VerdePharmHealth Signs Exclusive Partnership Agreement with HAI Health for Oncologist-Formulated Medical Cannabis Product Line

On June 23, 2020 VerdePharmHealth reported the signing of an exclusive national agreement with HAI Health for the HealthyDose product line formulated by a highly respected oncologist, Dr. Alberto Bessudo (Press release, VerdePharmHealth, JUN 23, 2020, View Source [SID1234561416]).

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"There is growing evidence that medical cannabis may be effective in helping patients manage certain types of cancers at various stages, in conjunction with and as an alternative to traditional medical treatments. Medical cannabis may also be effective in managing the side effects of cancer therapies and the symptoms of the disease. Unfortunately, most people wait too long after diagnosis to begin cannabis therapies. They begin looking for alternative therapy when conventional treatments haven’t worked, and the disease is already advanced, sometimes with a terminal diagnosis," said Dr. Alberto Bessudo, founder & chief executive officer at HAI Health. "After careful consideration and diligence, we selected VerdePharmHealth given our alignment of mission and values for patient care, their solid commitment towards innovation in integrative medicine, and robust offering to healthcare providers and their patients."

"Dr. Alberto Bessudo has been on the cutting edge of medicinal cannabis in patient care, developing integrative plans with cannabinoids targeted towards specific symptoms, without the numerous side effects of conventional pharmaceuticals and procedures. Dr. Bessudo and his team have designed synergistic formulations, which are comprised of curated ingredients that are specifically designed to work and support the body’s own functions and accelerate health," said Dr, Ralph Boccia, oncologist, board member, & medical director at VerdePharmHealth. "As part of their ongoing commitment to quality medical cannabis products, the ingredients are grown without pesticides or herbicides, and several in the product line are organic. Furthermore, several tests are conducted, including testing for heavy metals, pesticides, mold and yeast, microbes, and cannabinoid potency, instilling a higher level of confidence for our provider member network and their patients."

Both companies will further partner around systematic, structured real-world observational studies to better understand and improve the appropriate use of cannabinoids, support cost of care, improve quality of life, and treatment optimization paradigms, with HealthyDose Clinical Premium product made available through HAI Health and the clinical research platform and services, decision-support tools, patient engagement app, and data analytics provided by VerdePharmHealth.

ITM and POINT Biopharma Sign Two Supply Agreements for No-carrier-added Lutetium-177

On June 23, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and POINT Biopharma Inc., a clinical oncology company, reported that they have signed two supply agreements for the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu) / EndolucinBeta to support clinical and commercial supply of PNT2002, a 177Lu-PSMA radiopharmaceutical for prostate cancer treatment (Press release, ITM Isotopen Technologien Munchen, JUN 23, 2020, View Source [SID1234561415]).

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Under the terms of the first agreement, ITM has partnered with POINT Biopharma for their clinical development of PNT2002, a 177Lu-PSMA radiopharmaceutical for the treatment of metastatic castrate-resistant prostate cancer. PNT2002 is a radiopharmaceutical candidate with an excellent profile and will be investigated in a phase III clinical trial launching with the enrollment of patients in the fourth quarter of 2020. Additionally, both parties signed a long-term commercial agreement for the supply of n.c.a. 177Lu following the marketing approval of PNT2002. Further terms of the agreements are not disclosed.

ITM’s no-carrier-added Lutetium-177 (brand name EndolucinBeta) is a radiopharmaceutical precursor used for Targeted Radionuclide Therapy in Precision Oncology. ITM manufactures n.c.a. 177Lu for development partnerships, distribution to clinics worldwide, and its own growing Precision Oncology Pipeline. N.c.a. 177Lu has marketing authorization in the EU and DMF in the US. Radiolabeled to disease-specific targeting molecules like antibodies or peptides, the tumor tissue is precisely targeted and destroyed by cytotoxic doses of medium-energy ionizing radiation. ITM has developed a unique methodology to produce a highly pure form of Lutetium-177, containing no metastable Lutetium-177m.

POINT Biopharma has a growing portfolio of best in class pharmaceutical assets and is working to revolutionize radiopharmaceutical drug development and commercialization for cancer treatment. The company specializes in radioligand therapies and is committed to bringing them to market quickly. The company anticipates its clinical trial programs to commence in 2020.

"ITM has a proven track record of exceeding market demands. Choosing the right partner, with significant capacity, is critical to meeting the needs of our future patients", said Dr Joe McCann, CEO of POINT Biopharma. "We look forward to using these radioisotopes for our upcoming products including in our phase three prostate cancer trial starting this year," Dr McCann added.

Steffen Schuster, CEO of ITM, commented: "Like ITM, POINT Biopharma is eager to improve treatment outcomes and quality of life of cancer patients with Targeted Radionuclide Therapies. We are very pleased to establish this long-term alliance making significant contribution to innovative and promising therapies for cancer patients worldwide."

Century Therapeutics Announces Acquisition of Empirica Therapeutics

On June 23, 2020 Century Therapeutics reported its acquisition of Empirica Therapeutics to leverage its iPSC-derived allogeneic cell therapies against glioblastoma (GBM) (Press release, Century Therapeutics, JUN 23, 2020, View Source [SID1234561414]).

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"We are pleased to welcome the Empirica team to the Century family. Their deep expertise and unique capabilities will allow us to accelerate efforts to develop iPSC derived immune effector cell products designed to treat and potentially cure brain cancer," said Lalo Flores, PhD, Chief Executive Officer of Century Therapeutics. "GBM is a particularly aggressive, often treatment-resistant form of adult brain cancer with an average survival time of under two years. Together, we are in a stronger position to develop potentially curative cell therapies for this devastating disease."

Empirica Therapeutics was founded by Dr. Sheila Singh, MD, PhD, Professor of Surgery and Biochemistry and chief pediatric neurosurgeon at McMaster Children’s Hospital, and Dr. Jason Moffat, PhD, Professor of Molecular Genetics at the University of Toronto and an expert in functional genomics and gene-editing platforms. The company’s science is based on a powerful integrative multi-omics platform, combined with its unique patient-derived, therapy-adapted models of recurrent GBM, that has led to the discovery and validation of novel brain tumor targets. Empirica’s cutting edge preclinical models of recurrent GBM, have demonstrated the potential of CAR-T cell therapy in GBM, as published in a May 2020 Cell Stem Cell paper.

"Our team is excited to become part of Century Therapeutics, whose iPSC-derived allogeneic cell therapies show immense potential for treating solid as well as hematologic malignancies," said Dr. Singh. Dr. Singh served as Empirica’s CEO after co-founding the company with Chief Scientific Officer Dr. Moffat. "We look forward to combining our unique patient-based cancer models with Century’s platform to create promising treatments for the patients who need them most," Singh said.

Janelle Anderson, PhD, Chief Strategy Officer at Century Therapeutics, shepherded the deal forming the subsidiary, which will be known as Century Therapeutics Canada and based in Hamilton, Ontario. Financial terms of the deal have not been disclosed.

AngioDynamics to Report Fiscal 2020 Fourth Quarter and Full-Year Financial Results on July 16, 2020

On June 23, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the fourth quarter and fiscal year 2020 before the market open on Thursday, July 16, 2020 (Press release, AngioDynamics, JUN 23, 2020, View Source [SID1234561413]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13705722.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, July 16, 2020, until 11:59 p.m. ET on Thursday, July 23, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13705722.

RubrYc Therapeutics To Present at AACR Virtual Conference

On June 23, 2020 RubrYc Therapeutics, Inc., a pre-clinical biotherapeutics company developing epitope selective therapies to improve outcomes for cancer and serious autoimmune disease patients, reported the presentation of discovery and pre-clinical data from their lead program RTX-003, a CD25 targeted monoclonal antibody for selective depletion of regulatory T cells (Tregs) in the tumor microenvironment (TME) (Press release, RubrYc Therapeutics, JUN 23, 2020, View Source [SID1234561412]).

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A poster titled "Discovery of Epitope-Selective Anti-CD25 Targeting Therapeutic Antibodies for Effective Treg Cell Depletion in Cancer using a Machine Learning-Based Platform" will be presented by Dr. Phung Gip, Director of Biology, at the AACR (Free AACR Whitepaper) Virtual Conference on June 22nd (Abstract #6055).

RubrYc’s technology addresses one key limitation in early antibody discovery, which is immunodominance – an evolutionary bias toward specific epitopes that steer antibody selection away from potentially high-efficacy epitopes. An integrated computational and laboratory approach to antibody discovery enables us to build focused epitope embodiments of structural epitopes. These epitope embodiments, called Meso-scale Engineered Molecules (MEMs), are used in antibody selections to steer hits towards the intended epitopes. In our lead program RTX-003, we target CD25 (IL2Rα) which is highly expressed on regulatory T-cells (Tregs) that drive immunosuppression in the TME. Depletion of Tregs can restore anti-tumor T effector (Teff) function in the TME by increasing the Teff/Treg ratio, especially when combined with checkpoint-inhibitors. Using our epitope-selective antibody discovery platform, we built MEMs that embody eight CD25 structural epitopes outside the CD25:IL-2 interface. Through both immunization and in vitro selection based approaches, several medium to high-affinity (median KD = 25 nM) anti-CD25 antibodies from each of the eight intended CD25 epitopes were identified and confirmed to be on prescribed epitope by cross-blocking assays and in-epitope alanine mutations. Several conventional- and epitope-selective anti-CD25 clones were converted to human IgG1 and tested in in vitro assays. As a result, these antibodies bound specifically to CD25+ cells, preserve IL-2 signaling via pSTAT5 assays and elicited potent ADCC activity using human effector cells, and had in vivo efficacy superior to benchmark antibodies. These studies demonstrate that our integrated computational and laboratory platform improves the productivity of epitope-selective antibody discovery and produces clones with improved biological function and therapeutic potential.

Dr. Isaac Bright, CEO, said, "The in vivo results from our lead program RTX-003, are the first demonstration that RubrYc Discovery Engine can yield highly epitope-specific monoclonal antibodies with enhanced biological function. These mAbs can be used for internal or partnered programs in monospecific and bispecific antibodies, antibody drug conjugates or cellular therapies. We look forward to refining the platform and bolstering our development capabilities for accelerated discovery and development of epitope-specific therapeutics for patients in need."