On November 20, 2020 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that it will host a virtual Investor Day today, which will feature the Company’s Senior Leadership team and Dr Dejka Araujo of the MD Anderson Cancer Cente (Press release, Adaptimmune, NOV 20, 2020, View Source [SID1234571478])r. The link to register is HERE and further background information on Adaptimmune and the event can be found HERE. After the event, a copy of the presentation materials and webcast links will be posted on the Events and Presentations page under the Investors section of the Adaptimmune website.

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"We will lay out the strategy confirming our leadership position as a company designing and delivering cell therapies for people with cancer," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "Over the next five years, we plan to deliver two marketed products, one in sarcoma and one in gastroesophageal cancers, and two additional BLAs in other solid tumor indications. We also plan to develop a robust autologous and allogeneic clinical pipeline that takes us towards the ultimate goal of curative and mainstream cell therapies for people with cancer."

Adaptimmune’s Virtual Investor Day will cover the following topics:

Opening Remarks by Adrian Rawcliffe, CEO

Strategic vision for Adaptimmune and core value drivers for the next five years
Delivering TCR T-cell therapies and building the cell therapy company of the future ​
MAGE-A4 is a target with large market potential across a broad range of solid tumor indications including synovial sarcoma, lung, head and neck, bladder, and gastroesophageal cancers
Synovial sarcoma care: the need for cell therapy

Dejka Araujo, M.D. (Professor in the Department of Sarcoma Medical Oncology, Division of Cancer Medicine of the MD Anderson Cancer Center) will discuss the current treatment landscape and unmet medical need for people with synovial sarcoma
Driving towards delivery of two marketed products and two further BLAs by 2025

An overview of plans to launch the first TCR T-cell therapy (ADP-A2M4) in synovial sarcoma as enrollment in the SPEARHEAD-1 trial is on track
Plan to file a BLA with ADP-A2M4D8 in gastroesophageal cancers in 2024
Potential addressable population across all tumor types with significant MAGE-A4 expression of ~39,000 patients per year in the US and EU factored for HLA-A21; additional BLA(s) projected with ADP-A2M4CD8 in tumor types beyond gastroesophageal cancers
Additional BLA projected for ADP-A2AFP (first or next-generation CD8α) with a potential market opportunity of ~16,000 patients per year based on serum AFP expression1 and factoring for HLA-A2
Plan to incorporate next-generation CD8α enhancement into SPEAR T-cells targeting AFP in a clinical trial next year
The importance of building an integrated cell therapy company for rapid execution and success

An overview of the Company’s integrated structure with its leading capabilities for designing and delivering cell therapies
Case studies demonstrating the value that this integrated approach has delivered: rapid execution of clinical programs, security of vector supply, reduction of costs, and learnings applied to the allogeneic platform
A rich cell therapy pipeline for the future over the next 5 years

Focusing on curative intent: leveraging translational insights for best next-generation products:
Positioning multiple enhancements for next-generation SPEAR T-cells including:
ADP-A2M4 SPEAR T-cells co-expressing IL-7, IL-15, dnTGFβ, and/ or PDE7
Enhancing SPEAR T-cells with IL-7 for proliferation and survival and CCL19 for migration into tumor in collaboration with Noile-Immune
Enhancing SPEAR T-cells using transmembrane and surface immunoregulatory mechanisms with Alpine Immune Sciences
Focusing on enabling mainstream access – broadening patient coverage and patient access:
Plans to expand into HLAs beyond A2 to increase the addressable patient population
Bringing forward HiT candidates for multiple targets including GPC3
Announcing collaboration with leading TIL therapy center (CCIT, Denmark) for nextgeneration TILs co-expressing IL-7
Bringing two allogeneic targets into the clinic:
In-house MAGE A4 targeted iPSC T-cell products
Mesothelin, a target expressed in multiple solid tumors, named as first HiT target in partnership with Astellas
An update on the Company’s financial position

Total liquidity position of $400 million as of September 30, 2020
Current cash runway into early 2023
The Virtual Investor Day will also include two Q&A sessions.

On November 20, 2020 Shanghai Antengene, a three-year old oncology company, reported that it completed a $340 million IPO in Hong Kong (Press release, Antengene, NOV 20, 2020, View Source [SID1234571518]). The company, which was originally backed by Celgene, said the offering was significantly oversubscribed . Antengene has built a portfolio of 12 first-in-class, only-in-class and best-in-class cancer therapies, six of which have begun clinical trials. It combines in-licensings with internal research. The company says it uses a synergistic approach to "unlock the full therapeutic potential" of its candidates.

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On November 20, 2020 Diamyd Medical reported that it will invest its pro rata share corresponding to approximately SEK 19.3 million in a rights issue in the associated company NextCell Pharma AB, which means that Diamyd Medical’s book value of the holding in NextCell Pharma after the investment increases from approximately SEK 11.7 million to approximately SEK 30.9 million (Press release, Diamyd Medical, NOV 20, 2020, View Source;ClipID=3832829 [SID1234571456]).

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Diamyd Medical is one of the main owners in NextCell Pharma with an ownership share of approximately 12.8%. The Board of Directors of NextCell Pharma has annunced its intention to decide on a fully guaranteed rights issue which, upon full subscription, will provide NextCell Pharma with approximately SEK 150 million before issue costs.

"NextCell has made impressive progress both as a company and in its development of the stem cell-based study drug ProTrans, says Ulf Hannelius, CEO of Diamyd Medical. "Through our increased investment in NextCell together with the development of our own study drugs, we work purposefully to be able to cure type 1 diabetes."

On November 20, 2020 INOVIO (NASDAQ: INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, reported that data from the company’s novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed glioblastoma (GBM), will be presented by Dr. David Reardon in the plenary session at the Society for Neuro-Oncology (SNO) 2020 Annual Meeting (Press release, Inovio, NOV 20, 2020, View Source;INO-9012-in-Novel-Combination-with-PD-1-Inhibitor-Libtayo-cemiplimab-in-the-Treatment-of-Newly-Diagnosed-Glioblastoma-Multiforme-at-Society-for-Neuro-Oncology-2020-Annual-Meeting/default.aspx [SID1234571479]). The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT) and temozolomide (TMZ) are tolerable, immunogenic, and may improve median survival for patients with newly diagnosed GBM. Survival data at 18 months showed that 70% (14/20) of MGMT promoter methylated GBM patients were alive, and 50% (16/32) of MGMT promoter unmethylated patients, which are the more difficult to treat group, were alive after 18 months. Median overall survival in the unmethylated GBM patients was 17.9 months, which compares favorably to historical controls; Median OS for methylated patients has not yet been reached and the study is ongoing.

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Dr. David Reardon, Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and coordinating principal investigator of GBM-001 said, "This is a landmark combination trial in which a novel DNA vaccine is combined with a checkpoint inhibitor and radiation and chemotherapy. We look forward to continuing to review these data, with an eye towards those patients who are most likely to benefit from this innovative approach and to see whether, over time, there is an extension of survival in these very hard-to-treat patients. Coupling immune response with clinical outcome may prove insightful."

Interim data demonstrated that in the MGMT promoter unmethylated cohort, 19/22 (86%) subjects to date had an IFN-gamma T cell response that increased over baseline to one or more of the antigens encoded by INO-5401. In the MGMT promoter methylated cohort, 16/17 (94%) subjects to date had an IFN-gamma response that increased over baseline to one or more of the antigens encoded by INO-5401. The novel combination of INO-5401 + INO-9012 continues to demonstrate a well-tolerated safety profile when given not only with radiation and TMZ, but also with PD-1 blockade by Libtayo, which is being jointly developed by Regeneron and Sanofi.

Dr. Jeffrey Skolnik, INOVIO’s senior vice president, clinical development, said, "INO-5401 + INO-9012, with Libtayo and RT/TMZ, generates cancer antigen-specific T cells that may be able to attack GBM and provide a survival advantage. We are using our knowledge of immunology to define a patient population for which this novel DNA medicine plus checkpoint inhibitor combination may offer a survival advantage, by continuing to assess all of our data: efficacy, safety and most important, immunogenicity and tissue expression data."

Additional data will be provided in the coming months, including correlative immunology and tissue data, as well as total study drug exposure and concomitant medication use.

INO-5401, INO-9012 and Libtayo, and the combination of these products have not been approved or evaluated by any Regulatory Authority worldwide for the treatment of newly diagnosed GBM.

Presentation Details

Abstract: LTBK-01

Title: "INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma"

Presenting Author: Dr. David Reardon
Plenary Session Date and Time: 2020 SNO Annual Meeting, Plenary 1A, Friday, November 20, 2020 beginning at 11 a.m. EST

Study Design

The trial was designed to evaluate safety, immunogenicity and efficacy of INO-5401 and INO-9012 in combination with Libtayo, with radiation and chemotherapy, in subjects with newly diagnosed glioblastoma (GBM). This is a Phase 1/2, open-label, multi-center trial conducted in 52 evaluable patients with GBM. There are two cohorts in this trial. Cohort A includes 32 participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B includes 20 participants with a tumor with a MGMT methylated promoter. Both cohorts received INO-5401 and INO-9012 and Libtayo at the same doses and on the same dosing schedule, and both cohorts received radiation and TMZ. For more information of the clinical study, see www.clinicaltrials.gov, identifier NCT03491683.

About Glioblastoma Multiforme (GBM)

GBM is the most common and aggressive type of brain cancer and remains a devastating disease for both patients and caregivers. Its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 to 22 months and the median progression-free survival is approximately 7 months. In the U.S., the estimated annual incidence of GBM is 11,362 cases or 3.21 cases per 100,000 persons and the median age at diagnosis is 65 years.

About INO-5401 and INO-9012

INO-5401 encodes for INOVIO’s SynCon antigens for hTERT, WT1, and PSMA, and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted hTERT, WT1, and PSMA among a list of important cancer antigens, designating them as high priorities for cancer immunotherapy development. These three antigens were reported to be over-expressed, and often mutated, in a variety of human cancers, and targeting these antigens may prove efficacious in the treatment of patients with cancer. INO-9012 encodes for IL-12, which is a T cell immune activator.

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

On November 20, 2020 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported the nomination of BDTX-1535 as the Company’s development candidate for the treatment of glioblastoma multiforme (GBM), as well as the commencement of Investigational New Drug (IND)-enabling studies (Press release, Black Diamond Therapeutics, NOV 20, 2020, View Source [SID1234571569]).

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Additionally, Black Diamond Therapeutics reported a presentation at the 2020 Society for Neuro-Oncology Annual Meeting (SNO) of the pre-clinical data for BDTX-1535 and the biological rationale for a MasterKey approach to treating GBM patients whose tumors harbor allosteric oncogenic mutations in epidermal growth factor receptor (EGFR).

"These pre-clinical data demonstrate the achievement of our program’s key design principles, including potent and selective inhibition of the family of EGFR variants implicated in GBM and penetration of the blood-brain barrier, and further support our ability to develop a novel and differentiated candidate for the treatment of this disease," said Elizabeth Buck, Ph.D., Executive Vice President, Discovery and Translational Sciences at Black Diamond Therapeutics. "This profile, coupled with the in vivo data that showed tumor growth inhibition in intracranial patient-derived xenograft (PDX) tumor models expressing allosteric EGFR mutants, supports the potential for BDTX-1535 to meaningfully transform the treatment paradigm for patients with GBM."

GBM tumors express a family of allosteric oncogenic EGFR variants that often appear together in GBM and, as shown by the Company’s pre-clinical work, must all be effectively inhibited to secure a meaningful anti-tumor response. In cell-based assays, BDTX-1535 achieved potent MasterKey inhibition of all members of the family of oncogenic EGFR variants expressed in GBM with selectivity v. wild-type-EGFR (WT-EGFR). Additionally, in mouse models, BDTX-1535 demonstrated a pharmacokinetic profile that supports its ability to penetrate the blood-brain barrier. BDTX-1535 achieved complete and sustained inhibition of the phosphorylated state of EGFR in mouse models bearing Ba/F3 allosteric EGFR mutants, as well as tumor growth inhibition in mouse models bearing intracranial PDX tumors expressing allosteric EGFR mutants.

"Glioblastoma places an enormous burden on patients and their families, and we’re encouraged by these pre-clinical data that support BDTX-1535’s potential to improve treatment options for those impacted by GBM. The advancement of BDTX-1535 into early development is a critical step in our pursuit of a truly innovative approach for the treatment of this devastating disease," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We remain committed to the broad deployment of our proprietary MAP platform to produce novel MasterKey inhibitor therapies for a range of genetically defined diseases."

The presentation from the SNO 2020 meeting is available on the "Scientific Presentations and Publications" section of the Black Diamond Therapeutics website.