Backed by gi­ants, an­tibi­otics up­start Macrolide gets $20M and an ex-No­var­tis ex­ec as CEO

An an­tibi­otics start­up found­ed by the same guy who start­ed boom-and-bust an­tibi­otics com­pa­ny Tetraphase has hauled in $20 mil­lion in new cap­i­tal and a long­time No­var­tis ex­ec­u­tive as its new pres­i­dent and CEO.

Ma­hesh Karande

With cash in hand and a new chief at the helm, the com­pa­ny plans to tack­le some of the most dan­ger­ous su­per­bugs around by tweak­ing an old class of an­tibi­otics.

Wa­ter­town, MA-based Macrolide Phar­ma­ceu­ti­cals raised the Se­ries B round from three phar­ma gi­ants, in­clud­ing the ven­ture arms of Glax­o­SmithK­line (SR One), No­var­tis (No­var­tis Ven­ture Fund), and Roche (Roche Ven­tures), among oth­er in­vestors.

Macrolide al­so has a big phar­ma ex­ec­u­tive on board with the re­cruit­ment of Ma­hesh Karande, who spent sev­er­al years hop­ping around the world lead­ing No­var­tis’ in­ter­na­tion­al busi­ness units. He was a VP and on­col­o­gy busi­ness head in the US, pres­i­dent and phar­ma head for Africa and Egypt, and head of strat­e­gy and busi­ness de­vel­op­ment for Asia-Pa­cif­ic, Mid­dle East and Africa. But Karande left No­var­tis last year to join Intar­cia as VP and gen­er­al man­ag­er — a role he left to take the helm at Macrolide.

As its name sug­gests, Macrolide (the com­pa­ny) is fo­cused on macrolides, a class of an­tibi­otics that has been wide­ly used for decades to treat pneu­mo­nia and oth­er bac­te­r­i­al in­fec­tions. The ef­fec­tive­ness of these an­tibi­otics has been neg­a­tive­ly im­pact­ed by bac­te­ria’s frus­trat­ing abil­i­ty to be­come im­mune to drugs.

An­drew My­ers

But Macrolide says its found a way to en­gi­neer a so­lu­tion. The start­up was found­ed on tech from the lab of An­drew My­ers, a Har­vard Uni­ver­si­ty chemist. You might rec­og­nize My­ers as the guy who co-found­ed Tetraphase, an an­tibi­otics mak­er that grew to a pub­lic val­u­a­tion of over $1 bil­lion be­fore crash­ing hard fol­low­ing a Phase III flop of its lead an­tibi­ot­ic.

Macrolide has an ex­clu­sive li­cense from My­ers’ lab that gives the start­up ac­cess to tech­nol­o­gy to en­gi­neer syn­thet­ic macrolides from scratch. Macrolide says its tech can ex­pand the ther­a­peu­tic range of these drugs to in­clude not just gram-pos­i­tive in­fec­tions, but al­so gram-neg­a­tive ones — those dan­ger­ous in­fec­tions for which treat­ments are lim­it­ed.

The new fi­nanc­ing round is meant to sup­port work that will back up an IND ap­pli­ca­tion for its lead pro­gram for re­sis­tant gram-neg­a­tive pathogens.

“This po­si­tions Macrolide to fur­ther the pi­o­neer­ing work the team has done to date in ad­vanc­ing new macrolide an­tibi­otics with Gram-neg­a­tive ac­tiv­i­ty,” Karande said in a state­ment. “We be­lieve that ad­vanc­ing first-in-class an­tibi­otics that are ac­tive against lethal mul­ti-drug re­sis­tant bac­te­ria opens the door to a new and mean­ing­ful way to ad­dress the grow­ing pub­lic health is­sue of treat­ment gaps due to an­tibi­ot­ic re­sis­tance.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rajesh Devraj, Rectify Pharmaceuticals CEO

At­las backs a long­time Ver­tex em­ploy­ee’s quest to bring CF suc­cess to nu­mer­ous oth­er dis­eases

One of Vertex’s longest-tenured employees believes he can take the biotech’s biggest medical and scientific accomplishments and use it to develop treatments for more than just cystic fibrosis.

Three years ago, Jonathan Moore, a scientist and then executive at Vertex from 1990 to 2018, founded a company to develop treatments for diseases that, like CF, are caused by mutations in a “super family” of proteins known as ABC transporters.