LiPlaCis (liposomal cisplatin) / Allarity Therap, Smerud Medical Research, Chosa Oncology - LARVOL DELTA

Targeted therapies for cholangiocarcinoma in the second line setting (YouTube) - "Lorenza Rimassa...comments on the development of targeted therapies for patients with cholangiocarcinoma (CCA) pre-treated with cisplatin and gemcitabine. Pemigatinib and futibatinib have both been approved for FGFR2-mutant bile duct cancer and ivosidenib has been approved for CCA with an IDH1 mutation."

Video

Predictive biomarker for cisplatin in prospective phase 2 of liposomal cisplatin in metastatic breast cancer. (ASCO 2023) - P1/2 | "LiPlaCis shows efficacy in heavily pretreated mBC patients, especially when using the DRP method as a companion diagnostic. Further, this is the first clinical study to prospectively validate DRP as a method to identify responders to chemotherapy cisplatin. 1) Buhl et al PLOS One doi: 10.1371/journal.pone0194609."

Biomarker • Clinical • Metastases • P2 data • Breast Cancer • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First Prospective Clinical Validation of Allarity’s DRP Companion Diagnostic to be Presented at 2023 ASCO Annual Meeting (GlobeNewswire) - P1/2 | N=50 | NCT01861496 | Sponsor: Allarity Therapeutics | "Allarity Therapeutics, Inc...announced the results of a prospective Phase 2 clinical study of the Company’s proprietary DRP® technology that will be presented in a poster at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2023....Data from the poster presentation will show that the cisplatin-DRP^® identified all four mBC patients who demonstrated a partial response (PR) in the trial as likely responders to the LiPlaCis™ treatment regimen using a DRP80+ score as a cut-off for likely responders. In addition, the cisplatin-DRP^® also identified mBC patients demonstrating other efficacy signals, including improved progression-free survival. Based on these data, researchers concluded that the cisplatin-DRP^® companion diagnostic can differentiate, in a statistically significant way, clinical responders and non-responders to cisplatin administered as LiPlaCis™."

Diagnostic • P2 data • Breast Cancer • Oncology • Solid Tumor

CHOSA Oncology AB presents clinical phase 2 results of LiPlaCis and its Drug Response Predictor test at ASCO 2023 [Google translation] (Cision) - P1/2 | N=50 | NCT01861496 | Sponsor: Allarity Therapeutics | "CHOSA Oncology AB today publishes results from the prospective phase 2 study of LiPlaCis^® (a liposomal formulation of cisplatin) in previously heavily treated patients with metastatic breast cancer, when the abstract will be released on the ASCO website on May 25, 2023 , at 17:00 (ET) / 23:00 CET...The results show that patients who score high in the DRP reading (DRP 80+) are the best responders and show 2.5 times longer median PFS (Progression Free Survival)....We believe that a 250% increase in progression-free survival (PFS) from the sensitive 20% provides a potential treatment breakthrough and a pathway for LiPlaCis approval....A DRP score >80% (DRP80+) distinguished well between responders and non-responders to liposomal cisplatin. All four partial reductions in the study were in the DRP80+ group, and other key endpoints were in favor of DRP80+ compared to the lower scores (DRP80-)."

P2 data • Breast Cancer • Oncology • Solid Tumor

Abstract Evaluating Allarity’s DRP Companion Diagnostic for Cisplatin Accepted at 2023 ASCO Annual Meeting (GlobeNewswire) - "Allarity Therapeutics, Inc...announced that an abstract on the Company’s proprietary DRP^® technology has been accepted for a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting....The poster shows the final data from a phase 2 study evaluating the ability of the DRP^® companion diagnostic for cisplatin to prospectively identify patients with metastatic breast cancer that are likely to respond to treatment with LiPlaCis^®, a targeted liposomal formulation of cisplatin."

Diagnostic • P2 data • Breast Cancer • Oncology • Solid Tumor

Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours (clinicaltrials.gov) - P1/2 | N=50 | Completed | Sponsor: Allarity Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Genetic Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Skin Cancer • Solid Tumor

Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours (clinicaltrials.gov) - P1/2; N=50; Active, not recruiting; Sponsor: Allarity Therapeutics; Trial completion date: Apr 2021 ➔ Oct 2021; Trial primary completion date: Apr 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Genetic Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Skin Cancer • Solid Tumor

Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours (clinicaltrials.gov) - P1/2; N=50; Active, not recruiting; Sponsor: Oncology Venture; Trial completion date: Dec 2020 ➔ Apr 2021; Trial primary completion date: Dec 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Genetic Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Skin Cancer • Solid Tumor

Allarity Therapeutics Gains Allowance from U.S. Patent and Trademark Office for New DRP Biomarker Patents (Streetinsider.com) - "Allarity Therapeutics A/S...announced that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance to the Company...U.S. Patent Application No.: 15/858,703, 'METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS' – Directed to a DRP^® biomarker for Cisplatin, including the Company’s cancer drug LiPlaCis®; U.S. Patent Application No.: 15/978,655, 'METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS' – Directed to DRP^® biomarkers for anthracyclines, including doxorubicin, epirubicin, and the Company’s cancer drug 2X-111..."

Biomarker • Patent • Breast Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours (clinicaltrials.gov) - P1/2; N=50; Active, not recruiting; Sponsor: Oncology Venture; Recruiting ➔ Active, not recruiting; Trial completion date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Genetic Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Skin Cancer • Solid Tumor

Press release Oncology Venture signs agreement to out-license two pipeline assets as part of prioritized portfolio strategy (GlobeNewswire) - "Oncology Venture A/S....announced that it has signed a definitive agreement out-licensing two clinical pipeline assets, LiPlaCis® and 2X-111, to Smerud Medical Research International for further clinical and commercial development. Under the terms of the agreement, OV will receive regulatory milestone fees of nearly US $30M plus royalties on sales for each drug payable to OV if all the milestones are met. OV also terminated its prior license agreement with Cadila Pharmaceuticals for the development of LiPlaCis® in India....Under their new agreement, Smerud will advance the specific development of LiPlaCis® in late stage metastatic breast cancer and 2X-111 in glioblastoma multiforme, in connection with each program’s DRP® companion diagnostic."

Licensing / partnership • Breast Cancer • Glioblastoma • Oncology

The latest advances of Cisplatin liposomal formulations: essentials for preparation and analysis. (PubMed, Expert Opin Drug Deliv) - "There have been much efforts for improving Cisplatin delivery to the site of action via liposomes both in research and clinical trials such as SPI-077®, Liplacis®, and Lipoplatin®.Areas covered: In this review, we have discussed about Cisplatin and its liposomal formulations, focusing on different preparation methods and analysis approaches such as atomic absorption, mass spectroscopy, UV, electrochemical methods, and emphasizing on HPLC as one of the accurate and specific methods for determination of Cisplatin species and also measurement of total platinum by derivation.Expert Opinion: Liposome of Cisplatin have offered potential beneficial aspects over Cisplatin formulation. Cisplatin resistance is another challenge which should be prevented by higher loading capacity. Charge dependent interactions should also be highly considered especially in the preparation step."

Journal

Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours (clinicaltrials.gov) - P1/2; N=50; Recruiting; Sponsor: Oncology Venture; Trial completion date: May 2019 ➔ Sep 2020; Trial primary completion date: May 2019 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date

"#FDA grants IDE approval to use #OncologyVenture’s #LiPlaCis DRP for patient selection in a pivotal Phase 3 study $OV https://t.co/lNqnwBu4yL" (@1stOncology)

Clinical • FDA event

FDA grants IDE approval to use Oncology Venture’s LiPlaCis DRP for patient selection in a pivotal phase 3 study (GlobeNewswire) - "Oncology Venture A/S...informs that the US Food & Drug administration (FDA) has approved an IDE (Investigational Device Exemption) application for use of the company’s drug response predictor LiPlaCis DRP® in a planned pivotal Phase 3 study. In parallel, the FDA is evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis®, which is primarily being developed as a potential new treatment of metastatic breast cancer in heavily pre-treated patients."

FDA event

Oncology Venture receives response from the FDA to the IND-application and proposed pivotal study for LiPlaCis (GlobeNewswire, Oncology Venture A/S) - Oncology Venture A/S (“OV” or “the Company”) today announced that the FDA has given its initial response to the Company’s IND application and proposed pivotal Phase 3 study of LiPlaCis® in the US. The FDA has requested some additional testing of the LiPlaCis related to the product characterization. LiPlaCis® is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin.

Regulatory

Oncology Venture prolongs subscription period (GlobeNewswire, Oncology Venture A/S) - In light of the clinical news published in press release today April 30, 2019 “Oncology Venture provides news on its clinical development projects dovitinib, 2X‑121 and LiPlaCis”, the board of directors in Oncology Venture A/S has decided to extent the subscription period in the rights issue until May 10, 2019. DRP® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 37 clinical studies that were examined and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis and its DRP® to track, match and treat patients with metastatic breast cancer.

Clinical

Oncology Venture provides news on its clinical development projects dovitinib, 2X‑121 and LiPlaCis (GlobeNewswire, Oncology Venture A/S) - Hørsholm, Denmark and Cambridge, MA, US, April 30, 2019 – Oncology Venture A/S today provides news on DRP® based analyses of biopsies from clinical trials with dovitinib. Also, Oncology Venture has submitted an IND (Investigational New Drug Application) for LiPlaCis® and its DRP® to the FDA, with the intention to start a pivotal study in metastatic breast cancer. Dovitinib. 2X-121/PARPi. The first U.S. patient has now been dosed at Dana-Farber Cancer Institute Boston with 2X-121, a PARP inhibitor in development for advanced ovarian cancer.

Clinical data • Enrollment status • Regulatory

First patient dosed in phase II study of LiPlaCis in prostate cancer (Targeted Oncology) - "The first patient has been dosed in a phase II study investigating the safety and tolerability of the novel agent LiPlaCis for the treatment of advanced or refractory prostate cancer (NCT01861496)."

Enrollment open

First patient dosed in a Phase 2 study with LiPlaCis in prostate cancer (GlobeNewswire, Oncology Venture A/S) - "Oncology Venture A/S...today announced that the first patient has been dosed in a Phase 2 study with LiPlaCis® in prostate cancer. Oncology Venture has clearance from the Danish health authorities to treat up to 15 prostate cancer patients with LiPlaCis®. LiPlaCis® is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin."

Enrollment open

Clinical update: Dovitinib DRP data mining successfully completed and new LiPlaCis data continues to support an FDA breakthrough designation strategy (GlobeNewswire, Oncology Venture A/S) - Oncology Venture has finalized the data mining process for dovitinib and its companion DRP® in renal cancer and endometrial cancer. The DRP gives dovitinib with a strong competitive edge. Further, Oncology Venture provides an up-date from the ongoing phase 2 study of LiPlaCis®, showing continued strong data that supports an FDA breakthrough therapy designation. The updated data shows that the efficacy of LiPlaCis® is better than competitors – both in terms of response rate and time to progression. This new data also supports a future marketing authorization application to the EMA.

Breakthrough therapy designation • Clinical • European regulatory • P2 data