On April 26, 2022 INOVIO (NASDAQ: INO) reported that first quarter 2022 financial results will be released after the market close on May 10, 2022 (Press release, Inovio, APR 26, 2022, View Source [SID1234612969]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

On April 26, 2022 Evaxion Biotech A/S (Nasdaq: EVAX) and Personalis (Nasdaq: PSNL) reported that Evaxion will deploy Personalis’ ImmunoID NeXT Platform in a Phase 2b trial to evaluate the efficacy and safety of Evaxion’s personalized cancer immunotherapy EVX-01 (Press release, Evaxion Biotech, APR 26, 2022, View Source [SID1234612986]). The study will combine EVX-01, a neoepitope-targeting immunotherapy based on Evaxion’s proprietary PIONEER AI technology, with KEYTRUDA (pembrolizumab) for the treatment of patients with metastatic melanoma.

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"We believe we have found the key to efficiently activating the immune system to combat cancer. With our core AI tool called PIONEER, we accurately predict the patient’s most potent neoepitopes, which are the significant mutations of cancer. Then we train the immune system to target those exact mutations, not everything else. That means a higher precision in the therapy than the standard of care treatments out there," said Lars Wegner, CEO of Evaxion. "We are happy to work with Personalis on this crucial next step when we embark on the Phase 2b study, potentially bringing us closer to fulfilling our aspiration of saving the lives of patients with our AI-powered immunotherapy."

"Over the past decade, a number of drugs have emerged based on the discovery that the immune system plays a key role in fighting cancer. However, the development of new therapies has been challenged by difficulties in understanding the precise interaction between cancer and the immune system," said John West, CEO and co-founder of Personalis. "ImmunoID NeXT provides a broad set of insights on tumor and immune biology. Our collaboration with Evaxion may contribute to a better understanding of how combination therapeutics can improve patient outcomes and offer the path to companion diagnostics when relevant biomarkers are identified."

ImmunoID NeXT provides a comprehensive, multidimensional view of both a tumor and its immune microenvironment from a single sample. The platform consolidates multiple biomarker assays into one, including advanced analysis of mechanisms of tumor escape, human leukocyte antigen typing and loss of heterozygosity, microsatellite instability, gene expression signatures, T-cell and B-cell receptor repertoires, and immunocellular quantification. ImmunoID NeXT offers a seamless platform for discovery, from translational testing to companion diagnostics.

On April 26, 2022 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported its audited preliminary results for the year ended 31 December 2021 (Press release, Midatech Pharma, APR 26, 2022, View Source [SID1234613004]).

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2021 HIGHLIGHTS

Operational

·In June 2021, in an R&D update we announced:

oBreakthrough data on the successful encapsulation of a biologic using Q-Sphera technology. We believe no other commercial or academic organisation has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scale up.

oDelivery of proof of concept formulations of MTX214 and MTX216 to our collaboration partner Janssen for them to undertake in vivo studies.

oSuccessful development of a long-acting formulation of MTD211 (Q-brexpiprazole) which, in in vivo studies, demonstrated that a single injectable dose could deliver therapeutic blood levels of brexpiprazole over a period of three months.

·In July 2021, we closed a Placing of 35.1m new ordinary shares with investors in the UK to raise gross proceeds of £10m (£9m net of expenses).

·In August 2021, we announced that the Company had moved its headquarters, including offices and custom built laboratories to new facilities at Caspian Point in Cardiff. The new premises were officially opened by Vaughn Gething MS, Welsh Government Minister for the Economy.

·In December 2021, we announced the successful completion of the 30-day FDA review period of our Investigational New Drug Application for a planned Phase I study of MTX110 in recurrent Glioblastoma Multiforme.

Post period end

·In January 2022, we announced an extension of our R&D collaboration with Janssen. Under the extended collaboration we will focus on maximizing drug loading and optimizing in vitro duration of release for Janssen’s undisclosed experimental molecule using our Q-Sphera technology.

·In February 2022, we announced Janssen had added a second molecule to the collaboration with the same objectives of maximizing drug loading and optimizing in vitro duration of release.

Financial

·Total gross revenue(1) for the year of £0.58m (2020: £0.34m).

·Customer revenue(2) for 2021 of £0.58m (2020: £0.18m).

·UK Placing in July 2021 raised £9.0m, net of expenses.

·Cash and deposits at 31 December 2021 of £10.06m (2020: £7.55m).

·Net loss from continuing operations of £5.46m (2020: £22.19m loss).

·Net cash inflow in the year of £2.52m (2020: £3.64m outflow).

·Tax credit receivable of £0.67m (2020: £1.16m).

1.Total gross revenue represents collaboration income from continuing operations plus grant revenue.

2.Customer revenue represents total gross revenue, excluding grant revenue.

On April 26, 2022 Servier reported that treatment has gained official approval from China’s National Medical Products Administration (NMPA) to be used for patients with metastatic pancreatic cancer (Press release, Servier, APR 26, 2022, View Source [SID1234612954]).

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Pancreatic cancer is called the "emperor

Pancreatic cancer is called the "emperor of all cancers" due to its insidious symptoms, high degree of malignancy and high fatality rate. There were 124,994 new cases of pancreatic cancer and 121,853 deaths in China in 2020[1]. Thus, there are huge needs for treatment options as the incidence of pancreatic cancer is increasing year by year.

No other treatment for pancreatic cancer indications had become available in Mainland China since 1999. There is still a high unmet medical need for the treatment of pancreatic cancer.

For Stephane Mascarau, General Manager of Servier Tianjin Pharmaceutical, "This approval marks an important step forward for Servier to play a key role in oncology in China".

As cancer is the second leading cause of death worldwide2, Servier’s ambition is to become a recognized player in oncology, initiating therapeutic progress where the need is greatest. Therefore, the Group dedicates more than 50% of its R&D budget to this field.

On April 26, 2022 VBL Therapeutics (Nasdaq: VBLT), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ofra-vec (ofranergene obadenovec or VB-111) in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer (Press release, VBL Therapeutics, APR 26, 2022, View Source [SID1234612970]).

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"We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer. The Fast Track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "The readout of the progression free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a Biologics License Application submission to the FDA."

Ofra-vec is VBL Therapeutics’ investigational anti-cancer, gene-based agent in development to treat a wide range of solid tumors. The lead clinical program for ofra-vec is the OVAL Phase 3 registration-enabling trial in recurrent platinum-resistant ovarian cancer patients. VBL recently completed patient enrollment of 409 patients in this global trial being conducted at centers in the United States, Europe, Israel and Japan. In addition, the Independent Data Safety Monitoring Committee (DSMC) unanimously recommended to continue the trial as planned, following review of unblinded data from 370 randomized patients.

About the OVAL Trial

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec or VB-111) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration. A top-line readout of the OS primary endpoint is anticipated in 2023. OVAL is being conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.

About Ofra-Vec (ofranergene obadenovec; `VB-111`)

Ofra-vec is an investigational anti-cancer, gene-therapy agent in development to treat a wide range of solid tumors. Ofra-vec is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. Ofra-vec is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 trials. Ofra-vec has received orphan designations for the treatment of ovarian cancer and for the treatment of glioma by the European Commission. The FDA granted ofra-vec orphan designation for the treatment of malignant glioma and fast track designation for the treatment of rGBM and the treatment of platinum-resistant ovarian cancer. Ofra-vec demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and platinum-resistant ovarian cancer (NCT01711970).