Macro­Gen­ics ear­marks $580M for ADC tech; Do­mainex, non­prof­it team up on Parkin­son's pro­gram

Synaf­fix and Macro­Gen­ics have signed a deal to code­vel­op and com­mer­cial­ize a clin­i­cal plat­form for an­ti­body-drug con­ju­gates to fight can­cer.

Synaf­fix will li­cense out its Gly­co­Con­nect an­ti­body con­ju­ga­tion plat­form, po­lar spac­er tech­nol­o­gy and toxSYN link­er pay­loads. In re­turn, it will get $586 mil­lion in up­front and mile­stone pay­ments across the three pro­grams and is el­i­gi­ble for roy­al­ties on com­mer­cial sales.

Macro­Gen­ics will be re­spon­si­ble for R&D, man­u­fac­tur­ing and com­mer­cial­iza­tion of the AD­Cs, and Synaf­fix will sup­port Macro­Gen­ics re­search and man­u­fac­tur­ing com­po­nents for Gly­co­Con­nect, Hy­dra­Space and toxSYN. Each of these pro­grams are de­signed to ef­fec­tive­ly en­able AD­Cs, and they will be com­bined with Macro­Gen­ics pro­pri­etary an­ti­body and bis­pe­cif­ic DART an­ti­body plat­form to cre­ate next-gen­er­a­tion AD­Cs.

“The col­lab­o­ra­tion with Macro­Gen­ics is an im­por­tant mile­stone for Synaf­fix as our ADC tech­nol­o­gy will be de­ployed for the gen­er­a­tion of both mono­spe­cif­ic and bis­pe­cif­ic AD­Cs,” Synaf­fix CEO Pe­ter Van de Sande said in a press re­lease. “We are pleased to fur­ther ex­pand the use of our tech­nol­o­gy with an­oth­er lead­ing biotech com­pa­ny that has deep prod­uct de­vel­op­ment ca­pa­bil­i­ties and a long-term com­mit­ment to de­liv­er­ing nov­el ther­a­pies for the treat­ment of can­cer.”

Non­prof­it do­nates $3.4M to bat­tle Parkin­son’s

A Parkin­son’s dis­ease non­prof­it and Do­mainex are team­ing up to de­vel­op small mol­e­cule ther­a­pies that could po­ten­tial­ly slow the pro­gres­sion of the dis­ease by tar­get­ing neu­roin­flam­ma­tion.

Parkin­son’s UK will in­vest up to $3.42 mil­lion in the project through its drug de­vel­op­ment arm, dubbed the Parkin­son’s Vir­tu­al Biotech. Do­mainex will car­ry out drug dis­cov­ery, in the hopes of send­ing a can­di­date to clin­i­cal tri­als.

Pa­tients with Parkin­son’s ex­pe­ri­ence chron­ic in­flam­ma­tion in the brain, which is be­lieved to play a role in dam­ag­ing brain cells and caus­ing the con­di­tion. The or­ga­ni­za­tion has iden­ti­fied small mol­e­cules that tar­get a pro­tein on the sur­face of the mi­croglia, a main im­mune cell in the brain that can be­come over­ac­tive in Parkin­son’s.

“We look for­ward to work­ing with the team at Parkin­son’s UK and sup­port­ing the wider Parkin­son’s com­mu­ni­ty to progress the de­vel­op­ment of po­ten­tial­ly life-chang­ing med­i­cines,” Do­mainex CEO Tom Man­der said in a state­ment. “Hav­ing stud­ied mi­croglial cells dur­ing my DPhil and spent a good part of my ear­ly in­dus­tri­al ca­reer work­ing on macrophage ac­ti­va­tion, I am es­pe­cial­ly in­ter­est­ed to see whether a new ther­a­py emerges from our part­ner­ship.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Emer Cooke, EMA director (AP Photo/Geert Vanden Wijngaert)

Ahead of FDA, EMA rec­om­mends au­tho­riz­ing new gene ther­a­py treat­ment for ul­tra-rare dis­ease

Aromatic amino acid decarboxylase (AADC) deficiency is an ultra-rare genetic disease that leaves patients unable to produce certain hormones in the brain, such as dopamine and serotonin, usually leading to developmental delays, weak muscle tone and inability to control the movement of the limbs. It can also lead to multiple organ failure.

To date, there have been no treatments approved for AADC deficiency, which has been identified in less than 150 patients.

Ather­sys tries to post-hoc-an­a­lyze its way out of an­oth­er tri­al fail for stroke stem cell ther­a­py

Athersys’ stem cell therapy has failed yet again.

In a 206-person trial conducted in Japan, Athersys’ stem cell therapy for stroke failed its primary endpoint of “excellent outcome,” a combined measure of three stroke recovery scores.

While a greater percentage of patients in the treatment group reached the primary endpoint compared to placebo, that difference was not statistically significant.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.