David Ho (L) and Yaoxing Huang (RenBio)

HIV re­searcher David Ho has a new line of at­tack on SARS-CoV-2, and his fledg­ling start­up is gun­ning for the clin­ic

The famed AIDS re­searcher David Ho start­ed off the Covid-19 pan­dem­ic work­ing to de­vel­op an an­ti­body against the SARS-CoV-2 virus, but now he’s be­hind a new biotech that’s tak­ing a slight­ly dif­fer­ent ap­proach to fight the dis­ease.

Ho is a co-founder of Ren­Bio, which pulled in its first fundraise Thurs­day morn­ing with a $24 mil­lion Se­ries A, the com­pa­ny an­nounced. The biotech is pour­ing its first ef­forts in­to a bis­pe­cif­ic an­ti­body tar­get­ing two sites on the SARS-CoV-2 spike pro­tein, and is tout­ing ac­tiv­i­ty against sev­er­al Covid-19 vari­ants of con­cern in­clud­ing strains orig­i­nat­ing from the UK, South Africa and Brazil, among oth­ers.

Funds from the raise are ex­pect­ed to help com­plete IND en­abling stud­ies and ad­vance a Phase I/II clin­i­cal tri­al for the bis­pe­cif­ic, dubbed RB-100, some­time around the end of 2021. Co­lum­bia Uni­ver­si­ty, which hous­es Ho’s lab and li­censed the an­ti­body to Ren­Bio, has re­tained an eq­ui­ty stake in the com­pa­ny, the size of which was not dis­closed.

Yaox­ing Huang is Ren­Bio’s oth­er co-founder, one of Ho’s col­leagues at Co­lum­bia.

When the pan­dem­ic got un­der­way, Ho and his team worked to iso­late an­ti­bod­ies from Covid-19 pa­tients. He not­ed in an an­nounce­ment from Co­lum­bia last Ju­ly that his team had been work­ing “non­stop 24/7 since ear­ly March,” shift­ing their fo­cus al­most en­tire­ly away from AIDS to try to coun­ter­act the pan­dem­ic. They pub­lished their find­ings in Na­ture that month as well.

Two of the an­ti­bod­ies from the lab have since been li­censed to un­named phar­ma com­pa­nies, but Ho warned in a pa­per ear­li­er this year that emerg­ing virus vari­ants pose a threat to mon­o­clon­al an­ti­body ther­a­pies for Covid-19. The South Africa vari­ant was par­tic­u­lar­ly trou­ble­some for the cock­tails, with Ho writ­ing their abil­i­ty to neu­tral­ize was “com­plete­ly or marked­ly abol­ished.”

Neal Padte

Con­cern over such vari­ants was top of mind for Ren­Bio COO Neal Padte and R&D di­rec­tor Rachel Lib­er­a­tore when they de­cid­ed to li­cense Ho’s new bis­pe­cif­ic. Padte had worked with Ho in an­ti­body de­vel­op­ment for about a decade, he told End­points News, and they felt li­cens­ing RB-100 out to Ren­Bio was the best way to get it in­to the clin­ic.

The rise in vari­ants was al­so one of the main rea­sons Ren­Bio de­cid­ed to take on the pro­gram, Lib­er­a­tore said, and with more strains con­tin­u­ing to emerge, she not­ed that a bis­pe­cif­ic mod­el could end up be­ing the new nor­mal to treat fu­ture Covid-19 cas­es.

“I think there’s a grow­ing un­der­stand­ing that the more [ar­eas] a ther­a­peu­tic can tar­get on the virus, the more breadth it will have and hope­ful­ly the longer it will stay rel­e­vant,” Lib­er­a­tore told End­points. “The idea of sin­gle mon­o­clon­als as ther­a­peu­tics is re­al­ly sort of wan­ing in pop­u­lar­i­ty in fa­vor of this idea of a mul­ti-pronged ap­proach, whether it’s a cock­tail of mon­o­clon­als or bis­pecifics.”

Though Ren­Bio is get­ting start­ed with this in-li­censed pro­gram, its core tech­nol­o­gy is some­thing sep­a­rate. It’s still fo­cused around an­ti­bod­ies with a lead pre­clin­i­cal can­di­date for SARS-CoV-2, and al­so spun out of work with Ho and Huang.

Rachel Lib­er­a­tore

The orig­i­nal in­ter­est here came from want­i­ng to de­vel­op an­ti­bod­ies against HIV, as it specif­i­cal­ly spawned out of Ho’s AIDS Re­search Cen­ter, Lib­er­a­tore not­ed. Such ther­a­pies are gen­er­al­ly cost pro­hib­i­tive and time-con­sum­ing for pa­tients, how­ev­er, and Ren­Bio’s goal with the plat­form is to ad­dress the af­ford­abil­i­ty and dura­bil­i­ty of an­ti­body ther­a­pies.

“In the HIV field, it is a well-known fact that neu­tral­iz­ing an­ti­bod­ies that ex­ist are very broad and po­tent as pro­phy­lac­tic and ther­a­peu­tic agents, but are very ex­pen­sive,” Lib­er­a­tore said. “We took that and de­vel­oped that at Ren­Bio in­to an idea for the broad-based de­liv­ery of an­ti­bod­ies, but al­so for many oth­er clin­i­cal in­di­ca­tions and in­flam­ma­to­ry dis­eases.”

Lib­er­a­tore added that the team’s train­ing in in­fec­tious dis­eases led them to this area first, de­spite the broad in­ter­est. Be­hind the pre­clin­i­cal SARS-CoV-2 can­di­date, Ren­Bio is al­so de­vel­op­ing a pro­gram for in­fluen­za and po­ten­tial­ly HIV.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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