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Corporate Spotlight

Race Oncology Ltd (RAC) is a specialty pharmaceutical company. Its business model is to pursue later stage drug assets, principally in the cancer field. Its important asset is a chemotherapy drug, called Bisantrene. Race Oncology is rediscovering Bisantrene.
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CHIEF SCIENTIFIC OFFICER

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Race appoints Dr Daniel Tillett Chief Scientific Officer

ASX Announcement 1 October 2019 


1 October 2019 – Race Oncology Limited (ASX: RAC) is pleased to announce that Dr Daniel Tillett has been appointed Chief Scientific Officer (CSO) of RAC.


Dr Tillett recently anchored a share placement in RAC and was recently appointed as a NonExecutive Director of RAC. Because of his new executive responsibilities, Dr Tillett’s Board role will change to Executive Director.


The CSO role at RAC was vacated by US-based Dr John Rothman during 2018. Dr Tillett will now fill that role and assume responsibility for RAC’s overall R&D strategy, including manufacturing, and will assist the CEO in licensing discussions and with investor communications.


The CSO role is part-time, on average representing 40% of a full-time commitment by Dr Tillett. Dr Tillett has agreed to receive no cash compensation, but subject to shareholder approval, will receive 2.5 million options priced at $0.19 each; the options expire three years from date of grant.


“Daniel is going to add huge value to Race over the next year, not only as an investor and director, but now also as Chief Scientific Officer,” said Race CEO, Peter Molloy 


“I am very excited about taking a hands-on role with Race and helping get Bisantrene back into the clinic as quickly as possible. The more I have learned about Bisantrene the more potential I see it having in AML and other cancers. Teams as good as Race are rare in our industry and I couldn’t turn down the opportunity to help.” said Dr Daniel Tillett.


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LEADS INVESTMENT IN RACE

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Prominent biotech investor leads investment in Race

ASX Announcement 20 August 2019 


HIGHLIGHTS 

  • $1.45 million placement at a premium 
  • Placement anchored by a sophisticated biotech investor 
  • Race directors also participated in the placement 
  • Funds to be used to advance cancer drug Bisantrene clinical projects


20 August 2019 – Race Oncology Limited (ASX: RAC) announced today the successful completion of a $1.45 million placement, led by prominent biotechnology investor Dr Daniel Tillett.


The total placement comprised approx. 21.9 million new ordinary shares at an issue price of $0.066 (6.6 cents) per share.


The issue price represented a 10 per cent premium over the 30-day VWAP (volume-weighted average share price) and above the previous close on the 15 August 2019. The Placement was fully-subscribed.


Dr Daniel Tillett, the founder and CEO of Sydney-based biotechnology company Nucleics, which specialises in DNA sequencing services and software, anchored the placement acquiring 8.5 million shares ($561,000) under Race’s 10 per cent placement capacity.


“I investigated all the public biotechs in Australia and Race came out on top as the company with the most upside and potential,” said Dr Tillett. “I’m delighted to become involved with Race and look forward to working with the Race team.”


After completion of the placement, it is anticipated that Dr Tillett will join the Race board. 


Three current RAC directors also invested a total of $375,000 in the Placement, including $250,000 from Dr John Cullity.


In addition, other current RAC shareholders invested a total of $510,000, comprised of 5.0 million shares ($330,000) under the Company’s 15% capacity and a further 2.7 million shares ($180,000), subject to shareholder approval.


“These Placement funds will provide Race with the resources needed to drive forward valuecreating research and development programs on Bisantrene,” said RAC CEO, Peter Molloy. “We now have sufficient funding for at least the current financial year.”


All shares to be issued under the Placement will have attached 1:2 unlisted options (one option for each two shares), which are exercisable at $0.099 (9.9 cents) on or before 31 August 2021. A shareholders’ meeting will be held as soon as possible to approve the issue of shares and options to directors and the 2.7 million (and attaching options) that were above the Company’s current placement capacity.


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BISANTRENE

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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.


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INVESTIGATOR APPOINTED

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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.


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