Vysioneer Announces Data Sharing Agreement with Pfizer to Augment Oncology Clinical Trials with Artificial Intelligence

On February 21, 2023 Vysioneer, a pioneer in AI for Oncology, reported a data sharing agreement with Pfizer, a global leader in pharmaceuticals (Press release, Vysioneer, FEB 21, 2023, View Source [SID1234627489]). The agreement aims to lay the foundation for the application of AI in oncology clinical trials. Vysioneer’s AI technology provides objective tumor response assessments and unlocks novel biomarkers that cannot be derived by human readers due to time and resources constraints, to predict patient outcomes at earliest timepoints.

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As part of the agreement, Vysioneer gains access to one of Pfizer’s oncology clinical trial datasets to apply Vysioneer’s advanced machine learning techniques to facilitate the drug efficacy assessment process, thereby allowing Pfizer to assess drug efficacy with greater granularity and explore advanced biomarkers and novel endpoints.

The current standard to measure how well a cancer patient responds to treatment, such as response evaluation criteria in solid tumors (RECIST) is labor-intensive and prone to intra- and inter-reader variability by human readers. The use of AI has the potential to markedly improve clinical trial image reading processes as well as enhance the ability to provide more granular insights down to every single tumor. Through successful use of this valuable technology, Vysioneer and Pfizer hope it will lead to expanded clinical trial use cases, and ultimately, better patient care.

"We are thrilled to collaborate with Pfizer on this data sharing agreement. Pfizer has continually led the biopharma industry into the next wave of innovation, and we look forward to offering our AI technology to support their efforts," said Jen-Tang Lu, Chief Executive Officer of Vysioneer. "By objectively assessing drug efficacy on a large scale and uncovering new endpoints that more accurately reflect patient outcomes, we have a strong opportunity to significantly de-risk clinical trials and ensure that cancer patients receive the right treatment promptly."

Learn more at www.vysioneer.com.

Sorrento Therapeutics, Inc. Receives Court Approval for $75 Million Financing in Chapter 11 Case

On February 21, 2023 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a biopharmaceutical company dedicated to the development of life-saving therapeutics to treat cancer, intractable pain, and infectious disease, reported that the U.S. Bankruptcy Court for the Southern District of Texas granted interim approval of Sorrento’s $75 million debtor-in-possession financing from JMB Capital Partners, in connection with Sorrento’s chapter 11 case, which was filed on February 13, 2023 (Press release, Sorrento Therapeutics, FEB 21, 2023, View Source [SID1234627488]).

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The financing will provide Sorrento with immediate liquidity so that it can continue operating its business as usual during its chapter 11 case. A hearing for final approval of the financing is currently set for March 29, 2023.

Dr. Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento, commented: "We are pleased to have received approval from the Court for this financing, which will ensure Sorrento has the liquidity and ability to continue normal business operations, including the payment of employee wages and benefits and post-petition vendor obligations. We will continue our important work of developing new and innovative therapies for patients struggling with cancer, intractable pain, infectious disease, and more."

As of its chapter 11 filing, Sorrento had over approximately $1 billion in assets. However, due to the possibility of certain actions by a litigation creditor, Sorrento and its wholly-owned, non-operating subsidiary Scintilla Pharmaceuticals, Inc. sought chapter 11 relief to safeguard its business and ensure the continuation of business operations, while protecting and maximizing value for stakeholders.

Scilex Holding Company (Nasdaq: SCLX, "Scilex"), which is majority-owned by Sorrento, is not a debtor in Sorrento’s chapter 11 case. Scilex is continuing to operate its business as usual, focusing on growing revenues, offering innovative, non-opioid pain management products, and developing meaningfully differentiated programs that address significant unmet needs and lead to better health outcomes for the millions of acute and chronic pain patients.

Latham & Watkins LLP and Jackson Walker LLP are serving as legal counsel to Sorrento. M3 Partners is serving as restructuring advisor.

TC BioPharm Announces Publication of Paper in AML Research Highlighting the Company’s Development of Allogeneic Gamma-Delta T cell Therapies

On February 21, 2023 TC BioPharm(Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported the publication of a paper entitled, "A Phase I trial of allogeneic γδ T lymphocytes from haploidentical donors in patients with refractory or relapsed acute myeloid leukemia" in Clinical Lymphoma, Myeloma and Leukemia, a monthly peer reviewed journal (Press release, TC Biopharm, FEB 21, 2023, View Source [SID1234627487]).

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The article highlights the abilities of allogeneic γδ T lymphocytes from haploidentical donors in patients with refractory or relapsed acute myeloid leukemia.  The publication can be accessed online through the portal ScienceDirect at "A phase I trial of allogeneic γδ T lymphocytes from haploidentical donors in patients with refractory or relapsed acute myeloid leukemia. – ScienceDirect"

"I feel privileged to be part of the team that achieved the successful publication on our phase I trial using OmnImmune (haploidentical allogeneic γδ T lymphocytes) in advanced AML patients," said Dr. Emilio Cosimo, Director of Product Development. "The study shows the safety of this type of cell therapy and is the basis for TCB’s next steps in the allogeneic cell therapy sector."

Dr. Jan Vydra, Institute Of Hematology And Blood Transfusion, commented, "The results of our phase I clinical trial of γδ T cell immunotherapy of advanced AML support further research and development of this cell therapy platform, as it was shown to be both safe and feasible in this setting."

"This marks the first publication generated by TC Biopharm, a hallmark moment for our company and our team to be recognized within the industry," said Bryan Kobel, CEO of TC BioPharm. "I’d like to thank Dr. Vydra for all his hard work running the study and our former clinical director, Tomasz Zaremba, as well as Angela Scott, Dr. Mike Leek, Dr. Sebastian Wanless, Dr. Emilio Cosimo and the rest of the contributors. We look forward to additional publications in the future from our team."

Anixa Biosciences Announces Formation of Breast Cancer Clinical Advisory Board

On February 21, 2023 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported the formation of its Breast Cancer Clinical Advisory Board comprising preeminent experts across the breast cancer research and clinical development fields (Press release, Anixa Biosciences, FEB 21, 2023, View Source [SID1234627486]). This represents another milestone as the Company prepares for the next steps in advancing its breast cancer vaccine.

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"We are privileged to have the opportunity to work with leading experts in the breast cancer field who have extensive experience in and understanding of the clinical development of treatments and preventions for breast cancer," stated Amit Kumar, Ph.D., Chairman and CEO of Anixa. "Working with these individuals will better equip Anixa to plan and prepare for future clinical trials of our breast cancer vaccine."

The Anixa Biosciences Breast Cancer Clinical Advisory Board is comprised of the following members:

Arnold Baskies, MD, FACS, is a specialist in surgical oncology and general surgery, affiliated with Virtua Health Systems. He is former Chairman of the National Board of Directors of the American Cancer Society and current Chair of the society’s Global Cancer Control Advisory Council. He is a member of the Global Breast Cancer Initiative, World Health Organization (WHO), and Director and Scientific Advisory Board Member of Anixa Biosciences.

G. Thomas Budd, MD, FACP, is a specialist in breast cancer and the principal investigator of the Cleveland Clinic and Anixa partnered Phase 1 trial of the Breast Cancer Vaccine. He is Professor of Medicine in the Department of Hematology and Medical Oncology, Taussig Cancer Center, Cleveland Clinic Cancer Center, and Professor in the Department of Medicine, School of Medicine and member of the Immune Oncology Program, Case Comprehensive Cancer Center. He is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Lisa H. Butterfield, Ph.D., is a tenured academician (UCLA and University of Pittsburgh) and former President of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). She is an Adjunct Professor of Microbiology and Immunology at UCSF, a member of the UCSF Helen Diller Family Comprehensive Cancer Center, Cancer Immunotherapy, and core faculty at the Herbert Perkins Cellular Therapy and Transfusion Medicine Fellowship. She is a member of the AACR (Free AACR Whitepaper) Cancer Immunology Working Group Steering Committee, and a member and Chair of the U.S. Food and Drug Administration (FDA) Cellular, Tissues and Gene Therapies Advisory Committee.

Brian Czerniecki, MD, Ph.D., is the Chair and Senior Member in the Moffitt Cancer Center Department of Breast Oncology and a renowned surgeon and physician scientist investigating the development of vaccines for the prevention of breast cancer and other solid tumors. He is recognized nationally for his contribution to the development of sentinel lymph node mapping. He has published over 100 scientific articles and is the recipient of numerous grants for his research.

Brian Leyland-Jones, MBBS, MD, Ph.D., FACP, FRCPC, is a pre-eminent clinical trialist in oncology and the recipient of numerous awards. He is the Chief Medical Officer of AIM-HI Accelerator Fund, OTraces, and the N OF 1 Mission. In addition, he is a Scientific Advisory Board Member of the National Foundation for Cancer Research and NED Biosystems, Inc. He is the CSO of The Darwin Foundation, collectively devoted to the implementation of prevention and cure of malignancy globally, and Director Emeritus for the WIN (Worldwide Innovative Networking in personalized cancer medicine) Consortium.

Hope Rugo, MD, FASCO, is a leader and specialist in breast cancer research and recipient of numerous awards. She is Professor, Department of Medicine (Hematology/Oncology), and Director, Breast Oncology and Clinical Trials Education, at the UCSF Helen Diller Family Comprehensive Cancer Center. She is Co-chair of the Triple Negative Working Group, a member of the Translational Breast Cancer Research Consortium (TBCRC), Alliance Breast Committee of the Alliance for Clinical Trials in Oncology (formerly CALGB), and a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

Pamela D. Garzone, Ph.D., Anixa’s Chief Development Officer, who recruited and will chair the Clinical Advisory Board stated, "We are looking forward to advice and guidance from the world’s foremost breast cancer thought leaders as we design and advance the clinical trials for our breast cancer vaccine."

About Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences.

Devyser Diagnostics AB publishes Year-End Report for the period January to December 2022

On February 21, 2023 Devyser Diagnostics further strong organic growth was reported for the year and quarter. Efforts to build an international marketing and sales organization are starting to pay off (Press release, Devyser Diagnostics, FEB 21, 2023, View Source [SID1234627482]).

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"I am confident that we will achieve our important financial target of generating an operating margin of more than 20% starting sometime in 2024/2026."

Fredrik Alpsten, CEO, Devyser

Quarter October-December 2022

Net sales amounted to SEK 34.2 million (24.5), corresponding to a 39.5% increase. Adjusted for exchange rate fluctuations, net sales increased by 29.8%.
Gross profit totaled SEK 27.2 million (18.5), corresponding to a gross margin of 79.5% (75.3).
The operating loss (EBIT) amounted to SEK -25.9 million (-13.9).
The loss after tax totaled SEK -16.7 million (-10.6).
Earnings per share before and after dilution amounted to SEK -1.04 (-0.87).
Cash flow from operating activities stood at SEK -13.4 million (-5.9).
The period from January to December 2022

Net sales amounted to SEK 126.6 million (93.5), corresponding to a 35.4% increase. Adjusted for exchange rate fluctuations, net sales increased by 29.0%.
Gross profit totaled SEK 103.4 million (71.9), corresponding to a gross margin of 81.7% (76.9).
The operating loss (EBIT) amounted to SEK -52.0 million (-21.2).
The loss after tax totaled SEK -46.0 million (-20.7).
Earnings per share before and after dilution amounted to SEK -2.89 (-1.85).
Cash flow from operating activities stood at SEK -40.5 million (-16.5).
The Board proposes no dividend for 2022.
Important events during the quarter

CLIA lab to be set up in the US

Devyser will set up a CLIA laboratory in Atlanta, Georgia, USA. The CLIA lab will allow customers to send their samples to Devyser, which will then perform the diagnostic tests and provide customers with the test results. These services should be available from the second quarter of 2023.

Strengthening of operations in North America

In November, John Murad took over as Vice President and General Manager of the US subsidiary Devyser Inc. John Murad has more than 20 years’ experience from leading positions in the pharmaceutical and diagnostics industry.

Market maker

Carnegie Investment Bank was retained as the company’s market maker on November 1, 2022.

Important events after the end of the quarter

Provision due to retroactive payback levy

As a result of the newly introduced payback levy in Italy, a SEK 6.4 million provision has been made in the year-end close for costs in Italy for 2015 to 2018, and for estimated costs for 2019 to 2022. See Note 7 on page 16.

Annual report and annual general meeting

Devyser’s annual report will be published on April 4, 2023. The Board of Directors has decided that the annual general meeting will be held on May 10, 2023, in Stockholm. Invitation will be given in due course.

This report and previous financial reports as well as press releases are available on the company’s webpage www.devyser.com.

Presentation

The report will be presented at an audiocast at 09:00 CET today. More information and links are available on View Source

This information is information that Devyser Diagnostics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was submitted for publication, through the agency of the contact persons below, on February 21, 2023, at 07:30 CET.

For more information, please contact:

Fredrik Alpsten, CEO
E-mail: [email protected]
Tel: +46 706 673 106

Sabina Berlin, CFO
E-mail: [email protected]
Tel: +46 739 519 502