Suda Pharmaceuticals to Combine New iNKT Cell Therapy Platform with CARs to Target Blood Cancers | 2021-07-20
PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock rise nearly 44% on the heels of an oversubscribed A $ 3.65 million (US $ 2.71 million) capital increase following the acquisition of a new therapy platform invariant natural killer cell (iNKT) for oncology.
The funds raised will help support the development of the new cell therapy platform that Suda has licensed from Imperial College London. Treatment is expected to enter the clinic within the next 12-24 months.
CEO Michael Baker said BioWorld that Suda plans to combine iNKT cell technology with chimeric antigen receptors (CARs) to target blood cancers. He said the combination therapy was more effective than conventional CAR T therapy in preclinical studies.
INKT technology was developed at Imperial College by Anastasios Karadimitris. His research group was the first to demonstrate that cells protect against graft versus host disease (GVHD).
INKT cells offer two key advantages: They already contain a receptor that targets cancer cells, and they should be able to be assayed commercially. To date, cell therapies have been successful in blood cancers, but only with cell therapies that rely on the use of the patient’s own cells.
In preclinical studies, CAR-iNKT cells have shown superior activity compared to conventional cell therapies to eradicate cancer cells and prolong tumor-free survival. CAR19-iNKT cells are under development for the treatment of cancers expressing CD19, including non-Hodgkin lymphoma.
“Cellular therapies have transformed the way we think about cancer treatment,” Baker said. “The iNKT cell therapy platform offers an opportunity to target multiple cancers using a product that is expected to have higher potency and be more cost effective, which should allow the therapy to reach more people.
“Suda will be the only ASX-listed CAR-iNKT cell therapy company working on this cellular platform, and we look forward to advancing the technology into clinical trials. “
Suda’s iNKT program may have advantages over traditional CAR T therapies, such as Yescarta (axicabtagene ciloleucel, Gilead Sciences Inc.), based on in vitro and in vivo testing, analysts at Edison Investment Research Ltd wrote. . Maxim Jacobs and Jyoti Prakash.
“CAR-iNKT cells targeting CD19 also appear to be effective against lymphoma in the brain, unlike CAR T cells targeting CD19,” the analysts noted. “Finally, the dual targeting of CD1d and CD19 has been shown to improve the anti-tumor effect compared to CAR T targeting CD19 alone.”
Animal testing also suggests a much greater ability to target lymphomas that have passed through the brain, analysts said, noting that Agentus, a subsidiary of Agenus Therapeutics, is also developing CAR-iNKT cells, but the indication remains undisclosed.
While the specific terms of the exclusive global license agreement were not disclosed, Suda has paid Imperial College an upfront fee and will pay development and commercial milestones as well as single-digit sales royalties.
Suda plans to enter into a collaborative research agreement with Imperial College London to facilitate further research to expand the platform and develop additional intellectual property.
Fundraising to support development
In conjunction with the licensing agreement, Suda raised AU $ 3.65 million in an oversubscribed placement with investors consisting of 96.163 million common shares at a price of AU3 cents per share. Baker Young Ltd. acted as the leader of the offer.
The funds raised through the placement will provide Suda with a 12-month lead for the initial development of the iNKT cell therapy platform, Baker said.
The iNKT cell therapy platform adds to Suda’s existing oncology active, anagrelide, which is being developed to reduce high platelet levels in cancer patients.
Over the past decade, studies have shown that cancer survival rates for solid tumors are related to a patient’s platelet count. Cancer cells are thought to stimulate the overproduction and activation of platelets.
Anagrelide is currently used to reduce high platelet count and reduce thrombotic risk in myeloproliferative diseases associated with high platelet count.
“More and more evidence shows that if you have cancer and an increase in your platelet count, your survival time is much shorter,” Baker said.
But when people take anagrelide in tablet form, it has a cardio-stimulatory effect which can be potentially dangerous for cancer patients. To this end, Suda is developing an oral spray of anagrelide that passes through the oral mucosa into the bloodstream to avoid first-pass metabolism in the liver, “and we bypass the generation of this toxic intermediate that actually causes these unwanted cardio. – stimulating effects.
“We think we’ll have a product that we can use to help and support extending the lives of cancer patients, but we’re doing it in a much safer way than you would be able to do if this product was still in pill form. . “
Two platform technologies
The company has two technological platforms in oncology and in the central nervous system.
The Perth-based company was founded in 1999 and Baker became the new CEO in 2020 to acquire new technology. Although he holds a doctorate in biochemistry, he also has a background in venture capital.
Previously, Suda was viewed as a drug distribution company that focused on developing low-risk oral sprays using its Oromist technology platform to reformulate existing drugs.
Once a drug is taken orally, only about 10-30% is absorbed and is bioavailable to the body, Baker said. The administration of a drug by mouth where it can penetrate the lining of the cheek or under the tongue, “is only a second after the injection of a drug directly into the bloodstream, which makes it difficult for you. makes more than 90% bioavailable, ”he said.
“If we can get more of the bioavailable drug, we can actually potentially lower the dose, which is good because you can make a safer product, but also lower the cost of the goods.
“Second, if we pass through the oral mucosa, because it goes more directly into the bloodstream, it penetrates faster,” he said, adding that the company offers treatments for migraine and insomnia, therefore rapid onset is important.
A significant portion of the population suffers from dysphagia, an inability to swallow, which worsens with age, and oral labor is a better option. Young children are another segment of the population who have difficulty swallowing pills or tablets.
Although some drugs have been formulated for oral mucosal administration, few companies are developing a platform for this type of administration, Baker said.
In July 2020, Australia’s Therapeutic Goods Administration (TGA) approved Suda’s Zolpimist, an oral spray formulation of zolpidem tartrate for insomnia. Suda holds the license outside of the United States and is in partnership with Teva Pharmaceuticals International GmbH and Mitsubishi Tanabe.
Other oromucosal products in development include sumatriptan for migraine headaches, for which the company is a partner of Strides Pharma Science Ltd. ; and medical grade cannabis, for which the company is in partnership with Cann Pharmaceutical Australia Ltd. It also has an undisclosed partnership with Sanofi SA.
Suda’s shares on the Australian Securities Exchange (ASX: SUD) were trading at AU 6 cents per share at the close of trading on July 16, 2021.