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Targovax ASA: third quarter 2020 results

On November 5, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its third quarter 2020 results (Press release, Targovax, NOV 5, 2020, View Source [SID1234569886]).

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An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

RECENT HIGHLIGHTS

Announced that the ONCOS-102 and Imfinzi (durvalumab) trial successfully completed part 1 in colorectal cancer. The pre-defined disease control efficacy threshold in the colorectal cancer cohort was met and the part 2 has opened for recruitment of 14 additional patients.
Announced that an abstract on the mesothelioma trial has been accepted and will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, 9 -14 November 2020. The abstract presents the 12-month analysis of biomarkers and clinical outcome from the phase I/II trial in malignant pleural mesothelioma where ONCOS-102 is added to standard of care chemotherapy (pemetrexed / cisplatin). This analysis supports the data previously presented in June.
Completed a private placement, raising gross proceeds of approximately NOK 75 million (USD 8 million). The Private Placement attracted strong interest from existing shareholders and new institutional investors, both in the Nordics and internationally, and the transaction was oversubscribed multiple times.
Announced grant of European Patent no 3293201 by the European Patent Office. The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors until 2036.
Formed a new Scientific Advisory Board (SAB), consisting of a group of world-renowned experts in immuno-oncology research and drug development carefully selected to act as advisors to guide the Targovax R&D strategy.
Øystein Soug, CEO commented: "As the end of 2020 is approaching, we are entering a period of intensive data analysis and reporting from our ongoing ONCOS-102 clinical program. Important efficacy and immune marker readouts from our two Targovax-sponsored ONCOS-102 trials in mesothelioma and melanoma are due late in the year. In October we reported that the pre-defined threshold for clinical benefit was met in the colorectal cancer cohort of the ONCOS-102 and Imfinzi collaboration trial. The second part of this trial has now been opened for recruitment, and results are expected in about a year’s time. As we wrap up these phase I/II clinical trials, we are in parallel planning the next steps for ONCOS-102 development and expanding our pre-clinical pipeline to shape our future R&D programs."

Presentation
As a consequence of the Corona situation, there will not be a physical presentation of the results. Instead, we invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

Alligator Bioscience presents the CD40 antibody mitazalimab at the World Immunotherapy Congress 2020

On November 5, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that its CD40 targeting antibody mitazalimab will be presented at the World Immunotherapy Congress, November 2-6, 2020 (Press release, Alligator Bioscience, NOV 5, 2020, View Source [SID1234569885]). The presentation will include new benchmark data demonstrating that mitazalimab has the potential to be best-in-class in the CD40 field.

The new preclinical data include analyses of mitazalimab compared with analogues of the CD40 antibodies of key competitors. The comparison demonstrates the potent immune-activating properties and anti-tumor effects of mitazalimab.

Mitazalimab’s mode of action is clearly dependent on Fc-gamma-receptor engagement, resulting in a more tumor-selective immune-activation. This differentiation may translate into a superior risk-benefit profile in patients.

The presentation will also summarize previously released clinical data from the Phase I study performed by Janssen Biotech Inc. Mitazalimab shows a manageable safety profile both with and without corticosteroid premedication. A partial response was observed in one patient with renal cell cancer and 10 patients with different advanced cancers showed stable disease lasting ≥ 6 months. In addition, clinical biomarker data confirm proof of mechanism in patients.

"The solid clinical package from Phase I and the new favorable benchmark data to our key competitors further strengthen our belief in mitazalimab as a potent immunotherapy agent. Mitazalimab has demonstrated strong activity and superior tolerability, which probably reflects the fact that the antibody has been optimized for more tumor-selective effects", said Per Norlén, CEO at Alligator Bioscience. "We are now completing the clinical file for the submission of the CTA for the upcoming Phase Ib/II efficacy study in pancreatic cancer," he added.

Dr Peter Ellmark, VP Discovery, Alligator Bioscience will give an oral presentation with the title "Mitazalimab – a CD40 agonist to unleash CD40 in immuno-oncology" on November 5, 2020, at 12:50 p.m CET. For further information, please see View Source

Transgene Presents Its Individualized Immunotherapy, TG4050, at The Annual Neoantigen Based Therapies Summit

On November 5, 2020 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that its Executive Vice President and Chief Scientific Officer, Eric Quéméneur, Pharm.D., PhD, will present today at the virtual 5th Annual Neoantigen Based Therapies Summit (Press release, Transgene, NOV 5, 2020, View Source [SID1234569884]).

Presentation

Title: Viral Immunotherapy Meets AI Technology
Session: Clinical Translation – Utilizing Different Delivery Platforms to Enhance Clinical
Timing: November 5th at 11.45 am ET / 5.45 pm CET
Éric Quéméneur, Pharm.D., Ph.D., Executive VP and Chief Scientific Officer of Transgene, said: "Viral immunotherapy constitutes a very promising modality based on harnessing the natural capabilities of the immune system to target cancer cells. TG4050 is an individualized cancer vaccine based on our myvac technology that has the ability to elicit an immune response against up to 30 patient-specific tumor neoantigens. Our partnership with NEC enables us to benefit from its cutting-edge AI capabilities that allows us to select the best combination of neoantigens to include in TG4050 to induce a strong anti-tumor immune response. We are convinced that the success of TG4050, which is at the crossroad of immunotherapy and big data sciences, will herald the start of a new era in the fight against cancer."

The Neoantigen Based Therapies Summit is the leading end-to-end meeting dedicated to delivering the promise of accurate identification, prediction, and validation of neoantigens to develop highly efficacious vaccines and cell therapies.

About TG4050
TG4050 is an individualized cancer vaccine based on the myvac platform; it is based on an optimized viral platform for cancer vaccination and integrates NEC’s artificial intelligence capabilities. This therapeutic vaccine aims at stimulating the immune system of patients to induce a T-cell response against tumor-specific antigenic alterations, called neoantigens. These neoantigens are derived from genomic mutations and selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. TG4050 has been designed to target up to 30 patient-specific neoantigens. Transgene is sponsoring two Phase 1 trials that are expected to deliver a first proof of concept of this virus-based individualized approach.

PCI Biotech: Invitation to third quarter 2020 results presentation

On November 4, 2021 PCI Biotech’s (OSE: PCIB) reported that third quarter 2020 interim report will be released on 11 November 2020 at 07.00 CET (Press release, PCI Biotech, NOV 4, 2020, View Source [SID1234585152]). The interim report and presentation will be made available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com.

A results presentation (in English) will be held through a webcast at 08.30 CET the same day. The webcast can be accessed through www.pcibiotech.com and it will be possible to post questions through the webcast console.

Bristol Myers Squibb and MyoKardia Announce Expiration of HSR Act Waiting Period

On November 4, 2020 Bristol Myers Squibb (NYSE: BMY) and MyoKardia, Inc. (Nasdaq: MYOK) reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, or HSR Act, in connection with Bristol Myers Squibb’s previously announced tender offer to acquire all outstanding shares of MyoKardia for a purchase price of $225.00 per share in cash, or approximately $13.1 billion (Press release, Bristol-Myers Squibb, NOV 4, 2020, View Source [SID1234573352]). The expiration of the waiting period occurred at 11:59 p.m. EST on November 3, 2020.

Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transaction, which remains subject to the tender of a majority of the outstanding shares of MyoKardia’s common stock, as well as other customary closing conditions. Unless the tender offer is extended, the offer and withdrawal rights will expire at midnight (New York City time), one minute after 11:59 p.m. New York City time, on November 16, 2020.