Sung Joo Lee, Orum Therapeutics CEO

In­vestors give Orum Ther­a­peu­tic­s' unique take on pro­tein de­graders an­oth­er nudge to­ward the clin­ic

While pro­tein de­graders have seen an in­flux of cash in re­cent years, small mol­e­cule drugs can run in­to tox­i­c­i­ty prob­lems, due to their dif­fi­cul­ty dif­fer­en­ti­at­ing healthy cells from can­cer­ous ones, Sung Joo Lee said. His com­pa­ny Orum Ther­a­peu­tics thinks it has a so­lu­tion — and the idea has in­vestors reach­ing a lit­tle deep­er in­to their pock­ets.

Orum closed its Se­ries B round for the sec­ond time on Wednes­day morn­ing, rak­ing in an ex­tra $54 mil­lion. The team had ini­tial­ly raised $30 mil­lion back in 2019, and the suc­ces­sive round came as the re­sult of on­go­ing “or­gan­ic dis­cus­sion” with ex­ist­ing in­vestors, ac­cord­ing to CFO Jae Won Kim.

Jae Won Kim

The com­pa­ny is look­ing to con­ju­gate pro­tein de­graders to an an­ti­body, cre­at­ing first-in-class AD­Cs, or as Orum calls them, AnD­Cs: an­ti­body neode­grad­er con­ju­gates. The con­cept is sim­i­lar to tra­di­tion­al AD­Cs, which con­sist of a can­cer-killing tox­in at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. Ex­cept in this case, the pay­load is a pro­tein de­grad­er.

With pro­tein de­graders, the idea is to make en­tire pro­teins dis­ap­pear us­ing the body’s nat­ur­al garbage dis­pos­al sys­tem. Orum’s pro­tein de­graders de­ploy ubiq­ui­tin tags, which sig­nal the pro­tea­some to pick up the tar­get pro­tein, un­fold it and de­grade it in­to small frag­ments. What’s dif­fer­ent here is that the an­ti­body com­po­nent of the AnDC di­rects the pro­tein de­grad­er right to the cy­tosol — the aque­ous com­po­nent of the cy­to­plasm — of tar­get cells, which Lee thinks could make the drugs safer and more ef­fec­tive than oth­er can­di­dates.

“We are bring­ing a very unique pay­load,” the CEO said. “What we’re do­ing is we’re con­ju­gat­ing to an an­ti­body that is in­ter­nal­ized specif­i­cal­ly to a tu­mor cell so ide­al­ly … with a low­er dose of the drug, we could achieve a high­er ef­fi­ca­cy and low­er risk of tox­i­c­i­ty.”

The com­pa­ny has two lead can­di­dates in the works — ORM-5029 for sol­id tu­mors and ORM-6151 for hema­to­log­i­cal can­cers — which are ex­pect­ed to hit the clin­ic in 2022 and 2023, re­spec­tive­ly. Orum will use the new round — led by IMM In­vest­ment with KDB In­vest­ment, At­inum, In­ter­vest, KB In­vest­ment, and oth­ers chim­ing in — to ad­vance those two can­di­dates to­ward the clin­ic.

A steady stream of fund­ing flowed in­to pro­tein degra­da­tion last year. Back in March, Nurix and Kymera scooped up a to­tal of $222 mil­lion in con­sec­u­tive days. And a month lat­er, Am­phista launched with a $7.5 mil­lion Se­ries A and help from field ex­pert Alessio Ciul­li. C4 Ther­a­peu­tics made the jump to Nas­daq in Oc­to­ber.

Be­fore launch­ing Orum with an $8 mil­lion Se­ries A back in 2017, Lee worked at Sanofi, where he was head of re­search in the Asia Pa­cif­ic R&D unit.

“I felt that some in­no­v­a­tive nov­el plat­forms, they have a more vivid or vi­brant life in a small biotech, so I de­cid­ed to leave Sanofi and start a new com­pa­ny,” he said. “So far it’s been very fo­cused, very quick, and we’ve made a lot of progress so I’m quite hap­py I made that move.”

The lede has been up­dat­ed to clar­i­fy that Lee was re­fer­ring to tox­i­c­i­ty re­lat­ed to small mol­e­cule drugs in gen­er­al.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”