BioN­Tech and Re­gen­eron launch new melanoma col­lab; Har­bour Bio­Med finds in­cu­ba­tion part­ner

BioN­Tech and Re­gen­eron have an­nounced they are col­lab­o­rat­ing on a Phase II tri­al to study how the com­bi­na­tion of the for­mer’s BNT111 can­di­date with the lat­ter’s Lib­tayo can treat melanoma.

The tri­al will en­roll pa­tients with an­ti-PD1-re­frac­to­ry/re­lapsed, un­re­sectable Stage III or IV cu­ta­neous melanoma. More de­tails about the tri­al will be re­vealed at a lat­er date, with the com­pa­nies hop­ing to launch some­time in the fourth quar­ter.

Re­gen­eron is a late­com­er in the PD-(L)1 mar­ket and has been de­vel­op­ing Lib­tayo to­geth­er with Sanofi over the last sev­er­al years. Though Lib­tayo has seen set­backs, in­clud­ing last Oc­to­ber when a pair of clin­i­cal tri­als failed in com­bi­na­tion with Sanofi’s CD38, the drug re­cent­ly re­turned pos­i­tive da­ta in a sin­gle-arm study for basal cell car­ci­no­ma in pa­tients whose dis­ease had ad­vanced be­yond the reach of a Hedge­hog path­way in­hibitor.

BNT111, an mR­NA can­cer im­munother­a­py, is the most ad­vanced of BioN­Tech’s can­di­dates com­ing out of its Fix­Vac plat­form. The com­pa­ny says it tar­gets four anti­gens fre­quent­ly ex­pressed in the tu­mors of pa­tients with melanoma: NY-ESO-1, MAGE-A3, ty­rosi­nase, and TPTE. — Max Gel­man

Har­bour Bio­Med finds part­ner for start­up in­cu­ba­tion

Har­bour Bio­Med, the Chi­nese-Dutch-Cam­bridge an­ti­body com­pa­ny from for­mer Sanofi ex­ec Jing­song Wang, has signed an agree­ment with Shang­hai-based Vi­va Biotech to help in­cu­bate new star­tups.

The agree­ment comes sev­er­al weeks af­ter Har­bour an­nounced they had raised $102 mil­lion to fund a slate of clin­i­cal and pre­clin­i­cal pro­grams, most­ly in can­cer. The com­pa­ny has now raised near­ly since $300 mil­lion since its found­ing in 2016, and Wang has es­tab­lished over 160 em­ploy­ees in Chi­na, Cam­bridge and Rot­ter­dam.

The new col­lab­o­ra­tion will make Har­bour’s trans­genic mice and Vi­va’s struc­ture-based drug dis­cov­ery plat­form avail­able to emerg­ing biotechs. “Some of these in­no­v­a­tive star­tups may be­come the next big biotech in the in­dus­try,” Wang said. — Ja­son Mast

Ax­o­vant and Ox­ford Bio­med­ica ex­pand Parkin­son’s part­ner­ship

Ax­o­vant has ex­pand­ed their part­ner­ship with Ox­ford Bio­med­ica to ad­vance their Parkin­son’s gene ther­a­py deep in­to the clin­ic.

The Vivek Ra­maswamy neu­ro­science and gene ther­a­py out­fit has signed a three year clin­i­cal sup­ply agree­ment with Bio­med­ica, the UK-based gene ther­a­py CD­MO. Ax­o­vant orig­i­nal­ly li­censed the gene ther­a­py from Bio­med­ica two years ago, af­ter a ma­jor tri­al fail­ure in Alzheimer’s forced the biotech to re­think its pipeline.

Al­though orig­i­nal­ly found­ed as a gene ther­a­py de­vel­op­er, Bio­med­ica has long since or­ga­nized much of its busi­ness around man­u­fac­tur­ing gene ther­a­py and vi­ral vec­tor tech­nol­o­gy for oth­er com­pa­nies. Most no­tably, they make the lentivi­ral vec­tors for No­var­tis’s CAR-T ther­a­py Kym­ri­ah. They were al­so con­tact­ed in the spring to help pro­duce As­traZeneca’s vi­ral vec­tor vac­cine.

Ax­o­vant is now in Phase II for its Parkin­son’s gene ther­a­py, with 6-month safe­ty and ef­fi­ca­cy da­ta ex­pect­ed in Q4 of this year. — Ja­son Mast

Take­da fore­casts high­er prof­its with con­tin­ued R&D re­fo­cus­ing

Fol­low­ing the $62 bil­lion ac­qui­si­tion of Shire last year, Japan­ese drug­mak­er Take­da has re­vised its 2020 prof­it pro­jec­tion up­ward to $3.78 bil­lion.

The re­vi­sion was an­nounced Fri­day as Take­da re­port­ed quar­ter­ly earn­ings, in­clud­ing about $871 mil­lion in prof­its this quar­ter. Pre­vi­ous­ly, the phar­ma ex­pect­ed $3.36 bil­lion in rev­enue. The changes re­flect a net gain from one-time items rec­og­nized in the first quar­ter.

Take­da has been sell­ing off as­sets left and right since the Shire pur­chase and re­fo­cused its pipeline around pre­scrip­tion drugs in or­der to re­duce lever­age. The com­pa­ny ex­pects to file sev­en Wave 1 NME ap­pli­ca­tions over the next 12 months as it con­tin­ues this R&D push. — Max Gel­man

Cincin­nati/At­lanta-based Ex­pres­sion Ther­a­peu­tics an­nounces new con­struc­tion plans

Ex­pres­sion Ther­a­peu­tics is plan­ning to con­struct a 43,000 square foot man­u­fac­tur­ing fa­cil­i­ty in Cincin­nati, OH to ful­fill the com­pa­ny’s ex vi­vo cell pro­cess­ing and re­com­bi­nant pro­tein pro­duc­tion needs. The new digs will man­u­fac­ture lentivi­ral, retro­vi­ral and ade­no as­so­ci­at­ed vi­ral GMP vec­tors, with the ca­pa­bil­i­ty to man­u­fac­ture up to 100 GMP vec­tor prod­ucts per year.

Ex­pres­sion al­so an­nounced Thurs­day that it has ap­point­ed Bill Swaney as vice pres­i­dent of man­u­fac­tur­ing. Swaney pre­vi­ous­ly worked at the Cincin­nati Chil­dren’s Hos­pi­tal Med­ical Cen­ter. — Max Gel­man

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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