On January 21, 2020 SHINE Medical Technologies LLC, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and GE Healthcare reported the production of patient dose quantities of the therapeutic isotope lutetium-177 (Lu-177) (Press release, Shine Medical Technologies, JAN 21, 2020, View Source;pk_kwd=shine-iocb-deliver-lu-177-doses-to-ge [SID1234553393]). The lot passed GE Healthcare’s quality control testing, including internationally recognized radionuclide purity (RNP) standards. The delivery of Lu-177 in this quantity and purity demonstrates the suitability of the IOCB technology for Lu-177 production. It is a major step toward commercial production of the therapeutic isotope by SHINE.

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Last May, SHINE entered an agreement with IOCB Prague that granted the company exclusive access to IOCB Prague’s novel technology, which is used to separate lutetium from enriched ytterbium targets. The technology enabled the production of the non-carrier-added (nca) Lu‑177 supplied to GE Healthcare. The isotope was produced in collaboration with the Nuclear Physics Institute in Czechia. The Nuclear Physics Institute and IOCB Prague are members of the Czech Academy of Sciences.

Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers. The isotope is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule.

"Non-carrier-added Lu-177 at the dosage and purity delivered to us bodes well for the potential to provide physicians and patients with a vital, highly effective therapeutic isotope," said Charles Shanks, GE Healthcare’s principal engineer, Life Sciences. "Lu-177 is one of the key drivers of growth in the medical isotope market. It represents a major opportunity to better serve the market."

"The delivery of patient dose quantities of Lu-177 to GE Healthcare is a significant step forward for SHINE Therapeutics," said Katrina Pitas, the vice president and general manager of SHINE Therapeutics. "Together with our collaborators from the Czech Academy of Sciences, we have demonstrated the capability to produce Lu-177 at a very high standard of purity. We look forward to continuing to work with GE Healthcare to move Lu-177 closer to commercialization and the patients who will benefit from it most."

"Producing clinically relevant doses of any therapeutic radionuclide is not easy and we have demonstrated that our technology can meet the challenge for nca Lu-177," said Dr. Miloslav Polasek of IOCB Prague. "I am very grateful to the SHINE, IOCB and NPI teams for the progress we are making together."

On January 21, 2020 Cell>Point reported, based on its sponsored chelator and therapeutic research conducted at the University of Texas M.D. Anderson Cancer Center on Platinum-Oncardia and 177Lu-Oncardia, and the positive results of its lung cancer imaging trials with 99mTc-Oncardia, that it will be moving forward with these two intra-nuclear therapeutics expanding its focus in theranostic medicine (Press release, CELLPOINT DIAGNOSTICS, JAN 21, 2020, View Source [SID1234553390]). The company believes that Oncardia (a proprietary organic formulation of ethylenedicysteine-glucosamine), which functions as an intra-nuclear compound, will provide an effective means to deliver highly targeted low dose therapy with minimal impact to collateral healthy cells. The research focus will involve studies to treat relapsed aggressive diffuse type B-cell lymphoma and lung cancer. Other cancer targets will likely eventuate from these initial studies.

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The research objective is to target cancers with Platinum or 177Lu (depending on the type of cancer) by delivering the therapy to the nucleus of the diseased cell to cause cell apoptosis. The cell nucleus contains the DNA and thus controls growth and reproduction. Oncardia targets the nucleus. The stability of Oncardia allows it to be used with a range of therapeutic isotopes and cold metals. Based on the affinity of hyperactive cancer cells to maintain metabolic activity using glucose or the transition of cells being depleted of glucose, Oncardia based therapeutic compounds should be effective in the treatment of a wide range of cancers.

Theranostic personalized medicine involves the combination of therapy and imaging to improve the detection, staging, treatment and assessment of the patient’s response to treatment. No two patients are identical and their responses to treatment for the same type of cancer will not necessarily be the same. Medical management in oncology is evolving from a generalized approach in the treatment of many forms of cancer to a more patient centric approach. Theranostic medicine should play a central role in this transformation.

On January 21, 2020 Diaprost entered into an exclusive Research and Option Agreement with a Top 10 Pharmaceutical company strategic partner in October 2017 (Press release, Diaprost, JAN 21, 2020, View Source [SID1234553389]). Diaprost now announces that its strategic partner has exercised its option to acquire rights to its h11B6 antibody.

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An upfront payment and research funding has already been paid and an early-stage clinical trial has been initiated. In payments made prior to option exercise, Diaprost received $13M. The option fee and potential future payments, including commercial milestones, for its h11B6 antibody for prostate cancer may be up to $90 million. No royalties are payable.

Diaprost announced that its partner has exercised its option, under which its partner acquires Diaprost’s patents and assets for antibody h11B6, and its associated target. H11B6 has advanced to clinical development for prostate cancer, the most common cancer in men and with a high unmet medical need. Work completed since October 2017 has successfully demonstrated the potential of the therapy and the partner now wishes to gain full rights.

"We believe the early exercise of the Option by our strategic partner shows the potential of both Diaprost and the h11B6 program," said Johan Drott, CEO of Diaprost. "We believe going forward, h11B6 has the potential to be an important new oncology therapy for patients."

On January 21, 2020 LUNGevity Foundation reported that is partnering for the second time with patient-led group ALK Positive to support the ALK-positive Lung Cancer Research Award Program (Press release, LUNGevity Foundation, JAN 21, 2020, View Source [SID1234553388]). ALK Positive members are the first group of ALK-positive patients to influence the direction of research into their mutation that may, one day, save their lives. This year, the group will fund at least two research awards up to a total of $1 million over two years—their largest funding to date. The ultimate goal of the research is to transform ALK-positive lung cancer into a chronic or curable condition.

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"ALK Positive is delighted to partner once more with LUNGevity. Our partnership with LUNGevity allows us to use a rigorous selection process and access experts to help us choose the research most likely to save the lives of patients," notes Dr. Colin Barton, ALK-positive patient/survivor since 2016 and chair of ALK Positive’s Medical and Pharmaceutical Advocacy Committee. "This $1 million research award program is our biggest to date. The members of ALK Positive have made amazing efforts to raise the funds for this award program. Currently, there is no known cure for this type of cancer in the advanced stage."

There are two paths to receive a 2020 Lung Cancer Research Award:

Transformational Award: This award will be funded up to $250,000–$500,000 over two years. Research in this award may include projects that incorporate patient samples.
Clinical Trial Innovation Award: This award will be funded up to $750,000 over two years. Research in this award includes clinical trials.
ALK Positive is a group of 1,900+ lung cancer patients and caregivers in 50+ countries. ALK-positive lung tumors have a cancer-causing rearrangement of the anaplastic lymphoma kinase (ALK) gene. ALK-positive patients account for approximately 5% of those with non-small cell lung cancer.

ALK Positive members raise funds for the award program and patients have the ability to contribute their own tissue and data directly to the funded project, as needed. Research projects are expected to have a direct impact on the outcomes of patients with ALK-positive lung cancer.

"We are excited to solicit another round of high-quality research proposals that will help to expand treatment options for ALK-positive lung cancer patients," says Dr. Upal Basu Roy, Vice President of Research at LUNGevity Foundation. "Members of the ALK Positive group have not only fundraised, but will also be integral in the selection of these research projects. Awardees from the initial awards, given in 2018, have already made significant progress."

The deadline to submit a letter of intent for the ALK-positive Lung Cancer Research Award is Friday, February 14, 2020. The award announcement will be made in summer 2020. For more information about this award, visit www.LUNGevity.org/ALK-RFA.

On January 21, 2020 OncoHost, global leader in host response profiling for improved personalized cancer therapy, together with its partner RayBiotech, a leading life sciences company developing high-throughput protein detection technologies for biomarker discovery initiatives, reported the companies have been awarded a $1 million grant from the Israel-U.S (Press release, OncoHost, JAN 21, 2020, View Source [SID1234553387]). Binational Industrial Research and Development (BIRD) Foundation. The BIRD Foundation supports cooperation between U.S. and Israeli companies for developing joint products or technologies in a wide range of technology sectors that are of mutual benefit to the U.S. and Israel.

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The grant will support OncoHost and RayBiotech’s combined development and clinical validation of host response testing for the early prediction of treatment responsiveness in non-small-cell lung carcinoma (NSCLC) patients undergoing immunotherapy. It will also be used to further develop and implement an automated slide assistance platform (ASAP) for reducing the time of large-scale protein processing as part of a new joint service: host response enrichment for pharmaceutical companies. Both of these developments will contribute towards the enablement of personalized cancer therapy for patients.

"The BIRD Foundation Board of Governors selected to support the project between OncoHost and RayBiotech on their mission to counteract therapy resistance in order to improve cancer treatment response," said Dr. Eitan Yudilevich, Executive Director of the BIRD Foundation. "This joint project contains a high level of innovation and knowledge that could benefit the treatment of lung cancer patients."

"The grant and support from the BIRD Foundation represents an important milestone for OncoHost," said Dr. Ofer Sharon, CEO of OncoHost. "We are committed to develop a system for the early identification of resistance to cancer therapy in patients treated with immune checkpoint inhibitors (ICIs), as well as a discovery tool for new drug targets. Our unique approach of host response analysis represents a significant step forward for precision oncology and personalized cancer treatment."

OncoHost’s host response profiling platform PROphet leverages proprietary machine learning and bioinformatics technology, and will be used together with RayBiotech’s high-throughput protein analysis platform to identify treatment resistance in cancer patients.

"This partnership perfectly aligns with our mission to advance precision medicine," said Dr. Ray Huang, CEO of RayBiotech. "Antibody array-based profiling of patient samples has proven a critical approach to informing personalized therapies and biomarker discovery studies, particularly in cancer research. We are eager to see how the PROphet platform can harness the power of high-throughput protein detection."