JohnDe
La dolce vita
- Joined
- 11 March 2020
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40% would bring them back into the blackSomething strange is happening, RAC +10%
40% would bring them back into the black
Race Receives Positive Guidance on Zantrene via Pre-IND Meeting with US FDA
- Race Oncology has received positive feedback and guidance from the US FDA regarding Zantrene and its clinical plans
- FDA has indicated the clinical hold issues raised with Race’s previous IND submitted in 2019 have been satisfactorily addressed
- FDA guidance provides a viable path for the clinical advancement of Zantrene in the US.
23 November 2022 – Race Oncology Limited (“Race”) is pleased to announce that it has received confidential and constructive guidance by way of a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) for Zantrene (bisantrene dihydrochloride). Race submitted a pre-IND meeting package to the FDA in September 2022, which included a summary of the preclinical and clinical data for Zantrene, an overview of the proposed clinical development plan, and specific questions on the requirements to open an Investigational New Drug (IND) application.
Opening an IND is a requirement before undertaking clinical trials in the United States and is a key step in the process of obtaining a New Drug Application (NDA) and marketing approval for a new drug. In written correspondence, the FDA provided insightful and helpful feedback on the proposed clinical d...
Trials and development are progressing well. A big payday in the next few years.
Had.They have a good team.
Race executes global license agreement with City of Hope to access FTO IP
- Race executes worldwide license agreement with City of Hope, one of the largest cancer research and treatment organisations in the United States.
- Under the agreement, Race will exclusively secure rights to a City of Hope patent application and associated know-how identifying that bisantrene may be the most potent inhibitor of the FTO pathway.
- Agreement grants Race freedom to explore and operate under certain City of Hope patent rights, subject to specified conditions.
- Agreement builds engagement with City of Hope and the related opportunity for scientific collaboration as Race progresses its evaluation of bisantrene’s targeted impact on the FTO and m6 A1 pathways.
10 July 2023 – Race Oncology Limited (“Race”) is pleased to announce execution of an exclusive licence agreement (“Agreement”) to access U.S. cancer research and treatment organisation City of Hope’s intellectual property (“IP) which highlights bisantrene as a
potent inhibitor of the human fat mass and obesity-associated protein, or FTO. City of Hope, one of the largest cancer research and treatment centres in the United States and a leading research centre for diabetes and other life-threatening illnesses, encourages the use of its inventions, discoveries and intellectual property for the benefit of the public.
These rights granted under the Agreement include the exclusive license of IP potentially arising from a patent application (PCT Application No. PCT/US2020/043294) (“Patent Application”) as filed by City of Hope and know-how relating to data included in the Patent
Application (“Know-How”). The Agreement ensures Race’s exclusive access to that IP, which the Company believes will construct a transparent path for collaborative research and the downstream commercialisation of FTO inhibitory applications. A summary of the material terms of the Agreement are provided on page 3 of this announcement.
CEO and Managing Director, Damian Clarke-Bruce commented: “In 2020, City of Hope published research highlighting bisantrene as a potent inhibitor of FTO. This exclusive worldwide agreement secures access for Race to important IP associated with that work and opens exciting opportunities for us to collaborate closely with Professor Jianjun Chen and his research group.
With the agreement in place, collaborative discussions regarding Race-sponsored research are now easier to facilitate. Moreover, this agreement secures a clear path for Race’s FTO research agenda. We are excited about further validating this targeted application for bisantrene through preclinical and clinical studies and anticipate that FTO inhibition may offer a highimpact, personalised medicine solution for cancer patients.”
--ENDS-
Some good news today -Still a waiting game. RC220 is on track to be available to commence testing late next quarter.
While RC220 contains the same active pharmaceutical ingredient as previous formulations, it is considered a new ‘drug product’ by
regulators. The big difference is that RC200 is for peripheral infusion, a much more simple method of delivery.
Notice of Exercise of Options
On 22 November 2023, Race Oncology Limited (the Company) announced to the ASX a pro-rata non-renounceable entitlement issue of one (1) loyalty bonus option (Bonus Option) for every twenty (20) Shares held by Eligible Shareholders registered at the Record Date (Bonus Options Offer) for nil consideration, and a further offer to Eligible Optionholders of three (3) Options (Piggyback Options) for every one (1) Bonus Options exercised prior to the Bonus Options Expiry Date (Piggyback Options Offer), (together, the Offers).
The Bonus Option is exercisable at $0.75 per option (Exercise Price) on or before 4 June 2024, 5:00pm (AEST) (Bonus Options Expiry Date). Upon exercise, each Bonus Option entitles the holder to one (1) share and three (3) Piggyback Options. Each Piggyback Option entitles the holder to subscribe for one Share upon exercise of the Piggyback Option.
The Prospectus dated 22 November 2023 contains information about the Offers and you should carefully read the Prospectus before exercising your options. This Notice of Exercise of Options should be read in conjunction with the Prospectus. If you do not understand the information provided in the Prospectus or you are in doubt as to how you should deal with it, you should seek professional advice. Other than as defined in this Notice of Exercise of Options, capitalised terms have the same meaning as defined in the Prospectus.
Race Chief Financial Officer Appointment
18 March 2024 – Race Oncology Limited (“Race”) is pleased to announce the appointment of Mr Brendan Brown as Chief Financial Officer (CFO) of Race Oncology, effective from Monday 1 April 2024. Brendan is a Partner and Director of Prime Accounting & Business Advisory Pty Ltd (“Prime”), part of the Prime Financial Group (ASX PFG).
He brings significant practical experience having worked with numerous life science clients through the past 20 years. Brendan is a Chartered Accountant (CA ANZ) and Registered Tax Agent with a Bachelor of Commerce (Accounting) from La Trobe University
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