On June 16, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it has expanded its program for the manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for its lead drug candidate, Oncoprex immunogene therapy, by entering into a new agreement with manufacturing partner Aldevron, LLC, ("Aldevron") (Press release, Genprex, JUN 16, 2020, View Source [SID1234561135]). The new agreement provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. The Company’s manufacturing at this scale should also result in significantly lower costs per unit of product manufactured due to economies of scale.

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Genprex’s upcoming clinical trials include a Phase I/II trial of Oncoprex combined with osimertinib (marketed by AstraZeneca as Tagrisso) for non-small cell lung cancer (NSCLC), which received Fast Track Designation in January 2020 and is expected to be initiated in early 2021. A clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck as Keytruda) in NSCLC is also planned.

"We are pleased with continued progress in the scale-up of our manufacturing processes. This new agreement with Aldevron increases our manufacturing capabilities in support of our clinical trials utilizing Oncoprex immunogene therapy in combination with targeted therapies and immunotherapies against lung cancer," said Rodney Varner, Chairman and Chief Executive Officer of Genprex.

"Our team is excited about the expansion of our manufacturing agreement and elevation of our long-standing relationship with Genprex," said Michelle Berg, President of GMP Nucleic Acids at Aldevron. "Aldevron’s GMP facility and campus buildout ensures we can meet the future manufacturing demands of companies experiencing significant growth such as Genprex; thereby enabling our ultimate goal of impacting the lives of patients."

Oncoprex consists of TUSC2 plasmid DNA encapsulated in a lipid nanoparticle. The TUSC2 gene is the active agent in Oncoprex. Data indicate that the resultant product when transfected into cancer cells both induces cell signaling that triggers programmed cell death and modulates the immune system so that the cancer cells are more susceptible to treatment.

On June 16, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) ("Lantheus" or the "Company"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents reported that, Lantheus’ stockholders voted to approve the issuance of common stock related to the Company’s proposed merger with Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer (Press release, Lantheus Medical Imaging, JUN 16, 2020, View Source [SID1234561151]).

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Lantheus and Progenics previously entered into an Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Merger Agreement"), by and among Progenics, Lantheus and Plato Merger Sub, Inc., a wholly-owned subsidiary of Lantheus ("Merger Sub"). Pursuant to the Merger Agreement, Merger Sub will be merged with and into Progenics (the "merger"), with Progenics surviving the merger as a wholly-owned subsidiary of Lantheus.

Approximately 99% of the total votes cast by holders of Lantheus common stock were voted in favor of the share issuance proposal (excluding abstentions), representing approximately 87% of Lantheus’ shares issued and outstanding as of the close of business on May 12, 2020, the record date.

Mary Anne Heino, President and Chief Executive Officer of the Company, said, "We are very excited that our stockholders have approved the share issuance in connection with the Progenics merger and that the Progenics stockholders also approved the transaction earlier today. We believe that the combined company will offer a diversified portfolio of precision diagnostics, radiopharmaceutical therapeutics, digital solutions and pharma service offerings, delivering value across the patient health care continuum."

The merger remains subject to customary closing conditions. The parties expect to close the merger on or about June 19, 2020.

On June 16, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported it has entered into a master services agreement ("MSA") with PJSC Pharmsynthez to advance the development of the XCART technology for B-cell malignancies (Press release, Xenetic Biosciences, JUN 16, 2020, View Source [SID1234561137]). Under the terms of the MSA, Pharmsynthez will act as the primary contract research organization ("CRO") to assist in managing the collaboration with multiple academic institutions in Russia and Belarus.

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The initial stage of the collaboration will include an exploratory trial to evaluate and refine the XCART front-end process of target identification, screening and lead characterization, in a real-world clinical setting. This exploratory stage entails enrollment of NHL patients, obtaining tumor biopsies and then refining the XCART front-end methods. Subsequently the collaboration may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-cells. If successful, the Company has the potential to expand the clinical study component to dose a number of NHL patients in a Phase 1 dosing study.

"This agreement represents another significant milestone for the Company and provides access to a number of world-renowned academic institutions, researchers and clinical investigators in the area of oncology and hematology. Additionally, we are excited to again be working with the Shemyakin and Ovchinnikov Institute as they are intimately familiar with the XCART platform having been one of the primary inventors," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Coupled with our recently announced collaboration with Scripps Research, we believe we are well-positioned to execute on our strategic development plan as we work to advance this innovative technology, which we believe has the potential to address a significant unmet need in NHL."

Alexander Gabibov, academic, Head of the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS, commented, "The XCART platform was thoughtfully designed to target personalized, patient-specific tumor neoantigens and has demonstrated encouraging potential. Our team is uniquely positioned to carry out this important foundational work and, through this collaboration is able to leverage the additional expertise from the Belarus academic institutions. We are pleased to continue our collaboration with Xenetic through this agreement and look forward to helping to advance the XCART platform towards first-in-human dosing."

The XCART technology platform was designed to utilize an established screening technique to identify polypeptide domains that selectively bind to the unique B-cell receptor ("BCR") on the surface of an individual lymphoma patient’s malignant B-cell clones. This BCR-selective targeting domain is engineered into the antigen-binding domain of a chimeric antigen receptor ("CAR"), creating the possibility of a CAR T treatment that should only recognize a given patient’s malignant B-cell clones. An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

On June 16, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020 at 9:00 am ET (Press release, Scholar Rock, JUN 16, 2020, View Source [SID1234561152]).

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A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On June 16, 2020 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H and SSEA-4), reported that data highlighting the role of Globo H antigen in cancer survival and its prevalence in different tumor types, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II from June 22–24, 2020 (Press release, OBI Pharma, JUN 16, 2020, View Source [SID1234561121]).

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"We are excited to share that we have demonstrated Globo H antigens (GH) may play an important role in cancer survival, both in vitro and in vivo. Furthermore, anti-GH antibody treatment can abolish the GH effects and overcome the erlotinib resistance in lung cancer cells in vivo. We are also pleased to share our recent findings on the presence of GH-positive immune cells in the intra- or peri-tumor region using an IHC assay approved by the FDA for investigational use, which suggest GH-ceramide may suppress normal immune functions. The heterogeneous expression of GH among different molecular subtypes of cancer cells may provide a biomarker in the selection of patients for GH-directed therapies," stated Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma.

Session PO ET04.02 Identification of molecular targets 2
Title: The role of Globo H in cancer cell survival
Presenter: Tzer-Min Kuo, PhD, et. al., OBI Pharma, Inc., Taipei, Taiwan
Virtual Meeting II: E-Posters Session: Poster 2934/8
Date/Time: June 22, 2020 from 9:00 AM – 6 PM EST
View Source!/9045/presentation/1616

Session PO ET04.02 Identification of molecular targets 2
Title: The prevalence of Globo H in different tumor types: Breast, pancreatic, lung, gastric, colorectal, liver, and esophageal cancers
Presenter: I-Ju Chen, PhD, et. al., OBI Pharma, Inc. Taipei, Taiwan
Virtual Meeting II: E-Posters Session: Poster 2946/20
Date/Time: June 22, 2020 from 9:00 AM – 6 PM EST
View Source!/9045/presentation/1631

The above poster presentations will be available online at www.obipharma.com on June 22, 2020.