On November 23, 2020 ImmunityBio, a privately-held immunotherapy company, reported the publication in Cancer Immunology, Immunotherapy of preclinical data demonstrating that ImmunityBio’s AnktivaÔ (IL-15 superagonist also known as N-803) improves interferon-gamma (IFN-g) production and killing of tumor of cells in vitro and in vivo by CD34+ progenitor-derived natural killer (NK) cells (Press release, Altor BioScience, NOV 23, 2020, View Source [SID1234571563]). Anktiva is currently being evaluated in late-stage clinical trials in combination with NantKwest’s (NASDAQ: NK) NK cell therapies for multiple indications including metastatic pancreatic cancer, triple negative breast cancer (TNBC), bladder cancer and lung cancer.

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"While allogeneic NK cell therapy is a promising and potentially paradigm-shifting approach for cancer immunotherapy, there are still considerable challenges remaining in the field," said Patrick Soon-Shiong, M.D., Chairman and CEO of ImmunityBio. "One way to boost NK cell function is through the use of IL-15, however, its short in vivo half-life limits its utility in the clinic. Anktiva was developed to overcome the limitations of IL-15 to fully unleash the potential of NK cell immunotherapy. These preclinical data are an important step forward in demonstrating the potential of Anktiva to boost NK cell functionality by increasing the production of key cytokines and improving killing properties across diverse in vitro and in vivo cancer models. Importantly, these data provide validating proof-of-mechanism that support the encouraging clinical data observed to date when combining Anktiva with NantKwest’s NK cell therapies across a range of challenging solid tumors with poor prognoses. We look forward to the continued evaluation of Anktiva as a promising IL-15 superagonist, which may be broadly applied to improve NK cell-based immunotherapies."

Key findings from the study performed under the guidance of Prof. Harry Dolstra at the Radboud Institute for Molecular Life Sciences in The Netherlands, reported in the publication titled, "IL‐15 superagonist N‐803 improves IFN-g production and killing of leukemia and ovarian cancer cells by CD34+ progenitor‐derived NK cells" include:

Anktiva induces HPC-NK cell proliferation in a dose-dependent manner;
Treatment with Anktiva increases IFN-g production in CD34+ hematopoietic progenitor-derived NK cells (HPC-NK) stimulated with leukemia cells lines and improves killing of primary AML samples from patients;
Anktiva improves serial killing properties of HPC-NK cells against leukemia as measured by live cell imaging with single cell resolution;
Anktiva increases CXCL10 production and improves long-term HPC-NK cell-mediated killing in ovarian cancer spheroids, an ovarian cancer model which mimics three-dimensional growth of ovarian cancer in vivo;
HPC-NK cells combined with Anktiva and nanogam (human immunoglobulins) show anti-tumor effects in a human ovarian cancer mouse model;
Together, these data point to the clear potential of AnktivaÔ to improve efficacy of NK cell-based immunotherapies by promoting HPC-NK cell expansion and functionality.

On November 23, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that an IND (Investigational New Drug) application for its prophylactic breast cancer vaccine has been filed with the U.S. Food and Drug Administration (Press release, Anixa Biosciences, NOV 23, 2020, View Source [SID1234571562]).

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This vaccine technology was invented by a research team from Cleveland Clinic, led by Dr. Vincent Tuohy, 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. Anixa has a worldwide, exclusive license to this technology.

The technology takes advantage of self-proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein, alpha-lactalbumin, is expressed only in the mammary glands during lactation and then disappears once lactation ceases. Dr. Tuohy discovered that this protein is abnormally expressed again when a woman contracts breast cancer, especially Triple Negative Breast Cancer (TNBC), the most deadly form of this disease. Dr. Tuohy postulated that if women could be immunized against this protein after their childbearing years, the immune system could be trained to destroy cancer cells as they arise while ignoring normal cells that no longer express this protein, thus making it difficult for the cancer to gain critical mass. Early studies to test this theory demonstrated highly significant prevention of breast cancer in animal models.

The technology is being developed at Cleveland Clinic with funding from the U.S. Department of Defense. The funding is expected to enable completion of two Phase 1 clinical trials.

"This has the potential to be a paradigm-shifting clinical study," said Dr. Tuohy. "If our data demonstrate results similar to the pre-clinical studies, this vaccine could have a significant impact on breast cancer, the most common malignancy in women. Furthermore, the way we think about controlling breast cancer may completely change."

"We look forward to moving this novel technology into the clinical stage of development," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "If the data in humans is comparable to the data in animals, Dr. Tuohy’s ‘retired’ protein hypothesis will usher in a new way to prevent breast cancer, as well as other types of tumors."

"This initial clinical trial will be with women who have been diagnosed with high-risk early stage TNBC and are receiving standard of care at Cleveland Clinic," said Dr. G. Thomas Budd, Department of Medical Oncology at the Taussig Cancer Center at Cleveland Clinic, and the Clinical Investigator who will be conducting the trial. "We look forward to commencing the Phase 1 clinical trial and evaluating these patients."

On November 23, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it is updating 2020 financial guidance to reflect the signing of a global collaboration and license agreement with Horizon Therapeutics plc (Press release, Halozyme, NOV 23, 2020, View Source [SID1234571561]).

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The Company is raising full year 2020 revenue guidance to $265 million to $275 million to reflect incremental anticipated revenues as Halozyme and its partners continue to execute on a number of fourth quarter revenue-related activities.

The Company now expects:

Revenues of $265 million to $275 million, increased from prior guidance of $250 million to $260 million, representing growth of 35% to 40% over prior year revenues;

Earnings per share on a GAAP basis of $0.90 to $0.95, increased from prior guidance of $0.80 to $0.85.

On November 23, 2020 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, reported that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will participate in a virtual fireside chat at the 32nd Annual Piper Sandler Virtual Healthcare Conference taking place between December 1-3, 2020, as well as in a panel discussion at the 3rd Annual Evercore ISI HealthCONx Conference, which is also being held from December 1-3, 2020 (Press release, NeuBase Therapeutics, NOV 23, 2020, View Source [SID1234571560]).

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A webcast of the Piper Sandler fireside chat will be available on the Piper Sandler conference site from November 23rd to December 3rd. In addition, this webcast will also be available on the NeuBase website, www.neubasetherapeutics.com, for 90 days following the recording of the presentation.

On November 23, 2020 ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, reported that L1 Capital Global Opportunities Master Fund ("L1") has converted $200,000 (plus accrued but unpaid interest) of the convertible security issued pursuant to the convertible security deed dated 10 June 2020, details of which were announced by the Company on 11 June 2020 (Press release, ImmuPharma, NOV 23, 2020, View Source [SID1234571559]). The conversion price is 11p per share resulting in the issue by the Company of 1,430,510 new ordinary shares of 10p each in the Company ("New Ordinary Shares").

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New Ordinary Shares and Admission

The New Ordinary Shares have been allotted today and are issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued ordinary shares.

An application will be made for the New Ordinary Shares to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") and Euronext Growth Brussels ("Admission"). It is anticipated that Admission to AIM will occur at 8.00am on or around Thursday 26 November 2020.

The New Ordinary Shares represent 0.58% of the Company’s enlarged issued share capital.

Total Shares in Issue

For the purposes of the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority ("DTR"), the Board of ImmuPharma hereby notifies the market that following Admission, the Company’s total issued share capital will consist of 247,716,315 Ordinary Shares with a nominal value of 10p each.

This figure may be used by Shareholders as the denominator for the calculations by which they may determine if they are required to notify their interest in, or a change to their interest in, the Company under the DTR.

The allotment of the New Ordinary Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s Annual General Meeting held on 18 June 2020.