On May 20, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has made further important progress in optimizing the complete manufacturing process, including significant improvement of the growth characteristics of the cells from PharmaCyte’s Master Cell Bank (MCB) after encapsulation (Press release, PharmaCyte Biotech, MAY 20, 2019, View Source [SID1234536480]). These encapsulated cells will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

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PharmaCyte can now provide additional information as an update to its recent press release on the production of its clinical trial product called, "CypCaps." PharmaCyte, together with its team of experts, has successfully implemented additional changes to the manufacturing process that have resulted in a remarkably improved and more reproducible encapsulated live cell product.

Use the link below to view a picture that captures the growth process post encapsulation from day 8 to day 22 of the cells from the MCB. In the linked picture, you will see the cells from the MCB growing in the capsules over the course of 22 days. On day 22 the cells in the capsules have stopped growing because of contact inhibition and have been placed into syringes and frozen. They have also been thawed and tested for viability and the level of enzymatic activity necessary to convert ifosfamide from its inactive form to its cancer-killing form. Both tests met the required specifications: View Source

As previously reported, the cells from PharmaCyte’s MCB that were produced by Eurofins Lancaster Laboratories showed slightly different growth properties when compared to the cells that were previously tested by Austrianova from PharmaCyte’s Research Cell Bank, a finding that is not unusual when a new cell bank is established. Although minor in nature, these different growth characteristics of the MCB cells initially affected many of the steps required for the overall production process of the CypCaps, necessitating counter measures to re-align and restructure the production process.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "With these changes in place, GMP production of the CypCaps for PharmaCyte can now proceed at Austrianova’s manufacturing facility in Bangkok, Thailand.

"This is great news for everyone who has worked so diligently through what has been a complicated and meticulous process to get the production of our clinical trial product exactly right before we approach the FDA with an Investigational New Drug application. It’s also great news for our many shareholders who have waited patiently as we navigated these unchartered waters with encapsulating the live cells from our MCB."

On May 20, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that the company will present at Advances in Immuno-Oncology Congress UK 2019 in London on May 21st at 11:00 AM BST (Press release, Personalis, MAY 20, 2019, View Source [SID1234536479]).

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The presentation, entitled "Advancing Precision Oncology Biomarker Discovery with a Multi-dimensional Immunogenomics Platform," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will introduce preliminary data from an ongoing study in which this platform is being used to evaluate IO-related biomarkers and potential tumor escape mechanisms in a cohort of melanoma patients treated with anti-PD-1 therapy.

ImmunoID NeXT is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Robert Power, MS, Global Product Manager for Personalis.

On May 20, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that, after discussions with the FDA, the company has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma (Press release, Oncopeptides, MAY 20, 2019, View Source [SID1234536478]). The company targets to submit the application in the first quarter of 2020.

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During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether melflufen could be eligible for accelerated approval based on the promising data generated in the ongoing phase 2 HORIZON clinical trial. The target indication would be for the treatment of patients with relapsed refractory multiple myeloma whose disease is triple-class refractory (i.e. refractory to at least one IMiD, one proteasome inhibitor and one anti-CD38 monoclonal antibody). In the discussions, the FDA has requested and received all available clinical data at hand for melflufen.

As a result of the dialogue with the FDA, Oncopeptides has initiated preparations for an NDA submission based on the available HORIZON data. The detailed plan for the filing process is still under development, but Oncopeptides currently targets to submit the application during the first quarter of 2020. This could then lead to the first melflufen market approval in the US in 2020.

"We are very excited over the opportunity to help patients with triple-class refractory multiple myeloma who currently have very limited treatment options to potentially access a new treatment alternative that may have a large impact on their lives. The outcome of the regulatory discussions during the spring is even better than we anticipated and is a major milestone for Oncopeptides as it means that we can start the application process and potentially attain market approval significantly earlier than planned," says Jakob Lindberg, CEO of Oncopeptides.

"Potential approval will of course depend on the formal FDA review once we have submitted the application, but based on the discussions and the data at hand, we believe we have a very good chance to secure an approval, provided that the results generated in the HORIZON trial continue to be in line with the data we have seen so far. It will therefore be very exciting to present updated HORIZON data at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam on June 16," concludes Jakob Lindberg.

Conference call for investors, analysts and the media
Oncopeptides will host a conference call and present an operational update on Tuesday May 21, 2019 at 10:00 (CET). It will be presented by CEO Jakob Lindberg and members of the Oncopeptides management team. The conference call will also be streamed via a link on the website: www.oncopeptides.com.

Phone numbers for participants from:
Sweden: +46 8 505 583 65
Europe: +44 3333 009 035
USA: +1 833 526 8381

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 (0)8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on May 20, 2019 at 18.00 (CET).

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class of Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On May 20, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported that it will be presenting at the 20th Annual B. Riley FBR Institutional Investor Conference on Thursday, May 23rd, at 3:00 PM, PST at The Beverly Hilton in Beverly Hills, California. Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting a company overview (Press release, Heat Biologics, MAY 20, 2019, View Source [SID1234536477]).

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On May 20, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that it has entered into a research agreement with FLX Bio, Inc., a biopharmaceutical company developing orally-available, small molecule drugs targeting the immune drivers of cancer and inflammatory diseases (Press release, FLX Bio, MAY 20, 2019, View Source [SID1234536476]). Under the terms of the agreement, FLX Bio will utilize Personalis’ universal cancer immunogenomics platform, ImmunoID NeXT, to evaluate therapy-related changes in tumors of advanced cancer patients participating in a Phase 1/2 clinical trial evaluating FLX475, a CCR4 antagonist, as monotherapy or in combination with pembrolizumab.

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"Using the ImmunoID NeXT Platform for our FLX475 studies will help confirm its mechanism of action and demonstrate that inhibiting the CCR4 receptor with FLX475 blocks the migration of regulatory T-cells (Treg) into tumors," said Brian Wong, M.D., Ph.D., President and CEO of FLX Bio, Inc. "With this cutting edge platform, we may be able to show that FLX475, by blocking Treg migration, decreases immune suppression and stimulates an immune response against cancer cells in the tumor microenvironment."

Via the deep interrogation and analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor escape mechanisms (including HLA typing and somatic mutation detection), immune repertoire profiles, neoantigen load, tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and immune checkpoint gene expression.

With the ImmunoID NeXT Platform, FLX Bio will be able to compare pre- and post-treatment tumor biopsy samples, providing a comprehensive picture of treatment-related changes in tumors. In addition, FLX Bio will use the platform to assess levels of a variety of inflammation-related and immune cell type-related markers in its ongoing Phase 2 clinical studies of FLX475.

FLX Bio is now enrolling patients with multiple types of cancer in the Phase 1 portion of its open-label, dose-escalation and cohort expansion Phase 1/2 study. The study is being conducted at leading cancer centers across the United States, Australia and Asia. The study will evaluate the tolerability profile of FLX475 as a monotherapy and in combination with pembrolizumab. Additionally, using Personalis’ ImmunoID NeXT Platform as well as other biomarkers, the study will also assess changes in the tumor microenvironment of both monotherapy and combination therapy. For more information please visit clinicaltrials.gov identifier NCT03674567.

"We’re delighted to work with FLX Bio, innovators who share our vision that a more comprehensive approach to tumor immunogenomic profiling is necessary to enable the development of more efficacious, next-generation cancer therapies," Personalis CEO, John West, said. "ImmunoID NeXT is ideal for applications such as this: maximizing the data generated from a single tumor sample with the goal of characterizing the complex interplay between the tumor cells and immune cells of the tumor microenvironment. Our companies share a common belief that the complexity and dynamic nature of the tumor-immune interactions demands that combinatorial biomarkers will likely be required to most effectively predict responders and non-responders to these therapies."