Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Sh­pigel­mach­er start­ed the project, he knew he’d have to fund it him­self. Every oth­er ef­fort of its kind was aca­d­e­m­ic, re­ject­ed as too risky by in­vestors.

Sh­pigel­mach­er, a ro­bot­ics geek and en­tre­pre­neur who had drift­ed in­to con­sult­ing for phar­ma, want­ed to build the re­al-life equiv­a­lent of tech­nol­o­gy from the 1960s film “Fan­tas­tic Voy­age,” the one where a sub­ma­rine crew is shrunk to “about the size of a mi­crobe” and sent on a mis­sion to re­pair a sci­en­tist’s brain. He scanned the lit­er­a­ture, found the lab that was work­ing on the most ad­vanced project — at the Max Planck In­sti­tute in Ger­many, it turned out — and start­ed fund­ing them with mon­ey from his and his co-founders’ own ac­counts, along with some seed cash from friends and fam­i­ly.

Five years lat­er, Sh­pigel­mach­er has a com­pa­ny, Bio­naut Labs, and even a few in­vestors will­ing to take a shot on what they pro­duced: a mil­lime­ter-sized, screw-shaped, cell-pen­e­trat­ing ro­bot, de­signed to drop bi­o­log­i­cal bombs on com­mand to pre­cise spots in the body. That in­cludes Khosla Ven­tures, the promi­nent Sil­i­con Val­ley tech VC, who is lead­ing a $20 mil­lion Se­ries A round for the biotech, help­ing push them and their re­mote-con­trolled ther­a­peu­tic to­ward the clin­ic for brain dis­or­ders, ide­al­ly by 2023.

“As far as I know, there is no oth­er com­pa­ny that does re­mote-con­trolled mi­cro-ro­bot­ics in the in­dus­try,” Sh­pigel­mach­er told End­points News. “We got it to the point where VCs were able to step in.”

The new ef­fort has pass­ing sim­i­lar­i­ties to the “ro­bot­ic pills” at de­vel­op­ment at Rani Ther­a­peu­tics and oth­er star­tups, but those, like any pill, can on­ly go to the gut, Sh­pigel­mach­er said. Bio­naut will try to re­mote guide their drug to or­gans through­out the body, de­vel­op­ing a se­ries of ro­bots with dif­fer­ent shapes and fea­tures for dif­fer­ent tasks and tis­sues.

The “bio­naut”

The goal for Bio­naut is broad­en­ing the so-called ther­a­peu­tic win­dow for drug de­vel­op­ment. For most drugs, de­vel­op­ers have to bal­ance a mol­e­cule’s abil­i­ty to, say, kill a tu­mor with the po­ten­tial harm it can do to all the oth­er cells ex­posed to it, cre­at­ing a nar­row win­dow for vi­able drugs. That win­dow ex­pands if you can de­posit the drug di­rect­ly in­to the part of the body where the dis­ease is based.

The biotech chose to fo­cus first on neu­rol­o­gy be­cause it’s an area where com­pa­nies have re­peat­ed­ly failed, and where the fail­ure of­ten traces back to how well they can de­liv­er to the brain, or spe­cif­ic parts of the brain. Their first pro­gram is for a rare and fa­tal child­hood tu­mor that ap­pears on the brain stem.

Es­sen­tial­ly, the com­pa­ny will load chemother­a­py on­to the mi­ni-ro­bots, in­ject them in­to the cen­tral ner­vous sys­tem and use a mag­net­ic wire to guide it to the tu­mor, where it drops the pay­load.

“We don’t want to start from con­cepts that sound too risky or untest­ed,” he said. “We know that if we get this thing to the tar­get, it’s go­ing to work.”

Even­tu­al­ly, though, the com­pa­ny al­so wants to de­liv­er var­i­ous oth­er tech­nolo­gies, in­clud­ing gene ther­a­pies, on­colyt­ic virus­es and an­ti­sense oligonu­cleotides. Ide­al­ly, they could more pre­cise­ly tar­get drugs al­ready be­ing de­vel­oped for neu­ro­log­i­cal dis­eases. For ex­am­ple, a Parkin­son’s drug might be more ef­fec­tive if it were de­liv­ered di­rect­ly in­to the sub­stan­tia ni­gra, a re­gion at the cen­ter of the brain where much of the de­gen­er­a­tion plays out.

Sh­pigel­mach­er said the com­pa­ny raised their Se­ries A in mid-2019 and wait­ed un­til they had suf­fi­cient proof-of-con­cept da­ta to be con­fi­dent they were on track for the clin­ic. Still, it re­mains ear­ly stage and the com­pa­ny’s in­vestors come en­tire­ly from the tech world, with a cou­ple, such as Khosla, that have been re­cent­ly inch­ing in­to biotech.

“We are thrilled to bring Bio­naut Labs out of stealth mode as it typ­i­fies the type of new im­pact­ful tech­nol­o­gy com­pa­nies we like to help build,” said Vin­od Khosla, founder of Khosla Ven­tures, which has been in­creas­ing­ly inch­ing in­to biotech over the past few years. “Bio­nauts hold great promise as a new tar­get­ed treat­ment modal­i­ty for se­vere brain dis­or­ders for which there are few, if any, ef­fec­tive treat­ment op­tions. More­over, the broad ther­a­peu­tic po­ten­tial of Bio­naut ex­tends to many dis­eases where con­ven­tion­al ther­a­pies are lim­it­ed or lack­ing.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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