Sir­naomics puts off an IPO a lit­tle longer as it pock­ets an­oth­er megaround. Is an S-1 around the cor­ner this time?

Back in Oc­to­ber, when small in­ter­fer­ing RNA play­er Sir­naomics land­ed its Se­ries D round, CEO Patrick Lu said he was open to prepar­ing for an IPO “in (the) near fu­ture.” Those S-1 pa­pers nev­er came, and now Lu’s tak­ing an­oth­er trip down VC lane.

Sir­naomics un­veiled a $105 mil­lion Se­ries E round on Thurs­day, led by the same firm that led the last megaround: Ro­tat­ing Boul­der Fund. The biotech says it will pump the funds in­to its RNAi port­fo­lio aimed at treat­ing can­cers, vi­ral in­fec­tions, fi­bro­sis and meta­bol­ic dis­eases.

siR­NA ther­a­peu­tics were pop­u­lar­ized by Al­ny­lam, which scored the first OK in the field with On­pat­tro back in 2018. Scott Got­tlieb, FDA com­mis­sion­er at the time, said the ap­proval was “part of a broad­er wave of ad­vances that al­low us to treat dis­ease by ac­tu­al­ly tar­get­ing the root cause.”

Patrick Lu

siR­NA kicks off ac­tion in the RNA-in­duced si­lenc­ing com­plex, which then goes on to cleave a spe­cif­ic mR­NA, there­by down­reg­u­lat­ing tar­get genes. But 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.

Sir­naomics’ lead can­di­dates — STP705 and STP707 — are dual tar­get­ing siR­NAs against TGF-β1 and COX-2, and can be ad­min­is­tered lo­cal­ly or sys­tem­i­cal­ly. In De­cem­ber, the com­pa­ny said Phase IIa re­sults showed that STP705 helped clear tu­mor cells in pa­tients with squa­mous cell skin can­cer.

“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.

The Gaithers­burg, MD-based biotech has a slate of oth­er can­di­dates in the works to treat a range of con­di­tions, from Covid-19 to car­diometa­bol­ic dis­eases. Back in April, Lu struck a co-de­vel­op­ment deal with Wal­vax Biotech­nol­o­gy for its an­tivi­ral siR­NA can­di­date STP702.

“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, short­ly af­ter nab­bing a $47 mil­lion Se­ries C round. He fol­lowed that up with a $105 mil­lion Se­ries D just last year.

Though head­quar­tered in Mary­land, Sir­naomics has sub­sidiaries in Suzhou and Guangzhou, Chi­na.

The com­pa­ny wasn’t avail­able for an in­ter­view be­fore press time, but Lu men­tioned in a state­ment that the com­pa­ny is en­ter­ing its “next phase of growth.” Could that mean an IPO? Looks like we’ll have to wait and see.

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.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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