On September 15, 2022 The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, reported that it has been awarded a 10-year Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract by the National Cancer Institute (NCI), part of the National Institutes of Health, to support NCI’s Cancer Trials Support Unit (CTSU) (Press release, Thermo Fisher Scientific, SEP 15, 2022, View Source [SID1234619595]). As part of the award, the PPD clinical research business will have the opportunity to coordinate the resources and processes necessary to identify, deploy, support and maintain a platform for the collection and migration of electronic patient-reported outcomes (ePROs) and other patient-generated health data into NCI Multi-Center Organization (MCO) clinical trials supported by CTSU.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Thermo Fisher’s PPD clinical research business has three decades of experience successfully delivering clinical research services to governmental agencies, contractors and nonprofits in conducting therapeutic, vaccine and medical device studies on a global scale across all trial phases and a broad array of therapeutic areas.

"NCI’s focus on progressing cancer research across the nation is one we all support, to advance scientific knowledge and to help all people live longer, healthier lives," said David M. Johnston, Ph.D., senior vice president and president, clinical research, Thermo Fisher Scientific. "The research that NCI champions is vital to improving the outcomes of patients battling this group of diseases. We are privileged to support NCI in those efforts."

Cancer is among the leading causes of death worldwide. In 2022, NCI estimates there will be more than 1.9 million new cases of cancer and more than 600,000 cancer deaths in the United States. Globally, the World Health Organization notes that nearly one in every six deaths can be attributed to cancer, with approximately 400,000 children developing cancer every year.

The business’ team of experts providing PPD Digital and Decentralized solutions works closely with leading research organizations around the world to navigate evolving trends in drug development, including the design and deployment of customized, remote clinical trials. The business employs innovative electronic clinical outcome assessment (eCOA) technologies to enable sites, patients and customers to share data more effectively than traditional methods. In addition, eCOAs and ePROs use digital platforms to enable direct data collection from study stakeholders, resulting in less paper documentation and more timely data, with greater consistency from patients. The business has been a guiding force in the industry, bringing long-standing expertise and establishing best practices for study teams embarking on new modes of clinical research.

The business’ oncology center of excellence provides strategic and operational oversight and promotes knowledge sharing and best practices, while its immuno-oncology center of excellence serves to deliver patient-centric solutions and collaborates with industry organizations to overcome challenges associated with immuno-oncology trials. In addition, the business’ early development oncology group features experts in the planning and operationalizing of Phase I-II studies, as well as the development of early-stage oncology compounds and the oversight of clinical programs.

The PPD clinical research business has conducted over 675 oncology and hematology studies in the past five years involving more than 114,000 patients at over 26,000 sites around the world. Those trials represent more than one-quarter of the studies the business has conducted in that time. The business’ team of experts providing PPD Laboratory services helped develop 24 of the top 25 best-selling oncology drugs of 2020.

This project will be funded in whole with federal funds from the NCI, National Institutes of Health (NIH) and Department of Health and Human Services (DHHS) under Contract No. 75N91022D00012.

On September 15, 2022 ImmunoScape, a pre-clinical biotechnology company focused on the discovery and development of next-generation TCR-T-cell therapeutics, reported that Dan MacLeod, Ph.D., the company’s vice president of discovery, will present at the 7th Annual CAR-TCR Summit taking place September 19-22, 2022 in Boston (Press release, immunoSCAPE, SEP 15, 2022, View Source [SID1234619593]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The CAR TCR Summit is a multi-day, industry leading comprehensive forum that explores discovery through to commercialization to deliver safe, effective, and commercially viable CAR and TCR therapies.

At the summit, Dr. MacLeod will participate in several sessions:

Discovery of TCRs Targeting Novel Antigens Using Deep Immunomics
Wednesday, September 21 at 11:30am ET
Discovery Track: Accelerating Target Identification & Validation – Morning Session
Discussion Points:
Discovery and development of novel TCR-based therapeutics using the Deep Immunomics platform
Identification of therapeutically relevant TCRs against both well characterized and novel targets across multiple HLA types
Applying computational approaches to advance TCR Discovery for novel targets
Panel Discussion: Driving Target Discovery with Novel AI Technology
Wednesday, September 21 at 3:00pm ET
Panel Discussion: Accelerating Target Identification & Validation – Post-Lunch Session
Panelists: Dan MacLeod, ImmunoScape; Ely Porter, Rootpath; Luke Pase, Anocca
Discussion Points:
How to advance the discovery of new epitope targets for solid tumors using innovative high-throughput screening and computational AI techniques
How can we better leverage bioinformatic platforms to advance drug discovery?
ImmunoScape’s differentiated Deep Immunomics platform utilizes the company’s proprietary combinatorial barcoding technology to enable the discovery and in-depth characterization of rare cancer-specific T-cells at high resolution. ImmunoScape’s platform is able to simultaneously evaluate tens of millions of T-cells in blood samples from hundreds of cancer patients to identify clinically relevant T-cell clones. The corresponding T-cell receptors (TCRs) are currently being evaluated and prioritized to form a diverse pipeline of TCR-T-cell therapies covering multiple antigens and HLA restrictions.

To see the full summit schedule, and to register for the event, please visit https://car-tcr-summit.com/.

To set up a time to meet with Dr. MacLeod or ImmunoScape CEO Choon-Peng Ng at the summit, please email [email protected].

To learn more about ImmunoScape, please visit View Source

On September 15, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL) (Candel or the Company), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on the Company’s application for orphan drug designation for CAN-2409 for the treatment of glioma (Press release, Candel Therapeutics, SEP 15, 2022, View Source [SID1234619592]). CAN-2409, a genetically modified adenovirus and the Company’s most advanced investigational therapy, is currently being evaluated in multiple phase 2 and phase 3 clinical trials for lung, brain, pancreatic and prostate cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The orphan drug designation follows the U.S. Food and Drug Administration (FDA) fast track designation, which was granted in June 2021, for CAN-2409 in combination with valacyclovir following standard of care treatment in newly diagnosed high-grade glioma.

Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, said, "Glioma, while mercifully rare, is a devastating disease with significant morbidity and mortality. The EMA’s orphan drug designation recognizes the high unmet need and the potential of CAN-2409 in this patient population. We look forward to working with the EMA and FDA in an effort to bring our investigational medicine to patients as we initiate our phase 3 clinical trial of CAN-2409 in high-grade glioma this year."

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA COMP. The EMA’s orphan drug designation is potentially available to companies developing treatments for life-threatening or chronically debilitating conditions that affect no more than five in 10,000 persons in the EU. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products. The designation can provide financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy product candidate, is a genetically modified adenovirus that is designed to encode the herpes simplex virus thymidine kinase (HSV-tk) gene. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills infected and nearby cancer cells. Intratumoral administration of CAN-2409 results in immunogenic cell death, followed by the release of tumor-specific neoantigens in the tumor microenvironment. At the same time, the adenoviral vector elicits a strong pro-inflammatory effect in the tumor microenvironment, creating the optimal conditions to induce a specific CD8+ cytotoxic T cell-mediated immune response against the injected tumor and the uninjected distant metastases. This dual mechanism of antigen unmasking and immune activation may enable CAN-2409 to generate a powerful and lasting immune response against a variety of the patient’s tumor-associated neoantigens, minimizing the possibility for immune escape and development of tolerance.

Because of its versatility, CAN-2409 may have the potential to treat a broad range of solid tumors. Encouraging activity has been shown in several preclinical and clinical settings as monotherapy as well as in combination with standard of care radiation therapy, surgery, chemotherapy, and immune checkpoint inhibitor treatment. Furthermore, more than 700 patients have been dosed to date with a favorable safety profile, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in high-grade glioma, non-small cell lung cancer, pancreatic cancer, and prostate cancer in ongoing clinical trials.

On September 15, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that a presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 15 September 2022 (US ET) as part of the US OTCQX’s Virtual Life Sciences Investor Forum (Press release, Starpharma, SEP 15, 2022, View Source;mc_eid=bf52dd3418 [SID1234619591]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Life Sciences Investor Forum is a leading investor conference that provides a forum for companies to present to tens of thousands of retail investors as well as advisors.

Details of the forum are found via this link: Virtual Life Sciences Investor Forum.

Starpharma’s pre-recorded presentation features a company overview, including:

the latest interim clinical trial results presented at ESMO (Free ESMO Whitepaper) oncology conference that show efficacy signals in 100% of prostate cancer patients assessed following DEP cabazitaxel treatment;
an overview of Starpharma’s DEP clinical-stage and preclinical assets, and corporate partnerships for its DEP drug delivery platform, including with Merck & Co., Inc (MSD) and AstraZeneca; and
a VIRALEZE overview and recent antiviral nasal spray results, including excellent protection against the SARS-CoV-2 Omicron variant, as well as updates on Starpharma’s portfolio more broadly.

ON September 15, 2022 Oxford Biomedica plc ("Oxford Biomedica" or "the Group") (LSE: OXB), a leading gene and cell therapy group, reported that interim results for the six months ended 30 June 2022 (Press release, Oxford BioMedica, SEP 15, 2022, View Source [SID1234619589]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Roch Doliveux, Oxford Biomedica’s Chair and Interim Chief Executive Officer, said:
"We have made significant strategic and operational progress towards our goal of becoming a global viral vector leader. In the first half of 2022 we achieved double digit revenue growth in our core business and since the start of the year have signed numerous new or expanded partnership deals, including a new AAV deal, resulting in an over 70% increase in the number of customers with whom we work. In addition, we executed the transformational launch of Oxford Biomedica Solutions which brings innovative AAV capabilities, further capacity and a significant platform in the US, delivering on our strategic objective to become vector agnostic and provide world-leading innovative process development and manufacturing services to our clients. With a strong cash position, a robust and growing business and entry into the fast-growing AAV market, Oxford Biomedica is in an excellent position to achieve long-term future profitable growth as a leading partner of choice to deliver life-saving cell and gene therapies to patients."

H1 2022 FINANCIAL HIGHLIGHTS
– Double digit revenue growth in the core business (excluding COVID-19 vaccine manufacturing) compared to H1 2021 offset by the decrease in COVID-19 vaccine manufacturing; total revenue decreased by 21% to £64.0 million (H1 2021: £81.3 million)

– Bioprocessing and commercial development revenues decreased by 24% to £57.3 million (H1 2021: £75.6 million) largely driven by a reduction in COVID-19 vaccine manufacturing revenues but partly offset by an increase in revenues from lentiviral vector and AAV commercial development and manufacturing activities

– Licences, milestones & royalties were £6.7 million (H1 2021: £5.7 million), the increase of 18% resulting from licence fees from new partner programmes

– The launch of Oxford Biomedica Solutions, enabling entry into the fast-growing AAV market whilst also establishing a key strategic presence in the US, including one-off acquisition-related costs, drove an increase in operating expenses to £56.2 million (H1 2021: £23.6 million). Active cost control initiatives were initiated to reduce the Group’s operating cost base as the COVID-19 pandemic continues to ease

– Operating EBITDA1 loss and operating loss of £5.8 million and £19.2 million respectively (H1 2021 EBITDA1 profit and operating profit of £27.1 million and £19.7 million respectively); this included one-off acquisition-related due diligence costs of £5.1 million relating to the transaction with Homology Medicines to establish Oxford Biomedica Solutions

– Cash used in operations was £24.5 million compared to £22.2 million generated in H1 2021
– The Group’s capital expenditure of £6.0 million (H1 2021: £3.5 million) consisted mainly of purchases of equipment required for manufacturing and laboratory facilities

– Cash at 30 June 2022 was £118.5 million and £115.8 million at 31 August 2022; net cash at 30 June 2022 was £50.1 million and £42.1 million at 31 August 2022

OTHER RECENT DEVELOPMENTS AND OUTLOOK
– The Group is in the process of part-repaying and refinancing the $85 million Oaktree loan facility taken out in March 2022 and a process is underway for the sale and leaseback of the Group’s Windrush Court facility in Oxford

– The Group expects similar levels of revenues in the second half of 2022 as those achieved in the first half of 2022 and is expecting to deliver broadly break-even Operating EBITDA for the second half of the year

1Operating EBITDA (Earnings Before Net Finance Costs, Tax, Depreciation, Amortisation, fair value adjustments of assets at fair value through profit and loss, and Share Based Payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share options. A reconciliation to GAAP measures is provided on page 12.

OPERATIONAL HIGHLIGHTS (including post-period events)
– Entered into fast-growing AAV market through a transformational deal with Homology Medicines, completed in March 2022, to establish Oxford Biomedica Solutions LLC ("Oxford Biomedica Solutions"), a high-performing full-scope scope AAV manufacturing and innovation business near Boston, US; new AAV partnership announced in September

– Expanded customer base by more than 70%, currently working on more than 20 programmes, with a robust new business pipeline across all key vector types

– Amended and expanded existing License and Clinical Supply Agreement with Juno Therapeutics ("Juno"), a wholly-owned subsidiary of Bristol Myers Squibb Company, to include two new viral vector programmes

– Continued strong relationship with Novartis with Kymriah available in more than 400 qualified treatment centres in 30 countries having coverage for at least one indication, and expansion into a third indication

– Signed a new three-year Master Services and Development Agreement with AstraZeneca to facilitate potential future manufacturing opportunities for the AstraZeneca COVID-19 vaccine

– Signed four new US-based customer agreements with Cabaletta Bio ("Cabaletta"), with an undisclosed private biotechnology company advancing a new generation of adoptive cell therapies, with an undisclosed late-stage cell and gene therapy company, and with an undisclosed new partner for Oxford Biomedica Solutions’ AAV platform

– Continued to strengthen the Board with the appointment of Namrata Patel as an Independent Non-Executive Director. John Dawson stepped down as CEO, with Chair Roch Doliveux assuming the role of Interim CEO in January 2022. The formal process to appoint a successor is progressing well

Analyst briefing
Management will be hosting a virtual briefing and Q&A session for analysts at 13:00 BST / 8:00 EST today, 15 September. The presentation will be available on the Group’s website at www.oxb.com