On June 2, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the first patient has been enrolled in its new Phase 2 clinical trial protocol of stenoparib for the treatment of advanced, platinum-resistant or platinum-ineligible ovarian cancer (Press release, Allarity Therapeutics, JUN 2, 2025, https://allarity.com/press-release/allarity-therapeutics-announces-first-patient-enrolled-in-new-phase-2-clinical-trial-protocol-of-stenoparib-in-advanced-ovarian-cancer/ [SID1234653633]).

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The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval. It builds on encouraging data from Allarity’s earlier and still ongoing Phase 2 study, which demonstrated that patients on twice-daily stenoparib showed durable clinical benefit and that stenoparib was well tolerated. Two patients remain on treatment and continue to derive benefit after more than 20 months. Reflecting the compelling and durable clinical responses observed in platinum-resistant patients to date, the new trial protocol specifically focuses on evaluating stenoparib in patients with advanced, recurrent, platinum-resistant, or platinum-ineligible ovarian cancer—patients for whom current treatment options are extremely limited and typically involve additional chemotherapy, which is associated with well-documented side effects.

"With the enrollment of the first patient, we are fulfilling our promise to accelerate stenoparib’s clinical development as a potentially safer, more effective alternative to chemotherapy for women with advanced, recurrent ovarian cancer," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "This new protocol reflects critical input from leading gynecologic oncologists, and allows us to solidify the importance of DRP for patients who are most likely to receive clinical benefit from stenoparib. This study also allows us to confirm and extend our current findings that show clinical benefit from twice daily dosing."

In addition to assessing overall efficacy and safety, the new trial protocol is designed to further advance the Company’s understanding of stenoparib’s modulation of the WNT signaling pathway—a key driver of disease progression in ovarian and other cancers. The Company is actively pursuing ways to deepen its insights into the therapeutic importance of this WNT-modulating activity and how this, in addition to a cleaner safety profile, distinguishes stenoparib from first-generation PARP inhibitors.

Building on the clinical benefit of the current dosing schedule, this updated study design also includes an additional dosing level to explore the optimal dose for enhancing clinical benefit, aligning Allarity with the FDA’s Project Optimus initiative to inform the start of pivotal registration trials.

The trial is expected to generate significant clinical data by late summer 2026. Allarity plans to pursue multiple advantaged regulatory pathways to expedite potential approval of both stenoparib and its DRP companion diagnostic (CDx).

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

On June 2, 2025 ASP Isotopes Inc. (NASDAQ: ASPI) and Isotopia Molecular Imaging Ltd. reported to have entered into a strategic agreement to secure the supply of Gadolinium-160 (Gd-160), a critical precursor isotope for producing Terbium-161 (Tb-161), an emerging medical isotope with significant potential in targeted radiotherapeutics (Press release, Isotopia Molecular Imaging, JUN 2, 2025, View Source [SID1234653649]).
This partnership addresses longstanding supply challenges for Gd-160, enabling Isotopia to advance Tb-161-based therapies for prostate cancer, neuroendocrine tumors, and other malignancies.

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Under the agreement, ASP Isotopes will leverage its proprietary Quantum Enrichment technology to provide Isotopia with enriched Gd-160, a stable isotope essential for manufacturing Tb-161.
The collaboration combines ASP Isotopes’ expertise in large-scale isotope enrichment—previously demonstrated through its production of Ytterbium-176 (Yb-176)—with Isotopia’s proven capabilities in commercial-scale medical isotope production. Isotopia has consistently manufactured Lutetium-177 (Lu-177) and maintained weekly Tb-161 production for its clinical trials over the past two years.

Paul Mann, CEO of ASP Isotopes, emphasized the agreement’s significance: "By supplying Gd-160, we are eliminating a major bottleneck in the development of Tb-161 therapies. Our investment in enrichment technology positions us to support the radiopharmaceutical industry’s growing demand for stable isotopes. This partnership accelerates the path to clinical adoption of Tb-161, which could redefine cancer treatment paradigms."

Dr. Eli Shalom, CEO of Isotopia, highlighted Tb-161’s therapeutic advantages: "Tb-161’s dual mechanism of action, including Auger electron emissions, enables precise targeting of micro-metastases while minimizing damage to healthy tissues. This partnership ensures a reliable Gd-160 supply chain, allowing us to scale production and advance our Tb-161-labeled drug candidates toward commercialization. We produce in our site in Israel and shortly the production will start in our second site in Indianapolis in the US."

Tb-161’s Auger electrons induce double-strand DNA breaks in cancer cells, offering potential advantages over Lu-177 and alpha-emitting isotopes. This precision aligns with the oncology field’s shift toward targeted radiotherapeutics, which improve efficacy and reduce side effects. The agreement comes as global interest in radiopharmaceuticals surges, driven by their ability to deliver localized radiation therapy via tumor-seeking molecules.

On June 2, 2025 RemeGen reported data from phase 1b/2 clinical trial of RC108 in combination with furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on EGFR-TKI treatment, and the results showed obvious synergistic effect between RC108 and furmonertinib (Press release, RemeGen, JUN 2, 2025, View Source;cid=115&id=2661 [SID1234656124]).

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RC108 is a c-mesenchymal-epithelial transition factor (c-MET) targeted ADC developed by RemeGen. It binds to MET with high affinity and precisely delivers cytotoxins into c-MET-expressing tumor cells. Furmonertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed by Allist Pharmaceuticals.

Studies have shown that MET-overexpression is the main resistance mechanism for the progression of EGFR-TKI treatment. RC108 has a good killing effect on tumor cells with different MET expression levels. The results of phase 1 study (NCT04617314) showed that the objective response rate (ORR) of RC108 alone in patients with MET-overexpressing (≥ IHC 1+) locally advanced or metastatic NSCLC who have progressed on EGFR-TKI treatment was 33%.

The study presented at 2025 ASCO (Free ASCO Whitepaper) is an open, single-arm, multicenter phase 1b/2 clinical trial to evaluate the safety, tolerability, efficacy, and pharmacokinetic profile of RC108 in treatment of patients, aiming to provide a reference basis for the development of a rational combination dosing regimen for subsequent studies.

Results of the analysis up to April 11, 2025 showed that RC108 in combination with furmonertinib demonstrated encouraging antitumor activity in patients with MET-overexpressing locally advanced or metastatic NSCLC with a manageable safety profile:

• In patients with ≥1+ tumor cells membrane staining and ≤20% tumor cells with strong (3+) cytoplasmic staining, ORR was 40.5%, and median progression-free survival (PFS) was 7.1 months.

• In patients with ≥3+ tumor cells membrane staining and ≤20% tumor cells with strong (3+) cytoplasmic staining, ORR was 61.1%, and median PFS was 8.2 months.

• Common AEs included: asthenia, nausea, decreased appetite, vomiting, etc.

RemeGen is currently preparing phase 3 clinical study of this combination therapy.

On June 2, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the ASCO (Free ASCO Whitepaper) 2025 (American Society of Clinical Oncology) Annual Meeting (Press release, Corcept Therapeutics, JUN 2, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-presents-pivotal-clinical-data-asco-late-breaker [SID1234653602]).

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The presentation abstract can be found here and the presentation slides here. The data have been simultaneously published in The Lancet, titled "Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial."

ROSELLA met its primary endpoint of improved progression-free survival as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). Median PFS-BICR was extended to 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. In addition, PFS assessed by investigators was consistent with PFS-BICR, with a hazard ratio of 0.71 (p-value: 0.0030). An interim analysis of overall survival (OS), showed that the addition of relacorilant reduced the risk of death by 31 percent, substantially lengthening patients’ lives. Median OS for patients who received relacorilant was 16.0 months, compared to 11.5 months for patients who received nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.0121). These benefits were seen in all clinically relevant subgroups, including those with poor prognoses.

Relacorilant plus nab-paclitaxel was well-tolerated, with a comparable safety profile between treatment arms. The addition of relacorilant did not increase patients’ safety burden. In addition, patients treated with relacorilant plus nab-paclitaxel had a lower incidence of ascites (5.3 percent), than did patients who received nab-paclitaxel alone (10.5 percent). The occurrence of abdominal paracenteses during treatment was also lower for patients treated with relacorilant plus nab-paclitaxel (7.4 percent), compared to nab-paclitaxel alone (13.2 percent).

"For many patients with advanced, recurrent ovarian cancer, the tumor eventually becomes resistant to chemotherapy, and oncologists have few good treatment options. Relacorilant plus nab-paclitaxel may provide a powerful tool for improving progression-free and overall survival in patients with this disease," said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial. "The data presented at ASCO (Free ASCO Whitepaper) 2025 and published in The Lancet support this regimen becoming a new standard-of-care treatment."

"These data show that treatment with relacorilant can help patients with platinum-resistant ovarian cancer live longer, without adding to their safety burden. We plan to bring this treatment option to patients as quickly as possible and are working on our regulatory applications in the U.S. and Europe. We want to thank all the patients and investigators who participated in this trial," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "These data also illustrate the benefits of modulating cortisol activity in patients whose tumors express the glucocorticoid receptor. We have initiated a trial evaluating the benefit of adding relacorilant to a regimen of nab-paclitaxel and bevacizumab (BELLA Trial), and are considering additional clinical trials."

ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia; biomarker selection was not required. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. ROSELLA has dual primary endpoints — PFS-BICR and OS. A positive outcome is achieved if either endpoint is met.

The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

On June 2, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported updated interim results from its ongoing dose escalation Phase 1 study evaluating PAS-004 in advanced cancer patients in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (Press release, Pasithea Therapeutics, JUN 2, 2025, View Source [SID1234653619]).

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The Phase 1 clinical trial is a multi-center, open-label, dose escalation, modified 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or patients who have failed BRAF/MEK inhibition (NCT06299839).

As of the cut-off date of April 2, 2025, a total of 21 patients had been enrolled and received at least one dose of PAS-004 in six cohorts (Capsules: 2mg, 4mg, 8mg, 15mg, 22mg / Tablets: 4mg). The most common cancer diagnosis was pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%).

All treatment-related adverse events (AEs) have been either grade 1 or grade 2. No known MEK inhibitor class-related AEs such as ocular toxicities, cardiotoxicities, and skin toxicities were observed during the DLT observation period. No DLTs were reported, and dose escalation is ongoing.

Preliminary PAS-004 PK analysis suggests linear PK with an estimated half-life in excess of 60 hours. The Cmax (peak) to Cmin (trough) ratio was below 2 at steady state in all dose levels and has achieved potentially sufficient exposures for target engagement. This is supported by previously reported preliminary pERK inhibition observed in cohort 3 (8mg capsule), with pERK inhibition of up to 91%.

PAS-004 has demonstrated a dose-dependent PK profile and preliminary clinical activity as a monotherapy in patients with heavily pre-treated, refractory solid tumors. In the efficacy evaluable population (n=16), early response evaluation reveals stable disease (SD) by RECIST 1.1 in 10 patients at some point during the trial, with progression free survival of up to 159 days and overall survival of up to 253 days. In Cohort 4A (15mg capsule), two out of three patients achieved stable disease and remain on therapy. One patient with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor diameter reduction of -9.8% and remains on study for over 5 months. The second patient with Stage 4 BRAF-mutated melanoma, having progressed on two prior lines of therapy, including a prior MEK inhibitor + BRAF inhibitor combination treatment, achieved tumor diameter reduction of -14.9% and remains on study for over 5 months.

"The interim results from our ongoing Phase 1 study are encouraging and we believe underscore the potential of PAS-004 as a best-in-class MEK inhibitor to serve patients with a broad range of MAPK pathway driven tumors," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "MEK inhibitors have been a transformative class of treatment therapies and we continue to witness groundbreaking advances and new approvals with this class of drug across tumor types and mutational profiles. At ASCO (Free ASCO Whitepaper) 2025, over 15 data sets featuring MEK inhibitors are being presented underscoring the growing momentum in this field. Additionally, we have recently seen approval of two novel MEK inhibitors, mirdametinib and avutometinib, highlighting the continued relevance of this drug class in the past several months alone. As a macrocyclic compound, PAS-004 potentially represents a significant advancement in the MEK inhibitor field by offering high selectivity and sustained pathway suppression while maintaining good tolerability. This profile may make it optimal for both monotherapy and combination therapy, including in patients who have failed prior MEK inhibitors."

The poster presentation will be available on the Pasithea website on the date of the poster session.