FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), PDGFRβ inhibitors(Platelet-derived growth factor receptor beta inhibitors)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases+ [2]

Active Indication

Ovarian CancerAdvanced Malignant Solid NeoplasmOsteosarcoma

Inactive Indication

Acetyl-Coa Carboxylase DeficiencyAcute Myeloid Leukemiaadenocarcinoma of biliary tract+ [40]

Originator Organization

Novartis Pharma AG

Active Organization

Allarity Therapeutics Europe ApSAllarity Therapeutics, Inc.

Oncoheroes Biosciences IncStartup

Inactive Organization

Novartis Pharmaceuticals Corp.

Novartis AG

Genentech, Inc.

+ [4]

Drug Highest PhasePhase 2

First Approval Date-

RegulationSpecial Review Project (CN), Orphan Drug (US)

Structure

Molecular FormulaC21H21FN6O

InChIKeyPIQCTGMSNWUMAF-UHFFFAOYSA-N

CAS Registry405169-16-6

Clinical Trials associated with Dovitinib

NCT05571969 / RecruitingPhase 1

A Phase Ib, Open Label, Multicenter Study to Determine the Maximum Tolerated Dose (MTD) of PARPi 2X-121 Monotherapy and the MTD of Dovitinib in Combination With 2X-121 in Patients With Advanced Solid Tumors

This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study will evaluate safety and tolerability, antitumor activity, pharmacokinetics and determine the MTD of dovitinib when given in combination with the MTD of 2X-121 determined in Part 1.

Start Date20 Feb 2023

Sponsor / Collaborator

Allarity Therapeutics, Inc.

[+1]

NCT02268435 / WithdrawnPhase 1IIT

A Trial of Dovitinib in Combination With Imatinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors After Failure to Imatinib and Sunitinib

The objective of this study is to determine the recommended dose of combination of dovitinib and imatinib in phase I study.

Start Date01 Mar 2015

Sponsor / Collaborator

Asan Medical Center

NCT02048943 / WithdrawnPhase 1IIT

A Phase Ib Study of Dovitinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer

This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation are anti-cancer drugs for treating many cancer types.

Start Date01 Mar 2015

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+2]

100 Clinical Results associated with Dovitinib

100 Translational Medicine associated with Dovitinib

100 Patents (Medical) associated with Dovitinib

218

Literatures (Medical) associated with Dovitinib

01 Nov 2024·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

FLT3-PROTACs for combating AML resistance: Analytical overview on chimeric agents developed, challenges, and future perspectives

Review

Author: Dokla, Eman M E ; Lasheen, Deena S ; Abou El Ella, Dalal A ; Elrazaz, Eman Z ; Hesham, Heba M

The urgent and unmet medical demand of acute myeloid leukemia (AML) patients has driven the drug discovery process for expansion of the landscape of AML treatment. Despite the several agents developed for treatment of AML, more than 60 % of treated patients undergo relapse again after re-emission, thus, no complete cure for this complex disease has been reached yet. Targeted oncoprotein degradation is a new paradigm that can be employed to solve drug resistance, disease relapse, and treatment failure in complex diseases as AML, the most lethal hematological malignancy. AML is an aggressive blood cancer form and the most common type of acute leukemia, with bad outcomes and a very poor 5-year survival rate. FLT3 mutations occur in about 30 % of AML cases and FLT3-ITD is associated with poor prognosis of this disease. Prevalent FLT3 mutations include internal tandem duplication and point mutations (e.g., D835) in the tyrosine kinase domain, which induce FLT3 kinase activation and result in survival and proliferation of AML cells again. Currently approved FLT3 inhibitors suffer from limited clinical efficacy due to FLT3 reactivation by mutations, therefore, alternative new treatments are highly needed. Proteolysis-targeting chimera (PROTAC) is a bi-functional molecule that consists of a ligand of the protein of interest, FLT3 inhibitor in our case, that is covalently linked to an E3 ubiquitin ligase ligand. Upon FLT3-specific PROTAC binding to FLT3, the PROTAC can recruit E3 for FLT3 ubiquitination, which is subsequently subjected to proteasome-mediated degradation. In this review we tried to address the question if PROTAC technology has succeeded in tackling the disease relapse and treatment failure of AML. Next, we explored the latest FLT3-targeting PROTACs developed in the past few years such as quizartinib-based PROTACs, dovitinib-based PROTACs, gilteritinib-based PROTACs, and others. Then, we followed with a deep analysis of their advantages regarding potency improvement and overcoming AML drug resistance. Finally, we discussed the challenges facing these chimeric molecules with proposed future solutions to circumvent them.

25 Sep 2024·MINI-REVIEWS IN MEDICINAL CHEMISTRY

Therapeutic Potental of Quinolin-2H-one Hybrids as Anticancer Agents

Article

Author: Meeramol, Chellappan ; Shivlingrao, Mamle Desai ; Soumya, Vasu ; M., Manickavasagam ; Soniya, Naik

The statistical data related to cancer in recent years has shown a great increase in the number of cases and is likely to further increase in the future. Even after seeking thorough knowledge on the aetiology of cancer and related disorders and attempting to cure it by various methods like gene therapy, T cell therapy, chemotherapy, surgery, hormone therapy, and photodynamic therapy, there has always been disappointment concerning the survival rate. Hence, there is still a great urge for the discovery of novel drugs for the treatment of cancer. Chemotherapy being one of the widely used methods, several drug entities possessing anticancer properties are already in the market but none of them is known to show good efficacy which necessitates researchers to design newer drugs for the treatment of cancer. The urge to synthesize novel anticancer entities directed researchers towards molecular hybridization as one of the novel methods for designing newer drugs. Literature reveals wide research carried out on quinolin-2-one hybrids, possessing anticancer properties through different mechanisms. Tipifarnib and Dovitinib are quinolin-2-one hybrids used to treat cancer, possessing imidazole and benzimidazole heterocyclic rings. Different heterocyclic scaffolds such as pyrone, pyrrole, pyrimidine, pyridine, thiazole, and pyrazole in combination with heterocyclic quinolin-2-one have shown high potential to become lead for newer anticancer agents with better and wider therapeutic properties and lesser side effects. The current review presents information on the different quinolin-2-one hybrids and their effect on different cancer cell lines. It also imparts knowledge of the structural requirements for designing novel anticancer agents.

01 Jul 2024·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Quantification and analyses of seven tyrosine kinase inhibitors targeting hepatocellular carcinoma in human plasma by QuEChERS and UPLC-MS/MS

Article

Author: Li, Yilin ; Song, Li ; Zhen, Xiaolan ; Li, Hui ; Liang, Yan ; Peng, Jiangning

Tyrosine kinase inhibitors (TKIs) are commonly used to treat various cancers. Literature suggests that the blood concentration of TKIs strongly correlates with their efficacy and adverse effects. Therefore, establishing a Therapeutic Drug Monitoring (TDM) methodology for TKI drugs is crucial to improving their clinical efficacy and minimizing the treatment-related adverse effects. However, quantifying their concentrations in the plasma using existing methods to avoid potential toxicity is challenging. Herein, seven TKIs, namely sorafenib tosylate, axitinib, erlotinib, cediranib, brivanib, linifanib, and golvatinib, were successfully analyzed in human plasma by following a quick, easy, cheap, effective, rugged, and safe (QuEChERS) pretreatment method combined with ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Briefly, biological samples were extracted using 1 mL of methanol, followed by the sequential addition of 250 mg of anhydrous magnesium sulfate and 25 mg of N-propylethylenediamine (PSA) for salinization and purification by adsorption, respectively. In this study, dovitinib was used as the internal standard. The seven TKIs were detected by the gradient elution method for 4 min in the positive ion electrospray mode. The mobile phase comprised methanol (phase A) and 0.1 % aqueous formic acid solution (phase B) on the Agilent Zorbax RRHD Stablebond Aq, (2.1 × 50 mm; 1.8 μm). Brivanib, linifanib, axitinib, sorafenib tosylate, and golvatinib exhibited good linearity in the range of 5-500 ng/mL, and erlotinib and cediranib exhibited good linearity in the range of 10-1000 ng/mL, with linear correlation coefficients (R²) ≥ 0.99. The limits of detection and quantification were 0.60-0.18 ng/mL and 5-10 ng/mL, respectively. The intraday and interday accuracy values ranged from -6.12 % to 7.31 %, with a precision (RSD) of ≤ 10.57 %. The method was rapid, accurate, specific, simple, reproducible, and suitable for the quantitative determination of the seven TKIs in human plasma.

News (Medical) associated with Dovitinib

10 Nov 2024

·www.prnewswire.com

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Allarity Therapeutics, Inc. Inc. of Class Action Lawsuit and Upcoming Deadlines - ALLR

NEW YORK, Nov. 10, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 24-cv-06952, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Allarity securities between May 17, 2022 and July 19, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased or otherwise acquired Allarity securities during the Class Period, you have until November 12, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at . To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Allarity is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP." On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA"). On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA"). On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic." Following these developments, Allarity continued to represent to investors and the market that it remained committed to pursuing the Dovitinib NDA and would work with the FDA to determine a clear regulatory path forward for resubmitting that application. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated the Dovitinib NDA's continued regulatory prospects; (ii) Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA; (iii) the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; (iv) following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times. On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities." The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same. Following these disclosures, Allarity's stock price fell $0.31 per share, or 19.02%, to close at $1.32 per share on June 30, 2022. On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy. On this news, Allarity's stock price fell $0.045 per share, or 3.688%, to close at $1.175 per share on August 2, 2022. On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP." On this news, Allarity's stock price fell $0.009 per share, or 3.8%, to close at $0.228 per share on February 6, 2023. On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date. On this news, Allarity's stock price fell $0.075 per share, or 13.37%, to close at $0.486 per share on December 11, 2023. Then, on July 22, 2024, Allarity disclosed in yet another SEC filing that it had received a Wells Notice from the SEC's staff "relating to the Company's previously disclosed SEC investigation," advising that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the [FDA] regarding the Company's NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021"; that, per the Company's understanding, "all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022"; and "that three of its former officers"—the same number of Company officers terminated during the Class Period—"received Wells Notices from the SEC relating to the same conduct." On this news, Allarity's stock price fell $0.004 per share, or 2.38%, to close at $0.164 per share on July 22, 2024. Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from [Defendant] Brown, its [CFO], effective September 12, 2024." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive ChangeNDA

17 Oct 2024

·www.prnewswire.com

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Allarity Therapeutics, Inc. Inc. of Class Action Lawsuit and Upcoming Deadlines - ALLR

NEW YORK, Oct. 17, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 24-cv-06952, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Allarity securities bet ween May 17, 2022 and July 19, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased or otherwise acquired Allarity securities during the Class Period, you have until November 12, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at . To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Allarity is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP." On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA"). On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA"). On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic." Following these developments, Allarity continued to represent to investors and the market that it remained committed to pursuing the Dovitinib NDA and would work with the FDA to determine a clear regulatory path forward for resubmitting that application. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated the Dovitinib NDA's continued regulatory prospects; (ii) Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA; (iii) the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; (iv) following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times. On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities." The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same. Following these disclosures, Allarity's stock price fell $0.31 per share, or 19.02%, to close at $1.32 per share on June 30, 2022. On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy. On this news, Allarity's stock price fell $0.045 per share, or 3.688%, to close at $1.175 per share on August 2, 2022. On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP." On this news, Allarity's stock price fell $0.009 per share, or 3.8%, to close at $0.228 per share on February 6, 2023. On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date. On this news, Allarity's stock price fell $0.075 per share, or 13.37%, to close at $0.486 per share on December 11, 2023. Then, on July 22, 2024, Allarity disclosed in yet another SEC filing that it had received a Wells Notice from the SEC's staff "relating to the Company's previously disclosed SEC investigation," advising that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the [FDA] regarding the Company's NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021"; that, per the Company's understanding, "all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022"; and "that three of its former officers"—the same number of Company officers terminated during the Class Period—"received Wells Notices from the SEC relating to the same conduct." On this news, Allarity's stock price fell $0.004 per share, or 2.38%, to close at $0.164 per share on July 22, 2024. Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from [Defendant] Brown, its [CFO], effective September 12, 2024." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive ChangeNDA

03 Sep 2024

·oncoheroes.com

Oncoheroes Obtains Exclusive Worldwide Oncology Pediatric Rights Of Dovitinib

Boston, MA, Sept 3, 2024 – Oncoheroes Biosciences Inc. ("Oncoheroes") and Novartis have signed a worldwide, exclusive licensing agreement for dovitinib, a multi-tyrosine kinase inhibitor originally developed by Novartis. Under the terms of this agreement, Novartis granted Oncoheroes the exclusive rights to research, develop, and commercialize dovitinib for pediatric oncology indications. Dovitinib is a pan-tyrosine kinase inhibitor (TKI) of multiple proteins known to be overexpressed in osteosarcomas and other bone sarcomas, including fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR), and other receptor tyrosine kinases (RTKs). It has shown potential in treating various cancers by inhibiting pathways critical for tumor cell proliferation and survival and is considered, together with other TKIs, an interesting drug candidate for pediatric bone sarcomas. Dovitinib received both Orphan Drug and Rare Pediatric Disease Designations from the U.S. Food Drug and Administration (FDA). In September 2023, Oncoheroes received FDA clearance (study may proceed notification) to advance an Investigational New Drug (IND) application for dovitinib, targeting advanced or relapsed pediatric solid tumors, including osteosarcoma. “We are profoundly grateful to Novartis for this opportunity and partnership, which holds the promise of bringing new treatment opportunities to children battling cancer. This milestone is a testament to our unwavering commitment to advancing pediatric oncology and improving the lives of young patients and their families,” stated Ricardo Garcia, Oncoheroes’ CEO. Oncoheroes is currently in discussion with international clinical trial centers in North America and Australia in view of supporting a Phase 1/2 study for dovitinib in pediatric cancer patients. About Oncoheroes Biosciences: Oncoheroes Biosciences is a Boston-based biotech company exclusively focused on the discovery and development of better drugs for children and adolescents with cancer. Our vision is to deliver benefits to young cancer patients and create value in the process. Oncoheroes is actively looking for in-licensing opportunities in the pediatric oncology space while working to generate new proprietary assets for a number of pediatric cancer indications with high unmet medical needs.

Orphan DrugLicense out/inClinical StudyIND

100 Deals associated with Dovitinib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05928

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	DK	Novartis Pharmaceuticals Corp.	28 May 2014
Metastatic Renal Cell Carcinoma	Phase 3	US	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	JP	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	AR	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	AU	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	AT	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	BE	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	BR	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	CA	Novartis Pharmaceuticals Corp.	01 Mar 2011
Metastatic Renal Cell Carcinoma	Phase 3	CO	Novartis Pharmaceuticals Corp.	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01223027 (ESMO2021)	Phase 3	Solid tumor	570	Dovitinib	xathiduugl(dzwthuophu) = dgdzalqdrk layqdjzznn (osoywopxcl, 9.53 - 35.58) View more	-	16 Sep 2021
NCT01223027 (ESMO2021)	Phase 3	Solid tumor	570	Sorafenib	-	-	16 Sep 2021
NCT01753713 (Pubmed) Manual	Phase 2	Recurrent Glioblastoma	33	Dovitinib (included patients with recurrent GBM)	odrtxqacey(easxruxrqg) = omtbuaievt fmmhlqtiex (haegxnizhc ) View more	Negative	01 Sep 2019
NCT01753713 (Pubmed) Manual	Phase 2	Recurrent Glioblastoma	33	Dovitinib (anti-angiogenic naïve patients with recurrent GBM that had progressed on prior anti-angiogenic therapy.)	odrtxqacey(easxruxrqg) = bmfnvbxhxj fmmhlqtiex (haegxnizhc ) View more	Negative	01 Sep 2019
NCT01732107 (GU12-157, CTgov)	Phase 2	Bladder Cancer \| Transitional Cell Carcinoma	13	Dovitinib	asuytsvpyo(qcpezvyjfd) = praqfboihd yphqlpdryc (tfqfgflakq, mnwozkiefb - vwfagjgmse) View more	-	22 Aug 2018
NCT02116803 (CTgov)	Phase 2/3	Solid tumor	12	dovitinib (Dovitinib)	uaehdexgiu(bbcbgufsbm) = ibwmujhmwz pxrlcfmjpa (vyhnzzptjj, pyprbqiwqn - ysqrjzwome) View more	-	01 Feb 2018
NCT02116803 (CTgov)	Phase 2/3	Solid tumor	12	Fulvestrant+dovitinib (Dovitinib + Fulvestrant)	uaehdexgiu(bbcbgufsbm) = qitcehvbum pxrlcfmjpa (vyhnzzptjj, blxehjhyig - axvilgiynn) View more	-	01 Feb 2018
NCT01478373 (Pubmed \| Med J Aust) Manual	Phase 2	Gastrointestinal Stromal Tumors Second line	38	Dovitinib	dvtmdkabdo(ttijmesnks) = ketjjkilcl xakhzsqjiz (yzgduawfrc, 38.2 - 66.7) View more	Positive	24 Oct 2017
NCT01753713 (CTgov)	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	33	laboratory biomarker analysis+dovitinib (Anti-angiogenic Therapy Naive Patients)	ldeerdcage(hdrdtozmva) = ophhnnmhjp nihcogkxjq (lqsyllusjl, bmrjcquekm - pihawsxhrc) View more	-	08 Aug 2017
NCT01753713 (CTgov)	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	33	laboratory biomarker analysis+dovitinib (Anti-angiogenic Therapy Patients)	ldeerdcage(hdrdtozmva) = tppfkhhkzi nihcogkxjq (lqsyllusjl, kzgyqpxldb - vlgqmidpkr) View more	-	08 Aug 2017
NCT01266070 (CTgov)	Phase 2	Von Hippel-Lindau Disease	6	Dovitinib	aizktvspat(xytuwceyox) = khgcwtksdg lzrdbczwqf (pjdfwagoku, yjghjftnih - kdmtcwwyge) View more	-	13 Feb 2017
NCT01262027 (CTgov)	Phase 2	Inflammatory Breast Neoplasms \| Metastatic breast cancer	22	Dovitinib	qsmddratby(fbvkdvkucy) = orcgubspch sjqilacqyz (swnmwxgtld, xlxrlzbcgh - bcmqgxbumj) View more	-	02 Feb 2017
NCT01769547 (Pubmed \| Lung Cancer) Manual	Phase 2	Malignant Pleural Mesothelioma	12	dovitinib	qucczprkkt(rlwmlvdsqr) = crmwisdagz dfoqjvpmwi (tvtqtkrnnw, 28.4 - 88.0) View more	Negative	01 Feb 2017
NCT01678105 (DOVE, ESMO2016) Manual	Phase 2	Adenoid Cystic Carcinoma	21	Dovitinib	huzdcfraod(tjrclqqhlv) = avlxqpmcuc tfbhdohmxr (tinelhmpmw ) View more	Negative	09 Oct 2016

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis