Latest news with #Stenoparib
Associated Press
a day ago
- Business
- Associated Press
Allarity Therapeutics Announces Research Collaboration with Indiana Biosciences Research Institute to Further Advance Understanding of Stenoparib's Unique, Dual Therapeutic Mechanism of Action
TARPON SPRINGS, Fla., June 4, 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—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP®) patient selection technology—today announced a research collaboration with the Indiana Biosciences Research Institute (IBRI). The collaboration is aimed primarily at further deepening the Company's mechanistic understanding of the dual mechanism of action of stenoparib. Stenoparib is a novel, orally available small-molecule inhibitor of PARP1/2 and tankyrase1/2. As such, stenoparib not only impairs DNA repair to selectively kill cancer cells but also inhibits the WNT signaling pathway—a cellular pathway commonly associated with chemoresistance and advanced-stage disease in multiple cancer types. This unique dual activity distinguishes stenoparib as a highly differentiated therapeutic candidate with the potential to address cancers that are resistant to standard-of-care therapies. Under the agreement, IBRI will conduct advanced molecular and cellular studies to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib's observed anticancer effects. 'Understanding how stenoparib exerts its dual biological effects is central to our long-term clinical development strategy. It will enhance our ability to raise awareness of this molecule among leading oncologists and help us engage more effectively with sophisticated biotech investors,' said Thomas Jensen, CEO of Allarity Therapeutics. 'In addition to deepening our understanding of the foundational biology behind stenoparib's differentiated profile, this research may further strengthen our DRP®-based patient selection strategy and potentially open new opportunities for additional therapeutic combinations and indications, such as colorectal cancer, where WNT pathway activation is very common.' The collaboration is also expected to support Allarity in potential future efforts to pursue marketing approval for stenoparib, and to further clarify its mechanism of action in both the Company's ongoing Phase 2 trial in advanced ovarian cancer and its recently announced combination trial evaluating stenoparib with temozolomide in recurrent small cell lung cancer (SCLC). Furthermore, this collaboration underscores Allarity's commitment to scientific excellence, translational research, and data-driven development, which form the foundation of its personalized oncology strategy. About The Indiana Biosciences Research Institute The Indiana Biosciences Research Institute (IBRI) is a leading translational research institute that accelerates innovation by bridging academic and industry science through collaboration. Its team of scientists is focused on solving high-impact biomedical challenges in areas such as cancer, diabetes, Alzheimer's disease, and pediatric rare diseases, while also providing molecular innovation platforms and enabling technologies to drive the development of novel therapies. For more information, visit 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. About Allarity Therapeutics Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit Follow Allarity on Social Media LinkedIn: Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectations or forecasts of future events. The words 'anticipates,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predicts,' 'project,' 'should,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements related to the research collaboration with the Indiana Biosciences Research Institute (IBRI); the potential to further elucidate the dual mechanism of action of stenoparib; the role of PARP inhibition and WNT pathway modulation in clinical benefit; the ability to enhance or refine the Company's DRP® companion diagnostic; the potential identification of new therapeutic indications or combinations; and the impact of the collaboration on future clinical strategy, development timelines, or regulatory engagement. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to the risk that the collaboration may not yield actionable insights; the risk that mechanistic findings may not translate into clinical outcomes; the possibility that the DRP® may not be enhanced, validated, or accepted by regulators; and the broader risks related to drug development, including clinical, regulatory, manufacturing, and commercial risks. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in our Form 10-K annual report filed with the Securities and Exchange Commission (the 'SEC') on March 31, 2025, available at the SEC's website at and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. ### Company Contact: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected] Attachment
Business Upturn
12-05-2025
- Business
- Business Upturn
Allarity Therapeutics Announces Participation in Pharma Partnering Summit US
TARPON SPRINGS, Fla., May 12, 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 the Company's CEO, Thomas Jensen, will deliver a company overview focused on stenoparib and the Company's DRP® companion diagnostic platform and conduct one-on-one meetings at the Pharma Partnering Summit US. The event is a business development and licensing conference for executives of biotechnology and pharmaceutical companies, taking place May 14–15 in San Diego, CA. Registrants can request one-on-one meetings with Thomas Jensen, and more information about the summit can be found at the following link: 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. About Allarity Therapeutics Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit Follow Allarity on Social Media LinkedIn: Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectations or forecasts of future events. The words 'anticipates,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predicts,' 'project,' 'should,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, corporate presentation highlighting Allarity's clinical strategy and development progress for stenoparib. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, statements concerning clinical development progress, trial design and enrollment for stenoparib, the potential benefits of DRP®-guided therapy, and efforts to achieve regulatory milestones. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in our Form 10-K annual report filed with the Securities and Exchange Commission (the 'SEC') on March 31, 2025, available at the SEC's website at and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. ### Company Contact: [email protected] Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 [email protected]
Associated Press
24-03-2025
- Business
- Associated Press
Allarity Therapeutics Launches Comprehensive Effort to Combat Potential Illegal Naked Short Selling of Its Shares
Boston (March 24, 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/Wnt pathway inhibitor—today announced that it has engaged Shareholder Intelligence Services, LLC ('ShareIntel') to investigate potential illegal naked short selling and other potential trading irregularities by third parties in the Company's common stock. The engagement with ShareIntel is part of Allarity's commitment to protecting shareholder value and ensuring fair and transparent trading of its stock. ShareIntel utilizes its proprietary DRIL-Down™ technology, a compliance-driven data analytics platform, to track and analyze stock trading activity from broker-dealers, clearing firms, and reporting entities. Through this agreement, Allarity will monitor potential trading abuses, detect unusual short-selling patterns, and investigate possible market manipulation, taking corrective action, including legal recourse if necessary. Thomas Jensen, CEO of Allarity Therapeutics, commented: 'We have engaged ShareIntel as part of our commitment to protecting shareholder value and fostering confidence in the market for our stock. As we continue advancing the clinical development of stenoparib, ensuring trust that our shares are traded fairly and free from manipulation remains a key priority. In response to investor inquiries and our observations of notable stock volatility on multiple occasions, we believe this collaboration with ShareIntel is both timely and appropriate.' The Company will leverage ShareIntel's market surveillance tools to detect potential violations of the U.S. Securities and Exchange Commission's Regulation SHO, which governs short-selling practices, stock borrowing requirements, and fail-to-deliver obligations. If evidence of market manipulation or illegal short selling is uncovered, Allarity will consider all available options to hold responsible parties accountable. 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 Allarity Therapeutics Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit Follow Allarity on Social Media LinkedIn: X: Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectations or forecasts of future events. The words 'anticipates,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predicts,' 'project,' 'should,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, expectations regarding the investigation into potential naked short selling and trading irregularities, the findings from ShareIntel's analysis, and the Company's ability to take appropriate corrective action. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to the effectiveness of ShareIntel's investigation, the identification of any trading irregularities, the potential impact of corrective measures, and the Company's ability to protect shareholder value. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in our Form S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the 'SEC') and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC's website at and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. Company Contact: Media Contact: Thomas Pedersen Carrotize PR & Communications
Yahoo
17-03-2025
- Business
- Yahoo
Allarity Therapeutics Announces Presentation of Phase 2 Clinical Data from Ongoing Trial in Advanced Ovarian Cancer Patients at the 2025 Annual Meeting for the Society of Gynecologic Oncology
The Annual Meeting is the foremost educational and scientific event for gynecologic oncologists Stenoparib has shown clinical benefit in heavily pre-treated patients, including those with platinum-resistant and refractory ovarian cancer Findings may reflect stenoparib's dual PARP/Wnt pathway inhibitionBoston (March 17, 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/Wnt pathway inhibitor— announced the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, held March 14-17 in Seattle, Washington. SGO is the world's premier organization for professionals working to lessen the impact of gynecologic cancers, and the Annual Meeting on Women's Cancer is the premier educational and scientific event for gynecologic oncologists and others dedicated to advancing gynecologic cancer care. The poster presentation, titled "A Phase II Trial of Stenoparib (2X-121): A Novel Dual Tankyrase and PARP Inhibitor in Advanced, Recurrent Ovarian Cancer," will be presented by Dr. Fernanda B. Musa, MD, MS, Director of Clinical Trials in Gynecologic Oncology, Providence-Swedish Cancer Institute. Session: Poster Tour Group 14: Clinical Trials Impacting Future Therapies Date/Time: Monday, March 17, 10:30 a.m. PST The poster presents data from the first Phase 2 study of stenoparib in advanced ovarian cancer and the first stenoparib study ever to dose twice daily. The study exclusively enrolled patients who had been previously treated with three or more lines of therapy and included patients with especially difficult-to-treat disease. Fourteen of the fifteen enrolled were platinum-resistant, while one patient had primary platinum-refractory disease that did not respond to first-line chemotherapy. There are very few effective treatment options for patients with platinum-resistant and refractory ovarian cancer, who unfortunately tend to have their disease recur within an average of three months. In this study, five patients stayed on therapy longer than four months, with four of these staying on beyond 20 weeks. Importantly, one patient showed a confirmed complete response (i.e., absence of measurable disease) that lasted more than 10 months. The patient with primary platinum-refractory disease remained on therapy beyond 40 weeks. Two patients remain on therapy currently—now more than 17 months. The data also revealed significant clinical benefit in patients who typically do not get benefit from first-generation PARP inhibitors—those without mutations in the DNA repair gene, BRCA. One of the two patients still on therapy, now more than 17 months, did not have a BRCA mutation or other deficit in homologous DNA repair. Benefit in these BRCA wild-type patients may reflect the unique, dual therapeutic action of stenoparib in inhibiting not only PARP but also the Wnt pathway—a pathway activated in ovarian, colon, and other advanced cancers. Key Findings: First study to dose stenoparib twice daily optimizing inhibition of PARP and Tankyrase across every 24-hour period. First stenoparib study to show potential durable clinical benefit in platinum-resistant and refractory patients. Data continue to show that stenoparib is well-tolerated and does not elicit the bone marrow toxicity typical of first-generation PARP inhibitors. Study shows clinical benefit across distinct genetic backgrounds including in both BRCA-mutant patients and in BRCA wild-type (non-mutated) patients, a larger patient group than those with BRCA mutation. Study supports the unique mechanism of action for stenoparib, which inhibits PARP and the Wnt oncogenic pathway. Study sets the stage for the newly announced protocol to evaluate stenoparib monotherapy dosed twice daily in platinum-resistant patients. Dr. Fernanda B. Musa, MD, MS, site investigator for the study, commented, 'This remains a challenging disease with limited therapies for patients who have already undergone many prior lines of treatment and who have been declared platinum-resistant or platinum-refractory. The findings from this study suggest that stenoparib may offer a new, well-tolerated therapeutic approach for a broader group of patients, including those with BRCA wild-type disease, who historically have had fewer options. It is a privilege to present these data at SGO 2025 and to share our findings with esteemed colleagues dedicated to advancing gynecologic oncology research.'Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated, 'These results are foundational for us as they show stenoparib monotherapy can provide durable clinical benefit to very heavily pre-treated patients, both platinum-resistant and refractory. These data also show clinical benefit in patients both with and without BRCA mutations, or defects in homologous DNA damage repair, and may reflect the unique dual action of stenoparib on both PARP and Tankyrase targets. The data also continue to show that stenoparib is well-tolerated and does not show the bone marrow toxicity of earlier PARP inhibitors. All in all, the results of this exploratory phase 2 study have helped us to craft a new protocol designed with Dr. Fernanda Musa, Dr. Kathleen Moore, and other ovarian cancer thought leaders that will deepen and enrich our understanding of stenoparib's durable clinical benefit—even in heavily pre-treated patients, enhance our understanding of its unique mechanism of action and accelerate the advance of stenoparib toward regulatory approval.' Given the relatively heterogeneous patient population in this study, there are no direct comparisons to earlier studies. Importantly, this exploratory trial allowed enrollment of patients with very advanced disease, including massive ascites, following multiple prior lines of therapy. Some of these patients progressed very quickly in the study. The recently announced phase 2 protocol trial was expressly designed to narrow in on patients with platinum-resistant disease who have progressed through only a single, additional line of chemotherapy after the emergence of platinum resistance and who are without active evidence of ascites. The poster presentation will be available on March 17 at 7:00 a.m. CT on Allarity's website under the Scientific Publications StenoparibStenoparib 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 Allarity TherapeuticsAllarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit Follow Allarity on Social MediaLinkedIn: Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectations or forecasts of future events. The words 'anticipates,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predicts,' 'project,' 'should,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, expectations regarding the presentation of stenoparib Phase 2 trial data at the SGO 2025 Annual Meeting and its potential implications for future clinical development. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, to the successful delivery and reception of the stenoparib Phase 2 data presentation at the SGO 2025 Annual Meeting and its impact on ongoing and planned trials. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in our Form S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the 'SEC') and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC's website at and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. ### Company Contact: investorrelations@ Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 tsp@ Attachment Allarity Therapeutics Announces Presentation of Phase 2 Clinical Data at the 2025 Annual Meeting for the Society of Gynecologic Oncology
Yahoo
06-03-2025
- Business
- Yahoo
Allarity Therapeutics Announces Phase 2 Trial of Stenoparib in Combination with Temozolomide for Recurrent Small Cell Lung Cancer Fully Funded by the US Veterans Administration
Trial to explore novel combination therapy for patients with recurrent Small Cell Lung Cancer who have failed frontline treatment Fully funded by the U.S. Veterans' Administration Special Emphasis Panel on Precision Oncology Trial builds on promising clinical evidence supporting a PARP inhibitor and temozolomide combination in Small Cell Lung Cancer Boston (March 6, 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/Wnt pathway inhibitor—today announced plans for a Phase 2 trial evaluating the combination of stenoparib with temozolomide, a DNA-alkylating chemotherapy agent, for the treatment of recurrent Small Cell Lung Cancer (SCLC). The trial is fully funded by the U.S. Veterans Administration (VA) through the Special Emphasis Panel on Precision Oncology and is being led by the VA and Academic Medical Oncologists at Indianapolis and Pittsburgh VA Medical Centers. This phase 2 trial builds on the compelling mechanistic synergy of temozolomide with a PARP inhibitor and selection of patients most likely to respond to this combination. Prior clinical studies had shown that PARP inhibitors combined with temozolomide provide clinical benefit as evidenced by ~40% response rates in recurrent SCLC patients but that these prior clinical studies showed dose-limiting hematologic toxicity. Stenoparib, a novel dual PARP and tankyrase inhibitor, may offer a more favorable tolerability profile while providing additional therapeutic advantages. Its inhibition of PARP prevents DNA repair, possibly increasing temozolomide-induced cancer cell death, while its tankyrase inhibition uniquely impacts the Wnt pathway, which is known to be implicated in SCLC progression and treatment resistance. Given these properties, stenoparib could provide a next-generation approach to overcoming temozolomide resistance while potentially avoiding the severe toxicity observed with other PARP inhibitors when combined with temozolomide. This phase 2 study aims to evaluate the safety and efficacy of stenoparib in combination with temozolomide to determine whether this approach could offer improved therapeutic options for SCLC patients who have relapsed following frontline therapy, a population with a dire need for additional treatment options. Moreover, many patients with metastatic SCLC present with brain metastases. Importantly, stenoparib can cross the blood brain barrier, making it a promising option for treating both systemic tumors and brain metastases. Thomas Jensen, CEO of Allarity Therapeutics, stated, 'We are excited to see stenoparib being investigated in additional cancer indications, especially this trial for recurrent SCLC, a patient population with a significant unmet medical need. This trial fits perfectly with our long-term strategy for stenoparib- to leverage the unique clinical benefit we have seen from stenoparib in advanced ovarian cancer for additional cancer indications and our deeper appreciation of its differentiated mechanism of therapeutic action. Given the safety profile of stenoparib we have seen thus far, this study—the first to explore a stenoparib-based combination treatment—may help to establish stenoparib as the PARP inhibitor of choice for therapeutic combinations. This study will further allow Allarity to build out the stenoparib franchise and to drive enterprise value for the whole of Allarity Therapeutics. Importantly, our recently completed drug product campaign more than covers the amount of stenoparib needed for our clinical plans in ovarian cancer, in this combination trial and in others.' Clinical Study DesignThe trial is expected to enroll approximately 65 extensive-stage SCLC patients on the drug combination treatment across 11 VA medical centers. It will assess progression-free survival, as well as determine the recommended Phase 2 dose for the combination in an initial safety lead-in phase. Clinical Study RationaleStenoparib is a dual PARP/tankyrase inhibitor that blocks DNA repair, making tumor cells more susceptible to DNA-damaging agents like temozolomide. Its tankyrase inhibition also affects the Wnt signaling pathway, which is linked to SCLC progression and treatment resistance, setting stenoparib apart from first-generation PARP inhibitors. Temozolomide is an oral chemotherapy drug that damages tumor DNA, leading to cell death. However, resistance can develop through the MGMT enzyme, which repairs DNA damage, and mismatch repair (MMR) deficiency, which allows tumors to tolerate the drug. This study will assess whether stenoparib's dual mechanism can help overcome resistance by disrupting key DNA repair pathways and targeting Wnt Status and Next StepsInvestigators are in the process of obtaining final regulatory approvals for this stenoparib-temozolomide combination trial from the U.S. Food and Drug Administration (FDA), the VA, and the Institutional Review Board (IRB) before patient enrollment can be initiated.. Funding and Financial ConsiderationsAs previously disclosed on November 14, 2024, Allarity's cash position supports operations into 2026. Since this Phase 2 trial of stenoparib in combination with temozolomide for recurrent SCLC is fully funded by the VA, it will not impact Allarity's financial outlook, its Phase 2 program in advanced ovarian cancer, or its share repurchase plan. About StenoparibStenoparib 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 TemozolomideTemozolomide is an orally available, small-molecule alkylating agent used as the standard-of-care chemotherapy for glioblastoma multiforme and other high-grade brain tumors. As a DNA-methylating agent, temozolomide exerts its cytotoxic effect by inducing DNA damage, primarily through the formation of O6-methylguanine adducts, which trigger cell death in tumor cells lacking functional O6-methylguanine-DNA methyltransferase (MGMT) repair activity. Due to its ability to cross the blood-brain barrier, temozolomide remains one of the few effective systemic therapies for central nervous system malignancies. Originally developed by researchers at Aston University, temozolomide was later licensed by Schering-Plough (now part of Merck & Co.) and has been commercially available since 1999 under the brand name Temodar® (Temodal® outside the U.S.). About Allarity TherapeuticsAllarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit Follow Allarity on Social MediaLinkedIn: Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectations or forecasts of future events. The words 'anticipates,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predicts,' 'project,' 'should,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the investigator-initiated Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent SCLC, its potential to inform future clinical development, and the ongoing regulatory process associated with the forward-looking statements in this press release are based on management's current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the successful execution and outcomes of the Phase 2 trial, potential future clinical development of stenoparib in SCLC, securing necessary regulatory approvals, and other operational and financial risks that could impact the Company's ability to achieve its goals. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in our Form S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the 'SEC') and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC's website at and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. ### Company Contact: investorrelations@ Media Contact: Thomas Pedersen Carrotize PR & Communications +45 6062 9390 tsp@ Attachment Allarity Therapeutics Press Release - Allarity Announces Phase 2 Trial of Stenoparib in Combination with Temozolomide for Recurrent Small Cell Lung CancerSign in to access your portfolio
