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

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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