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Defence Receives No Objection Letter from Health Canada for Phase I Trial of Its ACCUM-002 (AccuTOX) as an Anti-Cancer Molecule in Patients with Melanoma

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Defence Therapeutics has received a No Objection Letter (NOL) from Health Canada for its Phase I clinical trial of ACCUM-002 (AccuTOX) for treating unresectable Stage IIIB and IV melanoma. The trial, designated ACCUM-002-01, will assess the safety and tolerability of intratumoral administration of AccuTOX, both as a monotherapy and combined with the LAG-3 checkpoint inhibitor relatlimab and PD-1 inhibitor nivolumab (Opdualag). Secondary objectives include collecting preliminary efficacy data and determining the Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D). The trial is expected to be conducted in hospitals in Quebec and Ontario. According to Vision Research Reports, the global cancer immunotherapy market is projected to grow significantly, reaching USD 280.11 billion by 2033, with a CAGR of 8.34% from 2024 to 2033.

Positive
  • Received a No Objection Letter (NOL) from Health Canada.
  • Initiating Phase I clinical trial for ACCUM-002 (AccuTOX) in patients with unresectable Stage IIIB and IV melanoma.
  • Primary objectives include determining the safety and tolerability of AccuTOX.
  • Secondary objectives include preliminary efficacy data and recommending Phase 2 Dose (RP2D).
  • Defense Therapeutics is preparing to conduct the trial in Quebec and Ontario.
  • Global cancer immunotherapy market projected to grow to USD 280.11 billion by 2033.
Negative
  • None.

Vancouver, British Columbia--(Newsfile Corp. - July 8, 2024) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, is pleased to announce that it received a No Objection Letter ("NOL") from Health Canada for its Clinical Trial Study number ACCUM-002-01 entitles "A Phase I trial of Intratumoral Administration of ACCUM-002TM as a Monotherapy and in Combination with Opdualag in Patients with Unresectables, Stage IIIB and IV, Melanoma".

The primary objectives of this study are to determine the safety and tolerability of intratumoral administration of AccuTOX®, as a monotherapy and in combination with Opdualag which combines the LAG-3 checkpoint inhibitor relatlimab and PD-1 inhibitor nivolumab. The secondary objectives are to obtain preliminary efficacy data and to determine the Maximum Tolerated Dose ("MTD") and recommended Phase 2 Dose ("RP2D") of AccuTOX® exploits as immune booster and anti-cancer molecule.

According to Vision Research Reports, the global cancer immunotherapy market size was estimated at USD 125.73 billion in 2023 and it is projected to increase USD 280.11 billion by 2033 with a CAGR of 8.34% from 2024 to 2033.

https://www.biospace.com/article/releases/cancer-immunotherapy-market-size-to-increase-usd-280-11-bn-by-2033/

The Defence's team is already preparing this Phase I in Canada, most likely to be conducted in both Quebec and Ontario from which the hospitals sites will be confirmed upon agreements finalization.

"AccuTOX® is Defence's flagship asset in the anti-cancer therapeutics field and this Phase I clinical trial shall demonstrate and confirm primarily its safety and secondly its potency. We are thrilled to getting ready for this Phase I in Canada. Defence remains committed to its mission of addressing unmet clinical needs and in pursuing its goals to become a global leader in the development of innovative anti-cancer therapies," said Sebastien Plouffe, Chief Executive Officer of Defence Therapeutics.

About Defence:

Defence Therapeutics is a publicly-traded clinical-stage biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of vaccine antigens or ADCs inside target cells and favoring their processing and activities. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.

For further information:

Sebastien Plouffe, President, CEO and Director
P: (514) 947-2272
Splouffe@defencetherapeutics.com
www.defencetherapeutics.com

Cautionary Statement Regarding "Forward-Looking" Information

This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/215556

FAQ

What is the purpose of Defence Therapeutics' Phase I clinical trial for ACCUM-002?

The Phase I clinical trial aims to determine the safety and tolerability of ACCUM-002 (AccuTOX) as a monotherapy and in combination with Opdualag in patients with unresectable Stage IIIB and IV melanoma.

When did Defence Therapeutics receive the No Objection Letter from Health Canada?

Defence Therapeutics received the No Objection Letter from Health Canada on July 8, 2024.

What are the primary and secondary objectives of the ACCUM-002-01 trial?

The primary objectives are to assess safety and tolerability, while the secondary objectives include obtaining preliminary efficacy data and determining the Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D).

Where will the Phase I clinical trial for ACCUM-002 be conducted?

The trial is expected to be conducted in hospitals in Quebec and Ontario, Canada.

What is the potential market impact of ACCUM-002 on the cancer immunotherapy industry?

According to Vision Research Reports, the global cancer immunotherapy market is projected to grow to USD 280.11 billion by 2033, indicating significant market potential for successful treatments like ACCUM-002.

Defence Therapeutics Inc.

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