Quest Diagnostics to Speak at the Jefferies Healthcare Conference

May 26, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Jefferies Healthcare Conference. Steve Rusckowski, Chairman, CEO and President and Jim Davis, CEO-elect, will discuss the company’s vision, goals, and capital deployment strategies (Press release, Quest Diagnostics, MAY 26, 2022, View Source [SID1234615098]). The presentation is scheduled for Friday, June 10, 2022, at 11:00 a.m. Eastern Time.

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The presentation and Q&A session will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until August 10, 2022.

Propanc Biopharma Presents 100 Years of Clinical Evidence for “Novel” Enzyme Therapeutic Approach to Treat Cancer

On May 26, 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 100 years of clinical evidence supporting the use of proenzymes as a new therapeutic approach to treat cancer can be considered ‘compelling’ (Press release, Propanc, MAY 26, 2022, View Source [SID1234615114]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, has researched the effects of proenzymes against cancer for over 15 years and first came across the technology in his search to extend the life of several late-stage patients suffering from malignant solid tumors in the mid 2000’s. It was Professor John Beard from Edinburgh University who first proposed that pancreatic enzymes represent the body’s primary defense against cancer and would be useful as a cancer treatment. Since then, several scientists have endorsed Beard’s hypothesis with encouraging data from patient treatment.

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In 1902, in an article published in The Lancet, Professor Beard proposed that the answer to questions about the origin of cancer could be found in the field of embryology. Professor Beard tested his theory in a mouse model of cancer. After injections of commercially available pancreatic enzyme trypsin, the tumor in a treated mouse was much smaller than that in an untreated control. Over several years, a number of physicians in the UK and US injected enzyme preparations with some remarkable success stories. As a result, the physicians began writing letters to the editor summarizing their clinical cases, such as Medical Record in the early 1900’s.

For example, Dr Campbell wrote about a 56-year-old male with a malignant left tonsil the size of a hen’s egg, experiencing left facial paralysis and constant pain. After periodic injections for a month, the infiltrations in the tongue and tonsil were greatly decreased, pain free and felt well. A second example, Dr Oldfield, reported a 65-year-old male with an abdominal tumor with secondary metastases in the stomach, full of solid tumor and in great pain. After daily injections for 3 months, the patient was reported to eat and sleep well, returned to a normal weight. Dr Outfield concluded that "No-one…can doubt the immense improvement that has taken place." However, mixed results in the early stages of treatment were observed and attributed by Beard to the wide variation in the quality of enzymes of available enzymes at the time.

Over the years, there have been further clinical cases investigated into the use of enzymes as a way to treat cancer. Of particular note was the work undertaken by molecular biologist from Bucknell University, Dr Josef Novak and a retired Czech oncologist, Dr Frantisek Trnka. Drs Novak and Trnka undertook extensive laboratory work in the late ‘90s and 2000s, publishing their work in the journal Anticancer Research in the mid 2000s, where they first proposed that the enzyme extracts as recommended by Beard, must be used in the "proenzyme" form to ensure their selective activation at the tumor site. They also undertook clinical research, administering a proenzyme treatment via a suppository formulation to 20 late-stage cancer patients, with a range of malignancies, of which 10 survived, ranging from 8 months to 10 years, with minimal, or non-existent side effects normally seen with current standard therapies. The conclusion of Drs Novak and Trnka from this work was the discovery "that proenzyme therapy mandated first by John Beard nearly one hundred years ago, shows remarkable selective effects that result in growth inhibition of tumor cells with metastatic potential."

As a result of the clinical evidence observed throughout the years, Dr Kenyon decided to undertake his own investigation motivated by the condition of a number of late-stage cancer patients he treated in his clinical practice at The Dove Clinic, in Hampshire, UK. Consequently, the clinical efficacy of a suppository formulation containing pancreatic proenzymes was evaluated in the context of a UK Pharmaceuticals Special Scheme and results published in a peer reviewed journal, Scientific Reports. Clinical effects were studied in 46 patients with advanced metastatic cancers of different origin (prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancer and melanoma) after treatment with a rectal formulation consisting of pancreatic 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. In order to assess the therapeutic activity of rectal administration, overall survival of patients under treatment was compared to the life expectancy assigned to a patient prior to treatment start. Nineteen (19) from 46 patients (41.3%) with advanced malignant diseases, most of them suffering from metastases, had a survival time significantly longer than their expected, in fact, for the whole set of cancer types, mean survival (9.0 months) was significantly higher than mean life expectancy (5.6 months). Although the number of patients per cancer indication was naturally quite low, 3 out of 8 patients with prostate cancer and 5 out of 11 patients with gastrointestinal cancers appeared to particularly benefit from the treatment with the proenzyme suppositories.

"As a result of my research over the last 15 years, as well as the clinical evidence over the last 100 years, proenzyme therapy can have a meaningful and long-lasting clinical benefit on patients suffering from solid tumors, but without the side effects associated with standard therapies, which is simply compelling," said Dr Kenyon. "Since the pioneering work undertaken by Professor John Beard and his medical colleagues, in the early 1900’s, their approach was ahead of their time, but since then, our understanding of tumor cell biology means we have elucidated how the activated enzymes works against solid tumors and in particular, cancer stem cells, optimized the formulation and its clinical effects, and developed a product candidate to pharmaceutical standard which can be administered by I.V. injection to maximize the exposure at the tumor site. My scientific and clinical research team at Propanc Biopharma are preparing to take our lead product candidate, PRP, into a world first, Phase I, First-In-Human study in advanced cancer patients suffering from solid tumors. The 100-year history of enzyme therapy gives me confidence we are on the right pathway with an exciting approach for the treatment and prevention of metastatic cancer from solid tumors, which is the main cause of patient death for sufferers."

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.

Aura Biosciences Announces Publication of Preclinical Data of the Combination of VDCs with Immune Checkpoint Inhibitors at the 2022 ASCO Annual Meeting

On May 26, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors. AU-011 is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer (NMIBC) (Press release, Aura Biosciences, MAY 26, 2022, View Source [SID1234615130]). The abstract has been published online as part of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 3-7, 2022, in Chicago, IL.

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"These data show that AU-011, a first in class VDC, in combination with immune checkpoint inhibition is effective against both primary tumors and distant metastases in a preclinical model, demonstrating its clinical potential for the treatment of choroidal melanoma and certain other cancers. This includes the potential to treat both the primary tumor in early-stage disease and to treat metastatic lesions, whether clinically present or not at initial treatment." "We are so appreciative of our collaboration with the scientists and clinicians at Leiden University Medical Center in The Netherlands, one of the top European clinical and research centers in ocular oncology," said Dr. Cadmus Rich, Chief Medical officer and Head of R&D of Aura Biosciences.

"It is promising to see the results of these experiments, as we have shown that in murine models, the previously observed positive effects of AU-011 as a single agent could be enhanced with the addition of immune checkpoint inhibitors," said Dr. Martine Jager, Professor of Ophthalmology at Leiden University. "In addition, we show that not only the primary tumor, but also distant lesions, are targeted. Our survival data in murine models show that the combination of VDCs with immune checkpoint inhibitors is a potential new treatment modality that may generate a potent targeted cytotoxicity on local tumors as well as potential metastases."

Abstract details:

Title: A novel Virus-Like-Drug Conjugate (VDC) in combination with immune checkpoint inhibitors for the treatment of primary tumors and distant metastasis
Authors: Ruben Victor Huis in ‘t Veld1, Sen Ma1, Rhonda Kines2, Anneli Savinainen2, Cadmus Collins Rich2, Ferry Ossendorp3, Martine Jager1; 1Leiden University Medical Center, Leiden, Netherlands; 2Aura Biosciences, Cambridge, MA; 3Department of Immunology, Leiden University Medical Center, Leiden, Netherlands
Session Category: Publication – 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings
Session Title: Developmental Therapeutics – Immunotherapy
Abstract Number: e14544
The published abstract is available here.

Leap Therapeutics to Present Initial Data from the Investigator-Sponsored Study of DKN-01 Plus Docetaxel in Patients with Prostate Cancer at the 2022 ASCO Annual Meeting

On May 26, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) will be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7, 2022 (Press release, Leap Therapeutics, MAY 26, 2022, View Source [SID1234615146]).

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"As the initial data show, DKN-01 in combination with docetaxel is a promising therapy option for prostate cancer patients, particularly for those with aggressive variant prostate cancer," said David Wise, MD, PhD, Medical Oncologist at Perlmutter Cancer Center, NYU Langone Health and principal investigator on the study. "DKN-01, as a monotherapy and in combination with docetaxel, was well tolerated by patients, with partial responses in all of the patients treated with DKN-01 in combination with docetaxel who had measurable disease. Accrual into the Phase 2 portion of this study is ongoing, alongside preclinical and correlative studies aiming to further investigate the mechanism of action of DKN-01 in prostate cancer and to identify the best clinical path forward."

Key Initial Findings from the Investigator-Sponsored Phase 1b/2a Clinical Trial:

Data that will be presented at ASCO (Free ASCO Whitepaper) is from the completed Phase 1 portion of the study. Thirteen patients were enrolled, with 7 patients in the DKN-01 monotherapy cohort and 6 patients in the DKN-01 plus docetaxel combination cohort. The primary endpoint of the Phase 1 dose escalation cohorts was safety, characterized by dose-limiting toxicity (DLT). The study also aims to study correlations between DKK1 expression and tumor genetics, histology and anti-tumor activity.

Highlights from the data include:

No DLTs were observed at DKN-01 300mg or 600mg dose levels as monotherapy or in combination with docetaxel, and no treatment-related adverse events occurred in either cohort
No partial responses (PR) were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients
In the combination cohort, all 5 evaluable patients had a PR as measured by RECIST (3 confirmed, 2 unconfirmed) and by PSA50
Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer (AVPC)
Further accrual into the phase 2 part of this study is ongoing, alongside preclinical and correlative studies aimed at investigating the mechanism of action of DKN-01 in prostate cancer.

Immunocore announces upcoming presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 26, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune, and infectious diseases reported it will deliver an oral presentation and two poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from June 3 – 7, 2022 (Press release, Immunocore, MAY 26, 2022, View Source [SID1234615163]).

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CLINICAL SCIENCE SYMPOSIUM

Title: Updated overall survival (OS) data from the phase 1b study of tebentafusp (tebe) as monotherapy or combination therapy with durvalumab (durva) and/or tremelimumab (treme) in metastatic cutaneous melanoma (mCM)

Presenter: Mark Middleton
Date and Time: June 5, 2022; 9:45 a.m. CDT
Session: Clinical Science Symposium: Bispecifics: Are two better than one?
Abstract ID: 104
POSTER PRESENTATIONS & ABSTRACTS

Title: Treatment with tebentafusp beyond radiographic progressive disease (PD) in metastatic uveal melanoma (mUM)

Presenter: Ryan Sullivan
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9585
Title: Analysis of the effect of systemic corticosteroids on survival from tebentafusp in a phase 3 trial of metastatic uveal melanoma

Presenter: Alexandra Ikeguchi
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9584
Title: Overall survival (OS) in metastatic uveal melanoma: A summary of recent prospective trials

Author: Josep M. Piulats
Publication only
Presentations and posters will be available for registered attendees on the ASCO (Free ASCO Whitepaper) website from June 3-7, 2022.

About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.