On September 19, 2019 Y-Trap, Inc. reported that it has signed a collaboration and license agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, for the exclusive development of multiple specific antibody-ligand traps for cancer immunotherapy (Press release, Y-Trap, SEP 19, 2019, View Source [SID1234632231]).

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The collaboration leverages Y-Trap’s proprietary platform of multifunctional antibody-ligand traps for immuno-oncology. The Y-Trap platform exploits combinatorial protein engineering to counteract key determinants of immune dysfunction in the tumor microenvironment. Y-Trap and Merck KGaA, Darmstadt, Germany, will collaborate to explore the pharmacology of Y-Trap multifunctional proteins and Merck KGaA, Darmstadt, Germany, will be responsible for all development, manufacturing and commercialization activities.

Under the agreement, Merck KGaA, Darmstadt, Germany, will provide Y-Trap with an upfront payment in addition to milestone payments and royalties based on the achievement of specific pre-clinical, clinical development, regulatory, and commercial milestones.

"Cancers evolve to counteract and defeat immune surveillance by co-opting and amplifying natural mechanisms of immune suppression," said Atul Bedi, MD, MBA, Co-founder and Chief Scientist of Y-Trap, Inc. "Y-Trap’s multifunctional antibody-ligand traps are designed to counteract key determinants of immune tolerance to entrain more effective antitumor immunity. We look forward to dovetailing the respective strengths of Y-Trap and Merck KGaA, Darmstadt, Germany, to advance the development of multiple molecules from this platform for cancer immunotherapy."

"We are encouraged by the potential of antibody-ligand traps to target multiple types of advanced cancers that may not be addressed by current treatment options," said Joern-Peter Halle, Head of External Innovation and Head of Translational Innovation Platform Immuno-Oncology at Merck KGaA, Darmstadt, Germany. "Merck KGaA, Darmstadt, Germany, has long-standing expertise in the research and development of bi-functional antibodies and proteins and we are looking forward to collaborating with Y-Trap to develop candidates for immuno-oncology from their highly innovative platform."

On September 19, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that Potomac Urology Center, PC ("PUC") has joined its Cchek early cancer detection study (Press release, Anixa Biosciences, SEP 19, 2019, View Source [SID1234539639]). PUC will provide patient samples for Anixa’s ongoing prostate cancer study, including support of clinical validation of Anixa’s Cchek Prostate Cancer Confirmation test.

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Dr. Nilay M. Gandhi, who will serve as the Principal Investigator at PUC for the study, stated, "We’re excited to take part in the development of Anixa’s Cchek prostate cancer detection test and we look forward to the impact this test may have on improving patient care."

"We are pleased to have PUC join us as a key collaborator in the development of Cchek, our artificial intelligence driven liquid biopsy for early cancer detection," stated Dr. Amit Kumar, CEO of Anixa. "Further, we look forward to PUC’s participation as we prepare for the commercial launch of our Cchek Prostate Cancer Confirmation test later this year."

PUC is an expert urology practice committed to providing the highest quality care to patients throughout the Northern Virginia area in the diagnosis and treatment of urology related conditions.

On September 19, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, reported the promotion of Larry Zhang to President (Press release, CASI Pharmaceuticals, SEP 19, 2019, View Source [SID1234539655]).

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Wei-Wu He, Ph.D., Chairman and CEO of CASI, commented, "We are excited to have Larry assume this expanded role. His cross-functional and, in particular, commercial experience has been invaluable to CASI’s advancement and growth in China. He was instrumental with the successful launch of EVOMELA and we expect Larry to continue to have an immediate impact on the growth and commercialization of our current and future pipeline."

Mr. Zhang first joined CASI Pharmaceuticals in September 2018 as President of CASI Pharmaceuticals (Beijing) Co., Ltd., the China operating subsidiary of CASI.

Mr. Zhang possesses over 20 years of executive experience in commercial operations, regulatory affairs, sales and marketing, and business development within the healthcare and biopharmaceutical industries in the U.S., Asia Pacific and China. Prior to joining CASI’s Beijing office, Mr. Zhang was Vice President, Head of Public Affairs and Corporate Responsibility at Novartis Group (China) focusing on the public affairs and public relations strategy including initiating Novartis’ China policy focusing on China FDA (NMPA), new drug approval reform, intellectual property protection, generic quality consistency evaluation and new regulations on biosimilars. Prior to joining Novartis Group (China), he served as Chief Executive Officer of Sandoz (China) Pharmaceutical Co. Ltd, a Novartis Company, where he oversaw the successful launch of six new products. Mr. Zhang has also held executive leadership roles within Bayer Healthcare and Baxter International Corporation in the U.S. and Asia Pacific.

On September 19, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that the first patient has been dosed at a European site in its Phase 2b clinical study evaluating IMG-7289 (bomedemstat) for the treatment of myelofibrosis (Press release, Imago BioSciences, SEP 19, 2019, View Source [SID1234551956]).

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The multi-center Phase 2b trial is evaluating the safety, tolerability, and efficacy of IMG-7289. Outcome measures include reduction in spleen volume based on MRI scans and assessment of total symptom scores throughout the study. The trial is an expansion of a Phase 2a safety and dose-range finding study in which IMG-7289 was generally well tolerated in a cohort of 18 patients. Evaluable patients showed a reduction in spleen size with a majority demonstrating a reduction in symptom scores. "Participation of European Investigators in this study takes advantage of the excellence in hematology that resides in Europe as well as their great experience as trialists. Their involvement will help us further advance, on a global scale, this novel agent as a treatment option for patients with myelofibrosis," said Hugh Young Rienhoff, Jr. M.D., chief executive officer of Imago BioSciences. "This study is part of a broader effort in the evaluation of novel treatments for myeloid diseases."

About IMG-7289

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of IMG-7289, which is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression, myeloid differentiation and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancy models, including the myeloproliferative neoplasms, which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with checkpoint inhibitor agents in non-clinical models. Additional clinical studies in myeloid diseases are under evaluation.

On September 19, 2019 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA"), a leader in large-scale PCR-based DNA manufacturing, reported that LineaRx, Inc. ("LineaRx"), its majority-owned subsidiary focused on next-generation biotherapeutics, and its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA (Press release, Applied DNA Sciences, SEP 19, 2019, View Source [SID1234539640]). Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence.

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Evvivax S.R.L. designed a synthetic gene sequence to produce immunity in companion animals, directed against the protein telomerase (TERT), which is overexpressed in 85% of all mammalian cancers, whereas Takis S.R.L. designed a neoantigen-based cancer vaccine (TK), as a proof-of-concept of personalized immunology. For the studies, the TERT and TK based vaccines were produced in linear DNA form by LineaRx. Here is a summary of the recently completed studies performed in vivo:

Previous results from Phase 1 of the collaboration’s Joint Development Agreement (JDA) confirmed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase. The results reported herein are from the Phase 2 of the JDA using mice implanted with murine colon cancer.
In the prophylactic use of the telomerase vaccine, wherein vaccination is done before addition of tumor cell lines to the mice, transplanted tumors were cleared within 10 days.
In the therapeutic application using either TERT or TK linear DNA vaccine application, cancer cells were introduced and allowed to grow before administration of the vaccine. The successful reduction of total tumor mass was accomplished in conjunction with antibodies that targeted PD-1 and CTLA4. These antibodies, known as Checkpoint Inhibitors, are commonly used in oncology strategies that rely upon immunotherapy. In this setting the tumor cells were reduced significantly within 30 days.
The strategy of the Takis TK neoantigen vaccine uses unique multiple-target antigenic epitopes that have been identified from the tumor of a human patient. The linear DNA can utilize the genes for several of the most effective universal antigens such as TERT, or neoantigens that are more personalized to the patient.
"We know that immune system has a key role in fighting cancer" said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. "Thanks to a deep knowledge of cancer immunobiology and cutting-edge vaccination technologies we have now the tools to provide new therapies to our pet friends and human patients."

"Our unique triumvirate of JDA partners is compelling, in that clinical data accumulated from linear DNA vaccines for companion animals can be used to accelerate translation to human therapies by Evvivax and Takis" said Dr. James Hayward, president and CEO of Applied DNA and LineaRx. "Cancer vaccines would extend the lives of many family pets, and the benefit we believe would rapidly enure to humans."

Linear DNA vaccines are being spearheaded by LineaRx to drive more efficient production methods and what are believed to be safer therapies for patients. Current production standards for human DNA vaccines use the circular DNA of plasmids that are grown in bacteria. However, this raises concerns regarding the risk of integration of bacterial genes including the antibiotic-resistance genes into the human genome or transfer into commensal bacteria, that are a normal part of the human bacterial flora.

Dr Aurisicchio concluded, "The advantages of linear DNA should improve the safety and efficacy of all gene therapies, both in animals as well as humans." The JDA partners expect to publish their results in the scientific literature soon and will initiate planned Phase 3 work in companion animals.