Boehringer In­gel­heim VC backs plan to send GMO bac­te­ria af­ter tu­mors

Chris Thanos wants to send bac­te­ria af­ter your tu­mors.

Specif­i­cal­ly, he wants to send sal­mo­nel­la af­ter your tu­mors, a ge­net­i­cal­ly mod­i­fied form of the mi­crobe that he and his team have neutered and retro­fit­ted with ge­net­ic war­heads. It’s an at­trac­tive idea, at least to Boehringer In­gel­heim Ven­ture Fund and Panacea Ven­ture, who to­day co-led a $34 mil­lion Se­ries A round for Thanos’s Berke­ley-based com­pa­ny, Ac­tym Ther­a­peu­tics.

“Think about a cock­tail ther­a­py in a sin­gle drug,” Thanos, founder and CEO of the new com­pa­ny, told End­points News. “These en­gi­neered mi­crobes can eas­i­ly do that be­cause you can load up a de­sired com­bi­na­tion of pay­loads.”

The idea is a riff off on­colyt­ic virus­es. This form of treat­ment, first ap­proved in 2015, in­fects a pa­tient with a virus that, in turn, trig­gers an im­mune re­sponse against cer­tain tu­mors. The prob­lem, Thanos said, is that they can be giv­en on­ly once and they af­fect the en­tire body, po­ten­tial­ly caus­ing off-tar­get ef­fects as dos­ing in­creas­es.

The idea be­hind sal­mo­nel­la and oth­er bac­te­ria — and Ac­tym is not alone in this idea — is that you can en­gi­neer to se­lec­tive­ly grow in tu­mor mi­cro-en­vi­ron­ments, which are im­mune-sup­press­ing. When the can­cer cells con­sume the bac­te­ria, they give off vi­ral-like ge­net­ic ma­te­r­i­al that trig­ger an im­mune re­sponse, at­tract­ing T Cells and mono­cytes that go af­ter the tu­mor.

The idea, Thanos said, is to get the hom­ing ac­cu­ra­cy of bac­te­ria with the im­mune sig­nal­ing of virus­es.

“It’s the best of both worlds,” he said.

The com­pa­ny is still ear­ly stage. Thanos, who pre­vi­ous­ly worked at Halozyme and Sutro, and two oth­er co-founders in­cu­bat­ed over the past three years in Berke­ley. They’re up to 8 em­ploy­ees and are plan­ning to an­nounce a drug can­di­date by the end of the year, al­though Thanos ac­knowl­edged that Covid-19 could de­lay that time­line. They’ll start out try­ing to get the bac­te­ria to stim­u­late type 1 in­ter­fer­on. The goal, though, is to be able to hook up al­most any­thing to the mi­crobes: cy­tokines, al­ter­na­tive an­ti­body scaf­folds, even cy­to­tox­ic chem­i­cals. The last ap­proach would act like an an­ti­body-drug con­ju­gate, al­low­ing high dos­es of chemother­a­py to be de­liv­ered di­rect­ly to tu­mors.

”The sky’s the lim­it,” Thanos said.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images))

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would eliminate a federal mandate for animal testing for new drugs.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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