Big Phar­ma VC firms put $11M in seed funds be­hind can­cer start­up with bold vi­sion

The ven­ture arms of three Big Phar­mas have jumped in to seed a Swiss can­cer start­up with a bold twist on tar­get­ed ther­a­py that, the founders say, could have ef­fects on vir­tu­al­ly every type of can­cer.

No­var­tis Ven­tures, Pfiz­er Ven­tures and Mer­ck’s M Ven­tures, along with Omega and LSP, have seed­ed FoRx Ther­a­peu­tics with €10 mil­lion ($11 mil­lion). The biotech, found­ed by syn­thet­ic bi­ol­o­gy pi­o­neer Thanos Ha­la­zonetis, will look to tar­get and dis­rupt a DNA re­pair mech­a­nism he dis­cov­ered sev­er­al years ago and that, he said,  al­most all can­cers re­ly on to pro­lif­er­ate.

“This is a fea­ture of al­most all can­cers,” Ha­la­zonetis told End­points News. “Nor­mal cells are not af­fect­ed.”

Thanos Ha­la­zonetis

The com­pa­ny re­lies on a con­cept known as syn­thet­ic lethal­i­ty. Gen­er­al­ly, that refers to when a par­tic­u­lar mu­ta­tion helps gives rise to can­cer but al­so makes that can­cer re­liant on cer­tain process­es that nor­mal cells don’t re­ly on. The most fa­mous ex­am­ple is PARP in­hibitor. Pa­tients with mu­ta­tions in a DNA re­pair en­zyme called BR­CA1 or BR­CA2 are prone to can­cer. Be­cause those can­cer cells, though, are miss­ing one func­tion­ing DNA re­pair en­zyme, they be­come re­liant on a dif­fer­ent one, called PARP, to prop­er­ly repli­cate.

New biotechs, such as Third Rock Ven­ture’s Tan­go Ther­a­peu­tics, are us­ing tech­nol­o­gy like CRISPR screens to find new pairs of genes that are sim­i­lar­ly linked.

FoRx, though, is go­ing af­ter a path­way they say vir­tu­al­ly all can­cer cells re­ly on, called the break-in­duced repli­ca­tion path­way. Ba­si­cal­ly, nor­mal healthy cells be­gin DNA repli­ca­tion at pre­cise points on the dou­ble he­lix. Can­cers with onco­genes, though, in their rush to prop­a­gate as fast as pos­si­ble, start at the wrong point. Strands that be­gin copy­ing them­selves at the wrong point even­tu­al­ly bump up against the rest of the tran­scrip­tion­al ma­chin­ery, col­li­sions that in­ter­fere with their abil­i­ty to copy.

“It’s like some­one try­ing to run too fast and they trip and fall down,” Ha­la­zonetis said.

Can­cer cells can sur­vive this, though, be­cause all cells have pro­teins to fix the dam­age wrought when DNA re­pairs at the wrong start­ing point. FoRx plans to block those pro­teins. Ha­la­zonetis said this should kill can­cer cells but should have lit­tle ef­fect on healthy cells, who rarely need to use this method of re­pair­ing their DNA.

“As far as we know, there are no oth­er biotechs fo­cus­ing on this,” Vin­cent Os­sipow, a part­ner at Omega and a FoRx board mem­ber, told End­points.

Os­sipow com­pared this in­vest­ment to Omega’s past ef­forts to get in on the ground floor of new can­cer re­search, in­clud­ing with bis­pe­cif­ic an­ti­bod­ies and on­colyt­ic virus­es.

Ha­la­zonetis first pub­lished on the dis­cov­ery of the path­way in Na­ture in 2005, and fur­ther on how it works and might be drugged in 2014 in Sci­ence, and again in Na­ture in 2018. Be­cause the path­way is used by vir­tu­al­ly all can­cers, Ha­la­zonetis sug­gest­ed that it should not lead to the re­sis­tance most oth­er tar­get­ed can­cer ther­a­pies even­tu­al­ly give rise to.

The spe­cif­ic com­pounds the FoRx might use, though, re­main un­der wraps. They hope to bounce a tar­get in the next 18-24 months and be in the clin­ic 12-18 months af­ter that. They will go first af­ter can­cers that lack good tar­get­ed op­tions, such as colon can­cer, with the goal of be­com­ing lead­ers in syn­thet­ic lethal­i­ty.

“It’s a hot but not yet crowd­ed land­scape,” Therese Maria Liecht­en­stein of M Ven­tures told End­points. “Thanos is a pi­o­neer.”

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Covid-19 roundup: Sanofi and GSK pledge 200M vac­cine dos­es for a glob­al dis­tri­b­u­tion cam­paign

Sanofi and GSK have agreed to give 200 million doses of their vaccine candidate to the COVAX Facility, which is part of a program set up by CEPI, the WHO and Gavi to equitably distribute vaccines around the world.

The idea behind COVAX is to give all participating countries equal access to vaccines, regardless of income level. As of Oct 14, more than 180 countries had signed agreements to the COVAX Facility, including France and the UK. China joined earlier this month, pledging to make its vaccines a “global public good.” One country notably off the list is the United States.

UP­DAT­ED: Re­searchers shut­ter 2 Covid-19 stud­ies as mon­i­tors flag Eli Lil­ly an­ti­bod­ies as a flop for pneu­mo­nia, hos­pi­tal­ized pa­tients — but EUA hunt con­tin­ues

Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.

The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.