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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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 SynOx Therapeutics Ltd ("SynOx"), a clinical stage biopharmaceutical company, reported the closing of a €37 million Series A financing co-led by HealthCap and Medicxi and joined by investors Forbion and Gimv (Press release, SynOx Therapeutics, NOV 19, 2020, View Source [SID1234571398]).

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SynOx, a spin out of Celleron Therapeutics Ltd ("Celleron"), secured exclusive world-wide rights for the clinical development, manufacturing and commercialization of emactuzumab under a licence agreement with Roche. The financing will enable SynOx to continue the development of emactuzumab, for the treatment of diffuse tenosynovial giant cell tumours ("TGCT"), also known as pigmented villonodular synovitis ("PVNS"), and other indications.

Emactuzumab is a clinical-stage humanised IgG1 CSF-1R targeted antibody designed to target and deplete macrophages in the tumour tissue. It has shown a favourable safety profile in patients and encouraging efficacy for TGCT, a rare disease characterised by the proliferation of macrophages in the synovial tissue in the joint and tendon sheath.

Professor Nick La Thangue, Chief Executive Officer of SynOx, commented: "We are very excited to be developing emactuzumab as a breakthrough treatment for the extreme and debilitating effects of TGCT. SynOx will be focused on generating all necessary data to register this new therapy in a time- and cost-efficient way."

Jacob Gunterberg, Partner at HealthCap, said: "With the objective to develop a new therapy for TGCT patients who suffer from a significantly reduced quality of life, the involvement in the establishment and investment in SynOx fits very well with our investment strategy."

Francesco De Rubertis, Partner at Medicxi, commented: "We are excited to support SynOx in its continued development of emactuzumab, an agent which has demonstrated profound efficacy in over 60 TGCT patients treated to date."

The SynOx Board will consist of Jacob Gunterberg (HealthCap), Francesco De Rubertis (Medicxi), Dirk Kersten (Forbion), Michaël Vlemmix (Gimv), Declan Doogan (chairman of Celleron) and Nick La Thangue.

On November 19, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it enrolled the final two patients into the second safety cohort of its Phase 1 Archer-1 (LYMRIT 37-07) trial investigating safety and preliminary efficacy of Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab in 2nd-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 19, 2020, View Source [SID1234571374]).

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The dosing regimen in this cohort is a single administration of 15 MBq/kg Betalutin preceded by 40mg lilotomab, followed by 375 mg/m2 rituximab once per week for four weeks.

Data from this cohort is expected in H1’2021 and will be analysed alongside the data generated from the first cohort of patients receiving 10 MBq/kg Betalutin/40mg lilotomab.

As announced in April 2020, Archer-1 is expected to be paused pending this analysis, which is expected to inform plans for the further development of Betalutin development in 2L FL. The Company’s primary focus for its resources is on the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line FL (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "We are pleased to complete patient enrolment into the second safety cohort of Archer-1. We look forward to the results from this cohort in H1’2021, which will add to our understanding of Betalutin use in FL patients. The data will also inform our thinking towards further development strategies for Betalutin in broader FL populations than that being investigated in our PARADIGME trial in 3L FL."

About Archer-1

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial designed to assess the safety and preliminary activity of combining the CD37-targeted radioimmunoconjugate Betalutin with the CD20-targeted immunotherapy rituximab in patients with relapsed/refractory (2L) FL who have received one or more prior therapies.

Rituximab was approved for the treatment of non-Hodgkin’s lymphoma (NHL), including FL, more than 20 years ago and is the current standard of care. It is administered to patients with newly diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to rituximab, thus alternative targets and new treatments are important.

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.