Picking up drugs from Sanofi, startup Allrock targets two serious lung diseases
The goals of the Allrock Bio study have been validated by FDA-approved drugs. The Biotech startup expands science to the lungs and has obtained a SANOFI licensed drug candidate, thus providing the potential for first-class approaches to cardiopulmonary and fibrotic diseases. Allrock is now unstable, revealing its strategy for clinical trial plans and $50 million.
Allrock's Allrock Series financing announced Tuesday is led by Versant Ventures and Westlake Biopartners.
Allrock's drug candidate targets ROC-101 and inhibits two Rho kinases (rocks), which play a key role in cellular function. The excessive activity of these enzymes can cause vascular problems. For example, improper discharge of fluid from the eye can lead to glaucoma. Just as rock inhibitors treat glaucoma through treatments where blood vessels are enlarged to lower intraocular pressure, this approach can also solve vascular problems in the lungs.
The main disease target in Natick, Massachusetts is pulmonary arterial hypertension (PAH), a form of hypertension that develops in the arteries that flows blood from the heart to the lungs. For this sign, rock inhibition can provide more than just vasodilation, Marshall said. In PAH, arterial blockage is caused by the accumulation of inflammatory cells, scar tissue called fibrosis and the proliferation of muscle cells.
“Many of the drugs that have been approved (for PAH) are just targeting arterial contraction,” Marshall said. “Find drugs like rock inhibitors have the ability to solve cell proliferation, fibrosis, muscleization (vascularity).
Allrock is led by Co-founder and CEO Catherine Pearce. She and her team bring experience in cardiovascular drug development at Cincor Pharma, a company acquired by Astrazeneca two years ago whose $1.3 billion centers on the hypertensive drug candidate Baxdrostat.
Pearce's awareness of ROC-101 goes back about a decade. The molecule was originally developed by Kadmon Holdings, which acquired in 2021. Kadmon's main asset is Rezurock, a Rock2 inhibitor approved for graft and host disease. Pan-rock inhibitors, now known as ROC-101, are Kadmon's second in-house developed compound, one of the molecules Pearce discussed with Kadmon to establish a potential partnership. After selling Cincor, she saw the opportunity to acquire elements. Pearce brought together the old Cincor team to form Allrock in 2023 and said the ROC-101 license, which she said was not suitable for Sanofi's portfolio.
“They're not a company with pulmonary hypertension,” Pierce said of the drug giant. “But the science and preclinical package (from Kadmon) did a great job. So there's nothing else but we picked it up from that starting point and kept going.”
Allrock has completed the first phase of oral small molecule test for healthy volunteers. The results will be revealed at the European Respiratory Society Congress in Amsterdam later this month. Details about the pharmacokinetics, safety and target participation of ROC-101 are still under the embargo, but Marshall said he could say the drug is safe and well tolerated. He added that the main concern is that inhibiting Rock1 and Rock2 may lead to hypotension or hypotension. Marshall said there was no sign of hypotension in the 90-patient study.
Standard PAH therapy includes old vasodilators and drugs that inhibit overgrowth of cells in pulmonary blood vessels. Last year, the FDA approved Merck's Sotatercept, brand Winrevair, to launch a new PAH drug. Subcutaneously injected Winrevair is a fusion protein designed to capture proteins whose elevated levels are associated with cell proliferation that thickens the proliferation of lung blood vessels. The drug comes from a $11.5 billion acquisition by Merck in 2021 acquisition of Acceleron Pharma and is expected to be a sensational seller.
Pierce said Allrock is not a replacement for existing PAH drugs, including Winrevair. ROC-101 can supplement these products, thus providing patients with additional benefits beyond available PAH therapy. The 24-week Phase 2 trial was designed to test standard drug plus ROC-101 ARM, another arm test standard of care and Winrevair Plus ROC-101. Marshall said the trial will recruit patients who are under high lung stress despite currently taking the medication.
In addition to recruiting patients with PAH, the second phase of the test will also recruit patients with pulmonary hypertension with interstitial lung disease (pH-ELD), a type of hypertension caused by interstitial lung disease, a progressive lung disease. Tyvasso, a vasodilator originally approved for combination therapy for PAH, has become the standard treatment for pH-ild. Pure Pulmovant, a subsidiary of Roivant Sciences, is pursuing this sign using Bayer-licensed absorbable drug candidates. Pierce said Allrock can be separated by pill formula.
There are precedents in the use of pan-rock inhibition to arterial diseases. Marshall said the vasodil effect of decades-old pan-rock inhibitor Fasudil reduces blood pressure to treat cerebral vasospasm, which is narrowing of the cerebral artery, Marshall said. This intravenous drug is approved only in Japan and China, but labeling of products has been shown to be effective in PAH. Other evidence of clinical tests initiated by researchers showed better results than approved PAH drugs, Marshall said.
Fasudil's data provide clinical validation of Pan-Rock inhibition, a hypothesis that these results will translate into ROC-101 Clear and Derisks, Versant's Versant Venture partner Alica Levey said in an email. Versant's investment is also the bet of the Allrock team.
“At Cincor, they have had a huge success, identifying assets in the diamonds and effectively generating data that sparks interest in the drug and ultimately acquires it,” Levey said. “We use the same strategy here and bet on similar results.”
Cincor comes from the biotech incubator Cinrx. Pearce and her team are taking a similar approach to Allrock, the first startup of Jucabio, a biopharmaceutical company that scouts promising drug assets and forms subsidiary companies to advance them. Roivant and Bridgebio Pharma have similar “hub and spoke” business models. Jucabio CEO Pearce said ROC-101 was the first asset the company was able to acquire. Under Allrock, it developed from the preclinical stage to the second stage within 16 months. Pierce said she hopes the drug is just a few of Jucabio's drugs.
“We have high capital efficiency and we want to continue to do this repeatedly,” Pierce said.
Image: Jackie Niam, Getty Images
