Radiopharmaceutical is a hot space in biotech following recent deals
\nClarity is one of the only companies left with an advanced copper isotopes program
\nStockhead reached out to Clarity\u2019s executive chairperson, Dr Alan Taylor<\/p>\n
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Radiopharmaceutical<\/strong> has emerged as the hottest space in the biotech sector right now.<\/p>\n Over the last six months, three global blockbuster deals have taken place in this space \u2013 AstraZeneca acquiring Fusion for US$2.4b, Eli Lilly buying out Point Biopharma for US$1.4b, and Bristol Myers Squibb\u2019s purchase of Rayze Bio for US$4.1b.<\/p>\n The deals highlight the strong strategic interests in radiopharmaceutical assets, with these big pharma activities fuelling huge interest among investors.<\/p>\n What\u2019s also interesting is that these acquisitions were made while the target\u2019s lead programs were still in clinical trials, which is exactly where ASX-listed Clarity Pharmaceuticals (ASX:CU6)<\/a><\/strong> is at today.<\/p>\n The $760m market capped Clarity is a radiopharmaceutical-focused biotech which has developed a unique proprietary program involving the use of copper isotopes, in prostate cancer diagnosis and therapy.<\/p>\n \u201cRadiopharmaceutical, in the global sense, is a hot market right now. It\u2019s a very interesting space off the back of the antibody drug conjugate market which has already been hot,\u201d said Clarity\u2019s executive chairperson, Dr Alan Taylor.<\/strong><\/p>\n Taylor adds that there is now an extremely limited number of clinically advanced radiopharmaceutical companies remaining which could provide Big Pharma with a platform entry point to radiopharmaceutical therapeutics.<\/p>\n \u201cThere\u2019s no one left but us really in this exciting radiopharma space,\u201d he said.<\/p>\n The company has recently completed an institutional cap raise of $110m, and has just launched a fully underwritten retail offer to raise up to a further $11 million at $2.55 per share.<\/p>\n \u201cThe total of $121 million significantly strengthens our balance sheet to over $150 million, and allows us to continue to progress all of our products through their respective clinical trials,\u201d said Taylor.<\/p>\n This is the first capital raising since the company\u2019s record $92 million IPO capital raising on the ASX in August 2021.<\/p>\n \u00a0<\/p>\n Since IPO, Clarity has stamped itself as a global leader in Targeted Copper Theranostics (TCTs)<\/strong>, a disruptive platform in radiopharmaceutical that employs the \u201cperfect pairing\u201d of Copper-64<\/strong> and Copper-67<\/strong> for diagnosis and therapy (or theranostics), respectively.<\/p>\n \u201cWhat we have and no one else has, is copper theranostics \u2013 a combination of copper diganostic and copper therapy,\u201d explained Taylor.<\/p>\n \u201cSo we\u2019re bringing to the market this perfect pairing of copper isotopes, Copper-64 and Copper-67.\u201d<\/p>\n Taylor explains that Copper-64 (used for diagnosis), has a 12.7 hour half-life, and competes with currently used products like Gallium-68 and Fluorine-18, which only have a 1-2 hour half-life.<\/p>\n A short half-life can be problematic as a diagnosis agent for several reasons. First, a short half-life means there is only a limited time frame during which it can be detected in the body. And second, a short half-life may not allow enough time for the distribution of the agent in the body, resulting in poor imaging quality.<\/p>\n \u201cImportantly for us however, we have this perfect pairing with an isotope called Copper-67, which is a therapeutic isotope,\u201d said Taylor.<\/p>\n Copper-67 has a half-life of 2.6 days, compared to its competitor Lutetium-177, which has a half-life of 6.7 days.<\/p>\n \u201cSo Copper-67 is perfect for therapy, and it allows us to dose the patient a lot more on the same day,\u201d said Taylor, adding that the shorter half-life results in shorter duration of radiation exposure to the patient and surrounding healthy tissues.<\/p>\n \u201cThat\u2019s why it\u2019s so exciting, because we basically own this copper thermal theranostic market,\u201d he said.<\/p>\n \u00a0<\/p>\n Source: Clarity Pharma<\/strong><\/em><\/p>\n \u00a0<\/p>\n Clarity also leverages its proprietary SAR Technology<\/strong>, a highly stable bifunctional cage (chelator), which enables a superior ability to retain copper isotopes within it and prevent their leakage into the body.<\/p>\n \u201cWe believe that at this stage, we have the best PSMA (prostate-specific membrane antigen) agents ever invented, and we have a market ready to accept that,\u201d said Taylor.<\/p>\n \u00a0<\/p>\n Clarity\u2019s program revolves around three key product areas, as shown below:<\/p>\n Source: Clarity Pharma<\/strong><\/em><\/p>\n \u00a0<\/p>\n In a nutshell, the company\u2019s various trials essentially use the same two products for diagnosis and therapy.<\/p>\n \u201cThe only thing we change is the copper isotope tag. So every time we invent a product, it\u2019s actually just two products. One for diagnosis using Copper-64, and one for therapy using Copper-67,\u201d explained Taylor.<\/p>\n Near term catalysts and focus at this stage are on the prostate cancer program<\/strong>, with SAR-bisPSMA<\/strong><\/a> and SAR-Bombesin<\/strong> being the two product areas.<\/p>\n In the theranostic SECuRE trial<\/strong> \u2013 which is investigating SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC)<\/strong> patients \u2013 Clarity recently reported that the first patient in cohort 4 (first multi-dose cohort) has been treated with 67Cu-SAR-bisPSMA at 12GBq.<\/p>\n The SECuRE trial has so far shown remarkable results. Among the participants from cohorts 2 and 3, almost 80% showed reductions in PSA (prostate-specific antigen) levels of greater than 35% from a single dose of 67Cu-SAR-bisPSMA, and 44% showed reductions in PSA levels of greater than 80%.<\/p>\n \u201cThe PSA levels in those patients are basically gone, even in patient that had previously failed five to seven lines of therapy. This is amazing,\u201d said Taylor.<\/p>\n \u201cThe overwhelming majority of interest in the market revolves around this incredible therapy data from SECuRE.\u201d<\/p>\n Meanwhile, in the Phase 1\/2 diagnostic COBRA trial<\/strong>, Clarity reported that Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer lesions in patients with biochemical recurrence (BCR).<\/p>\n For all lesions, regardless of their size, 64Cu-SAR-bisPSMA lesion uptake increased by more than 80%, and lesion contrast increased almost five times when comparing same-day to next-day imaging.<\/p>\n \u201cThe cornerstone of better therapy is better diagnosis, and we are incredibly excited about the substantial degree of improvement in detection of lesions with our bisPSMA product compared to SOC imaging,\u201d said Taylor.<\/p>\n Other trials in the program are also moving forward rapidly; for example, the SABRE diagnostic trial has now imaged 50 patients in the US.<\/p>\n \u00a0<\/p>\n In all, Clarity has five open Investigational New Drug (IND) applications with the FDA, covering all six current clinical stage products that received clearance to proceed to clinical trials.<\/p>\n The company has also received approvals from the FDA for two Orphan Drug Designations (ODD), and two Rare Paediatric Disease Designations (RPDD).<\/p>\n Taylor says the next big catalyst will be the results from the SECuRE trial.<\/p>\n \u201cWhen you look at big pharmas, they don\u2019t necessarily love diagnostics but they love therapies. I don\u2019t know of any big pharma that\u2019s just focused on diagnostics.<\/p>\n \u201cSo, the value for Clarity is on the incredible therapeutic data we\u2019ve got today,\u201d he said.<\/p>\n \u201cThe market in this space is incredibly intense right now. There is a bunch of radiopharma companies that are being acquired without any real product.<\/p>\n \u201cBut our job is to focus on developing amazing products and differentiate ourselves from the rest of the market.<\/p>\n \u201cWe will focus on maintaining those barriers to entry, our strong intellectual property, because at the end of the day, we have to deliver these products to patients.<\/p>\n \u201cThat\u2019s our primary job, and that\u2019ll be our focus over the next period following the recent cap raise,\u201d said Taylor.<\/p>\n \u00a0<\/p>\n \u00a0<\/p>\n\n \ufeff<\/span><\/span><\/p>\n \u00a0<\/p>\n Radiopharm Theranostics (ASX:RAD)<\/a><\/strong><\/p>\n Radiopharm is developing Nano-mAbs,<\/strong> a novel radiopharmaceutical platform made using genetic engineered camelid derived single domain antibodies (sdAb), labelled with a radioisotope of therapeutic radiation.<\/p>\n The product is paired with a diagnostic, using the same antibody vector but labelled with a lower radiation radioisotope for imaging.<\/p>\n In the latest update, RAD said that a study featuring DUNP19, (Radiopharm\u2019s RAD 502) shows that it can halt tumour progression and prolong survival in various cancers.<\/p>\n The study, which was published on BioRxiv,\u00a0demonstrated for the very first time how DUNP19 can be used in various cancers for the detection and targeting of Leucine-Rich Repeat Containing 15 (LRRC15)-expressing cancers.<\/p>\n LRRC15 is a cellular marker and new therapeutic target in solid tumours (breast, head and neck, lung, pancreatic), and in cancers that arise from connective tissue (osteosarcoma, glioblastoma, melanoma).<\/p>\n DUNP19 is currently under pre-clinical investigation at Radiopharm.<\/p>\n \u00a0<\/p>\n <\/span><\/p>\n The post Radiopharmaceutical emerges as the hottest space in biotech; here\u2019s what it means for Clarity Pharma<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"Why copper?<\/h2>\n
Breaking down Clarity\u2019s clinical program<\/h2>\n
What\u2019s ahead?<\/h2>\n
Clarity Pharma share price today:<\/h2>\n
Another radipharmaceutical stock on the ASX<\/h2>\n