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PharmaCyte Biotech Successfully Completes Manufacturing of Clinical Trial Product

On October 14, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its partner, Austrianova Singapore (Austrianova), has completed the first of two staggered and back to back manufacturing runs for the production of PharmaCyte’s clinical trial product (Press release, PharmaCyte Biotech, OCT 14, 2019, View Source [SID1234540991]).

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The first manufacturing run has been completed successfully. A representative sample of frozen syringes filled with the encapsulated cells inside are in the process of being shipped to external testing laboratories for the release testing of the clinical trial product that is required by the U.S. Food and Drug Administration (FDA). The clinical trial product will be used in PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

Also, about two weeks ago, the second of the two manufacturing runs began. The cells from PharmaCyte’s Master Cell Bank (MCB) are reportedly growing well. The plan is to encapsulate them within the next week or two.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are exceedingly pleased that Austrianova has successfully manufactured PharmaCyte’s clinical trial product for our clinical trial in LAPC, and we’re equally as encouraged to hear that the second and final manufacturing run is proceeding as expected. During our recent shareholder update call, we committed to keeping our shareholders apprised of material developments related to PharmaCyte’s work in completing its Investigational New Drug application (IND). Today’s announcement is a major milestone towards the completion of that work.

"The efforts undertaken to meet this milestone were monumental and involved everyone associated with the technical aspects of the manufacturing process. We cannot be more thankful to our colleagues at Austrianova and those from PharmaCyte who were involved in the work. I feel strongly that we’re back on track to completing both of the required manufacturing runs that will generate the data needed to complete the IND."

During PharmaCyte’s shareholder update call on September 20, 2019, it was reported that Austrianova was in the post-encapsulation phase of the first of two staggered and back-to-back manufacturing runs required by cGMP Validation, the company that is taking responsibility for releasing the clinical trial product into the U.S. for use in PharmaCyte’s upcoming clinical trial.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

Corporate Presentation

On October 14, 2019 Aptose Biosciences presented the corporate presentation (Presentation, Aptose Biosciences, OCT 14, 2019, View Source [SID1234540990]).

Onxeo receives EPO Intent-to-Grant Notice for New Patent strengthening European Protection of Compounds sourced from its platON™ Platform

On October 14, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported having received a communication from the European Patent Office (EPO) informing the Company of its intent to grant a new patent strengthening the European protection of compounds sourced from its platON platform (Press release, Onxeo, OCT 14, 2019, View Source [SID1234540989]).

This new patent strengthens the patent portfolio around AsiDNA, the Company’s first-in-class DNA Damage Response (DDR) inhibitor. It protects AsiDNA and related compounds, as such and for their therapeutic use, in particular for the treatment of cancers, alone or in combination with other agents such as radiotherapy, chemotherapy or other tumor DNA-damaging agents.

"This intent-to-grant, which was obtained very quickly after filing the application, illustrates the value of our platON platform through its ability to generate new patentable compounds and confirms the highly innovative nature of the products resulting from our technology to block the signaling pathways involved in the repair of tumor DNA," said Françoise Bono, Chief Scientific Officer of Onxeo.

This patent will provide a term of protection valid until mid-2031, which could be further extended until 2036 via the supplementary protection certificate (SPC) system. It completes the already robust set of 9 patent families securing the protection of AsiDNA and its related compounds.

ImmunoPrecise Exhibiting at European Antibody Congress in Basel, October 15-19, 2019

On October 14, 2019 ImmunoPrecise Antibodies reported that it will attend the Festival of Biologics held at the Congress Centre, Basel October 15-19th (Press release, ImmunoPrecise Antibodies, OCT 14, 2019, View Source [SID1234540988]). The Festival of Biologics is a combination of four incredible conferences, the European Antibody Congress, the World Immunotherapy Congress, the World Biosimilar Congress, and the Clinical Trials World Congress. ImmunoPrecise Antibodies is excited to be exhibiting at the European Antibody Congress.

Dr. Jennifer Bath and Dr. Stefan Lang will be available at booth 42 to discuss with attendees how ImmunoPrecise Antibodies’ wide range of products and services, including the new Abthena bispecific antibody discovery platform and Artemis Intelligence Metadata (AIM) can decrease turnaround time and risk while promoting clinical success.

Femtogenix presents efficacy and toxicity data on antibody drug conjugates containing new generation of DNA-binding therapeutic payloads

On October 14, 2019 Femtogenix Ltd, a UK biotechnology company developing the next generation of DNA-interactive Antibody Drug Conjugate (ADC) payloads, reported data verifying the favourable toxicity profile and potent efficacy of its Pyridinobenzodiazepine (PDD) ADC payload platform in tumour cell models (Press release, Femtogenix, OCT 14, 2019, View Source [SID1234540987]). The data was presented by Professor David Thurston, Chief Scientific Officer, Femtogenix, on 11 October at World ADC 2019 in San Diego, CA.

ADCs are capable of delivering highly cytotoxic payloads directly at the tumour site. When attached to antibodies or other targeting moieties, Femtogenix’s novel PDD platform allows reversible/irreversible DNA minor groove binding, in a sequence-interactive manner, leading to highly targeted cytotoxicity towards tumour cells. The payloads are designed to have a novel mechanism of action and IP space compared to existing DNA-interactive payloads, to have minimal hydrophobicity, and to be resistant to P-Glycoprotein pumps in tumour cells.

These new data describe details of Femtogenix’s latest payload molecules for ADC use, and demonstrate that high potency mono-alkylators derived through the PDD platform have a favourable toxicity profile in rats, coupled with potent in vivo efficacy (sub mg/kg doses) and excellent tolerability (i.e., MTDs > 10 mg/kg) when conjugated to antibodies1. Femtogenix also introduced a new class of DNA cross-linking ADC payloads at the World ADC conference, based on its proprietary PDD platform, with potent in vivo efficacy and substantially enhanced tolerability profiles compared to competing technologies.

Dr Christopher Keightley, Chief Executive Officer of Femtogenix, commented: "These data show that our PDD technology overcomes many of the limitations of existing approaches to ADC payloads. The toxicity profile and ease of conjugation of the PDD mono-alkylators, along with their novel mechanism of action and significant in vitro and in vivo efficacy, suggest they represent a promising new payload class. We are delighted with the progress as we conclude significant collaborations with pharma partners who will help us achieve the practical application of our innovative approach to a new generation of ADCs."

Femtogenix has generated extensive data on the specific interaction of these payload molecules with DNA using a variety of biophysical techniques, including DNA footprinting and FRET studies. The molecules have been designed through proprietary molecular modelling methodologies to maximise interaction within the DNA minor groove. The design methodology has led to the creation of molecules with a range of potencies and has also been used to generate novel DNA cross-linking payloads that form unique DNA adduct structures with differing modes of action. Payloads with differing potencies and modes of action may be suitable for particular uses or specific target situations.

1. Professor David Thurston, Scientific Co-Founder and Chief Scientific Officer, Femtogenix: ‘New Developments with the Pyridinobenzodiazepine (PDD) Payload Platform’, 8.40-9.10am, 11 October 2019, World ADC, as part of the talk ‘What Lies Ahead for ADCs’.