On November 19, 2020 In this worldwide exclusive agreement, Carina Biotech reported that it will create Chimeric Antigen Receptor T cells (CAR-T cells) and other adoptive cell therapies to the leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5) using the first-in-class humanised antibody BNC101 developed by Bionomics Limited (Press release, Carina Biotech, NOV 19, 2020, View Source [SID1234571346]).

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LGR5 is a molecular marker that is highly expressed on cancer stem cells within solid tumours including colorectal, breast, pancreatic, ovarian, lung, liver and gastric cancers.

This will be Carina’s latest CAR-T cell candidate in a growing pipeline, underpinned by its proprietary platform that produces "supercharged" CAR-T cells. CAR-T cell therapy is a revolutionary new treatment option for cancer that harnesses the power of the immune system. CAR-T cells are genetically modified immune cells (T cells) that are targeted at certain molecular markers found on cancer cells.

Carina Biotech’s CEO Dr Deborah Rathjen said, "Cancer stem cells, or CSCs, seem to have some kind of resistance to anti-cancer therapies. Anti-cancer drugs can kill proliferating cancer cells but CSCs survive – hence some cancers will respond to initial treatment but inevitably the cancer returns".

"We are excited to have done this deal with Bionomics given the wealth of clinical data available on BNC101. By creating a CAR-T cell that targets CSCs, we will be able to get to the core of some cancers, to kill those cells that enable cancers to keep bouncing back. We hope that LGR5-targeting CAR-T cells will go a long way to achieving our vision – a future that defeats cancer."

This is the third commercial deal for Carina in three months, following the sale of its first proprietary CAR-T cell to UK company Biosceptre, and a deal with Sydney immuno-oncology company Glytherix.

"Our serial-killing CAR-T cells do what so far has been very difficult to do – travel to the site of the cancer and disrupt the immunosuppressive tumour microenvironment. This allows for our CAR-T cells to get up close to cancer cells for potent and repeated killing action," says Dr Rathjen.

Carina’s platform also enables efficient CAR-T manufacture – reducing manufacturing time, improving yield and quality with CAR-T delivery efficiency of more than 90%.

Under the worldwide, exclusive License Agreement, Carina will fund all research and development activities. Bionomics is eligible to receive up to A$118 million in clinical and development milestones plus royalty payments if Carina fully develops and markets the new therapy. In the event that Carina sub-licenses the CAR-T treatment, Bionomics is eligible to receive sub-licensing revenues.

On November 19, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that the Company has entered into separate, privately negotiated transactions (the "Agreements") with certain holders of its existing 2.25% Convertible Senior Notes due 2024 (the "2024 Notes") to repurchase approximately $83 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of an amount of cash estimated to be the sum of (i) approximately $110 million based on the Company’s November 18, 2020 closing stock price of $86.91 per share, (ii) an amount based in part on the daily volume-weighted average prices per share of the Company’s common stock during a five-trading day pricing period following execution of the Agreements and (iii) accrued and unpaid interest (Press release, Neurocrine Biosciences, NOV 19, 2020, View Source [SID1234571401]). The 2024 Notes repurchases are expected to close on December 2, 2020, subject to customary closing conditions. Such repurchases of the 2024 Notes could affect the market price of the Company’s common stock.
This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

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On November 19, 2020 Oncopeptides reported that (Press release, Oncopeptides, NOV 19, 2020, View Source [SID1234571424])

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Financial overview July 1 – September 30, 2020
Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 383.4 M (loss: 189.8)
Loss per share, before and after dilution, was SEK 5.71 (loss: 3.53)
On September 30 cash and cash equivalents amounted to SEK 1,251.6 M (1,122.3)
Significant events during the period July 1 – September 30, 2020
The FDA granted priority review of melflufen for patients with triple-class refractory multiple myeloma and set the PDUFA date to February 28, 2021
Patient enrolment in the pivotal phase 3 OCEAN study was completed including 495 patients
Patient enrolment for the phase 1/2 study in AL-amyloidosis began, this is the first study with melflufen in an indication outside multiple myeloma
The phase 2 PORT study evaluating alternative administration of melflufen and dexamethasone in multiple myeloma started
Oncopeptides further coordinated the global and US organizational structure and appointed Mohamed Ladha as General Manager of the US Business Unit
Significant events after the reporting period
Oncopeptides announced that the company intends to submit a conditional marketing authorization application for melflufen in the EU
Oncopeptides entered into a €40 M loan agreement with the European Investment Bank (EIB)
An IND application was submitted to the FDA to initiate clinical studies with OPD5, Oncopeptides’ second drug candidate

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on November 19, 2020.

On November 19, 2020 Novocure (NASDAQ: NVCR) reported 43 presentations on Tumor Treating Fields will be featured at the Society for Neuro-Oncology 2020 Virtual Annual Meeting on November 19 through November 21 (Press release, NovoCure, NOV 19, 2020, View Source [SID1234571440]). The presentations include two oral presentations and cover a broad and growing range of topics, with 36 of the 43 presentations prepared by external authors.

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The oral presentations on Tumor Treating Fields include:

Data from EF-19, a post-approval registry study of Tumor Treating Fields in recurrent glioblastoma (GBM), supporting results from Novocure’s EF-11 phase 3 pivotal trial in recurrent GBM and confirming the effectiveness and safety of Tumor Treating Fields as a monotherapy.
Therapeutic implications of conditional vulnerabilities caused by Tumor Treating Fields exposure in novel combination therapies for non-small cell lung cancer (NSCLC) and brain metastases from NSCLC. Study results suggest that the combination of cisplatin and etoposide together with Tumor Treating Fields may be beneficial for NSCLC patients and patients with brain metastases from NSCLC.
Highlighted topics among poster presentations include the TRIDENT study evaluating Tumor Treating Fields in combination with radiation therapy and temozolomide, long-term survival in GBM patients after Tumor Treating Fields therapy, Tumor Treating Fields in combination with immunotherapy, a subgroup analysis of the EF-14 trial focusing on efficacy of Tumor Treating Fields in elderly patients, optimizing use of Tumor Treating Fields during Covid-19, and safety and quality of life of GBM patients treated with Tumor Treating Fields in China.

"From our first presentation at the SNO Annual Meeting in 2008 to today, we and our external partners have shared nearly 300 presentations on Tumor Treating Fields, strengthening our foundational understanding of our therapy and our science every year," said Dr. Ely Benaim, Novocure’s Chief Medical Officer. "It remains an honor for us to participate and engage with our scientific colleagues at one of the most important neuro-oncology conferences worldwide. We look forward to gathering virtually to share our work and learn from our partners."

Oral Presentations

(Abstract #: CBIO-01) Therapeutic implications of conditional vulnerabilities caused by Tumor Treating Fields exposure in novel combination therapies for non-small cell lung cancer and brain metastases from non-small cell lung cancer. N, Karanam, M. Story. (Experimental and Translation Sciences Session I)

(Abstract #: CTNI-77) EF-19: a post-approval registry study of Tumor Treating Fields (TTFields) in recurrent glioblastoma (rGBM). J. Zhu, R. O’Donnell, S. Goldlust, Z. Ram. (Clinical Trials Session I)

Poster Presentations

(Abstract #: CTIM-17) Phase I study of the safety and immunogenicity of personalized neoantigen vaccines and Tumor Treating Fields in patients with newly diagnosed glioblastoma. J. Kodysh, A. Rubinsteyn, A. Blazquez, J. Mandeli, N. Bhardwaj, A. Hormigo. (Clinical trials: Immunologic)

(Abstract #: NIMG-37) Delayed pseudoprogression in two patients undergoing TTFields treatment for newly diagnosed glioblastoma. A. Lowman, S. Hurrell, S. Bobholz, J. Connelly, E. Cochran, W. Mueller, S. McGarry, M. Brehler, P. LaViolette. (Neuro-imaging)

(Abstract #: INNV-10) Effects of TTFields Usage and Duration of Usage on Cellularity and Ki67 Distributions at Autopsy. S. Bobholz, A. Lowman, J. Connelly, E. Cochran, W. Mueller, S. McGarry, M. Brehler, P. LaViolette. (Innovations in patient care)

(Abstract # NCOG-26) Impact of Gender on Tumor Treating Fields Compliance in Patients with Glioblastoma. L. Karpf, S. Chawla, L. Desiderio, S. Mohan. (Outcome measures and neuro-cognitive outcomes)

(Abstract #: CTNI-21) Scalp sparing radiation with concurrent temozolomide and tumor treatment fields (SPARE) for patients with newly diagnosed glioblastoma. R. Miller, A. Song, A. Ali, V. Bar-Ad, N. Martinez, J. Glass, D. Andrews, K. Judy, J. Evans, C. Farrell, M. Werner-Wasik, I. Chervoneva, M. Ly, J. Palmer, H. Liu, W. Shi. (Clinical trials: Non-immunologic)

(Abstract #: CTIM-04) Updates for a phase 2 open-labeled study of pembrolizumab plus TTFields plus maintenance temozolomide in patients with newly diagnosed glioblastoma (2-THE-TOP). A. Ghiaseddin, S. Warren, A. Allen, D. Sampson, D. Chen, A. Sherman, V. Greene, M. Rahman, D. Tran. (Clinical trials: Immunologic)

(Abstract #: NCOG-52) Tumor Treating Fields in Meningioma. C. Mawrin. (Outcome measures and neuro-cognitive outcomes)

(Abstract #: CTNI-59) First safety analysis of anaplastic meningioma patients treated with Tumor Treating Fields (TTFields). C Mawrin. (Clinical trials: Non-immunologic)

(Abstract #: CTNI-71) TTFields in routine clinical care of newly diagnosed GBM patients in Germany – first report on the fully enrolled TIGER study population. O. Bähr, G. Tabatabai, R. Fietkau, R. Goldbrunner, M. Glas. (Clinical trials: Non-immunologic)

(Abstract #: CTNI-46) A Phase II Trial of Tumor Treating Fields (TTFields) Concomitant with Radiosurgery for the Treatment of Recurrent, Bevacizumab-naïve Glioblastoma. M. Harat, M. Blok, M. Adamczak-Sobczak, P. Szymanski, I. Miechowicz, B. Malkowski. (Clinical trials: Non-immunologic)

(Abstract #: CTNI-79) PriCoTTF Trial: A phase I/II trial of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma. S. Kebir, L. Lazaridis, T. Schmidt, C. Oster, D. Pierscianek, N. Guberina, C. Kleinschnitz, M. Proescholdt, P. Hau, A. Grosu, U. Sure, B. Scheffler, M. Stuschke, M. Glas. (Clinical trials: Non-immunologic)

(Abstract #: RTID-06) Enhancing Tumor Treating Fields therapy for recurrent glioblastoma with targeted and individualized skull remodeling surgery. A multi-center randomized phase 2 trial. N. Mikic, A. Korshoej. (Randomized Trials in Development)

(Abstract #: RTID-12) Phase 2 trial of Tumor Treating Fields (TTFields) plus radiation therapy (RT) plus temozolomide (TMZ) compared to RT plus temozolomide in newly diagnosed glioblastoma (ndGBM). R. Grossman, D. Limon, F. Bokstein, C. Harosh, D. Blumenthal, Z. Ram. (Randomized Trials in Development)

(Abstract #: NIMG-58) The effect of cell confluence on the distribution of Tumor Treating Fields. T. Marciano, S. Levi, Z. Bomzon. (Neuro-imaging)

(Abstract #: NIMG-65) Study of local perturbation in computational modelling on Tumor Treating Fields (TTFields) therapy. O. Zeevi, Z. Bomzon, T. Marciano. (Neuro-imaging)

(Abstract #: INNV-05) Tumor Treating Fields (TTFields) treatment planning for a patient with astrocytoma in the spinal cord. J. De Los Santos, S. Arvatz, O. Zeevi, S. Levi, Z. Bomzon, T. Marciano. (Innovations in patient care)

(Abstract #: CBIO-09) Intratumoral heterogeneity of dielectric properties in glioblastoma. M. Proescholdt, A. Haj, C. Doenitz, N. Schmidt, Z. Bomzon. (Cell biology (cell cycle regulation, DNA repair/modulation))

(Abstract #: RBIO-04) New Therapeutic Delivery Methods for Tumor-Treating Fields for Higher Efficacy. K. Carlson, Z. Bomzon, J. Arle. (Radiobiology)

(Abstract #: COVD-17) Tumor Treating Fields for glioblastoma therapy during the COVID-19 pandemic: Expert consensus on use and experience. N. Gatson, J. Barnholtz-Sloan, J. Drappatz, R. Henriksson, A. Hottinger, P. Hinoul, C. Kruchko, V. Puduvalli, D. Tran, E. Wong, M. Glas. (Innovations in patient care)

(Abstract #: COVD-04) Real-world perspectives: Tumor Treating Fields (TTFields) utility to optimize treatment of patients with glioblastoma (GBM) amidst COVID-19 pandemic. P. Frongillo, M. Shackelford, L. Rain. (Innovations in patient care)

(Abstract #: NCOG-36) First health utilities of glioblastoma patients using TTFields treatment. G. Chavez, C. Proescholdt. (Outcome measures and neuro-cognitive outcomes)

(Abstract #: EXTH-76) The inovivo system: a novel preclinical tool for in vivo delivery of Tumor Treating Fields (TTFields). S. Davidi, R. Blat, A. Shteingauz, Y. Porat, M. Giladi, U. Weinberg, Y. Palti. (Preclinical Experimental Therapeutics)

(Abstract #: EXTH-69) Increased cancer cell permeability following Tumor Treating Fields (TTFields) application in vitro. T. Voloshin, Y. Porat, N. Kaynan, A. Klein-Goldberg, R. Paz, A. Volodin, M. Giladi, U. Weinberg, Y. Palti. (Preclinical Experimental Therapeutics)

(Abstract #: TAMI-04) Tumor Treating Fields (TTFields) hinder glioma cell motility through regulation of microtubule and actin dynamics. T. Voloshin, R. Schneiderman, A. Volodin, R. Shamir, N. Kaynan, E. Zeevi, L. Koren, A. Klein-Goldberg, R. Paz, M. Giladi, Z. Bomzon, U. Weinberg, Y. Palti. (Tumor Microenvironment/Angiogenesis/Metabolism/Invasion)

(Abstract #: EXTH-31) Increasing Tumor Treating Fields (TTFields) efficacy by targeting the G2 cell cycle checkpoint with combined Wee1 or Chk1 inhibitors in glioblastoma cell lines. P. Slangen, M. de Gooijer, M. van Geldorp, O. van Tellingen, G. Borst. (Preclinical Experimental Therapeutics)

(Abstract #: EXTH-33) Valproic acid enhances anti-proliferative effects of Tumor Treating Fields on patient-derived gliosarcoma cells in vitro. S. Michelhaugh, S. Mittal. (Preclinical Experimental Therapeutics)

On November 19, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835), a biotechnology company focused on developing first-in-class therapeutics targeting post-translational modifying enzymes, reported that it will publish its third quarter business update for the period ended September 30, 2020 on Thursday, November 26, 2020, in the form of an interim management report (Press release, Vivoryon Therapeutics, NOV 19, 2020, View Source [SID1234571403]).

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