TIDMROQ
RNS Number : 0733D
Roquefort Therapeutics PLC
19 June 2023
19 June 2023
Roquefort Therapeutics plc
("Roquefort Therapeutics" or the "Company")
Antibody Program Results & Orphan Drug Indication
Roquefort Therapeutics (LSE:ROQ), the Main Market listed biotech company focused on developing first-in-class medicines in the high value and high growth oncology market , is pleased to announce the progress of its anti-cancer antibody programs targeting Midkine expressing cancers.
Following the announcement in January 2023 where the Company
announced the Midkine antibody programs, targeting metastatic
breast cancer and metastatic lung cancer, successfully demonstrated
in vivo safety, Roquefort Therapeutics has continued the
development of its antibody portfolio with the Company's research
partners at La Trobe University. The Company is now releasing the
first in vivo efficacy results for its anti-Midkine antibodies
CAB-101 (ROQA2) and CAB-102 (ROQA1), including a new program for an
osteosarcoma orphan drug indication.
CAB-101 and CAB-102 are the lead programs in the Company's
family of patented humanised antibodies, which were developed
in-house, to target Midkine-expressing solid cancers. The in vivo
efficacy study tested the anti-cancer killing ability of CAB-101
and CAB-102 in a validated experimental model of osteosarcoma.
Treatment with CAB-101 was found to produce a statistically
significant reduction in lung metastasis, and CAB-102 was found to
reduce proliferation (growth rate) of the primary tumour. The more
detailed experimental results remain under embargo pending
publication at a leading cancer research conference.
CAB101 and CAB102 treat solid cancers, the market for which was
estimated to be $32 billion in 2021 and growing with a 7.8% CAGR
[1] . Osteosarcoma is the Company's first orphan drug indication
and reflects the strategic decision to target cancer niches in
which, there remains a high unmet clinical need (24% to 64% 5-year
survival rate) [2] , an accelerated development pathway [3] and the
potential to offer a best-in-class treatment in a significant
market niche.
Medicines to treat an orphan drug indication may be awarded
market exclusivity for 7 years in the USA and 10 years in the EU
and UK [4] , tax credits for the clinical drug testing cost, fee
reductions and, on average, will have a significantly higher
success rate in clinical trials [5] .
Osteosarcoma is the eighth-most common form of childhood cancer,
comprising 2.4% of all malignancies in paediatric patients, and
about 20% of all primary bone cancers [6] , w ith a market
estimated to reach $790 million by 2025 (6% CAGR) [7] . Midkine is
over-expressed in osteosarcoma and the level of Midkine expression
is correlated with poor prognosis [8] and therefore, represented a
promising target for anti-Midkine medicines.
Commenting on the antibody program results, Ajan Reginald, Chief
Executive Officer, said:
"We decided to target metastatic osteosarcoma because of the
high unmet medical need. There is a very poor 5-year survival rate
of just 24%, and this poor survival is associated with
over-expression of Midkine. Our rationale was that by targeting
Midkine, we would be able to attack both primary tumours and
metastasis. The in vivo results vindicate this approach and
demonstrate the potential for a best-in-class medicine. We look
forward to providing further information once the detailed results
have been published.
This strategy to focus on areas of high unmet medical need is
underpinned by the orphan drug incentives (including market
exclusivity, efficient clinical trials and tax incentives) and the
higher market valuation and return on investment for the investors
in companies with approved orphan medicines. Finally, this approach
seems to reduce risk, with significantly higher clinical trial
success rates particularly in phase 1 and 2 trials particularly
with a biomarker, which in our case is Midkine.
Therefore, this is a particularly promising scientific and
commercial strategy which was delivered on time and on budget. We
expect to announce more updates on our clinical progress and
business development activities over the next quarter."
-ENDS-
Enquiries:
Roquefort Therapeutics plc
Stephen West (Chairman) / Ajan +44 (0)20 3290
Reginald (CEO) 9339
Hybridan LLP (Joint Broker)
Claire Louise Noyce
Optiva Securities Limited (Joint +44 (0)203 764
Broker) 2341
+44 (0)20 3411
Christian Dennis 1881
Buchanan (Public Relations)
Ben Romney / Jamie Hooper / George +44 (0)20 7466
Beale 5000
LEI: 254900P4SISIWOR9RH34
About Roquefort Therapeutics
Roquefort Therapeutics (LSE:ROQ) is a Main Market listed biotech
company developing first in class drugs in the high value and high
growth oncology segment prior to partnering or selling to big
pharma.
Since listing in March 2021, Roquefort Therapeutics has
successfully acquired Lyramid Pty Limited, a leader in the
development of medicines for a new therapeutic target, Midkine (a
human growth factor associated with cancer progression), and most
recently acquired Oncogeni Ltd, founded by Nobel Laureate Professor
Sir Martin Evans, which has developed two families of innovative
cell and RNA oncology medicines.
Roquefort Therapeutics' portfolio consists of five fully funded,
novel patent-protected pre-clinical anti-cancer medicines. The
highly complementary profile of five best-in-class medicines
consists of:
-- Midkine antibodies with significant in vivo efficacy and toxicology studies;
-- Midkine RNA therapeutics with novel anti-cancer gene editing action;
-- Midkine mRNA therapeutics with novel anti-cancer approach;
-- STAT-6 siRNA therapeutics targeting solid tumours with significant in vivo efficacy; and
-- MK cell therapy with direct and NK-mediated anti-cancer action
For further information on Roquefort Therapeutics, please visit
www.roquefortplc.com and @RoquefortTherap on Twitter.
[1]
https://finance.yahoo.com/news/solid-tumor-testing-market-worth-103300895.html
[2]
https://www.cancer.net/cancer-types/osteosarcoma-childhood-and-adolescence/statistics#::text=If%20the%20cancer%20has%20spread,
relative%20survival%20rate%20is%2024%25.
[3]
https://www.medpace.com/wp-content/uploads/2023/03/Article-Regulatory-Strategies-and-Considerations-for-Orphan-and-Pediatric-Drug-Designations.pdf
[4]
https://www.propharmagroup.com/thought-leadership/orphan-drug-designations-in-the-u-s-and-eu
[5]
https://www.sciencedirect.com/science/article/pii/S0040595720300093
[6]
https://www.marketwatch.com/press-release/osteosarcoma-market-growth-2023-2030-2023-05-09
[7]
https://www.barchart.com/story/news/14577891/osteosarcoma-market-size-share-revenue-and-structure-forecast-to-2030
[8] Biochem Biophys Res Commun 2007 Jul 6;358(3):757-62. doi:
10.1016/j.bbrc.2007.04.183. Epub 2007 May 7
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