On November 17, 2020 VECT-HORUS, a biotechnology company that designs and develops vectors that facilitate the targeted delivery of therapeutic molecules and imaging agents, reported the signing of a collaboration agreement with CERIMED (European Centre for Research in Medical Imaging) to support the preclinical development of VECT-HORUS’ theragnostic agents (Press release, Vect-Horus, NOV 17, 2020, View Source [SID1234571301]).

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"CERIMED is very proud to announce the initiation of this collaboration with VECT-HORUS. The respective expertise of VECT-HORUS and CERIMED makes this consortium a major asset in the development of new theragnostic approaches to oncological pathology"

CERIMED, also based in the Timone Aix-Marseille University Campus, has expertise in medical imaging techniques (PET, SPECT, etc.) and provides a complete platform of in vivo preclinical and clinical imaging entirely dedicated to R&D of innovative clinical imaging tools.

VECT-HORUS is co-developing with RADIOMEDIX (Tx, USA) one agent which will enter clinical trials in 2021 for the diagnosis of glioblastoma. VECT-HORUS also pursues the investigations on its other theragnostic candidates targeting the Low-Density Lipoprotein Receptor, which has been shown to be expressed at high levels in some tumours, including pancreatic tumours.

"CERIMED offers a wide range of services in medical imaging, and we are tremendously pleased to work with them. This partnership is fully aligned with our strategy to collaborate with Regional Centers and to expand the use of our VECTrans technology in the theragnostic field," said Jamal Temsamani, Ph.D., Director of Drug Development of VECT-HORUS.

"CERIMED is very proud to announce the initiation of this collaboration with VECT-HORUS. The respective expertise of VECT-HORUS and CERIMED makes this consortium a major asset in the development of new theragnostic approaches to oncological pathology" said Pr Benjamin Guillet, director of CERIMED, head of radiopharmaceutical department of Marseille University Hospital and of Drug Department of Pharmacy faculty of Aix-Marseille University.

On November 17, 2020 Abzyme Therapeutics LLC, a biotech company focused on developing antibodies for diagnostic and therapeutic applications, reported that it has filed a patent application entitled "Antibodies Binding to Human CD3 at Acidic pH", USPTO number 63/109,005 (Press release, Abzyme Therapeutics, NOV 17, 2020, View Source [SID1234571300]). This patent application is an important step forward for Abzyme Therapeutics solidifying its intellectual property position in the field of therapeutic antibody development.

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Monoclonal antibodies are widely used for treatment of various cancers. On-target off-tumor binding to normal tissues is an obvious toxicity concern as many tumor-associated antigens are expressed in both tumor and normal tissues. Optimization of specific tumor targeting could be achieved by taking advantage of the extracellular acidity of solid tumors relative to normal tissues. Due to poor vascular perfusion, regional hypoxia, and fermentative glycolysis, the extracellular pH in most solid tumors is in the 6.0–6.8 range. In contrast, non-cancerous cells maintain their extracellular pH at physiological levels (7.3–7.4). Thus, an antibody with high binding affinity at acidic pH (pH 6.0 – pH 6.8), but with none or reduced binding affinity at normal pH will significantly minimize the on-target off-tumor toxicity. Tumor-microenvironment or TME-specific antibodies with reduced or no on-target off-tumor binding would find potential application in various forms of antibody-mediated and cell-mediated therapies including antibody monotherapies, antibody-drug conjugate or ADC therapy, T cell-engaging immunotherapy and CAR-T. TME-specific antibodies will reduce on-target off-tumor adverse effects while allowing dose-escalation

The invention provides for new anti-hCD3 antibodies that, in contrast to prior art anti-CD3 antibodies, bind specifically to human CD3 at acidic pH, but do not significantly bind to human CD3 at neutral or physiological pH, methods to produce these antibodies and therapeutic uses of these antibodies. These antibodies are able to activate T cells at acidic pH while having significantly reduced activity at neutral or physiological pH.

"We successfully created anti-CD3 antibodies that bind and activate human T cells at acidic pH that will be an important foundation for engineering bispecific T-cell engaging antibodies for solid tumors. As we pride ourselves as innovators, we are extremely pleased to achieve this milestone filing this application" said Dr. Tran, CEO and co-founder of Abzyme. "In addition, using the same approach, we were able to develop other pH-dependent antibodies targeting the acidic tumor microenvironment".

On November 17, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will webcast a presentation as follows (Press release, Theravance, NOV 17, 2020, https://www.prnewswire.com/news-releases/theravance-biopharma-to-present-at-the-3rd-annual-evercore-isi-healthconx-conference-301174097.html [SID1234571297]):

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Evercore ISI 3rd Annual HEALTHCONx Conference on Tuesday, December 1 at 2:40 p.m. ET (11:40 a.m. PT/7:40 p.m. GMT)
Webcast of the presentation may be accessed by visiting the "Investors" section of Theravance Biopharma’s website at www.theravance.com under the "Presentations and Events" tab. Replay of the webcast will be archived on the Company’s website for at least 30 days.

On November 17, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal care, reported that President and CEO Bryan Hanson and Executive Vice President and CFO Suky Upadhyay will be presenting at the 2020 Evercore ISI HealthCONx Conference on Tuesday, December 1, 2020, at 10:30 a.m. Eastern Time (Press release, Zimmer Holdings, NOV 17, 2020, https://www.prnewswire.com/news-releases/zimmer-biomet-to-present-at-2020-evercore-isi-healthconx-conference-and-piper-sandler-32nd-annual-virtual-healthcare-conference-301173015.html [SID1234571296]). Additionally, Executive Vice President and CFO Suky Upadhyay will be presenting at the Piper Sandler 32nd Annual Virtual Healthcare Conference Wednesday, December 2, 2020, at 11:00 a.m. Eastern Time.

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Live webcasts of the presentations can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. The webcasts will be archived for replay following the conference.

On November 17, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of Glioblastoma Multiforme (GBM) (Press release, CNS Pharmaceuticals, NOV 17, 2020, View Source [SID1234571295]). The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA’s acceptance of the Company’s filing.

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"Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible," commented John Climaco, CEO of CNS Pharmaceuticals. "Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM."

The planned Phase 2 trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease, and results will be compared to the current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin or Lomustine. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments. The trial’s adaptive design is intended to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.