tw0122
1 month ago
2.25 on pump now back to 1.60s is a low floater Allarity Therapeutics to be Granted European Patent for DRP® Companion Diagnostic for Stenoparib
Source: GlobeNewswire Inc.
European Patent Office to grant a patent for DRP® companion diagnostic for Allarity’s stenoparib cancer therapy
Patent applications for the Stenoparib DRP® are also pending in the US, Japan, China, Australia, and India
Boston (October 22, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selection technology, today announced that the European Patent Office (EPO) has issued a formal notice of its intention to grant a patent for Allarity’s Drug Response Predictor (DRP®) companion diagnostic specific to stenoparib, the Company’s dual-targeted PARP/Tankyrase inhibitor.
This patent represents a significant step forward in securing Allarity’s market position for stenoparib and the Stenoparib DRP companion diagnostic, which identifies patients most likely to derive clinical benefit from stenoparib treatment.
Thomas Jensen, CEO of Allarity Therapeutics, commented, “As we advance our clinical program for stenoparib, we are also focused on securing patents in key markets to pave the way for potential future commercialization. Though our main focus is to first achieve regulatory approval in the US for both stenoparib and its DRP companion diagnostic, we strongly believe stenoparib has the potential to help ovarian cancer patients worldwide. Therefore, knowing that the EPO intends to grant us a European patent for the Stenoparib DRP is an important step towards securing the foundation for an international market position for stenoparib and its companion diagnostic."
Patent applications for the Stenoparib DRP companion diagnostic are also pending in the United States, Japan, China, Australia, and India. Allarity has previously been granted 17 patents for drug-specific DRPs, including eight in the United States.
About Stenoparib
Stenoparib is an orally available, small-molecule, dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 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/ß-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and also blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic. Allarity has 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, are found to 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 significantly increased. 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 proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients dozens of clinical studies (both retrospective and prospective). The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.
About Allarity Therapeutics
tw0122
2 months ago
4.6 + 36% 2 patients staying alive .. Boston (September 16, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that two patients enrolled in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer have now exceeded one year on therapy.
The patients had been pre-screened using Allarity’s Drug Response Predictor (DRP®) companion diagnostic, which identified them as having a high likelihood of benefiting from stenoparib, the Company’s novel dual PARP/Tankyrase inhibitor.
This remarkably lengthy treatment period highlights the potential of stenoparib to provide durable clinical benefit, even in heavily pre-treated ovarian cancer patients who have limited treatment options. The trial continues to evaluate stenoparib’s safety and efficacy, showing a confirmed, complete response as well as long term disease stability for multiple patients.
Thomas Jensen, CEO of Allarity Therapeutics, commented on this clinical achievement:
“We are incredibly encouraged by the sustained clinical benefit seen in these patients, who have now been on stenoparib for over a year. For heavily pre-treated ovarian cancer patients, extending life by 52 weeks is particularly noteworthy. Stenoparib’s unique mechanism of action, as both a PARP and Tankyrase inhibitor, sets it apart from other treatments. These results reinforce our belief in stenoparib’s potential as an important new therapy for ovarian cancer patients who have exhausted other treatment options.”
Dr. Fernanda B. Musa, Director of Clinical Research in Gynecology Oncology and site Principal Investigator at the Swedish Cancer Institute for the trial added:
“We have been surprised and excited to see a long duration of response to a single-agent oral therapy in patients with ovarian cancer who had failed multiple other types of treatment. I credit the success to personalized medicine: the pairing of the therapy to the patient’s specific tumor profile. I look forward to seeing further development of this program!”
Allarity is actively planning the further advancement of its stenoparib program, with a focus on accelerating its path toward regulatory approval. The Company remains dedicated to exploring stenoparib’s long-term clinical benefit in DRP®-selected patients and is preparing for the next phase of development. Additional updates on the program’s progress and future trials will be shared in the coming months.
Background Information about the Trial
The above-mentioned trial is a Phase 2, prospective open-label, single-arm study with multiple sites in both the US and the UK. Investigators prescreened women with advanced, recurrent ovarian cancer using Allarity’s DRP® companion diagnostic (CDx), which comprises a complex transcriptomic signature of 414 mRNA biomarkers indicative of drug response or resistance. Each participant was assigned a DRP score, and those with scores above 50 -suggesting a higher likelihood of benefiting from treatment – were selected to receive stenoparib. The selected patients were administered stenoparib under a revised protocol implemented in Q1 2023, which involved a twice-daily dosing regimen (200 mg in the morning and 400 mg in the evening) instead of the previous once-daily 600 mg dose. This change was made to optimize daily drug exposure and target inhibition.
The patients enrolled have advanced through multiple lines of therapy, including platinum, taxanes, anti-angiogenesis inhibitors, and even the recently approved Antibody Drug Conjugate, Elahere. Importantly, most of the enrolled patients to date have been previously treated with a PARP inhibitor. These patients have few, if any, effective treatment options and typically advance through available therapies after only a few months.
About stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 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/ß-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. Allarity has 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, are found to 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 significantly increased. 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 proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients dozens of clinical studies (both retrospective and prospective). The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.
tw0122
3 months ago
In consideration of this extension, and the Company not achieving the minimum patient enrollment, by July 1, 2022, as set out in the second amendment to the Eisai License Agreement, the Company agreed to pay a one-time payment to Eisai of $1,250,000 (the “Extension Payment”) as follows: (i) $400,000, (ii) $425,000 within 10 days from August 19, 2024 and (iii) $425,000 upon completion of a 10 million dollar capital raising, but in no event later than September 1, 2024. To date, the Company has paid the full Extension Payment to Eisai, and no payments are currently outstanding.
tw0122
3 months ago
The Preferred Stock is convertible, at the option of the holders and, in certain circumstances, by the Company, into the Common Stock, as determined by dividing the net purchase price of $90 per share by the conversion price of $0.17, at the option of the holders. The conversion price can be adjusted pursuant to the Certificates of Designation for stock dividends and stock splits, subsequent rights offering, pro rata distributions of dividends or the occurrence of a fundamental transaction. The holders of the Preferred Stock have the right to require the Company to redeem their shares of preferred stock for cash at 100% of the stated value of such shares commencing after the earlier of the receipt of stockholder approval of the Amendment and 60 days after the Closing Date and until 90 days after the Closing Date. The Company has the option to redeem the Preferred Stock for cash at 100% of the stated value commencing after the 90th day following the Closing Date, subject to the holders’ rights to convert the shares prior to such redemption.
trendzone
4 months ago
Can't argue with that not being the case, it's an outright major crime that the SEC lets these criminals in their cheap suits getaway with it,day in and day out, sure many start out believing they can become something that could turn into something good,but most turn into a toxic cesspools with no way out,other than becoming the self-centered selfish toxic slobs they become, and think they are doing nothing wrong ripping off the public and lining their pockets and over compensating themselves with greedy payouts,that none of them deserve,when the company's are using burning through cash to support their scam until the worthless brainless SEC some times do their usual half-ass job of shutting them down,after the retail public ends up losing many millions,to be one of them I guess you have to have a few bucks buyout a shell company and hype of some kind of BS that you have something great,and sucker in the public to believe the BS, and have a few cheap suits,for when you get involved with the toxic note dilution lenders,and the pump and dump promoters.
trendzone
4 months ago
Funny how they are trying to scare share holders into voting yes for a RS, mean while they screwed over any one who got stuck in the last one they just did in May, $5.00 to $0.15 in just three months,great investment only if you were short, or a naked shorting hedge fund criminal enterprise, wouldn't be surprised if they themselves shorted their own stock back then, sure they want a RS so they can keep the toxic slob formula in place,and keep their over paid salaries from getting hit and cut in half,and keep sucking money out of it on the backs of the public.
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