Featured Image: WuXi STA and Impact Therapeutics, a Chinese clinical-stage biopharmaceutical company dedicated to the discovery and development of anti-cancer drugs, have signed a partnership agreement in which WuXi STA will become the preferred CDMO partner for Impact Therapeutics
Featured Image: WuXi STA and Impact Therapeutics, a Chinese clinical-stage biopharmaceutical company dedicated to the discovery and development of anti-cancer drugs, have signed a partnership agreement in which WuXi STA will become the preferred CDMO partner for Impact Therapeutics.

STA Pharmaceutical, a subsidiary of WuXi AppTec and Impact Therapeutics, a privately held clinical-stage biopharmaceutical company based in Nanjing, China, have signed a strategic partnership agreement. Im focuses on the discovery and development of innovative anti-cancer drug therapeutics,

Under the terms of this agreement, WuXi STA becomes the preferred Contract Development and Manufacturing Organization (CDMO) partner of Impact Therapeutics. WuXi STA will provide services covering the entire product development process of Impact’s pipeline new drug candidates for both drug substance and drug product.

The new partnership is expected to will accelerate Impact Therapeutics’ new pipeline drug development towards commercialization both in China and in the United States.

Cancer therapeutics
Impact Therapeutics holds independent intellectual property rights for a diverse anti cancer therapeutics drug pipeline that includes the Poly (ADP-ribose) polymerase (PARP) Inhibitors (IMP4297), Wee1 Inhibitors (IMP7068), DNA damage response (DDR) target Inhibitors and Hedgehog Pathway Inhibitors (IMP5471).

PARP enzymes play critical roles in DNA damage detection and repair. IMP4297 is a novel, potent PARP1/2 inhibitor (IC50 6.27nM/1.57nM) and has demonstrated to be 20-fold more potent than olaparib (Lynparza®; AstraZeneca) in anticancer animal models. In two phase I clinical trials involving Chinese and Australian patients, researchers evaluated the tolerability, safety, pharmacokinetics, and antitumor activity of single agent IMP4297 in advanced ovarian, breast, prostate and other solid tumors. The study results of these trials confirmed that IMP4297 was well-tolerated and demonstrated significant anti-tumor activity.

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Currently, IMP4297 is in Phase III clinical trials in China, with early clinical data targeting better safety and a wider treatment window.

IMP7068 is a Wee1 inhibitor currently in the preclinical development. Wee1 is a critical component of the G2/M cell cycle checkpoint control and mediates cell cycle arrest by regulating the phosphorylation of CDC2. Research has shown that the inhibition of Wee1 enhances the cytotoxic effect of DNA damaging agents in various cancers. According to some studies, DNA replication stress and double strand breaks are induced by the activation of CDK1 following WEE1 inhibitor treatment.

Impact Therapeutics is, according to some experts, expected to submit an Investigational New Drug (IND) application, both in China and the United States, for IMP7068 by mid-2020.

IMP5471, another drug in development, has, according to industry analysts, the potential to be a ”best-in-class” treatment of cancers with mutations in Hedgehog signaling pathway, including basal-cell carcinoma (BCC) and medulloblastoma.

The Hedgehog signaling pathway transmits information to embryonic cells required for proper cell differentiation.

Based on preliminary studies, IMP5471 has a good oral bioavailability. Oral administration of up to 200 mg/kg has not shown to is be significantly toxic to rats, and it has a good effect on the Ptch+/- medulloblastoma allograft model. Based on in vitro and in vivo data, researchers identified IMP5471 as a clinical drug candidate and initiated preclinical research. The aim is to develop IMP5471 for the treatment of medulloblastoma and basal cell carcinoma.

Regulatory amendment
On August 26, 2019, the government of China passed amendments to the Drug Administration Law. These amendments will take effect on December 1, 2019 and will update the Drug Marketing Authorization Holder (MAH) System including new evaluation and approval systems.

The agreement between WuXi STA and Impact Therapeutics between is vital to optimize the resource allocation and accelerate the new drug development process, which will be strengthened under the amended MAH system. The drug regulation is also designed to improve drug quality and safety.

“We have formed an excellent partnership with WuXi STA over the last few years, and almost all of our pipeline molecules are developed in partnership using their comprehensive service platform,” said Jun Bao, Ph.D, President & Chief Executive Officer of Impact Therapeutics.

“We chose WuXi STA to be our preferred CDMO partner because of their dedication as well as their world-leading integrated CMC (Chemistry, Manufacturing and Control) platform. This means they are able to expedite our products from clinical trial to commercial launch much faster,” Bao added.

“We are delighted to see the breakthroughs being made by Impact Therapeutics’ diverse pipeline. We are looking forward to further leveraging the scale and innovation capabilities at WuXi STA, along with our global standard quality systems to help our partners accelerate the process of launching new drugs to benefit global patients,” noted Minzhang Chen, Ph.D, Chief Executive Officer of WuXi STA.

Impact Therapeutics has raised US $46 million to date from recognized venture capital firms including Shanghai headquartered Lilly Asia Ventures, a leading venture capital firms investing in early-to-growth-stage biomedical, pharmaceutical and medical devices/diagnostics industries with capital, professional expertise and valuable resources.

Impact Therapeutics is current series D fundraising is ongoing.

Clinical trials

  • A Study of IMP4297 in Patients With Advanced Solid Tumors -Phase I – NCT03508011
  • The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors -Phase I – NCT03507543
  • Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer – Phase I – NCT04089189
  • IMP4297 Food Effect Trial in Healthy Volunteers – Phase I – NCT04057729
  • A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer – Phase III – NCT04169997

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