Patrick Lu (Sirnaomics)

Short­ly af­ter its lat­est mega-round, Sir­naomics CEO Patrick Lu says it's time to go pub­lic

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Af­ter briefly putting off an IPO to pull in a $105 mil­lion Se­ries E round ear­li­er this month, Sir­naomics has filed for a Hong Kong pub­lic de­but.

CEO Patrick Lu is plan­ning on us­ing about half the pro­ceeds to de­vel­op and (if all goes well) com­mer­cial­ize one of the com­pa­ny’s lead small in­ter­fer­ing RNA (siR­NA) can­di­dates, STP705. Back in De­cem­ber, Sir­naomics said the can­di­date helped clear tu­mor cells in pa­tients with squa­mous cell skin can­cer in a Phase IIa tri­al.

siR­NA ther­a­peu­tics were pop­u­lar­ized by Al­ny­lam, which scored the first OK in the field with On­pat­tro back in 2018. They work by kick­ing off ac­tion in the RNA-in­duced si­lenc­ing com­plex, which then goes on to cleave a spe­cif­ic mR­NA, there­by down­reg­u­lat­ing tar­get genes.

How­ev­er, Sir­naomics thinks it has a bet­ter ve­hi­cle to car­ry the siR­NA car­go to cells: a polypep­tide nanopar­ti­cle, or PNP. The pep­tide is biodegrad­able, of­fers pro­tec­tion to the siR­NA while in the blood­stream, and can car­ry mul­ti­ple siR­NA se­quences, al­low­ing the com­pa­ny’s prod­ucts to go af­ter mul­ti­ple genes at once.

“Based on suc­cess­ful clin­i­cal and pre­clin­i­cal stud­ies, a fu­ture clin­i­cal fo­cus will be tar­get­ed to­wards im­mune on­co­log­i­cal eval­u­a­tion, with com­bi­na­tion de­sign of the nov­el RNAi drug can­di­date and im­mune check­point in­hibitors, such as PD-1/PD-L1 mon­o­clon­al an­ti­bod­ies,” Sir­naomics said.

Lu is tag­ging about 6.8% of the IPO funds for fin­ish­ing Phase IIb and III tri­als in cu­ta­neous squa­mous cell car­ci­no­ma, and an­oth­er 10.1% for oth­er STP705 tri­als. An­oth­er 12.7% of the pro­ceeds are go­ing to­ward STP707, the com­pa­ny’s oth­er dual-tar­get­ing siR­NA. Both STP707 and STP705 tar­get TGF-β1 and COX-2. Ac­cord­ing to Sir­naomics’ IPO fil­ing, the com­pa­ny is plan­ning to put STP707 in clin­i­cal tri­als for liv­er can­cer, metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma, and non-small cell lung can­cer.

“At Sir­naomics specif­i­cal­ly, we are forg­ing a path to bring RNAi ther­a­peu­tics to the main­stream as ther­a­peu­tic modal­i­ties for treat­ment of many dis­eases, such as non-melanoma skin can­cer, liv­er can­cer, liv­er fi­bro­sis and NASH,” Lu said in 2019, up­on land­ing a $47 mil­lion Se­ries C round.

The com­pa­ny, head­quar­tered in Mary­land, has sub­sidiaries in Suzhou and Guangzhou, Chi­na. It has sev­er­al oth­er can­di­dates in the pipeline to treat a range of con­di­tions from Covid-19 to car­diometa­bol­ic dis­eases.

“We aim to cap­ture both the largest mar­ket in the world (U.S.) and one of the fastest grow­ing mar­kets in the world (Chi­na),” the com­pa­ny said in its IPO fil­ing.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.