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Allarity’s Early Phase 2 Stenoparib Data Indicates Clinical Benefit in Women with Advanced Ovarian Cancer Selected with DRP® Companion Diagnostic
All evaluable participants, with prior PARP inhibitor therapy and chemotherapy, showed significant tumor shrinkage including one complete response Early data follows Phase 2 dose optimization change from once-daily to twice-daily
Boston (December 5, 2023) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, today announced encouraging initial results from its ongoing Phase 2 clinical trial evaluating the efficacy of its PARP inhibitor, stenoparib, in women with advanced ovarian cancer (AOC). Of the five evaluable patients included in the initial data analysis, one patient experienced a complete response and the other four demonstrated stable disease.
Investigators prescreened women with AOC using Allarity’s DRP®-Stenoparib CDx, a complex transcriptomic signature comprising 414 mRNA biomarkers indicative of response/resistance to the drug. Each woman was assigned a DRP®-score, and those with scores above 50%, which suggested a higher likelihood of benefiting from treatment with stenoparib, were selected for treatment. Selected patients received stenoparib in a twice daily (BID) dosing regimen (200 mg morning, 400 mg evening) under a change in protocol, implemented earlier in the year, from prior once-daily dosing of 600 mg. Allarity implemented the protocol change to optimize the drug exposure taking into account the half-life of stenoparib in patients.
Of the 22 patients screened with the DRP®-Stenoparib CDx, 17 DRP® positive patients were identified. Eleven women have entered treatment, and among the five evaluable participants assessed up to the data evaluation cut-off, there were early signs of clinical benefit in all cases:
One patient experienced a complete response (CR) by scan (to be confirmed by second scan) and by decreased levels of CA125 (a biomarker of AOC).
One patient experienced stable disease with tumor shrinkage of 19%.
One patient experienced stable disease for more than 24 weeks with tumor shrinkage of 11%.
Two patients experienced stable disease with tumor shrinkage of 8%.
All five patients had previously been treated with another PARP inhibitor. All five patients remain in treatment with stenoparib and the four that did not have complete responses are showing stable disease at this time.
“We are enthusiastic about these early, promising data since the observed clinical benefit indicates that stenoparib is active in advanced ovarian cancer patients selected with the DRP® -Stenoparib CDx, even though these women had prior PARP inhibitor therapy and chemotherapy. While still early, these data suggest that BID dosing of this drug, and the use of the DRP® -Stenoparib CDx for patient selection and treatment, may provide advanced ovarian cancer patients meaningful benefit. The DRP® -Stenoparib CDx, if approved, may provide clinicians with an important diagnostic to guide patient treatment in this hard-to-treat patient population," said Marie Foegh, M.D., Chief Medical Officer of Allarity.
The initial data readout is from an ongoing Phase 2 open-label, single-arm trial that Allarity is conducting at multiple sites in the U.S. and Europe. The goal of the study is to evaluate the anti-tumor effect of stenoparib as monotherapy in DRP®-selected patients with locally recurrent or metastatic ovarian cancer after previous PARP inhibitor and chemotherapy treatments. The primary endpoint is objective response rate (ORR). Allarity anticipates an interim data readout in Q1 2024.
The DRP®-Stenoparib CDx is a transcriptomic signature comprising 414 mRNA biomarkers that are collectively predictive of tumor sensitivity or resistance to stenoparib. Using the DRP® CDx to select likely responder patients while excluding likely resistant ones, Allarity aims to improve the benefit-risk ratio of stenoparib in metastatic or locally advanced ovarian cancer. The initial data from Allarity’s ongoing DRP®-guided Phase 2 study of stenoparib suggests that the DRP®-Stenoparib CDx may identify a subset of AOC patients previously treated with a PARP inhibitor who may benefit from treatment with stenoparib. The DRP®-Stenoparib CDx is a clinical-stage companion diagnostic candidate and has not yet been approved by the U.S. FDA or the EU’s EMA.
All preliminary data are subject to change until the final study data readout. Early trial results may not be a reliable indicator of subsequent trial results based on a larger patient population.
About Stenoparib
Stenoparib is an orally-available, small molecule dual-targeted inhibitor of PARP1/2 and telomerase maintenance enzymes (Tankyrase 1 and 2). At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in the Wnt signaling pathway. Aberrant Wnt/ß-catenin signaling has been implicated in the development and progression of multiple cancers, potentially giving stenoparib a unique, dual tumor inhibitory action. Stenoparib was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has the exclusive, global rights for the development and commercialization of stenoparib.
Some approved PARP inhibitors have recently been shown to be associated with less favorable survival outcomes than initially established. Allarity’s Phase 2 trial data for stenoparib to date shows that the drug has much less myelotoxicity than the FDA approved PARP inhibitors. Specifically, in 42 evaluable women in Phase 2 studies with stenoparib, anemia (21%), neutropenia (2%) and thrombocytopenia (0%) was lower than the approved PARP inhibitor niraparib with anemia 51%, neutropenia in 20% and thrombocytopenia oberved in in 52% of 463 patients. Allarity anticipates that this lower myelotoxicity may make stenoparib a better candidate for combination with other drugs. Allarity is studying the therapeutic potential of stenoparib in combination with dovitinib (a pan-targeted kinase inhibitor) in an ongoing Phase 1b trial, with an anticipated data readout near early Q2 2024. The Company believes that stenoparib may have broad therapeutic potential in combination with other anti-tumor agents.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer, and in Phase 1 development for advanced solid tumors in a combination treatment with dovitinib, a pan-tyrosine kinase inhibitor (pan-TKI) that has previously been developed through Phase 3 in renal cancer; and IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP®, being developed via a partnership with CHOSA Oncolog
ALLR: Maybe a 52-wk. HIGH, this time around???
He's on his 5th wife...he would be better off finding one on ihub who could handle this volitility,lol
Long time since we chatted, ALLR is for the nimble, it runs quick but reverses back even quicker! What ever happened to imoutasight?
Took a flyer over here surf....can't believe 2 RS in 4 months....low float and AS.
Holding this bottom and range very well! This is the right time to buy!
The gap was closed now buying into ALLR again!
But gonna get pumped - show me a good one under 5$
https://stockcharts.com/h-sc/ui?s=allr&p=D&yr=0&mn=6&dy=0&id=p38090673899
https://www.barchart.com/stocks/quotes/allr/technical-chart?plot=CANDLE&volume=total&data=DO&density=M&pricesOn=1&asPctChange=0&logscale=1&indicators=BBANDS(20,2);SMA(13);PTP(50);ADX(14);SMA(50);SMACD(12,26,9);RSI(14,100);ACCUM;STOSL(14,3)&sym=CNNA&grid=1&height=500&studyheight=100
https://www.barchart.com/stocks/quotes/allr/opinion
https://finance.yahoo.com/quote/allr/
Worth a trade once it moves closer to the open gap this morning!
Could be go time- finally
PLOS ONE Publishes Data on Allarity Therapeutics’ DRP® Companion Diagnostic for Dovitinib
- The DRP®-Dovitinib companion diagnostic demonstrated an ability to identify advanced renal cell carcinoma patients that have improved clinical benefit from dovitinib treatment, as compared to unselected patients
BOSTON (August 30, 2023) — Allarity Therapeutics, Inc. (Allarity or the Company) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, announced today the publication of its clinical validation of a novel drug-specific DRP®-companion diagnostic (CDx) for dovitinib in the peer-reviewed journal PLOS ONE. Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients. PLOS ONE published the paper online today titled, “A novel drug-specific mRNA biomarker predictor for selection of patients responding to dovitinib treatment of advanced renal cell carcinoma and other solid tumors.”
“Having our work published in PLOS ONE underscores the importance and potential impact of our DRP®-Dovitinib CDx in oncology,” said Allarity’s Chief Scientific Officer and Study Author Dr. Steen Knudsen. “This is the first validated predictive biomarker in renal cell carcinoma, a long-standing goal in potentially improving the treatment of these patients. An additional prospective trial would be required before RCC patients that are candidates for dovitinib can benefit from this diagnostic breakthrough. This DRP® publication marks yet another important step forward in Allarity’s mission to redefine cancer treatment paradigms and realize true personalized cancer care.”
Dovitinib is a pan-targeted kinase inhibitor (pan-TKI) formerly developed through Phase 3 clinical studies. The DRP®-Dovitinib CDx is a complex transcriptomic signature comprising 58 mRNA biomarkers that are collectively predictive of tumor response to the drug. In the study evaluating pre-treatment biopsies of 135 advanced RCC patients, the DRP® positive subgroup (indicating that the patient was likely to respond) (N=49) had a median overall survival of 15 months (96% CI 12.94-26.25), whereas the DRP® negative subgroup (N=86) had a median overall survival of 9.13 months (95% CI 7.49-13.2). The hazard ratio was 0.60 (95% CI 0.39-0.91).
In addition to the 135 RCC biopsies, the DRP®-Dovitinib showed equally promising data in a number of other solid tumors, such as hepatocellular carcinoma (HCC), thereby demonstrating that it is independent of tumor type and has applicability beyond RCC.
The PLOS ONE article is Allarity’s 14th peer-reviewed publication of data from clinical validations of DRP® companion diagnostics for a range of different cancer therapeutics, further establishing the robustness of the DRP® platform.
Dovitinib has been the focus of numerous clinical studies, showing promising properties as an anti-cancer agent, but is not yet approved for the treatment of any cancer type. It is currently being advanced by Allarity in an ongoing Phase 1b clinical study exploring the potential synergy of dovitinib and stenoparib (a PARP inhibitor) for the treatment of advanced solid tumors, including ovarian cancer. In addition, in partnership with Allarity, Oncoheroes Biosciences has an ongoing program to develop dovitinib, together with the DRP®-dovitinib CDx, as a treatment for pediatric osteosarcoma.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer, and in Phase 1 development for advanced solid tumors in a combination treatment with dovitinib, a pan-tyrosine kinase inhibitor (pan-TKI) that has previously been developed through Phase 3 in renal cancer; and IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP®, being developed via a partnership with CHOSA Oncology AB for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Company’s website at www.Allarity.com.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP® score, the therapeutic response rate can be significantly increased. The DRP® method build
ALLR Looking at the bands, An I though my Crush Grace Thong Bottom was tight. I'm loaded , however I'd love to get more on a dip buy.
$ALLR - 👆Up 29% Pre-Market/ Current Price $3.41
Allarity and FivepHusion Announce Collaboration to Support Clinical Development of Deflexifol™ with DRP® Companion Diagnostics
Just bought way more. This is going to see a nice spike soon imo...
I sold at a huge loss!!!
8 are in the Green; all others in the Red. Can't believe this. What is going on with the market today?
If in water, sharks will eat you; if on land vultures will kill you!
Seriously, I have a list of some 100 stocks (not that I buy all of them) but seems like 90 of them are RED this morning. Strange?
This must be some record to drop this quick after rs
Wash rinse repeat
This is never coming back... otc bound is about it
Gosh your the perfect trader
Yes I did that’s why I sold @$13
Hope you seen this dump coming....
Lol okay okay
Maybe but I sold @ 13 for a decent profit wash rinse repeat
Still watching are ya this company is such a scam
25% gain from split levels.... not ambad trade but nothing to phone home about figurings 90% of people were in way higher pre split
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