Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

Short­ly af­ter Sir­naomics brought in a $47 mil­lion Se­ries C for its small in­ter­fer­ing RNA pipeline last year, Patrick Lu — the founder, pres­i­dent and CEO — was asked to out­line the sci­en­tif­ic ad­vances that will be nec­es­sary to make bet­ter drugs out of RNA tech.

Patrick Lu

“The next step in the evo­lu­tion of RNAi as a lead­ing ther­a­peu­tic will be the abil­i­ty to safe­ly tar­get or­gans out­side the liv­er such as lung, brain, etc,” he had of­fered. “This will rev­o­lu­tion­ize dis­ease treat­ments if the in­dus­try can demon­strate sim­i­lar da­ta sets for non-liv­er tar­gets as we have seen in liv­er-based dis­eases.”

Then in April, the trans-Pa­cif­ic biotech did just that. In a Phase II open-la­bel dose es­ca­la­tion study, Sir­naomics re­port­ed in­ter­im re­sults sug­gest­ing that its lead drug, STP705, helped cer­tain can­cer pa­tients clear their squa­mous cell car­ci­no­ma.

In­vestors now say it’s time for a Se­ries D, pump­ing $105 mil­lion in­to the STP705 pro­gram as well as an­oth­er lead drug named STP707. The clin­i­cal fo­cus, Sir­naomics added, will be eval­u­at­ing these dual-tar­get­ed siR­NA in­hibitors, which hit TGF-β1 and COX-2 ei­ther lo­cal­ly or sys­tem­i­cal­ly, to­geth­er with check­point in­hibitors. But with al­most 10 oth­er pro­grams in the pipeline, the com­pa­ny re­mains on track to ex­plore not just RNAi’s ap­pli­ca­tion in can­cer but al­so in fi­bro­sis dis­eases, meta­bol­ic dis­eases and vi­ral in­fec­tions.

Ro­tat­ing Boul­der Fund, an ex­ist­ing in­vestor, led the round along­side new back­ers Wal­vax Biotech­nol­o­gy and Sun­shine River­head Cap­i­tal. Oth­ers on the syn­di­cate in­clude San­gel Cap­i­tal, Long­men Cap­i­tal, Hong­Tao Cap­i­tal and Al­pha Win Cap­i­tal.

In ad­di­tion to a po­ten­tial col­lab­o­ra­tion with Wal­vax on tech­ni­cal trans­fer and com­mer­cial­iza­tion, Lu is open about prepar­ing for an IPO “in near fu­ture.”

“The com­pa­ny is the on­ly bio­phar­ma ven­ture con­duct­ing in­no­v­a­tive R&D and clin­i­cal de­vel­op­ment in the field of RNAi ther­a­peu­tics in both the US and Chi­na, the two largest mar­kets for can­cer and fi­bro­sis dis­ease treat­ments,” Don­ald (Xi­aochang) Dai, man­ag­ing part­ner of Ro­tat­ing Boul­der Fund, not­ed in a state­ment.

With of­fices in Gaithers­burg, MD and Suzhou BioBay just west of Shang­hai, Sir­naomics rec­og­nizes that it is trav­el­ing down a path blazed by the likes of Al­ny­lam and Ar­row­head. But it boasts of a plat­form com­pris­ing a new polypep­tide nanopar­ti­cle de­liv­ery sys­tem and a way to hit two tar­gets at once — promis­ing to push RNAi be­yond rare dis­eases or even car­dio­vas­cu­lar con­di­tions.

“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 his 2019 in­ter­view.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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