree­ment to ac­cel­er­ate this new col­lab­o­ra­tion agree­ment.”

→ Di­al­ing up the ap­pli­ca­tion of AI in its drug dis­cov­ery work, Roche has en­list­ed Cam­bridge, MA-based Rever­ie Labs for a mul­ti-tar­get col­lab­o­ra­tion to screen and op­ti­mize in­hibitors of sev­er­al ki­nas­es. James Sabry, head of phar­ma part­ner­ing, is ap­par­ent­ly in for the long run with Rever­ie Labs’ plat­form, which gen­er­ates mil­lions of chem­i­cal struc­tures to choose from.

Take­da is li­cens­ing a phage dis­play “li­brary of li­braries” from Twist Bio­science to search for, val­i­date and op­ti­mize its an­ti­body pipeline. The deal cov­ers the core ar­eas of on­col­o­gy, rare dis­eases, neu­ro­science and gas­troen­terol­o­gy.

Roche’s Chugai sub­sidiary is team­ing up with Ther­mo Fish­er to de­vel­op a com­pan­ion di­ag­nos­tic for Ro­z­lytrek in Japan, which has been ap­proved in the coun­try for ROS1-pos­i­tive non-small cell lung can­cer.

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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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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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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