Race files Bisantrene IND with FDA
ASX Announcement 25 March 2019
25 March 2019: Race Oncology Limited (‘RAC’) announced today that it had filed its IND (Investigational New Drug application) for Bisantrene and received receipt from the FDA confirming qualification of the file for submission. Race had previously advised the market of a target filing date of 31 March 2019.
“This is a major milestone in the approval pathway for Bisantrene,” said Race CEO, Peter Molloy.
The IND is the core regulatory document that will allow Race to undertake a registration clinical trial of Bisantrene in the treatment of adult AML (Acute Myeloid Leukaemia). Once successfully completed, that trial could allow Bisantrene to be approved in the US.
“The filing of the IND definitively brands Bisantrene as a Phase III asset,” said Mr Molloy.
A standard IND is subject to a 30-day review period by the FDA, after which the proposed trial can proceed, if the FDA has no questions. Because of the large size and scope of the Bisantrene dossier, Race believes that FDA will have a number of questions and that the Q&A process will likely push the start of the trial into the second half of 2019.
This is in line with our timetable for the adult AML trial, which in any case, is subject to our securing funding for the trial, potentially from a licensing partner,” said Mr Molloy.
One reason for more extensive discussions with the FDA in this case, is the size of the IND. Most INDs are filed prior to commencement of human trials and tend to be relatively small dossiers that are supplemented progressively as new data emerges.
Because Bisantrene is entering the clinical and regulatory process at Phase III, the IND comprises the entire history of Bisantrene’s preclinical and clinical development, along with Phase III quality manufacturing and other data.
As a result, the IND is around 2,000 pages long, including references and attachments. It also includes hundreds of pages presenting the pre-clinical data on Bisantrene and its extensive clinical history, with 1,800 treated patients.
“Compiling this IND has been a massive undertaking over more than six months, involving all Race personnel and NSF Health Sciences, our US regulatory consultants,” said Mr Molloy.
The IND dossier also includes approximately around 200 pages of new chemistry, manufacturing and quality control (CMC) data, which has all been generated by Race over the last three years.
“Overall, this was the most complex and detailed IND I have ever been a part of,” said Dr Daniel Levy, Race’s CMC consultant on the project. “We had to create from scratch an entire CMC package to Phase III standards.”
In addition to underpinning the adult AML approval of Bisantrene, the IND will be the core regulatory document and springboard for Race’s planned trial in paediatric AML. Race has received a Rare Paediatric Disease designation for Bisantrene from the FDA, and upon a successful paediatric trial, could receive a valuable and saleable ‘Priority Review Voucher’ (PRV). The Company is now in advanced discussions around the funding and conduct of the paediatric trial.
“Apart from supporting the adult and paediatric registration programs, the IND is the ultimate technical dossier for use in licensing discussions,” added Mr Molloy. The Company announced in November 2018 that it had appointed Biosynergy Partners LLC to pursue licensing deals for Bisantrene.
“This IND is the culmination of nearly three years of work and manufacturing and regulatory investment at Race, and now, it provides the launching pad for all our value creating programs,” said Mr Molloy.
“I regard this IND as our most important achievement to date,” added Mr Molloy.
Principal Investigator appointed for Bisantrene trial
ASX Announcement 25 February 2019
25 February 2019: Race Oncology Limited (‘RAC’) is pleased to announce that Dr Roland Walter has agreed to be the Principal Investigator for the US registration trial for Bisantrene.
Roland B. Walter, MD PhD MS, is a leading international haematologist and AML expert, based at the Fred Hutchinson Cancer Research Center in Seattle.
“We are fortunate to have a global AML leader like Dr Walter to lead the multinational Bisantrene study,” said Race Oncology CEO, Peter Molloy.
The trial is planned to be a Phase 2/3 study in support of the US FDA registration of Bisantrene for the treatment of relapsed/refractory AML (Acute Myeloid Leukaemia).
Trial commencement is subject to the filing by Race of an IND (Investigational New Drug application) with the FDA.
“We remain on track to see the IND filed by the end of March,” said Mr Molloy. “It will be an important milestone for the Company.”
Commencement of the trial is also subject to funding. Through an agreement with Biosynergy Partners, Race has been engaged in discussions with potential partners about funding of the trial.
About Professor Roland Walter
Dr Walter currently holds several positions including Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center; Associate Professor of Medicine, Division of Hematology/Department of Medicine, University of Washington; and Adjunct Associate Professor, Departments of Pathology and Epidemiology, University of Washington. He is also a current Leukemia & Lymphoma Society Scholar in Clinical Research. Dr Walter's clinical and translational research program is focused on AML, primarily on the preclinical and early clinical development of novel targeted therapeutics. Dr Walter is extensively published, has received numerous honours and awards, and has editorial responsibilities at key journals including Blood Reviews, Blood Advances and International Journal of Hematologic Oncology.
About Race Oncology (RAC.ASX)
Race Oncology is a specialty pharmaceutical company whose business model is to pursue later-stage drug assets in the cancer field that have been overlooked by big pharma. The company’s first asset is Bisantrene, a chemotherapy drug, which was the subject of more than 40 clinical studies during the 1980s and 1990s before the drug was abandoned after a series of pharmaceutical mergers. Bisantrene has compelling Phase II data in acute myeloid leukaemia (AML) and Race is seeking to gain US FDA approval for Bisantrene for AML under the accelerated 505(b)(2) regulatory pathway. Bisantrene is the subject of two recently granted US patents and has been awarded US Orphan Drug designation and a Rare Paediatric Disease designation.
Race agreement with TrueMed for Bisantrene NPP in Israel
ASX Announcement 17 December 2018
HIGHLIGHTS
- NPP distribution agreement with TrueMed in Israel
- Profit share agreement based on sales of Bisantrene
17 December 2018: Race Oncology Limited (RAC.AX) is very pleased to announce that it has signed an agreement with Israel-based TrueMed Ltd for distribution and sales of Bisantrene in Israel, under a named patient program (NPP)1.
TrueMed is a pharmaceutical distributor with experience in driving NPPs in Israel.
“We believe that Israel could be an important contributor to future global NPP sales of Bisantrene,” said Race CEO, Peter Molloy. “TrueMed has a unique approach and expertise in NPP, along with a firm belief in the opportunity for Bisantrene in AML, based on their own market research.”
According to TrueMed’s owners and co-CEOs, Shmulik Berkovich and Arie Koren, “TrueMed is proud to partner with Race Oncology to provide access to Bisantrene for patients who need it. Bisantrene’s long and robust development program makesit a potential game-changer and a significant option for those patients deemed appropriate by their treating physicians.”
Under the distribution agreement, Race and TrueMed will share the value of all Bisantrene NPP sales in Israel, with 60% of sales turnover paid to Race and 40% retained by TrueMed.
TrueMed will have the exclusive right to sell and distribute Bisantrene in Israel for NPP use and will source Bisantrene exclusively from Race’s global distribution partner Durbin, in the UK. TrueMed will be responsible for gaining the approval of the Israeli Ministry of Health (IMOH) for local NPP distribution of Bisantrene; sales cannot commence until that approval has been obtained. The agreement will operate for an initial period of three years, after which, it can be terminated with nine months’ notice by either party.
About TrueMed
TrueMed is a prominent rare disease and specialty care company in Israel, providing a complete local distribution and marketing solution for pharmaceutical partners with unique therapies in specific therapeutic areas. TrueMed stands out in the local market as an innovative company and the partner of choice for innovators with cutting-edge therapies such as Sarepta, Amicus, Lucane, AOP Orphan and other (http://www.truemedtx.com).
About Race Oncology (RAC.ASX)
Race Oncology is a specialty pharmaceutical company whose business model is to pursue later-stage drug assets in the cancer field that have been overlooked by big pharma. The company’s first asset is Bisantrene, a chemotherapy drug, which was the subject of more than 40 clinical studies during the 1980s and 1990s before the drug was abandoned after the results of a Phase III breast cancer study and a series of pharmaceutical mergers. Bisantrene has compelling Phase II data in acute myeloid leukaemia (AML) and Race is seeking to gain US FDA approval for Bisantrene for AML under the accelerated 505(b)(2) regulatory pathway. Bisantrene is the subject of two recently granted US patents and has been awarded US Orphan Drug designation, along with a Rare Paediatric Disease designation.
