Take­da hops on­to $61M round for CRISPR play­er syn­the­siz­ing Cas9 al­ter­na­tives

Take­da Ven­tures and Or­biMed have helped pump $61 mil­lion in­to a New York biotech join­ing the rush to dra­mat­i­cal­ly ex­pand the CRISPR tool kit.

One cru­cial com­po­nent in the CRISPR gene edit­ing process is a nu­cle­ase that cuts the tar­get DNA once it’s led there by a guide RNA. Cas9 is the most well known and broad­ly used among them, al­though re­searchers have been com­ing up with a va­ri­ety of al­ter­na­tives. The one that Emen­do Bio­ther­a­peu­tics will be ad­vanc­ing with its new fund­ing is dubbed OM­NI.

Their class of “op­ti­mized” en­zymes, ac­cord­ing to Emen­do, opens a new lev­el of pre­ci­sion un­at­tain­able with old­er ap­proach­es.

“For ex­am­ple, to treat dom­i­nant in­di­ca­tions, one al­lele needs to be edit­ed while leav­ing the oth­er one in­tact. Cur­rent CRISPR nu­cle­as­es are not spe­cif­ic enough to do this,” the biotech wrote on its web­site. “Dom­i­nant in­di­ca­tions are the vast ma­jor­i­ty of ge­net­ic dis­eases, high­light­ing the need for a nov­el ap­proach.”

That plat­form tech has at­tract­ed Take­da to a part­ner­ship in which Emen­do will syn­the­size OM­NI nu­cle­as­es for two undis­closed tar­gets. In re­turn, the Japan­ese phar­ma gi­ant agreed to par­tic­i­pate in this new fi­nanc­ing along­side Or­biMed Ad­vi­sors, Or­biMed Is­rael Part­ners and AnGes.

Tokyo and Os­a­ka-based AnGes was re­spon­si­ble for $50 mil­lion of the raise, up­ping its stake in Emen­do to 32%, ac­cord­ing to a fil­ing last month.

“Mak­ing Emen­do an af­fil­i­at­ed com­pa­ny of AnGes will as­sist us in the de­vel­op­ment of bio­phar­ma­ceu­ti­cals through genome edit­ing, mak­ing it pos­si­ble to fur­ther ex­pand our­de­vel­op­ment pipeline as the fourth pil­lar of our op­er­a­tions af­ter HGF gene ther­a­py,nu­cle­ic-acid med­i­cines, and DNA vac­cines,” AnGes wrote.

Emen­do, which has an R&D op­er­a­tion in Is­rael, is col­lab­o­rat­ing with the Uni­ver­si­ty of Wash­ing­ton and Seat­tle Chil­dren’s Hos­pi­tal on its lead pro­gram se­vere con­gen­i­tal neu­trope­nia. Oth­er pro­grams in pri­ma­ry im­mun­od­e­fi­cien­cy, bone mar­row fail­ure, in­her­it­ed eye dis­ease and can­cer are al­so at­tached to pres­ti­gious aca­d­e­m­ic part­ners.

So­cial im­age: Take­da

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

CDC’s Robert Redford, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA, ques­tions need to length­en process

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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