An Ox­ford spin­out rais­es $44M as it looks to res­ur­rect an old Roche an­ti­body in pur­suit of a rare dis­ease

Three months ago, a small and lit­tle-known Ox­ford Uni­ver­si­ty spin­out called Celleron an­nounced they would try to res­ur­rect an an­ti­body Roche re­tired back in 2018. Now that spin­out is spin­ning out its own new com­pa­ny and rais­ing cash from a high-pro­file in­vestor to push that an­ti­body through the clin­ic.

Francesco De Ru­ber­tis

Backed with €37 mil­lion in Se­ries A cash, Syn­Ox Ther­a­peu­tics will look to de­vel­op the an­ti­body, known as emac­tuzum­ab, for tenosyn­ovial gi­ant cell tu­mours (TGCT), a rare dis­ease where se­ries of be­nign tu­mors be­gin to grow around the joints and ten­dons. Health­Cap and Medicxi led the round and were joined by For­bion and Gimv.

Medicxi part­ner Francesco De Ru­ber­tis tout­ed the drug as an all-but-proven as­set for this dis­ease.

“We are ex­cit­ed to sup­port Syn­Ox in its con­tin­ued de­vel­op­ment of emac­tuzum­ab, an agent which has demon­strat­ed pro­found ef­fi­ca­cy in­over 60 TGCT pa­tients treat­ed to date,” he said.

John Reed Sanofi

A fa­vorite of John Reed’s back be­fore he left for Sanofi, emac­tuzum­ab was one of sev­er­al an­ti­bod­ies in de­vel­op­ment across phar­ma meant to block CSF1R. The re­cep­tor is found on in­nate im­mune cells called macrophages that swarm around tu­mors and, counter-in­tu­itive­ly, can help the tu­mor evade the rest of the im­mune sys­tem and grow. They test­ed it in com­bi­na­tion with their PD-1 in­hibitor Tecen­triq on the the­o­ry that it could help T cells en­ter the tu­mor’s mi­cro-en­vi­ron­ment and en­hance the check­point block­er’s ef­fi­ca­cy.

Al­though the drug showed re­sults as a monother­a­py, com­bin­ing it with Tecen­triq didn’t ap­pear to of­fer any ben­e­fit over Tecen­triq alone and Roche shelved it as part of a sweep out of the pipeline.

The drug, though, al­ways had ap­plic­a­bil­i­ty in at least one rare dis­ease out­side can­cer: TGCT. The dis­ease oc­curs when cells over­pro­duce CSF1R, mak­ing it a clear tar­get when com­pa­nies be­gan de­vel­op­ing mol­e­cules that in­hib­it the re­cep­tor. Al­though Roche chose not to pur­sue late-stage tri­als, they pub­lished a study in The Lancet that showed 24 out of 28 TGCT pa­tients re­spond­ed, with two pa­tients hav­ing a com­plete re­sponse.

Nick La Thangue

Syn­Ox said they could pur­sue oth­er in­di­ca­tions, but their main job will be to bring it through late-stage test­ing, try­ing to find the path of least re­sis­tance through the FDA.

“Syn­Ox will be fo­cused on gen­er­at­ing all nec­es­sary da­ta to reg­is­ter this new ther­a­py in a time- and cost-ef­fi­cient way,” Nick La Thangue, a pro­fes­sor of can­cer bi­ol­o­gy and CEO of the new com­pa­ny, said in a state­ment.

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.

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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.

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.

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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.

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Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.

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.

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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.

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