On September 8, 2022 Propella Therapeutics, Inc. ("Propella" or "the Company"), a private, clinical-stage biopharmaceutical company developing best-in-class oncology therapeutics, reported that Dr. Jose Avitia of the New Mexico Cancer Center will present data from the Company’s ongoing Phase 1/2 trial of PRL-02 for the treatment of advanced prostate cancer on Sunday, September 11 at 12:00 pm at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (Press release, Propella Therapeutics, SEP 8, 2022, View Source [SID1234619260]). Details of the poster presentation are below:

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Abstract: 2264
Title: 1/2a study of PRL-02, a long-acting IM depot injection of abiraterone decanoate in patients with prostate cancer (NCT04729114)
Presenter: Jose Avitia, M.D.
Date: September 11, 2022
Time: 12 pm CEST, Location: Hall 4, Paris Expo Porte de Versailles, Paris, France
Presentation Number: 1386P

The presentation will highlight results from the ongoing dose-escalation part of the Phase 1/2 study (NCT04729114) in 15 patients who have been treated at five different doses of PRL-02 (180mg; 360mg; 720mg; 1260mg; 1800mg), including safety, tolerability and response data.

Propella Therapeutics is focused on the creation of a pipeline of proprietary oncology therapeutics that utilize lymphatic system delivery. The Company’s most advanced clinical candidate, PRL-02 (abiraterone decanoate), is a long-acting, selective CYP17 lyase inhibitor that has been designed for optimal uptake through the lymphatic system so that a precise level of abiraterone can be released to continuously block CYP17 lyase over a three-month period, thereby reducing the risk of tumor breakthrough. PRL-02 is currently in an open-label, multi-center Phase 1/2 study for the treatment of metastatic prostate cancer.

About Metastatic Prostate Cancer

Prostate cancer is the most common non-skin cancer in men, and the second leading cause of cancer death, developing most often in older men. Metastatic disease occurs when prostate cancer cells travel through the lymphatic system or blood stream to other organs and tissues such as lymph nodes, liver, bone, and lungs. While early or localized prostate cancer remains highly curable, advanced prostate cancer remains difficult to treat, with a 5-year survival rate of only 30%. Although there are several treatment options for metastatic prostate cancer, the reduction of androgen activity remains the most effective approach.

About PRL-02

PRL-02 is a next generation androgen biosynthesis inhibitor being developed for the treatment of prostate cancer. A large body of both historic and modern data support a role for androgens in prostate cancer pathogenesis and progression. The only approved androgen biosynthesis inhibitor approved for the treatment of prostate cancer, Zytiga (oral abiraterone acetate), blocks the CYP17 lyase enzyme that is required for the biosynthesis of androgens, including testosterone, but also unnecessarily blocks the CYP17 hydroxylase enzyme activity, resulting in a large accumulation of mineralocorticoids that can produce a constellation of side effects (hypertension, hypokalemia, edema) and upstream steroids such as progesterone that can further stimulate prostate cancer growth. PRL-02 is a patented prodrug of abiraterone designed for lymphatic targeting of tissues and tumors that express the CYP17 lyase enzyme. PRL-02 is an intramuscular depot that, when given along with a gonadotropin releasing hormone agonist or antagonist, was engineered to precisely release the abiraterone needed to continuously block CYP17 lyase enzyme for 3 months, while avoiding adverse liver and drug-drug interaction effects and the accumulation of steroids that can further stimulate prostate cancer and produce the symptoms of mineralocorticoid excess that arise from unwanted CYP17 hydroxylase inhibition.

On September 8, 2022 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported significant effects of PRP against the tumor microenvironment and pre-metastatic niche has been reported by the Company’s joint researcher, Mrs. Belén Toledo Cutillas MSc, at the laboratory of Professor Macarena Perán, PhD, University of Jaén (Press release, Propanc, SEP 8, 2022, View Source [SID1234619259]). Treatment with PRP was shown to have a favorable impact inhibiting, slowing, or reversing tumor development by acting as an anti-tumor agent, decreasing tumor cell proliferation, developing a non-malignant phenotype (observable characteristics) and promoting cell adhesion (sticking close to one another) and differentiation (cell specialization rather than stem cell like). It was concluded that PRP could have a significant impact on the tumor microenvironment as a potential clinical application. PRP is a combination of the two proenzymes trypsinogen and chymotrypsinogen.

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Cancer remains one of the leading causes of death, globally. Despite recent advances in understanding its molecular and genetic basis, more than one third of those affected die each year from cancer. These alarming results are mainly attributed to current therapies not fully effective against cancer cells which may develop drug resistance, leading to recurrence and metastasis, causing more than 90% of cancer-related deaths. According to Mrs. Cutillas, "This is why we need to find better and more effective therapeutic strategies". She explains that tumor formation is influenced by two factors, genetic changes in tumor cells and the rearrangement of components of the tumor microenvironment. In recent years, cancer research has focused on the tumor microenvironment.

Numerous assays, in vitro and in vivo studies, were conducted by Mrs. Cutillas confirming that PRP appears to have an anti-tumor effect and can act selectively against specific tumor elements, without affecting the non-tumor microenvironment and preventing its malignification (i.e., the process of making malignant).

Dr Julian Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer said, "The work undertaken by Mrs Cutillas highlights the significant potential applications of PRP in a clinical setting, specifically relating to drug resistance, and consequently recurrence and metastasis, which is the biggest cause of death for sufferers. The pioneering research being undertaken with our joint researchers at the Universities of Jaén and Granada, continues to confirm our belief in the therapeutic potential of PRP, and may lead to exciting new ways to treat cancer patients suffering from solid tumors whilst reducing the threat of recurrence."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On September 8, 2022 Oxford Vacmedix reported the OVM-200 Phase 1 Clinical Trial at The Christie in Manchester was featured on ITV’s Granada News on Wednesday 7th September 2022 (Press release, Oxford Vacmedix, SEP 8, 2022, View Source;utm_medium=rss&utm_campaign=ovm-200-clinical-trial-featured-on-tv [SID1234619257]).

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It is a first-in-class of ROP cancer vaccine in human clinical trial. ROP therapeutic vaccines will provide additional options for the treatment of cancer patients.

Professor Shisong Jiang, Chief Scientific Officer and Founder of OVM said:

We see the potential benefits of a vaccination approach both in stimulating the body’s immune system to attack the cancer and also, in future trials, enhancing the efficacy of other immune-oncology agents. This Phase I trial is a first step towards having effective cancer vaccines.

On September 8, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA expression-based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported the initiation of dosing in a Phase 2 basket trial evaluating the anti-DLL4/VEGF bispecific antibody navicixizumab, alone or in combination with chemotherapy, in patients with select advanced solid tumors (Press release, OncXerna Therapeutics, SEP 8, 2022, View Source [SID1234619256]).

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The trial is a multicenter, open-label, signal finding study with cohorts in colorectal and triple negative breast cancer currently open for enrollment. The colorectal cancer cohort is evaluating navicixizumab alone and in combination with irinotecan, while the triple negative breast cancer cohort is evaluating navicixizumab alone and in combination with paclitaxel. Per the trial protocol, two additional cohorts designed to enroll patients with ovarian cancer and gastric or gastroesophageal cancer may be opened in the future.

In addition to evaluating the safety and efficacy of the studied treatment regimens, the basket trial also seeks to evaluate the potential of the Xerna TME Panel to predict clinical benefit from navicixizumab. The Xerna TME Panel is a novel RNA gene expression-based diagnostic panel developed by OncXerna. Samples will be tested using Exact Sciences Oncomap ExTra with the Xerna TME Panel to classify patient samples into one of four tumor microenvironment (TME) subtypes based on angiogenic and immune gene expression signatures. The relationship between TME subtypes and the anti-tumor activity of studied regimens will be evaluated as a secondary endpoint in the trial.

"Aberrant Notch expression is associated with poor prognosis and treatment resistance in many solid tumors, including colorectal cancer and triple-negative breast cancer. Navicixizumab simultaneously targets inhibition of DLL4, a ligand of the Notch pathway, and VEGF, making this a very attractive therapeutic strategy to evaluate," said Paul Oberstein, M.D., Director of GI Medical Oncology in the Perlmutter Cancer Center and Associate Professor of Medicine at NYU Langone Health. "We are excited to have this study underway and look forward to evaluating the potential clinical impact of navicixizumab in these settings where patients have limited treatment options and prognosis is poor."

Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna, commented, "This Phase 2 trial is an important milestone for navicixizumab’s development as we seek to build on our promising ovarian cancer data and explore its potential to address unmet needs in other settings where DLL4 plays a key role in treatment resistance. As part of our company’s commitment to expand precision medicine to improve outcomes for patients, we will also evaluate the potential of the Xerna TME Panel to identify patients more likely to respond to treatment with navicixizumab."

About the Phase 2 Trial
The Phase 2 basket trial (ONCX-NAV-G201) is a multicenter, open-label, signal finding study designed to enroll up to 180 patients across four cohorts:

Colorectal Cancer Cohort: Designed to evaluate navicixizumab alone and in combination with irinotecan in patients with colorectal cancer who have failed two lines of prior standard therapy, including treatment with prior bevacizumab or an equivalent antibody. This cohort will enroll up to 60 patients.
Triple Negative Breast Cancer Cohort: Designed to evaluate navicixizumab alone and in combination with paclitaxel in patients with triple negative breast cancer who have received at least two and no more than four prior lines of standard therapy for metastatic disease. Per the trial’s inclusion criteria, prior therapy must include both an immune checkpoint inhibitor in patients with combined positive score > 10, and sacituzumab govitecan. This cohort will enroll up to 60 patients.
Gastric/Gastroesophageal Cancer Cohort: Designed to evaluate navicixizumab plus paclitaxel in patients with second-line gastric or gastroesophageal cancer whose prior therapy included an immune checkpoint inhibitor. This cohort will enroll up to 30 patients.
Ovarian Cancer Cohort: Designed to evaluate navicixizumab monotherapy in patients with relapsed/refractory ovarian cancer who have received at least two and no more than five prior lines of standard therapy. This cohort will enroll up to 30 patients.
The primary endpoints of the trial are objective response rate and progression-free survival. Key secondary endpoints include overall survival, duration of response, safety and tolerability assessments, and the relationship between tumor Xerna TME Panel biomarker subtype and the anti-tumor activity of studied regimens. Xerna TME Panel assessments will be made using formalin-fixed paraffin embedded archive or core tumor samples collected during screening. For more information on the trial, see Clinicaltrials.gov Identifier: NCT05453825.

About Navicixizumab
Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that demonstrated antitumor activity in patients who were previously treated with Avastin (bevacizumab) in a Phase 1b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with Avastin. Navicixizumab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

About the Xerna TME Panel
The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.

On September 8, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that members of management will virtually present at the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care being held at the Roswell Park Comprehensive Cancer Center in Buffalo, NY September 8-10, 2022 (Press release, Moleculin, SEP 8, 2022, View Source [SID1234619255]).

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Details of the presentations are as follows:

Title: The Value of Collaboration in Clinical Development: Experience from Poland
Presenter: Walter Klemp, President and Chief Executive Officer
Session 2: Opportunities for International Collaborations & Funding
Date & Time: Friday, September 9 at 12:05 PM ET

Title: Translating Preclinical Research Into Clinical Trials
Presenter: Robert Shepard, MD, FACP, Medical Advisor
Session B: Translational Research
Date & Time: Saturday, September 10 at 11:10 AM ET