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."

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.

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.

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."

On June 23, 2020 Kadmon Holdings, Inc. (NYSE:KDMN) reported that the first patient has been dosed in a Phase 1 clinical trial evaluating KD033, an anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors (Press release, Kadmon, JUN 23, 2020, View Source [SID1234561410]). KD033 is a novel immunotherapy designed to stimulate innate and adaptive immune responses directed to the tumor microenvironment.

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"We are pleased to initiate clinical development of KD033, which has demonstrated encouraging efficacy and durability in a variety of tumor types in preclinical models," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "By directing the anti-tumor activity of IL-15 to the tumor microenvironment, KD033 has the potential to stimulate patients’ immune responses to fight cancer while avoiding systemic toxicities. This study initiation represents an important milestone for Kadmon and our platform of IL-15-containing fusion proteins. We look forward to providing further updates on this trial as they become available."

Recombinant IL-15 (rIL-15) is an immunostimulatory cytokine that has demonstrated clinical activity in the treatment of several cancers. rIL-15 expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) cells and memory T cells, without expanding immunosuppressive Treg cells, allowing for robust and durable anti-tumor responses. Clinical use of rIL-15 has been limited by its short half-life and narrow therapeutic window. To address these challenges, Kadmon has developed KD033, which is designed to direct IL-15 activity to the tumor microenvironment of PD-L1-expressing tumors and to achieve a greater therapeutic window. KD033 is designed to promote long-lasting efficacy while reducing systemic exposure of IL-15 to potentially increase safety and tolerability.

In preclinical studies, a single dose of KD033 demonstrated robust in vivo pharmacological activity and inhibited tumor growth across multiple syngeneic mouse models. KD033 also induced T-cell memory, resulting in mice that remained tumor-free following several tumor re-challenges. KD033 demonstrated significant tumor inhibition in animal models that are resistant to approved immunotherapies such as PD-L1, PD-1 or CTLA-4 antibodies.

About the KD033-101 Clinical Trial

KD033-101 is a Phase 1, open-label, dose-escalation and dose-expansion study investigating the safety and efficacy of KD033 in patients with metastatic or locally advanced solid tumors. The dose-escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) of KD033. The dose-expansion phase of the study will enroll approximately 15 patients who have progressed or are refractory to programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor therapy to assess safety, efficacy and determine the recommended Phase 2 dose (RP2D) of KD033.

About KD033

KD033 is a novel immunotherapy developed in-house and is fully owned by Kadmon. KD033 combines an anti-PD-L1 antibody with IL-15, a cytokine that expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) and memory T cells, to potentially induce durable responses and inhibit tumor growth. The anti-PD-L1 antibody directs IL-15 activity to the tumor microenvironment, limiting systemic exposure of IL-15 to potentially increase safety and tolerability. KD033 was well tolerated in GLP toxicology studies at clinically relevant doses. KD033 process development and manufacturing was completed through a successful collaboration with Wuxi Biologics and exhibited desired manufacturability and stability criteria.

KD033 is the most advanced candidate from Kadmon’s IL-15 fusion protein platform. The Company is developing a portfolio of therapies combining IL-15 with select antibodies for the treatment of cancer.