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

Roger Perl­mut­ter’s new gig, Covid-19 IP dra­ma, Vivek Ra­maswamy's coach on the SPAC train, and more

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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As­traZeneca, Dai­ichi Sankyo un­cork new TNBC da­ta for 2nd part­nered ADC — and it's adding more heat un­der Gilead­'s Trodelvy

After the approval of their partnered anti-HER2 antibody-drug conjugate earlier this year, AstraZeneca and Daiichi Sankyo are riding high on the promise of their blooming partnership. Now a second ADC is showing promise in hard-to-treat breast cancer, and the companies have their eyes set on their only approved competitor in the space.

AstraZeneca and Daiichi Sankyo’s next-gen ADC datopotamab deruxtecan posted a 43% response rate and five confirmed complete or partial responses among 21 patients with triple-negative breast cancer, according to cohort data from the TROPION-PanTumor01 Phase I study presented Saturday at the virtual ESMO Breast annual meeting.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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