On November 12, 2026 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 patients with cancer, reported that the United States (US) Food and Drug Administration (FDA) granted 64Cu-SAR-bisPSMA Breakthrough Therapy designation for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

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Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug/agent of interest may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)1. This designation is intended to get promising drugs developed and to the market as quickly and safely as possible, so that they can be available to optimise the treatment of the patients who need them most2. The benefits of a product having Breakthrough Therapy designation include1:

All Fast Track designation features
Intensive guidance on an efficient drug development program
Organisational commitment from the FDA involving senior managers for a more proactive, collaborative, cross-disciplinary review
While Fast Track designation can be granted based on early-stage or nonclinical data, Breakthrough Therapy designation requires preliminary clinical evidence of a treatment effect that may represent considerable additional clinical benefit over available products in a serious condition3. Breakthrough Therapy designation is also a positive indicator of potential eligibility for Priority Review due to overlapping qualifying criteria. Priority Review is requested at the time of the New Drug Application (NDA) submission and can substantially shorten the FDA’s review timeline for an NDA3.

The FDA Breakthrough Therapy designation was supported by data from the Phase II Co-PSMA trial4, Phase I/II COBRA trial5 (see About Co-PSMA and About COBRA sections below) and real-world evidence6, which collectively indicate enhanced diagnostic performance of 64Cu-SAR-bisPSMA over standard-of-care (SOC) PSMA PET in patients with biochemical recurrence (BCR) of prostate cancer.

Clarity is currently progressing two registrational Phase III trials with 64Cu-SAR-bisPSMA, AMPLIFY (NCT06970847)7 and CLARIFY (NCT06056830)8, both of which have successfully completed recruitment and are now in patient follow-up. Topline data from both pivotal trials are anticipated to be released in the first half of calendar year (CY) 2027. As pivotal trials, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer patients prior to undergoing definitive therapy (CLARIFY) and with BCR (AMPLIFY).

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "Receiving this Breakthrough Therapy designation is one of the most significant milestones in our prostate cancer program to date. Its importance is further amplified given fewer than half of designation requests across all therapeutic areas are successful9. The FDA’s award of the first Breakthrough Therapy designation in the history of PSMA PET imaging highlights both the unmet need for more accurate detection of recurrent prostate cancer lesions and the significance of the data generated to date, which indicates improved diagnostic performance of 64Cu-SAR-bisPSMA compared to SOC PSMA PET in patients with BCR of prostate cancer.

"Although PSMA PET represents a major advance over conventional imaging for prostate cancer detection, currently approved products miss metastatic disease in many patients, particularly in those with small volume disease. According to their respective FDA-approved prescribing information, the two leading PSMA PET agents demonstrate these limitations across different clinical settings. In initial staging, sensitivities as per the FDA-approved label are 47% for 68Ga-PSMA-1110 and 35% for 18F-DCFPyL11 (averages across readers). In BCR, PET positivity rates on the FDA-approved label are only 36% and 35%, respectively, in patients with PSA<0.5 ng/mL, and only increase to 56% and 50%, respectively, in patients with PSA 0.5 to < 1.0 ng/mL10,11, meaning that disease detection is still missed in up to half the patients even at these higher PSA levels. The Co-PSMA data that had participants with a median PSA level of 0.43 ng/mL and a 68Ga-PSMA-11 detection rate of 36% is comparable to the FDA-approved label. The detection rate for 64Cu-SAR-bisPSMA in Co-PSMA in the same patient group was more than double that of 68Ga-PSMA-11 at 78%4.

"With innovation, scientific rigour and highest standards of clinical development at the core of our Company, our lead product, 64Cu-SAR-bisPSMA, is testament to this approach. Our proprietary sarcophagine (SAR) Technology, derived from the benchtop of Australian science, is a platform technology that enables us to successfully use the ‘perfect pairing’ of copper-64 (for imaging) and copper-67 (for therapy). The potential benefits of copper-64 and copper-67 have been discussed in scientific literature for decades, but their adoption in the clinic had been limited due to issues with copper isotopes leaking from conventional chelators into the body. The SAR Technology is designed to overcome this challenge, opening new opportunities in Targeted Copper Theranostics (TCTs). Being able to successfully employ copper-64 with its longer half-life of 12.7 hours, compared to the gallium-68 and fluorine-18 isotopes with half-lives of 1-2 hours, enables extended imaging timepoints of up to 30 hours post-injection. Differentiating further, we went back to the benchtop and optimised the well-known PSMA target, developing a novel, bivalent bisPSMA agent and subsequently filing a patent for the composition of matter in June 2018, providing us with patent protection until at least 2038. The combination of the secure chelating SAR Technology, optimal imaging timepoints with copper-64 and the bivalent bisPSMA agent is what makes 64Cu-SAR-bisPSMA stand out from the FDA-approved PSMA PET products in the market, with the potential to improve the detection of prostate cancer and facilitate more informed, individualised clinical management in these patients. The longer product shelf-life (compared to Ga-68 and F-18 based products) also translates into supply chain benefits through centralised and regional manufacture as well as broad geographic distribution, which can improve patient access to this important imaging tool.

"The Breakthrough Therapy designation is supported by the Co-PSMA4 and COBRA5 trials as well as real-world evidence6. A key study contributing to this milestone is Co-PSMA, which investigated 64Cu-SAR-bisPSMA against 68Ga-PSMA-11 in a head-to-head and intra-patient comparison design. This investigator-initiated trial (IIT) was conducted by Prof Louise Emmett, a globally renowned nuclear medicine physician, at St Vincent’s Hospital in Sydney. The quality and significance of this work have been recognised globally with the manuscript selected as an Editor’s Choice article by the editors of European Urology, a world-leading clinical journal in the field of Urology with an impressive impact factor of 29.7. The data were showcased at the annual European Association of Urology (EAU) Congress and as a Top-Rated Oral Presentation at the European Association of Nuclear Medicine (EANM) Congress 2026, which underscore the significance of the findings for both the urology and nuclear medicine fields. We are proud to have supported this IIT and are committed to supporting high-quality research involving 64Cu-SAR-bisPSMA in the future.

"The field of PSMA PET imaging has evolved rapidly over the past few years, quickly becoming a blockbuster market with sales of around US$2 billion per year in the US alone, and this is expected to further grow to over US$3 billion by 2029. The substantial and growing PSMA PET market represents a significant opportunity for Clarity, but our ambition extends well beyond market size. Our focus remains firmly on developing products that will improve the outcomes of patients with cancer, and this Breakthrough Therapy designation is an important step in the progress we are making towards this goal.

"We would like to take this opportunity to acknowledge and thank the investigators who have contributed their knowledge, time and resources to the 64Cu-SAR-bisPSMA trials, our team of dedicated and driven individuals who continue tirelessly progressing this program towards launch and, importantly, the participants and their families who took part in our trials and special access cases to date."

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 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.

About Co-PSMA
Co-PSMA ("Comparative performance of 64Copper [64Cu] SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy") was an IIT led by Prof Louise Emmett at St Vincent’s Hospital, Sydney, evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bis-PSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 product in prostate cancer patients with PSA of 0.2 – 0.75 ng/mL. Eligible patients were required to have had radical prostatectomy with no salvage therapy. SOC 68Ga-PSMA-11 PET/CT per institutional protocol was followed by 64Cu-SAR-bisPSMA PET/computed tomography (CT) (at 1 hour and 24 hours post-injection, same-day and next-day imaging, respectively), on the same digital PET camera4.

The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number. Secondary endpoints included management impact questionnaires between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 and accuracy of the PET findings determined using a comprehensive reference standard, including biopsy, response to targeted treatment without androgen deprivation therapy (ADT), PSA rise without treatment or corroborative imaging4.

The study enrolled 50 participants (median PSA 0.43 ng/mL [interquartile range: 0.31–0.63]). In addition to meeting its primary endpoint, the study also demonstrated improved diagnostic performance of next-day 64Cu-SAR-bisPSMA PET across multiple parameters (minimal differences were observed between 1-hour 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET). The mean per-patient lesion for 64Cu-SAR-bisPSMA (24-hour imaging) was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95% confidence interval [CI]: 0.52 – 1.04), ratio 2.63 (95% CI: 1.64 – 4.20) (primary endpoint; p < 0.0001). On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on 64Cu-SAR-bisPSMA PET/CT (next-day imaging). The patient-level true positive rate also favoured 64Cu-SAR-bisPSMA next-day imaging (71% vs. 29% for 68Ga-PSMA-11, against the composite reference standard). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 24-hour 64Cu-SAR-bisPSMA imaging detected 63 lesions. The increase in the number of lesions identified by 64Cu-SAR-bisPSMA was noted in the prostatic bed region (local recurrence), pelvic/extrapelvic lymph nodes and bone.4

At 24 hours, 64Cu-SAR-bisPSMA demonstrated higher lesion uptake compared to 68Ga-PSMA-11 (median maximum standardised uptake value [SUVmax] 13.6 vs. 5.3), and lower background bladder activity (median SUVmax 12.0 vs. 34.5, respectively), improving tumour-to-background contrast. These imaging attributes likely contributed to an almost perfect agreement across the three independent blinded readers for the 64Cu-SAR-bisPSMA scans, whereas the agreement was lower for 68Ga-PSMA-11. This means the readers reached the same conclusions when assessing the 64Cu-SAR-bisPSMA scans far more often than when assessing the 68Ga-PSMA-11 scans in a blinded fashion (near perfect level of agreement for 64Cu-SAR-bisPSMA, Cohen’s Kappa 0.94 vs. 0.75 for 68Ga-PSMA-11)4.

Importantly, these imaging findings informed clinically meaningful changes in planned patient management, with a marked difference between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 (planned management changes observed in 44% of patients following 64Cu-SAR-bisPSMA imaging). The two most common modifications in treatment plan were changes from observation to active treatment (12/22) and changes in the radiation field (9/22). Active planned management increased from 66% based on 68Ga-PSMA-11 results to 90% based on 64Cu-SAR-bisPSMA findings. This highlights the potential impact of 64Cu-SAR-bisPSMA on the management of patients with BCR and at these PSA levels4.

Key data from the abstract was released in February 2026 and presented at the EAU Congress in March 2026. The manuscript was selected as an Editor’s Choice article in European Urology (impact factor of 29.7) in March 2026. The results were also showcased as a Top-Rated Oral Presentation at the EANM Annual Congress 2026 in October, highlighting the significance of its findings for the fields of urology and nuclear medicine.

About COBRA
COBRA was a Phase I/IIa, multi-centre, single arm, non-randomised, open-label study of 64Cu-SAR-bisPSMA in participants with BCR of prostate cancer and negative or equivocal findings on institutional SOC conventional imaging. The primary objectives of the trial were to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer. Patients underwent PET/ CT scans on same-day and next-day imaging (1-4 hours and 24±6 hours post-injection, respectively), which were interpreted by three blinded central readers. To determine the efficacy of 64Cu-SAR-bisPSMA imaging, same-day and next-day imaging results of the central readers were assessed against a composite reference standard that was determined by an independent, blinded, central expert panel. The reference standard consisted of histopathology, follow-up SOC imaging and/or confirmed PSA response to focal therapy12.

Fifty-two participants with negative or equivocal SOC scans were enrolled and imaged, of whom 42 were included in the calculation of the efficacy endpoints. The median PSA at study entry was 0.9 ng/mL (range 0.25 – 17.60). The study demonstrated that 64Cu-SAR-bisPSMA was safe and effective in detecting lesions in patients with BCR of prostate cancer who were negative or equivocal on SOC imaging (e.g. bone scan, CT or PET with approved PSMA imaging agents) at screening12.

The primary efficacy endpoints were patient-level correct detection rate (CDR, defined as the proportion of true positive participants out of all scanned participants who had at least one evaluable reference standard datapoint) and region-level positive predictive value (PPV, defined as the proportion of true positive regions out of all positive regions on the 64Cu-SAR-bisPSMA PET/CT scan with corresponding evaluable reference standard). The CDR range across the central readers in patients that were negative or equivocal on SOC imaging on same-day imaging was 19.0–26.2% (95% confidence interval [CI] 8.6–42.0), increasing to 26.2–33.3% (95% CI 13.9–49.5) on next-day imaging. The region-level PPV on same-day imaging range was 39.1–44.8% (95% CI 19.7–64.3), and on next-day imaging it was 32.7–43.3% (95% CI 20.3–62.6). The CDR and PPV results were substantially impacted by the large number of lesions that were detected, but unable to be biopsied as this would not be clinically appropriate, despite these patients being negative or equivocal SOC imaging. The study had biopsies performed in 9 patients, of whom 7 (almost 80%) had a positive result based on histopathology. This trial was the first study in the BCR setting, showing such considerable effects of 64Cu-SAR-bisPSMA even in patients who had failed SOC imaging12.

64Cu-SAR-bisPSMA was able to identify approximately 91% more lesions (median increase) on next-day imaging compared to same-day imaging (ranges across the readers for the total number of lesions: 53–80 on same-day vs. 82–153 on next-day imaging). The number of lesions in the pelvic lymph node region more than doubled on next-day imaging compared to same-day imaging (median increase of 108.3% across all readers comparing same-day vs. next-day imaging). The ranges of CDR and patient-level detection rate (DR, defined as the proportion of participants with a positive 64Cu-SAR-bisPSMA PET/CT scan out of all scanned participants) were both higher on next-day imaging compared to same-day imaging. The DR range on same-day imaging was 44–58% (95% CI 30–71.8), increasing on next-day imaging to 58–80% (95% CI 43.2–90)12.

The same-day and next-day 64Cu-SAR-bisPSMA scans were compared with follow-up conventional SOC PSMA PET scans in 20 participants (13 participants with 68Ga-PSMA-11 scans and 7 with 18F-DCFPyL scans) during the follow-up period. The median time from same-day 64Cu-SAR-bisPSMA imaging to follow-up SOC PSMA PET was 73.5 (range: 29-180) days. Both same-day and next-day 64Cu-SAR-bisPSMA imaging demonstrated a higher number of PET-positive lesions in a higher proportion of patients (26 and 53 lesions in 14 and 18 participants, respectively) compared with the follow-up SOC PSMA PET (20 lesions in 12 participants), indicating earlier and improved detection of recurrent prostate cancer lesions with 64Cu-SAR-bisPSMA compared with SOC PSMA PET agents12.

Following 64Cu-SAR-bisPSMA PET imaging, investigators indicated that they would change the treatment plan of approximately half of the patients (48%). Of these patients, nearly two-thirds (62.5%) proceeded to receive systemic and/or focal therapy or biopsy. Taken altogether, the findings from the COBRA trial have important clinical implications as the localisation of recurrence may lead to different treatment pathways for these patients.

About AMPLIFY
AMPLIFY (64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer) is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in participants with rising or detectable PSA after initial definitive treatment at clinical sites across the US and Australia7.

The aim of this registrational study is to investigate the diagnostic ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer in men with PSA levels above 0.2 ng/mL. The study co-primary endpoints are participant-level CDR and region-level PPV assessed independently for same-day and next-day imaging (1-4 hours and approximately 24 hours post-administration, respectively)7.

AMPLIFY commenced in May 2025, seeking to enrol approximately 220 participants, and the first trial participant was imaged in the same month at XCancer with Dr Luke Nordquist (Omaha, NE). The target number of participants in the AMPLIFY study was achieved in March 2026. All trial participants are expected to complete their follow-up in the coming weeks with topline data anticipated in the first half of CY2027.

On November 11, 2026 Hangzhou Eli Radiopharma Co., Ltd. ("Eli Radiopharma", or "the Company"), an innovative radiopharmaceutical company focused on integrated diagnostics and therapeutics for oncology and neurological diseases, reported the completion of a Series A financing round of nearly RMB 400 million. The round was led by Huagai Capital, with Bayland Capital as co-lead investor, and participation from Boyu Ventures, Delian Capital, InnoPinnacle Fund, Haibang Venture, Bairui Capital, Shenzhen Angel FOF Management, and Grand Flight Investment. Existing shareholders CSPC & Growth Bio Fund, Huaige Capital, KHK Fund, Longfeng Venture, Hongsheng Capital, Bioclub Fund, and Skyfield Capital also participated in the round.

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The proceeds will primarily support the advancement of the Company’s core innovative pipeline toward clinical development. Funding will be directed toward preclinical research, clinical trial applications, and early-stage clinical development, alongside further investment in R&D platforms, talent acquisition, and the Company’s clinical and business development. The financing will provide strong support for the continued advancement of the Company’s pipeline and its long-term growth. To date, the Company has advanced multiple programs targeting novel molecular targets through lead discovery and in vitro and in vivo validation, with promising target specificity and drug development potential. Several programs are approaching IND submission.

"The completion of this financing round marks an important milestone in Eli Radiopharma’s development and reflects our investors’ confidence in our R&D strategy, technological capabilities, and long-term vision," stated Dr. Feng Yu, Founder and CEO of Eli Radiopharma. "Moving our pipeline toward the clinic is a critical next step in translating our research into meaningful advances for patients. This financing will support our efforts to advance our lead programs through preclinical development and regulatory milestones, bringing differentiated radiopharmaceutical candidates closer to clinical evaluation. We remain focused on addressing unmet clinical needs and strengthening our R&D and clinical development capabilities, with the goal of delivering precision diagnostic and therapeutic options for patients with cancer and neurological diseases."

Cynix Wang, Chief Investment Officer of Healthcare at Huagai Capital, said, "Radiopharmaceuticals represent an exciting area of innovation at the intersection of molecular targeting, radionuclide technology, and precision theranostics. As the field continues to advance, expanding clinical applications, progress in therapeutic radionuclides, and the development of novel targets and differentiated pipelines are creating new opportunities for the radiopharmaceutical industry. The two BD deals in 2026 involving multinational pharmaceutical companies and Chinese radiopharmaceutical innovators further underscore the growing global recognition of China’s innovation capabilities and the significant potential for international partnerships. We are encouraged by Eli Radiopharma’s focused approach to radiopharmaceutical R&D and its ability to advance novel candidates into clinical development. Our investment reflects our confidence in the Company’s scientific capabilities and long-term potential. We look forward to supporting the advancement of its pipeline and helping translate promising science into clinical applications, while contributing to the broader advancement of the radiopharmaceutical field."

Xi Zou, Director and Project Lead at Bayland Capital, commented: "Bayland Capital has long been closely following innovations in the global radiopharmaceutical sector and strongly recognizes the clinical value and growth potential of radioligand therapy (RLT). We believe that, as more innovative therapies gain regulatory approval, RLT will play an increasingly important role in the treatment of a broad range of solid tumors. Eli Radiopharma has demonstrated distinct competitive strengths in its R&D strategy, innovation capabilities, and development efficiency. The company continues to expand its team, strengthen its technology and development capabilities, and steadily advance its global strategy. We are confident in Eli Radiopharma’s potential to build a globally competitive pipeline of innovative radiopharmaceuticals and deliver meaningful clinical value in international markets, including the US and Europe. Bayland Capital is delighted to co-lead this financing round. Looking ahead, we will continue to support Eli Radiopharma in expanding its technology platforms, accelerating the clinical development of its lead programs, and advancing differentiated, globally competitive radiopharmaceuticals, helping bring China-originated innovation to patients worldwide."

Yilun LIU, Partner of Boyu Ventures, said, "Radiopharmaceuticals hold significant potential to advance precision diagnostics and therapeutics. Eli Radiopharma is building a differentiated pipeline targeting oncology and neurological diseases with a clear focus on addressing unmet clinical needs. We believe the Company’s scientific expertise and R&D capabilities provide a strong foundation for advancing its pipeline toward clinical development. We look forward to seeing Eli Radiopharma progress its innovative programs and translate its research into meaningful clinical value for patients."

(Press release, Hangzhou Eli Radiopharma, NOV 11, 2026, View Source [SID1234674633])

On November 10, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported its financial results for the third quarter ended September 30, 2026, and reported on recent and upcoming business highlights. The Company also reported longer-term follow-up from weekly ("QW") dosing and initial safety from every-three-week ("Q3W") dosing in the ongoing Phase 1 trial of CTIM-76, its Claudin 6 ("CLDN6") x CD3 TCE.

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Longer-term Phase 1 follow-up showed median progression-free survival ("PFS") of 5.6 months at biologically active weekly doses of 140–280 µg. An emerging association between dose, cytokine and T cell activation, and tumor shrinkage is informing dose selection as the Company optimizes every-three-week dosing and advances toward Phase 1b at a dose of 280 µg or higher. CTIM-76 was generally well tolerated, supporting further Q3W dose escalation from 280 µg to 420 µg. Activity extended to liver metastases, which are typically difficult to treat with immunotherapy:1 all seven liver target lesions decreased in size, including two that disappeared completely. While preliminary, these efficacy, pharmacodynamic and tolerability findings support continued development of CTIM-76 and further evaluation of its potential as a best-in-class TCE for platinum-resistant ovarian cancer ("PROC").

"CTIM-76 continues to show promising activity in patients with PROC who had received a median of six prior lines of therapy," said Martin Lehr, Chief Executive Officer of Context. "Our Phase 1b strategy is to evaluate CTIM-76 in patients with no more than five prior lines of therapy. These less heavily pretreated patients generally have lower tumor burden and better T cell fitness,2 providing a rationale to evaluate whether treatment in this population, together with Q3W dosing, can deliver greater clinical benefit and improved tolerability.3 We view the results to date as an initial benchmark, with Phase 1b providing an opportunity to further define CTIM-76’s clinical potential."

Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs:

CTIM-76: CLDN6 x CD3 TCE

Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with CLDN6-positive PROC, testicular and endometrial cancers. The U.S. FDA has granted Fast Track designation to CTIM-76 for patients with PROC who have received all standard-of-care therapies.

Patients

As of October 30, 2026, 27 patients with ovarian (n=20), testicular (n=4) and endometrial (n=3) cancer had received CTIM-76 in dose escalation cohorts, either QW at 22.5 to 560 µg (n=21) or Q3W at 280 µg (n=6).
Fifteen patients with PROC were treated at biologically active doses, either 140 to 280 µg QW (n=9) or 280 µg Q3W (n=6). These patients had received a median of 6 prior lines of therapy (range, 3–16), and 12 (80%) had received a prior antibody-drug conjugate ("ADC") therapy, including 5 (33%) who had received two or more ADCs.
Efficacy

Among efficacy evaluable PROC patients treated QW at biologically active doses (n=9), the confirmed objective response rate ("ORR") was 22% and the disease control rate ("DCR") was 56%. Two patients (22%) achieved a confirmed partial response and 3 (33%) had stable disease.
As of October 30, 2026, median PFS was 5.6 months (95% CI: 1.2–7.4 months) among efficacy-evaluable PROC patients treated QW at biologically active doses.
Tumor reduction was observed across metastatic sites, including regression of 7 liver lesions in 4 patients (median −58%; range −16% to −100%).
Patients treated with Q3W dosing continue to be followed; initial Q3W efficacy data are expected in Q2 2027.
Pharmacokinetics and Pharmacodynamics

Exposure increased approximately dose-proportionally, and the pharmacokinetic profile supports evaluation of Q3W dosing.
CTIM-76 demonstrated dose-dependent induction of IFN-γ and IL-2, with higher peak cytokine levels and CD69+ CD8 T cell activation observed in patients with tumor reduction, providing clinical pharmacodynamic evidence consistent with the proposed mechanism of target-dependent T cell activation.
Safety

Cytokine release syndrome occurred in 5 of 27 patients (18.5%); all events were Grade 1 or 2.
Grade ≥3 treatment-emergent adverse events occurred in 22 of 27 patients (81.5%) overall. The most common were increased gamma-glutamyl transferase (GGT; 37.0%), increased aspartate aminotransferase (AST; 29.6%), increased alanine aminotransferase (ALT; 22.2%), increased lipase (18.5%), and anemia (14.8%).
Grade ≥3 liver enzyme elevations were dose-related, occurring most frequently at 560 µg QW. At biologically active doses, Grade ≥3 AST and ALT elevations each occurred in 4 patients (21.1%). Hepatic enzyme elevations generally occurred early in treatment, were asymptomatic, and resolved with continued dosing.
Dose Escalation and Backfill

The dose-limiting toxicity ("DLT") evaluation period at 280 µg Q3W is complete (n=6 patients), and dose escalation to 420 µg Q3W (n=3–6) has begun. An additional 6 patients are being enrolled at 280 µg Q3W to further characterize that dose level.
Upcoming Expected Milestones:

Q1 2027: Initiation of Phase 1b dose expansion
Q2 2027: Phase 1a initial efficacy data with Q3W dosing in PROC patients
CT-202: Nectin-4 x CD3 TCE

Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal and triple-negative breast cancers.

Recent Progress:

September 2026: First patient dosed in Phase 1 trial
Six sites are active in Australia
Upcoming Expected Milestones:

2H 2027: Phase 1a initial data
U.S. investigational new drug application filing on track by year-end 2026
Third Quarter 2026 Financial Results

Cash and cash equivalents were $34.4 million at September 30, 2026, compared to $66.0 million at December 31, 2025. The Company expects its cash and cash equivalents will be sufficient to fund its operations to early fourth quarter of 2027.
Research and development expenses were $5.7 million for the third quarter of 2026, compared to $8.7 million for the third quarter of 2025. The decrease was primarily driven by a $3.9 million reduction in CT-202 expenses, reflecting lower contract manufacturing and preclinical expenses. Higher CTIM-76, CT-95 and personnel-related costs partially offset this reduction.
General and administrative expenses were $2.2 million for the third quarter of 2026, as compared to $1.9 million for the third quarter of 2025. The increase was primarily driven by higher salaries and personnel-related costs, including share-based compensation as compared to the same period in 2025.
Other income was $0.3 million for the third quarter of 2026, as compared to $0.9 million for the third quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances.
Context reported a net loss of $7.6 million for the third quarter of 2026, as compared to $9.7 million for the third quarter of 2025.

(Press release, Context Therapeutics, NOV 11, 2026, View Source [SID1234674632])

On November 11, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, November 18 at 9:00 a.m. GMT/4:00 a.m. EST.

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A live audio webcast of the presentation will be available here and under "Events and Presentations" on the Investors and Media section of the Company’s website.

(Press release, Arvinas, NOV 11, 2026, View Source [SID1234674631])

On November 11, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapies, reported the grant of a new patent (number 12,788,796) entitled "Combined Preparations for the Treatment of Cancer or Infection" by the United States Patent and Trademark Office (USPTO).

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With this latest grant, Immutep now holds five United States patents within this patent family. The portfolio has expanded progressively through a series of patents granted in December 2020, March 2021, June 2023, July 2026 and, most recently, this latest patent.

The claims of the new patent build on the protection provided by the four previously granted patents and are directed to combined preparations and pharmaceutical compositions comprising eftilagimod alfa ("efti") and a PD-1 pathway inhibitor. Specifically, the claims encompass combinations with BMS-936559, durvalumab, atezolizumab and avelumab. The expiry date of the patent is 23 March 2038 (including 806 days of patent term adjustment).

The patent grant provides additional protection for the use of efti in combination with PD-1 pathway inhibitors, a key class of immunotherapies used in modern cancer treatment, further expanding Immutep’s patent portfolio covering efti-based combination therapies. Immutep has also filed a continuation application to pursue additional embodiments of the invention.

Marc Voigt, CEO of Immutep, said: "We are pleased to receive this latest US patent grant, which further strengthens the intellectual property protection surrounding efti. As we pursue our focused development strategy for efti, a good patent portfolio remains an important strategic asset, supporting future development and partnering opportunities. We believe in the potential of this unique biomolecule and that carefully selected clinical settings could provide meaningful opportunities for continued evaluation and value creation."

About Eftilagimod Alfa (Efti)
Eftilagimod alfa (efti) is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that activates antigen-presenting cells through the MHC Class II pathway, engaging both innate and adaptive immunity, including the priming of cytotoxic CD8+ T cells and the production of co-stimulatory signals and cytokines. Its favourable safety profile enables combination with anti-PD-(L)1 therapy, radiotherapy and/or chemotherapy. Efti has received Fast Track designation from the U.S. Food and Drug Administration in first-line head and neck squamous cell carcinoma and first-line non-small cell lung cancer, and Orphan Drug Designation in soft tissue sarcoma.

(Press release, Immutep, NOV 11, 2026, View Source [SID1234674630])