publication date: Oct. 2, 2020

Drugs & Targets

Innova Therapeutics receives Rare Pediatric Disease Designation from FDA for IVT-8086 for Osteosarcoma

FDA has granted Rare Pediatric Disease Designation for IVT-8086 for the treatment of Osteosarcoma.

IVT-8086 is a humanized monoclonal antibody with high affinity to a novel anticancer target, secreted frizzled-related protein 2.

The agent is sponsored by Innova Therapeutics Inc.

“IVT-8086 has the potential to become the first FDA-approved therapy for individuals with osteosarcoma in over 30 years,”  Robert Ryan, CEO of Innova Therapeutics, said in a statement.

The underlying research was conducted in the laboratory at the Hollings Cancer Center at the Medical University of South Carolina (MUSC) by Nancy Klauber-DeMore, who is a co-founder and professor of surgery and BMW Endowed Chair of Cancer Research.

 

Celyad Oncology collaborates with MSD to evaluate CYAD-101 with Keytruda in microsatellite stable mCRC

Celyad Oncology SA, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell therapies for cancer, has entered into a clinical trial collaboration with Merck & Co., Inc., through a subsidiary.

Celyad Oncology will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy, with MSD’s anti-­PD-­1 therapy, Keytruda (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease.

“We are extremely pleased to enter into this clinical collaboration with MSD, as we believe the mechanism of actions of CYAD-101 and Keytruda are highly complementary and could help to drive meaningful clinical benefit in patients with advanced metastatic colorectal cancer, in particular with microsatellite stable disease where a high unmet medical need exists” said Filippo Petti, CEO of Celyad Oncology. “In addition, the collaboration with MSD adds an important dimension to our clinical program for CYAD-101 for the treatment of mCRC and provides us with the opportunity to build upon the encouraging clinical activity we’ve reported to date from the ongoing alloSHRINK trial.”

 

University of Illinois scientists enter licensing deal with Bayer, Systems Oncology

Researchers affiliated with the Cancer Center at Illinois discovered a novel small molecule compound that is now the subject of a new global licensing agreement between the pharmaceutical company Bayer AG and the cancer drug development company Systems Oncology LLC.

Systems Oncology originally licensed the IP related to the compound in 2018, and this new deal will now give Bayer the exclusive rights to develop the compound, currently called ERSO, as a cancer therapy. This compound was originally discovered by the laboratories of Paul Hergenrother, a professor of chemistry at the University of Illinois, Urbana Champaign, and U of I biochemistry professor David Shapiro.

Their research was the first to show that the compound can effectively target and kill certain cancer cells, especially breast cancer cells that express the estrogen receptor. An estimated 70% of women diagnosed with breast cancer have ER-positive breast cancer. According to Dr. Hergenrother, these types of breast cancer cells are very sensitive to ERSO, which rapidly and selectively kills these cancer cells.

In 2016, U of I first partnered with Systems Oncology to advance another small molecule invented by Dr. Hergenrother towards the clinic, so when it came to selecting an industry collaborator to drive the development for ERSO, the decision was made in 2018 to partner again with the Systems Oncology team. 

CCIL member, Erik Nelson, a professor of molecular and integrative physiology, provided essential guidance to the scientists through their tumor studies. CCIL Research Program Leader, Timothy Fan, a professor of veterinary clinical medicine at Illinois, was their expert in toxicology and pharmacology.

 

Elevation Oncology and US Oncology Research collaborate to expand genomic testing of solid tumors

Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, and US Oncology Research, one of the largest community-based oncology site management organizations in the U.S., announced a collaboration to utilize the US Oncology Research Selected Trials for Accelerated Rollout (STAR) program for patient enrollment in the registration-enabling Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion.

“The ability to accurately detect rare genomic driver alterations in a patient’s tumor and subsequently open up a clinical study site in response, is paramount to bringing precision therapy opportunities to patients that may benefit from treatment,” said Shawn Leland, founder and chief business officer of Elevation Oncology. “US Oncology Research is ideally positioned to expand the reach of the CRESTONE study for patients with cancers harboring an NRG1 gene fusion for investigational treatment with seribantumab. A key component of this collaboration is the ability to quickly open CRESTONE clinical trial sites via the US Oncology Research STAR program, which minimizes patient travel and disruption in clinical care, a major advantage particularly given the current travel complexities due to COVID-19.”

The STAR program opens and activates clinical trials quickly across all cancer research sites managed by US Oncology Research. STAR is an operational model that allows for pre-screening of potentially eligible subjects upfront and only opens sites where subjects are identified. When a potential STAR trial patient is identified at a facility, the practice is trained in the details of the trial, and the study is opened within a two-week timeframe at the location where the patient will be treated.

US Oncology Research serves approximately 60 research sites and more than 165 locations, managing about 400 active trials at any given time.

Patients and physicians can learn more about the CRESTONE study at www.nrg1fusion.com or on www.ClinicalTrials.gov under the NCT number NCT04383210.

Copyright (c) 2020 The Cancer Letter Inc.