News brief­ing: Mer­ck buys in­to A2's T cell ther­a­py plat­form; Small Soli­genix re­ports PhI­II fail in head and neck can­cer

Mer­ck is dip­ping its toes in­to a cell ther­a­py part­ner­ship with A2 Bio­ther­a­peu­tics, with an of­fer to co-fund clin­i­cal de­vel­op­ment and al­lo­gene­ic man­u­fac­tur­ing ac­tiv­i­ties through Phase I.

In par­tic­u­lar, the phar­ma gi­ant has its eyes on an undis­closed can­di­date uti­liz­ing A2’s Tmod plat­form, which com­bines ac­ti­va­tion and block­ing mech­a­nisms in or­der to kill tu­mor cells while spar­ing healthy ones.

The deal fea­tures an up­front, an eq­ui­ty in­vest­ment and re­im­burse­ment of cer­tain ex­pens­es. Mer­ck is al­so promis­ing opt-in and mile­stone pay­ments plus roy­al­ties, while keep­ing the door open for col­lab­o­ra­tion on a sep­a­rate pro­gram.

A2 Bio­ther­a­peu­tics, which closed $71.5 mil­lion in Se­ries B fund­ing in Oc­to­ber, has two oth­er pro­grams that are fur­ther along in the lead op­ti­miza­tion phase.

The new pact “brings Mer­ck’s im­munother­a­py and oth­er ex­per­tise for the Tmod can­di­date es­pe­cial­ly in the lat­er stages of de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion and en­ables A2 to build al­lo­gene­ic prod­uct de­vel­op­ment and man­u­fac­tur­ing ca­pa­bil­i­ties,” said Scott Forak­er, A2’s pres­i­dent and CEO. — Am­ber Tong

Soli­genix shares crushed af­ter PhI­II flop in head and neck can­cer

Small rare dis­eases biotech Soli­genix $SNGX did not have a good Tues­day.

The Prince­ton, NJ-based com­pa­ny post­ed a Phase III fail in head and neck can­cer, say­ing its SGX942 pro­gram did not pro­duce a sta­tis­ti­cal­ly sig­nif­i­cant out­come. Soli­genix had been look­ing to treat se­vere­ly in­flamed mu­cous mem­branes re­sult­ing from oth­er can­cer ther­a­pies, but came up short.

Tues­day’s news crushed the com­pa­ny’s stock price, as shares were sliced by more than half at a 54% drop as the mar­ket opened. The price re­bound­ed slight­ly by the end of the day, but still re­sult­ed in a 49% loss.

Soli­genix did not re­port a p-val­ue from the pri­ma­ry end­point, which was the me­di­an du­ra­tion of se­vere oral mu­cosi­tis. They did note the da­ta showed a 56% re­duc­tion com­pared to place­bo, as the me­di­an in the con­trol arm came in at 18 days and 8 days in the treat­ment arm.

The com­pa­ny tried to shine a light on a pos­i­tive sec­ondary end­point — 50% re­duc­tion in the du­ra­tion of SOM in the per-pro­to­col pop­u­la­tion. Soli­genix’s p-val­ue came in here at 0.049, just clear­ing the sta­tis­ti­cal­ly sig­nif­i­cant hur­dle. The biotech said this end­point may point to some ev­i­dence of bi­o­log­i­cal ac­tiv­i­ty.

The study en­rolled 268 pa­tients ran­dom­ized 1:1 to re­ceive ei­ther SGX942 or place­bo. Soli­genix said it will turn its at­ten­tion to­ward an­oth­er pro­gram, SGX301, in the treat­ment of cu­ta­neous T cell lym­phoma. — Max Gel­man

Bridge­Bio goes to neigh­bors at UCSF for gene ther­a­py ideas

Tap­ping a new source for new gene ther­a­py pro­grams, Bridge­Bio has set up a three-year al­liance with the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co to iden­ti­fy ear­ly trans­la­tion­al re­search that it can ac­cel­er­ate in­to the clin­ic.

Bridge­Bio, which is based in the Bay Area, said the deal fol­lows a six-month pi­lot and is de­signed to for­mal­ize col­lab­o­ra­tive re­la­tion­ships with aca­d­e­m­ic sci­en­tists.

The col­lab­o­ra­tions may ini­tial­ly take the form of spon­sored re­search agree­ments with cer­tain labs, it added, which may then lead to cre­ation of new af­fil­i­ate com­pa­nies un­der the Bridge­Bio port­fo­lio.

That pipeline cur­rent­ly lists three pro­grams, uti­liz­ing AAV vec­tors to de­liv­er cor­rec­tive genes for con­gen­i­tal adren­al hy­per­pla­sia, Cana­van dis­ease and non­syn­dromic hear­ing loss, re­spec­tive­ly.

They are ready for more. Ear­li­er this year, Bridge­Bio inked an agree­ment with Catal­ent to se­cure ded­i­cat­ed gene ther­a­py de­vel­op­ment and man­u­fac­tur­ing ca­pac­i­ty to sup­port its needs down the line. — Am­ber Tong

Grit­stone rais­es $110M in pri­vate place­ment fund­ing

Grit­stone On­col­o­gy $GRTS has some new cash to play with.

The Emeryville, CA-based biotech an­nounced Wednes­day morn­ing it had raised $110 mil­lion in pri­vate place­ment fund­ing. Wednes­day’s deal val­ued com­pa­ny shares at $3.34 apiece, or Tues­day’s clos­ing price, and Grit­stone said the fund­ing would be pri­mar­i­ly di­rect­ed to­ward its GRAN­ITE and SLATE pipeline can­di­dates, two can­cer im­munother­a­pies.

News of the fund­ing was met with cheers by in­vestors, as Grit­stone’s stock was up more than 13% in ear­ly Wednes­day trad­ing.

GRAN­ITE, a per­son­al­ized neoanti­gen-based im­munother­a­py, is be­ing eval­u­at­ed in com­bi­na­tion stud­ies in the Phase II por­tion of a Phase I/II study for mi­crosatel­lite sta­ble col­orec­tal can­cer. SLATE is al­so neoanti­gen-based and us­es the same de­liv­ery sys­tem as GRAN­ITE, but con­tains a fixed set of anti­gens rather than per­son­al­ized. It’s al­so be­ing looked at in com­bi­na­tion stud­ies at the Phase II por­tion of a Phase I/II tri­al for NSCLC.

The fi­nanc­ing was led by ex­ist­ing and new in­vestors, in­clud­ing Red­mile Group, Avid­i­ty Part­ners and EcoR1 Cap­i­tal. The deal is ex­pect­ed to close by Dec. 28. — Max Gel­man

Ep­silon Mol­e­c­u­lar En­gi­neer­ing clos­es ex­tend­ed Se­ries A round 

Af­ter clos­ing its Se­ries A round, Ep­silon Mol­e­c­u­lar En­gi­neer­ing opened it back up, bag­ging ¥570 mil­lion ($5.5 mil­lion) to­tal from in­vestors, two bank loans and leas­ing.

The Saita­ma Uni­ver­si­ty spin­out will use the funds for its work with heavy chain sin­gle do­main an­ti­bod­ies, in­clud­ing col­lab­o­ra­tive re­search with Ki­tasato Uni­ver­si­ty and Kao Cor­po­ra­tion on po­ten­tial Covid-19 treat­ments.

“EME aims to dis­cov­er medi­um sized mol­e­c­u­lar bio-drugs with new modal­i­ties us­ing its pro­pri­etary VHH tech­nol­o­gy,” pres­i­dent Nao­to Nemo­to said in a state­ment. “We will lever­age this fi­nanc­ing to ac­cel­er­ate col­lab­o­ra­tive re­search with phar­ma­ceu­ti­cal man­u­fac­tur­ers and in­ter­nal re­search us­ing its own pipeline.”

The round was led by Mit­subishi UFJ Cap­i­tal, with help from Gun­ma Med­ical En­gi­neer­ing Vi­tal­iza­tion In­vest­ments, Gun­ma Bank and Kao Cor­po­ra­tion. EME al­so went for­ward with a sub­or­di­nat­ed loan from Shoko Chukin Bank, a loan from Saita­ma Res­ona Bank, and a lease from Syu­to­ken Leas­ing. — Nicole De­Feud­is 

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.