On January 28, 2025 Pfizer Inc. (NYSE: PFE) reported that it will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California (Press release, Seagen, JAN 28, 2025, View Source [SID1234649906]). Data from more than 20 company-sponsored, investigator-sponsored, and collaborative research abstracts, including five oral presentations, highlight advancements in developing new standards of care within prostate and bladder cancer across the company’s core scientific modalities, including small molecules and antibody-drug conjugates.

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"Our long-standing commitment to the genitourinary cancer community has been foundational in our mission to transform the treatment landscapes for patients with bladder and prostate cancers," said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. "Our strong presence at this year’s ASCO (Free ASCO Whitepaper) GU highlights the longer-term impacts of our approved leading medicines for patients in their respective indications. We are also looking forward to sharing updates from our rapidly growing pipeline of novel targets and combination approaches, which have the potential to help address the diverse needs of patients across various stages of disease."

Pfizer’s GU portfolio includes seven approved medicines across bladder, prostate, and kidney cancers, as well as a growing late-stage pipeline of scientific modalities and combination approaches. Key Pfizer presentations at ASCO (Free ASCO Whitepaper) GU include the detailed overall survival (OS) results from the Phase 3 TALAPRO-2 trial with TALZENNA (talazoparib) plus XTANDI (enzalutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC), which will be featured in ASCO (Free ASCO Whitepaper) GU’s official Press Program. In addition, updated analysis from the Phase 3 global EV-302 study of PADCEV (enfortumab vedotin-ejfv) in combination with pembrolizumab in locally advanced or metastatic urothelial cancer (la/mUC) will be presented, highlighting the long-term efficacy benefits of the combination.

From the pipeline, the first randomized progression-free survival (PFS) data from the ongoing Phase 1 dose-escalation study for mevrometostat plus XTANDI reinforce the potential of this investigational combination for patients with mCRPC. Additional pipeline presentations include updated data and real-world evidence for different types of bladder cancer, supporting the development of two potential transformative treatments, disitamab vedotin, an investigational antibody-drug conjugate (ADC), and sasanlimab, an investigational subcutaneous PD-1 blocker.

Key ASCO (Free ASCO Whitepaper) GU Presentations

Prostate Cancer

TALZENNA plus XTANDI:Oral and poster presentations from the pivotal Phase 3 TALAPRO-2 trial of TALZENNA in combination with XTANDI will provide detailed results on the statistically significant and clinically meaningful improvement in OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. TALZENNA in combination with XTANDI has been approved for use in over 35 countries globally for patients with certain types of mCRPC*. The OS results will be shared with global health authorities to potentially update the TALZENNA label.
XTANDI: Six abstracts continue to underscore the benefit of XTANDI across its approved indications, including two posters highlighting follow-up analysis from the EMBARK trial of XTANDI in combination with leuprolide in patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high-risk for metastasis.
Mevrometostat: The first randomized PFS results from the ongoing Phase 1 dose-expansion study examine the potential of mevrometostat (PF-06821497), an investigational selective inhibitor of enhancer of zeste homolog 2 (EZH2), in combination with XTANDI in patients with mCRPC, compared to XTANDI alone. Pfizer initiated two pivotal Phase 3 trials for mevrometostat plus XTANDI in 2024 and expects to start a Phase 3 study of mevrometostat plus XTANDI in first-line mCSPC during the first half of 2025.
Bladder Cancer

PADCEV: Long-term follow-up data from the groundbreaking Phase 3 EV-302 study of PADCEV in combination with pembrolizumab, including OS and safety data, continue to demonstrate consistent efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC.
Disitamab vedotin: Updated efficacy and safety data from an ongoing Phase 2 study (sponsored by Remegen) evaluating the HER2-targeting ADC disitamab vedotin plus toripalimab show encouraging results as a perioperative regimen in HER2-expressing muscle-invasive bladder cancer (MIBC). These data add to the growing body of evidence supporting the continued development of disitamab vedotin across stages of bladder cancer.
Sasanlimab: Three real-world evidence poster presentations highlight the need for advanced treatment options for patients with non-muscle invasive bladder cancer (NMIBC), including presentations on Bacillus Calmette-Guérin (BCG) treatment patterns, impact of BCG shortages, and outcomes and treatment patterns in patients with high-risk NMIBC. Pfizer recently reported positive topline results for sasanlimab in combination with BCG as induction therapy with or without maintenance in patients with BCG- naïve, high-risk NMIBC. Detailed results from the Phase 3 CREST trial will be presented at an upcoming congress.
Additional information on key Pfizer-sponsored abstracts at ASCO (Free ASCO Whitepaper) GU 2025, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here.

*TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023.

Prostate Cancer

Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial (Abstract #LBA18)

Agarwal, N

Oral Abstract Session

Thursday, February 13, 11:42 AM – 11:52 AM EST

Presentation Time: 8:42 AM – 8:52 AM PST

Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line (1L) treatment in patients (pts) with homologous recombination repair (HRR)-deficient metastatic castration-resistant prostate cancer (mCRPC) in the Phase 3 TALAPRO-2 trial (Abstract #LBA141)

Fizazi, K

Poster Session

Thursday, February 13, 2:25 PM – 3:45 PM EST

Presentation Time: 11:25 AM – 12:45 PM PST

Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study (Abstract #LBA138)

Schweizer, MT

Rapid Oral Abstract Session

Thursday, February 13, 8:25 PM – 8:30 PM EST

Presentation Time: 5:25 PM – 5:30 PM PST

Bladder Cancer

EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) (Abstract #664)

Powles, TB

Rapid Oral Abstract Session

Friday, February 14, 7:10 PM – 7:15 PM EST

Presentation Time: 4:10 PM – 4:15 PM PST

Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer (MIBC) with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial (Abstract #665)

Sheng, X

Oral Abstract Session

Friday, February 14, 11:57 AM – 12:07 PM EST

Presentation Time: 8:57 AM – 9:07 AM PST

On January 28, 2025 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported positive initial data from Part B of the DeFianCe study evaluating sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC), and initial data from Part C of the DisTinGuish study evaluating sirexatamab in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer (Press release, Leap Therapeutics, JAN 28, 2025, View Source [SID1234649905]).

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Key Findings from Part B of the DeFianCe study:

"Data from Part B of the DeFianCe study closely mirror the findings from Part A, and together they demonstrate the potential of sirexatamab to provide a compelling treatment option for second-line CRC patients who do not benefit from current standard of care," said Cynthia Sirard, M.D., Chief Medical Officer of Leap. "Along with consistently achieving higher response rates than the control arm, the data also point to a favorable safety profile. While not yet fully mature, we are encouraged by the progression-free survival data thus far across key subgroups in the study. We look forward to reporting additional data from Part B as it matures over the coming months and beginning our planning for Phase 3 registrational studies."

"The patient population in second-line CRC is heterogeneous, and there is a true unmet need for new treatment options that are safe and effective. The latest findings from DeFianCe Part B are highly encouraging, as sirexatamab combination therapy is outperforming bevacizumab and chemotherapy alone in ORR in the intent-to-treat analysis and across key subgroups of interest," said Zev Wainberg, M.D., Professor of Medicine and Co-Director of the GI Oncology Program at UCLA. "Initial results also show increased response rates in patients with high DKK1 levels, directly correlating with sirexatamab’s novel mechanism of action. These data support moving forward into Phase 3 registrational studies to further explore a unique treatment option for patients in need."

The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of sirexatamab in combination with bevacizumab and chemotherapy in patients with advanced microsatellite stable (MSS) CRC who have received one prior systemic therapy for advanced disease. Part B of the study is a 188 patient randomized controlled trial, with the primary objective being progression-free survival (PFS) in patients with left-sided cancers and in all patients. Key secondary and exploratory objectives include objective response rate (ORR), duration of response, and overall survival across tumor, treatment, and biomarker subgroups.

· Across the intent-to-treat (ITT) population with second-line MSS CRC (n=188):
o Patients treated with sirexatamab plus bevacizumab and chemotherapy (Experimental Arm, n=94) had ORR of 35% and disease control rate (DCR) of 86%, compared to an ORR of 23% and DCR of 84% in patients treated with bevacizumab and chemotherapy alone (Control Arm, n=94)

· Across the population with left-sided primary tumors (n=144):
o Patients treated in the Experimental Arm (n=71) had an ORR of 38%, compared to an ORR of 25% in the Control Arm (n=73)

· Plasma DKK1 highly correlated with clinical activity:
o Patients in the Experimental Arm with DKK1 levels above the median (n=49) had an ORR of 39%, compared to 22% ORR in the Control Arm (n=36)
o Patients in the upper-quartile of DKK1 levels in the Experimental Arm (n=25) had an ORR of 48%, compared to 11% ORR in the Control arm (n=18)

· Key patient subgroups demonstrated higher ORR in the Experimental Arm:
o No prior anti-VEGF therapy: Patients in the Experimental Arm (n=49) had an ORR of 51%, compared to 29% ORR in the Control arm (n=45)
o Prior anti-EGFR therapy: Patients in the Experimental Arm (n=28) had an ORR of 54%, compared to 27% ORR in the Control arm (n=22)
o RAS wildtype (RAS-wt) tumors: Patients in the Experimental Arm (n=35) had an ORR of 43%, compared to 32% ORR in the Control Arm (n=25)

· With only 3 months follow-up on the final patients enrolled and mean duration on study of approximately 6 months, PFS is not yet mature. Eighty-two patients are still on study, 46 in the Experimental Arm and 36 in the Control Arm. Early separation in the Kaplan-Meier PFS curves is being seen in many of the key patient subgroups, including DKK1 biomarker, anti-VEGF-naïve, anti-EGFR-experienced, and RAS-wt patients. Leap expects to report additional data as it matures in 2025.

· Sirexatamab plus bevacizumab and chemotherapy was well-tolerated, without additive toxicity to the standard of care.

The strong signal in CRC from the DeFianCe study supports Leap moving forward to plan a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC patients with high unmet need, subject to regulatory discussions. Potential Phase 3 patient populations include: DKK1 biomarker-selected, anti-VEGF naïve, anti-EGFR experienced, or RAS-wt patients. While the data matures, Leap intends to conduct global commercial and regulatory strategic analysis to select the optimal population.

Key Findings from Part C of the DisTinGuish study:

Leap also reported data from Part C of the DisTinGuish study evaluating sirexatamab in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy in first-line patients with advanced GEJ and gastric cancer. While demonstrating activity in biomarker populations, the study did not generate a clear positive signal and will be negative on the primary PFS endpoints when the study completes, resulting in the decision not to move forward with Phase 3 studies in gastric cancer.

"Sirexatamab plus tislelizumab and chemotherapy demonstrated improved confirmed response rates compared to the control arm in the ITT, DKK1-high, and PD-L1 negative patients by Blinded Independent Central Review (BICR). However, gastric cancer is a difficult tumor to assess radiologically, and unfortunately, there was a high level of discordance between investigator assessment (IA) and BICR," said Dr. Sirard. "Therefore, we have decided to focus our internal effort and resources on advancing sirexatamab in CRC and will explore strategic partnership opportunities to advance sirexatamab plus anti-PD-1 antibodies in gastric cancer and other indications where there is high DKK1 expression."

Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of sirexatamab in combination with tislelizumab and chemotherapy in first-line patients with advanced GEJ and gastric cancer. Part C enrolled 170 first-line, HER2-negative patients. Patients were randomized 1:1 to evaluate sirexatamab in combination with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone. The primary objective is PFS by IA in all patients and in DKK1 TPS > 20 (DKK1-high) patients. Secondary objectives include ORR, duration of response, and overall survival as measured by BICR and IA in all patients and in DKK1-high patients.

· Across the ITT population (n=170), patients treated with sirexatamab plus tislelizumab and chemotherapy (Experimental Arm, n=85) had a confirmed ORR of 52% by both IA and BICR, while patients treated with tislelizumab and chemotherapy alone (Control Arm, n=85) had a confirmed ORR of 56% by IA and 42% by BICR.

· Based on BICR:
o Patients in the Experimental Arm with DKK1-high tumors (n=22) had a confirmed ORR of 59%, compared to 36% in the Control Arm (n=22)
o Patients in the Experimental Arm with PD-L1-negative tumors (n=18) had a confirmed ORR of 44%, compared to 32% in the Control Arm (n=19)

· In the ITT population, preliminary median PFS in the Experimental Arm was 9.72 months by BICR and 7.66 months by IA compared to 11.99 months by BICR and 10.41 months by IA in the Control Arm. The median PFS for tislelizumab plus chemotherapy in the Phase 3 Rationale-305 study was 6.9 months (95% CI: 5.7, 7.2).

· In the DKK1-high population, preliminary median PFS in the Experimental Arm was 7.72 months by BICR and 7.43 months by IA compared to 7.79 months by BICR and 11.14 months by IA in the Control Arm. The hazard ratio for PFS by BICR was 0.68, representing a trend in favor of the Experimental Arm in the overall time to event analysis.

· Sirexatamab plus tislelizumab and chemotherapy was well tolerated, without additive toxicity to the standard of care.

Conference Call:

Leap’s management team will host a conference call today, January 28, 2025 at 8:00 a.m. Eastern Time to further discuss the data. The conference call will be broadcast live in listen-only mode and can be accessed via the webcast URL: View Source A replay of the event will be available for a limited time on the Investors page of the Company’s website at View Source

On January 28, 2025 Curium, a world leader in nuclear medicine, reported that in Estonia, Finland, Latvia, and Sweden, PYLCLARI is now available for patients with prostate cancer (Press release, Curium Pharma, JAN 28, 2025, View Source [SID1234649904]). PYLCLARI (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, CEO Europe commented, "The availability of PYLCLARI in Estonia, Finland, Latvia, and Sweden is an important milestone for patients with prostate cancer, since it is vital that we continue to improve the choice of diagnostic radiopharmaceuticals available to physicians to better diagnose and monitor prostate cancer. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are proud that the availability of PYLCLARI continues to grow and now covers eleven European countries."

In countries across the Nordic and Baltic regions, prostate cancer is one of the most common cancers among men with around 25,000 new cases diagnosed regionally every year according to the European Cancer Information System. PYLCLARI is being produced by Curium at its facilities in Helsinki, Finland – ensuring distribution to Estonia, Finland, Latvia, and Sweden.

For more information about PYLCLARI: www.pylclari.com

In the U.S., Lantheus received approval for PYLARIFY (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.

On January 28, 2025 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, reported that it has entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED Therapeutics Inc. ("SEED"), a biotechnology company focused on Targeted Protein Degradation (TPD) technology and a subsidiary of the Company, for gross proceeds of approximately $35.4 million (Press release, BeyondSpring Pharmaceuticals, JAN 28, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-35-4-million-sale-of-a-portion-of-equity-interest-in-seed-therapeutics-to-advance-lead-asset-plinabulin-to-anti-cancer-registrational-studies [SID1234649903]). Upon completion of the transactions, BeyondSpring, together with SEED Technology Limited, a majority-owned indirect subsidiary of the Company, is expected to retain approximately 14.4% of SEED’s outstanding shares.

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Strategic Background and Rationale

Since 2016, BeyondSpring has been at the forefront of TPD innovation, incubating its proprietary TPD technology internally and co-founding SEED with Eli Lilly and Company in 2020. Through this pioneering sponsorship, SEED has grown into a leader in TPD, a revolutionary drug discovery approach targeting previously undruggable proteins. SEED has developed a robust pipeline of therapies in oncology and neurodegeneration, leveraging its proprietary molecular glue-based platform. Research collaborations with Eli Lilly and Company, and Eisai Co. Ltd. ("Eisai") further validate its leadership in TPD.

The recent Series A-3 financing led by Eisai, at a pre-money valuation of $100 million, underscores SEED’s innovation and market potential. The transactions announced today will enable BeyondSpring to unlock value while retaining a meaningful ownership stake in SEED. The $35.4 million in proceeds will advance BeyondSpring’s late-stage clinical trials of its lead asset, Plinabulin, ensuring critical resources without diluting shareholder equity.

Plinabulin: A First-in-Class Agent with Broad Potential

Plinabulin is a first-in-class anti-cancer agent which has been used in over 700 cancer patients with good tolerability. It is a differentiated tubulin binder, which releases immune defense protein GEF-H1, leading to dendritic cell maturation that drives both direct anti-cancer activity and immune system activation1,2. It has demonstrated durable anti-cancer benefits across multiple clinical studies and addresses significant unmet medical needs in oncology:

DUBLIN-3 (103) Study (Sept. 2024): In a global phase 3 study (n=549)3, Plinabulin combined with docetaxel achieved significant overall survival benefit, and doubling 2-year and 3-year survival rate in second- and third-line non-small-cell lung cancer (NSCLC) with EGFR wild type, compared to docetaxel alone (Press Release Link).
303 Study (Nov. 2024): Plinabulin combined with pembrolizumab and docetaxel achieved an 89.3% disease control rate and a median progression-free survival (PFS) of 8.6 months in 30 NSCLC patients who progressed on immune checkpoint inhibitors (Press Release Link).
302 Study (Mar. 2024): Enrollment began for first-line extended-stage small cell lung cancer (ES-SCLC) patients treated with Plinabulin, etoposide, platinum therapy, and pembrolizumab (Press Release Link).
Dr. Trevor Feinstein, MD, a lead principal investigator of the DUBLIN-3 Study at Piedmont Cancer Center, Atlanta, highlighted the critical need addressed by Plinabulin:

"There is a poor prognosis for NSCLC patients without targetable alterations whose disease has progressed on platinum-based therapies and immune checkpoint inhibitors. Over 60% of patients progress on PD-1/PD-L1 inhibitors in NSCLC4. Unfortunately, multiple high-profile phase 3 studies failed to show overall survival benefit in this hard-to-treat population compared to standard of care docetaxel, a drug approved over 20 years ago. The data from the DUBLIN-3 Study demonstrates that the addition and proper sequencing of Plinabulin to docetaxel has a favorable benefit/risk ratio compared with docetaxel alone and may have broad utility. In addition, current ongoing 303 and 302 Studies are targeting additional severe unmet medical needs, which Plinabulin’s mechanism of action can help address."

"With this capital, BeyondSpring is strategically positioned to advance our 303 and 302 studies in Plinabulin combination with immune checkpoint inhibitors to registrational trials and explore business development partnerships to bring Plinabulin to cancer patients with limited treatment options," said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring. "At the same time, retaining a substantial stake in SEED Therapeutics ensures that we remain part of its continued success in revolutionizing drug discovery."

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 28, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the acceptance of two abstracts for presentation at the ASCO (Free ASCO Whitepaper) GU 2025 Conference on Clarity’s COBRA and CLARIFY trials and an abstract on the COBRA trial at the AUA Annual Meeting 2025 (Press release, Clarity Pharmaceuticals, JAN 28, 2025, View Source [SID1234649892]). These conferences are among the world’s most prestigious in oncology and urology, and the acceptance of these abstracts is testament to the strength of Clarity’s data and the exciting prospects for the diagnostic 64Cu-SAR-bisPSMA to change the paradigm in the diagnosis and treatment of cancer.

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The abstracts on Clarity’s COBRA trial showcase the improved efficacy of 64Cu-SAR-bisPSMA at detecting lesions compared to currently approved PSMA PET agents, and the potential for this product to become a best-in-class diagnostic. 64Cu-SAR-bisPSMA was able to identify lesions prior to detection by the standard-of-care (SOC) PSMA PET products, which are known to have low sensitivity.

In a subset of participants in the COBRA study who underwent follow-up SOC PSMA PET, 70% of participants had a positive scan on same-day imaging and 90% on next-day imaging using 64Cu-SAR-bisPSMA, compared to 60% of participants using SOC PSMA PET where only same-day imaging is possible. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA was also higher (26.3 lesions on same-day imaging, 52.6 on next-day imaging) than that detected by SOC PET agents (20 lesions). Results indicate that 64Cu-SAR-bisPSMA is able to identify lesions from 29 days to more than 6 months earlier than SOC PSMA agents. Across all participants in the study, histopathology confirmed the presence of prostate cancer in lesions identified by 64Cu-SAR-bisPSMA in up to 78% of cases in which biopsies were performed, which was considerably higher compared to less sensitive methods (e.g. SOC imaging) used to verify the 64Cu-SAR-bisPSMA PET findings. With regards to the biopsies, 100% of lesions which were located outside of the prostate bed were determined as positive, with only 2 participants showing negative results. These 2 participants had lesions located in the prostate bed and had undergone the complete removal of their prostate as part of their initial treatment. The prostate bed is an area notoriously difficult to biopsy following surgery due to anatomical changes and scarring of surrounding tissues as a result of the procedure, which may lead to negative results despite the presence of cancer. Investigators stated that they would change their intended treatment plan in approximately half (48%) of their patients due to the findings of the 64Cu-SAR-bisPSMA PET.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Our lead product, SAR-bisPSMA, continues generating impressive results as we work with world-class experts to conduct clinical research at the highest standard, bringing us closer to improving the diagnostic paradigm for prostate cancer patients around the world. It is a huge testament to the quality and importance of our data that it continues to be accepted for presentation at some of the world’s most prominent conferences.

"64Cu-SAR-bisPSMA has shown an impeccable safety profile and impressive diagnostic performance to date compared to current SOC PSMA PET agents, which are known to have significant sensitivity limitations. Not only is our product more effective on same-day imaging due to its dual-targeting "bis" structure, but the unique property of next-day imaging, enabled by the longer half-life of copper-64 isotopes, also opens a myriad of opportunities for significantly improving the accuracy of cancer diagnosis and making more informed treatment decisions for men with prostate cancer.

"The results presented in the most recent COBRA abstracts highlight how 64Cu-SAR-bisPSMA could change the scene of prostate cancer diagnostics. With 90% of next-day scans identifying prostate cancer, in comparison to only 60% on SOC PSMA PET scans, and identifying over 2.6 times the number of lesions with 64Cu-SAR-bisPSMA over the approved diagnostics, 64Cu-SAR-bisPSMA could be the game changer. The data provides physicians crucial information to make more informed decisions about treatment, and the high response from investigators in the COBRA trial who intended to change their treatment plan is an indication of how far reaching these changes could be. This opens the door for patients to potentially receive better treatment for their cancer based on these findings, improving their outcomes and quality of their lives.

"The data from the COBRA study, as well as from our earlier PROPELLER trial in the pre-prostatectomy setting, were used to support the design of our second registrational trial with 64Cu-SAR-bisPSMA, AMPLIFY, in patients with biochemical recurrence (BCR) of prostate cancer, planned to commence in the coming months. This trial, in conjunction with the ongoing pivotal CLARIFY trial, which currently has over 20 sites actively recruiting in the U.S. and Australia, is intended to provide evidence to support the U.S. Food and Drug Administration (FDA) approval of 64Cu-SAR-bisPSMA as a novel diagnostic imaging agent for newly diagnosed prostate cancer patients as well as those in BCR of their disease, bringing us closer to achieving our ultimate goal of improving treatment outcomes for people with cancer."

Title Conference and Session details
COBRA: Assessment of the efficacy of 64Cu-SAR-bisPSMA using histopathology as reference standard in patients with biochemical recurrence of prostate cancer following definitive therapy ASCO GU
Date: Thursday, February 13, 2025

Time: 11:25 AM – 12:45 PM PT; 5:45 PM – 6:45 PM PT

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Abstract #: 44

Poster Bd #: A22

CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy — A phase 3 diagnostic performance study ASCO GU
Date: Thursday, February 13, 2025

Time: 11:25 AM – 12:45 PM PT; 5:45 PM – 6:45 PM PT

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Abstract #: TPS429

Poster Bd #: M27

COBRA: Assessment of 64Cu-SAR-bisPSMA and standard of care prostate-specific membrane antigen Positron Emission Tomography in patients with biochemical recurrence of prostate cancer following definitive therapy AUA
Date: Sunday, April 27, 2025

Time: 9:30 AM – 11:30 AM PT

Session Title: MP13: Prostate Cancer: Staging

Room: To be announced

Presentations will be available on Clarity’s website after the conferences: claritypharmaceuticals.com/pipeline/scientific_presentations

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. Among 82 patients who received 64Cu-SAR-bisPSMA in PROPELLER and COBRA, 2 adverse reactions were reported in 2 participants (mild occasional metallic taste and moderate worsening of type II diabetes, both resolved).

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide3. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the U.S. and around 35,770 deaths from the disease.