Propanc Biopharma Believes PRP Reduced Toxicity Will Impact Cancer Patient Lives Significantly

On June 1, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, believes the reduced toxicity of PRP compared to standard treatment approaches will impact cancer patient lives significantly. Many standard therapies for advanced cancer urgently need improvement, generally providing modest benefits and frequently causing adverse effects (Press release, Propanc, JUN 1, 2022, View Source [SID1234615366]). Propanc’s focus is to provide oncologists and their patients with therapies for metastatic cancer which are more effective than current therapies and have a substantially reduced side effect profile. According to Cancer Treatment Centers of America, for all the advances made in cancer treatment over the past several decades, one statistic has remained unchanged: Metastatic cancer accounts for up to 90% of all cancer deaths in the United States each year.

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While surgery is often safe and effective for early-stage cancer, many standard therapies for late-stage cancer inflict too much trauma and provide too little benefit. Side effects include hair loss, nausea and vomiting, as well as blood related (hematological) side effects, which may include a low cell count of infection fighting white blood cells (neutropenia), low red blood cell count (anemia) and low platelet count (thrombocytopenia). In many cases, patients are often admitted to intensive care from the side effects of treatment. Infection is a significant cause of death among cancer sufferers due to immune suppression. The COVID-19 pandemic further highlights the plights of this poor patient population, adding to the stress of undergoing treatment with side effects that can be life threatening. Other examples of effects from standard treatment approaches include skin and gastrointestinal toxicities. Severe side effects such as rupture of the bowel and severe hypertension often requiring emergency treatment.

"We are developing a new cancer treatment to extend life and reduce pain and suffering. Our vision is to provide therapies which are more effective than current therapies and safe, which avoid short-term side effects, such as loss of hair, and long-term effects, such as permanent damage to healthy tissues," said Dr Kenyon. "Patients need access to a follow up therapy which is safe and effective enough to minimize the risk of recurrence, post-surgery. Whilst such a follow up therapy is worthwhile for some cancers, it is usually moderately effective and often too toxic for long-term use. This is where our lead product candidate, PRP, fits in. We believe it works with a number of cancers over a prolonged period. Also, PRP exhibits minimal side effects, where patients are unlikely to be hospitalized as a result of receiving treatment."

"Our management team have worked extensively with scientific researchers internationally over the last 15 years and have improved our understanding of the mode of action of PRP and most importantly, enhanced the potency of the formulation to maximize its anti-cancer effects, whilst continuing to exhibit no serious side effects," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our goal is to offer a cancer treatment which will improve the life expectancy of people with metastatic cancer and at minimal cost in terms of quality of life. We look forward to progressing PRP into a First-In-Human (FIH) study in advanced cancer patients."

Clinical experience was obtained via a compassionate use study in 46 late-stage cancer patients using a suppository formulation of two proenzymes, trypsinogen and chymotrypsinogen. Dr Kenyon concluded that no severe or serious adverse events related to the rectal administration were observed. Patients did not experience any hematological side effects as typically seen with classical chemotherapy regimens. No allergic reactions after rectal administration of suppositories were also observed.

A Good Laboratory Practice (GLP), non-clinical, 28-day repeat dose toxicity study of PRP administered via daily intravenous (I.V.) injections was also conducted. It was concluded that all dose levels were well tolerated. Furthermore, PRP was not associated with any morbidity or clinical signs of toxicity, no macroscopic pathology (disease) findings were considered treatment-related and all observed necroscopy (death related) findings were considered incidental. Also, no major toxicological findings or treatment-related changes were identified in organs examined by pathologists.

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.

EpicentRx Announces Poster Presentation for Phase 2 Randomized Clinical Trial with RRx-001 as an Anti-Mucositis Agent in Locally Advanced Head and Neck Cancer at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 1, 2022 EpicentRx, Inc, a privately-held clinical-stage biotechnology company at the forefront of developing oncolytic viruses and small molecules for the treatment of cancer and other inflammatory-driven diseases, reported that data from a Phase 2 randomized clinical trial with RRx-001 in first line head and neck cancer has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3-7, 2022, in Chicago, Illinois (Press release, EpicentRx, JUN 1, 2022, View Source [SID1234615382]). Positive results from the completed Phase 2 study called PREVLAR that was carried out in collaboration with Dr. Stephen Sonis, Distinguished Faculty member at the Dana-Farber Cancer Institute and CMO of Primary Endpoint Solutions and a leading expert in cancer-related oral mucositis, will be presented, highlighting the anti-inflammatory and antioxidant properties of RRx-001 as well as plans to initiate a follow-on trial called KEVLAR.

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Details on the company’s poster presentation are below:

Abstract Title: Phase 2 pilot trial of RRx-001 as an anti-mucositis agent in head and neck cancer patients treated with chemoradiation (PREVLAR)

Session Title: Head and Neck Cancer

Abstract Number for Publication: 6078

Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT

About RRx-001
RRx-001 leads EpicentRx’s CyNRGY platform as a first-in-class investigational treatment sourced from an exclusively licensed portfolio of aerospace-derived small molecules. RRx-001 is a multifaceted treatment with a dual-functioning mechanism that starts under "normal" conditions, or healthy tissues that are reasonably well-oxygenated, and the activity changes in poorly oxygenated (hypoxic) tissues, which is a distinguishing characteristic of cancerous tumors.

AccuGenomics joins the FNIH Biomarkers Consortium focused on Measurable residual disease in acute myeloid leukemia (MRD in AML)

On June 1, 2022 AccuGenomics Inc reported that it has joined the FNIH Biomarkers Consortium focused on Measurable residual disease in acute myeloid leukemia (MRD in AML) (Press release, Accugenomics, JUN 1, 2022, View Source [SID1234615483]). We look forward to our participation in advancing the accuracy of targeted NGS testing of liquid biopsy samples.

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As a disruptive precision diagnostics technology company, AccuGenomics’s mission is to improve the accuracy and performance of clinical sequencing testing for better patient outcomes. The rapid pace of innovation in NGS diagnostics continues to push the limits of detection for low abundance biomarkers, increasing the need to demonstrate the analytical performance of Companion Diagnostic (CDx) tests for patients and healthcare providers. We create internal standards for targeted NGS assays that reduce uncertainty and give clinicians and patients the accuracy in data to make confident medical decisions by eliminating false positive and false negative results, allowing the true underlying biology to be seen. We design and manufacture internal spike in standards that enable accurate detection of low abundance biomarkers from liquid biopsy or other sample types (can be any target, any platform, and any sample type). We improve the true limit of detection (LOD) for NGS assays so even rare variants can be identified so that the molecular markers of cancer can be detected earlier, even from liquid biopsy samples.

The Foundation for the National Institutes of Health (FNIH) is a not-for-profit charitable organization chartered by Congress to create and manage alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Biomarkers Consortium at FNIH is the preeminent public-private partnership focused on identifying, developing, and qualifying biomarkers that accelerate therapeutics and improve clinical care.

Hangzhou DAC Biotechnology Announces a Collaboration and License Agreement with Janssen for the Development of Novel Antibody-Drug Conjugates

On June 1, 2022 Hangzhou DAC Biotechnology Co., Ltd. ("DAC Biotechnology") reported a collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson ("Janssen") (Press release, Hangzhou DAC Biotech, JUN 1, 2022, View Source [SID1234618939]). Under the terms of the agreement, DAC Biotechnology will apply its innovative and proprietary antibody drug conjugate (ADC) platform to Janssen’s proprietary antibodies with the aim to develop novel ADC products against up to five targets. The negotiation and finalization of the agreement was facilitated by Johnson & Johnson Innovation. DAC Biotechnology has also received an equity investment from Johnson & Johnson Innovation – JJDC, Inc.

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"We are very proud to mark this important collaboration with Janssen," said Dr. Robert Yongxin Zhao, President and Chief Executive Officer of DAC Biotechnology. "After years of dedicated research and development, DAC technology has become a key player in the field of ADC innovation. Our advanced ADC platform, with abundant reserve of payload/linker pairs, conjugation technologies and CMC capabilities, enables us to build a deep pipeline of products, many of them being first-in-class ADCs. We are committed to bringing safe and efficacious medicines not only to patients in China, but also those around the world."

"The collaboration with Janssen is the very first collaboration milestone in our global roadmap. The combination of the license agreement and equity investment creates an exciting approach to progressing novel therapeutic innovations in overseas markets," Dr. Zhao continues.

With the aim to discover novel ADC products via license collaboration, DAC Biotechnology will fully leverage its intellectual properties and proprietary ADC platform, while Janssen will provide its expertise in proprietary antibodies, clinical development and global commercialization. Through the collaboration agreement, DAC Biotechnology is eligible to receive an upfront payment, cost reimbursement and milestone payments, plus royalties on worldwide sales for each selected product.

HUTCHMED Announces TAZVERIK® Approved to be Used in Hainan Pilot Zone in China

On June 1, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that TAZVERIK (tazemetostat) has been approved by the Health Commission and Medical Products Administration of Hainan Province to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone ("Hainan Pilot Zone"), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma ("ES") and follicular lymphoma ("FL") consistent with the label as approved by the U.S. Food and Drug Administration ("FDA") (Press release, Hutchison China MediTech, JUN 1, 2022, View Source [SID1234615314]). Launched in 2013 and located in China, the Hainan Pilot Zone is a destination for international medical tourism and global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data.

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TAZVERIK is a methyltransferase inhibitor of EZH2[1] developed by Epizyme, Inc. ("Epizyme"). It is approved by the FDA for the treatment of certain patients with ES and certain patients with FL under FDA accelerated approval granted in January and June 2020, respectively.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "The approval of TAZVERIK in the Hainan Pilot Zone allows patients to gain early access to this first-in-class EZH2 inhibitor in China, as part of our commitment to bringing innovative medicines to people in need. In addition to its use in the Hainan Pilot Zone, we also plan to initiate further registration-enabling studies in China under the terms of our agreement with Epizyme to facilitate wider and easier patient access."

In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize TAZVERIK in China, Hong Kong, Macau and Taiwan.

About FL and ES
Follicular lymphoma (FL) is a subtype of non-Hodgkin’s lymphoma ("NHL"). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. [2],[3],[4]

Epithelioid sarcoma (ES) is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.[5]

About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated in the United States for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

View the U.S. Full Prescribing Information here: www.tazverik.com

About Tazemetostat Clinical Development in China
HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly.

SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R² in patients with relapsed or refractory FL after at least one prior line of therapy(clinicaltrials.gov identifier: NCT04224493).

We intend to initiate a bridging study in FL to support registration of tazemetostat in China, as well as several combination studies of tazemetostat with HUTCHMED assets.