On October 17, 2022 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) reported that it will host a conference call (in English) for investors, analysts and media on Thursday, October 20, 2022, at 15:00 CET / 9:00 am ET (Press release, Alligator Bioscience, OCT 17, 2022, View Source [SID1234622048]). Alligator will publish the company’s interim report on Thursday, October 20, 2022, at 8:00 CET / 2:00 am ET.

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CEO Søren Bregenholt and CFO Marie Svensson will present the interim report for the period January – September 2022 followed by a Q&A session.

The conference call will be broadcast live on the web and can be accessed via the link:

The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on October 17, 2022.

On October 17, 2022 Patrys Limited (ASX: PAB, "Patrys" or the "Company"), a therapeutic antibody development company, reported that new preclinical data for its full-sized IgG antibody, PAT-DX3 (Press release, Patrys, OCT 17, 2022, View Source [SID1234622042]). Results from a new study support the potential to use deoxymabs to deliver small molecule therapeutics and gene editing technologies across the blood-brain barrier to treat various neurological targets and conditions.

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This study was conducted by a leading global contract research organisation which radioactively labelled both PAT-DX3 and a control antibody to monitor their relative uptake into various tissues over the course of four days. The study’s goal was to establish the distribution of PAT-DX3 in a range of different tissues to assist in the selection of future targets and payloads for future potential antibody drug conjugate (ADC) development programs.

The study found that the uptake into the brain (per cubic centimetre) of PAT-DX3 was 3–4 fold higher than that of a control antibody soon after injection, and this persisted for the duration of the study period. This compares favourably to antibodies that have been specifically engineered for enhanced blood-brain barrier crossing that have reported brain uptake values 2–3 fold higher than control antibodies1. The area under the curve (AUC) of PAT-DX3, a measurement of overall drug exposure, was approximately seven times greater for PAT-DX3 than it was for the control antibody in this study, with significant concentrations of antibody still in the brain after four days.

The ability of PAT-DX3 to cross the blood-brain barrier is consistent with current data which indicates that Patrys’ deoxymabs enter cells using the ENT2 transporter protein; a protein which is highly expressed in the neural vasculature. Elevated levels of PAT-DX3 were found in brain tissue but not in a range of other tissues including the lung, the liver and the thyroid adding further support to this proposed mechanism for crossing the blood-brain barrier. 1 Kouhi, A. et al. Brain Disposition of Antibody-Based Therapeutics: Dogma, Approaches and Perspectives. Int. J. Mol. Sci. 2021, 22, 6442. View Source

Patrys Chief Executive Officer and Managing Director, Dr. James Campbell said: "This is an important result that opens up a range of potential applications for Patrys and its development partners. PAT-DX3 appears to out-perform antibodies specifically developed by other companies for the delivery of payloads to brain tissue. Unlike deoxymabs, none of these other antibodies are able to deliver their payloads into the cell and the cell nucleus. These properties open up a range of applications for using deoxymabs to deliver small molecule therapeutics and gene editing technologies directed to various neurological targets and conditions. As we advance PAT-DX1 towards the first clinical trial in cancer patients in H2 CY2023, it is very exciting for Patrys to be able to identify additional applications for PAT-DX3 that may open up new development or partnering opportunities for the Company."

On October 16, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that a three-judge arbitration panel has issued a final decision in a dispute with Alkermes PLC (Nasdaq: ALKS) regarding licensing royalties relating to AMPYRA (dalfampridine). Acorda was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes (Press release, Acorda Therapeutics, OCT 16, 2022, View Source [SID1234622052]). In addition, as a result of the panel’s ruling, Acorda will no longer have to pay Alkermes any royalties on net sales for license and supply of AMPYRA, and Acorda is now free to use alternative sources for supply of AMPYRA, which the Company has already secured.

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"This award will allow Acorda to obtain more competitive market rates for the supply of AMPYRA, significantly reducing our cost of goods and meaningfully increasing the product’s value to the company," said Ron Cohen, M.D., Acorda’s President and CEO. "This will also help Acorda to continue to provide its customary high level of support for Ampyra, ensuring that as many people with MS as possible may benefit from it."

Acorda filed an arbitration demand with the American Arbitration Association in July 2020 after the parties were unable to resolve their dispute over license and supply royalties following the 2018 expiration of an Alkermes patent relating to AMPYRA.

On October 16, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an investigational new drug (IND) application to commence a pivotal Phase III registration study of TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), for the imaging of prostate cancer using Positron Emission Tomography (PET) that will bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA) (Press release, Telix Pharmaceuticals, OCT 16, 2022, View Source [SID1234622046]).

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The IND application was submitted in partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix’s partner in the Greater China region. The bridging study is required to provide data obtained in a Chinese population to establish that the diagnostic efficacy of TLX591-CDx is equivalent in Chinese and Western populations. This study will enroll up to 110 patients with suspected recurrent prostate cancer and is anticipated to commence in Q1 2023. Positive data from this Phase III bridging study will support a future marketing authorisation application for TLX591-CDx (Illuccix) in China.

Dr David N Cade, CEO Telix Asia Pacific, said "Each year 115,000 Chinese men will be diagnosed with prostate cancer, which makes it the most rapidly rising cancer in terms of incidence and mortality in China. PSMA PET imaging has the potential to profoundly impact the management of this disease, enabling clinicians to detect prostate cancer right throughout the body. This new imaging modality is already recognised in leading clinical practice guidelines, and is being adopted as a standard of care in many parts of the world. We look forward to working closely with our partner Grand Pharma to bring this important product to market in China, where there is currently unmet medical need."

About Prostate Cancer in China

The Asia Pacific region comprises approximately one third of the world’s male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, "Western-style" lifestyle, the two main demographic trends driving increasing cancer incidence rates.

Consequently, the incidence of prostate cancer is increasing in many parts of the region.

In China, 115,000 men are diagnosed with prostate cancer each year, increasing by approximately 6% each year.1

In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is forecast to reach 1,110 by the end of 2022, compared with 133 in 2010.2

On October 16, 2022 Akeso’s 开坦尼 (Cadonilimab injection), a first-in-class PD-1/CTLA-4 bi-specific antibody independently developed by the Company, was included in the guidelines as the top recommended second-line immunotherapy for recurrent or metastatic cervical cancer (R/M CC) (Press release, Akeso Biopharma, OCT 16, 2022, View Source [SID1234622045]).

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As the globally first approved dual immune checkpoint bi-specific antibody, Cadonilimab is the first approved immuno-oncology drug for advanced cervical cancer treatment in China. It was granted marketing approval by the National Medical Products Administration (NMPA) at the end of June 2022, addressing the unmet market demand for immunotherapy for cervical cancer. Cadonilimab has been included in the Guidelines for Cervical Cancer Treatment as the top recommendation by CSCO only after 4 months since its approval, which would enable the clinical doctors in China to obtain a more extensive and in-depth understanding of the clinical efficacy of Cadonilimab, that will further help Cadonilimab to satisfy the patients’ needs more promptly and extensively by improving their survival benefit.

China has the world’s second-largest population of cervical cancer patients, with 110,000 new cases in 2020. Akeso is now conducting a phase III trial of Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M CC and has completed patient enrollment. In addition, a registrational/phase III trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is also ongoing.