On November 15, 2021 Carsgen Therapeutics reported that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to CT041, an autologous CAR T-cell product candidate against the claudin18.2 protein (CLDN18.2) for the treatment of gastric/gastroesophageal junction cancer (GC/GEJ) (Press release, Carsgen Therapeutics, NOV 15, 2021, View Source [SID1234618646]).

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As of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND approvals from both the FDA and the NMPA. Also, CT041 is the first solid tumor CAR T-cell product to be granted PRIME eligibility. CARsgen is currently the only company with two CAR T-cell products active in the PRIME scheme.

"Access to PRIME support and enhanced interaction with EMA is an important milestone in accelerating the development and commercialization of CT041 CAR T cells," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen. "We believe that CT041 has the potential to become a backbone therapy for gastric/gastroesophageal junction cancer and pancreatic cancer in the future. With the mission of ‘making cancer curable,’ we will continue our efforts to develop more innovative technologies and products for cancer patients worldwide."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first in its class globally. CT041 targets the treatment of CLDN18.2-positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials.

In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in the United States. CT041 received Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020 and Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021. CARsgen has applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

About PRIME

PRIME is a scheme operated by the EMA to support the development of medicines that target an unmet medical need. Through PRIME, EMA offers early and proactive support to medicine developers to optimize the generation of robust data and enable accelerated assessment of medicine applications.

The PRIME scheme helps patients to benefit as early as possible from treatments that may significantly improve their quality of life. To be accepted for PRIME, a medicine must show its potential to offer a major therapeutic advantage over existing treatments, or to benefit patients without treatment options.

On November 15, 2021 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations, used to destroy various cancers, bacteria and viruses, safely and effectively, reported that the Company has expanded its Intellectual Property ("IP") portfolio (Press release, Theralase, NOV 15, 2021, View Source [SID1234596745]).

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Theralase has recently been granted an Indian patent for, "Metal-Based Coordination Complexes as Photodynamic Compounds and their Use".

This patent encompasses numerous Theralase’s PDCs destined for the Indian market; most importantly, TLD-1433, which is currently under clinical investigation in a Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study, being conducted in Canada and the United States.

The Mechanism of Action ("MOA") of the patented Theralase PDCs involves localization of the PDC inside the cancer cells of interest and then activating it by laser light to produce radical singlet oxygen and Reactive Oxygen Species ("ROS"), temporally and spatially to destroy the cancer cells, with minimum impact on healthy cells.

This patent further strengthens the extensive portfolio of patents already held by Theralase, by differentiating TLD-1433 cancer therapy versus its competitors and providing Theralase, a sustainable first-mover competitive advantage in PDC technology, in the oncology market. Theralase is focused on increasing shareholder value, by providing the Company international patents to protect its unique technology, as the Company moves closer towards commercialization.

Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer ("CEO") and Chief Scientific Officer ("CSO"), Theralase stated that, "This patent is strategic to opening up new international opportunities for Theralase by expanding its IP portfolio of medical laser and oncology focused technologies internationally. Theralase’s long-term strategy is to commercialize the Anti-Cancer Therapy ("ACT") division technology commencing with NMIBC and expanding into Glio Blastoma Multiforme ("GBM"), Non-Small Cell Lung Cancer ("NSCLC") and other various cancer indications to provide a safe, effective and rapid alternative treatment option for patients inflicted with these deadly diseases. The ability to provide personalized treatment for cancer patients to "hunt and destroy" their cancer and prevent its recurrence and progression, all in a single or dual treatment, remains at the forefront of our research and development objectives".

On November 15, 2021 Vaccibody reported that (Press release, Vaccibody, NOV 15, 2021, View Source [SID1234595955])

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HIGHLIGHTS:
 Initiated the Phase 1b clinical trial in patients with locally advanced and metastatic tumors (VB N-02) in collaboration with Genentech (VB10.NEO individualized vaccine). First site opened in the USA
 Entered into worldwide license agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes Highlights after September 30, 2021:
 First subject dosed in a two-arm phase 1/2 clinical trial with a second generation and a third generation SARS-CoV-2 vaccine candidate  Reached a headcount of more than 100 people
 Continues to explore a potential listing of the company’s shares on Nasdaq and expects during 2022 to apply for a transfer of the listing of its shares to the main market of Oslo Stock Exchange R&D UPDATE Vaccibody’s modular technology platform is very versatile and may be adapted to generate the desired immune response profile. Hence, Vaccibody’s platform may be applied across a broad range of immunotherapy areas as innovative solutions to an unmet medical need. Vaccibody continues to increase the headcount across all functions including R&D to continue to build competencies and support the strategy execution. Please find below an update on Vaccibody’s current research and development activities.

Oncology VB10.16 VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies:
 Clinical trial VB C-02: o Clinical stage: Phase II o Indication: HPV16+ advanced, non-resectable cervical cancer o Up to 50 patients o ClinicalTrials.gov Identifier: NCT04405349 Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 4 Status and highlights Investigational sites in 6 European countries are screening and enrolling patients. The trial is on track to complete enrolment during fourth quarter 2021. Vaccibody plans to report interim clinical data by the end of Q1 2022. The commercial potential in other HPV16 driven cancer indications such as HNSCC (Head and neck squamous cell carcinoma) is being explored. A development strategy update for VB10.16 will follow in 1H 2022

. VB10.NEO VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:  Clinical trial VB N-01: o Clinical stage: Phase I/IIa o Cancer indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN) o Fully enrolled o ClinicalTrials.gov Identifier: NCT03548467  Clinical trial VB N-02: o Clinical stage: Phase Ib o Cancer indications: Locally advanced and metastatic tumors o Up to 40 patients o ClinicalTrials.gov Identifier: NCT05018273 Status and highlights The first clinical site in the USA has been opened. The work on further site initiations in the USA and Europe continues. Infectious Diseases Vaccibody’s infectious disease initiatives spans both pre-clinical and clinical activities. VB10.COV2 Vaccibody has selected a 2-arm strategy for the VB10.COV2 project to fight SARS-CoV-2 variants of concern. VB10.2129 and VB10.2210 are two vaccine candidates designed based on Vaccibody’s modular and APC targeted technology:  In clinical trial VB-D-01, the two vaccine candidates, VB10.2129 and VB10.2210, are being investigated in previously vaccinated healthy volunteers. o VB10.2129-2nd generation vaccine addressing novel CoV-2 variants of concernVB10.2210-3rd generation universal broadly protective T cell vaccine, including T cell epitopes validated by Adaptive Biotechnologies

 Clinical stage: Phase 1/2
 Pathogen: SARS CoV-2  Up to 160 patients
 ClinicalTrials.gov Identifier: NCT05069623 Status and highlights Vaccibody reached the internal milestone of dosing the first subject with VB10.2129 in early November 2021.

With Vaccibody’s flexible and modular technology platform, it took only 267 days from design to first subject dosed. OTHER INFECTIOUS DISEASES Vaccibody has over the last years generated promising pre-clinical data in other infectious disease models. The Company has therefore initiated research discovery programs to explore and evaluate a focused set of pathogens as potential future clinical vaccine targets. Autoimmune disorders Autoimmune disorders are caused by unwanted immunogenicity to autoantigens.

Vaccibody continues to explore the modular technology platform and unique APC targeting approach to generate pre-clinical proof-of-concept for the ability to induce meaningful antigen-specific immune tolerance. The Company is investing significantly in the research area and is hiring to build further capacity and know-how. OTHER Capital market considerations Vaccibody continues to explore a potential listing of the company’s shares on the Nasdaq Global Market in the United States as first communicated in 1H 2021.

Furthermore, the Company expects during 2022 to apply for a transfer of the listing of its shares on the Oslo Stock Exchange from Euronext Growth Oslo to Oslo Børs, the main market of the Oslo Stock Exchange.

On November 15, 2021 Valo Health, LLC ("Valo"), the technology company using human-centric data and artificial intelligence (AI) powered computation to transform the drug discovery and development process and Khosla Ventures Acquisition Co. (Nasdaq: KVSA) ("KVSA"), a special purpose acquisition company sponsored by affiliates of Khosla Ventures, LLC, reported that both companies have mutually agreed to terminate their previously announced agreement and plan of merger (the "Business Combination Agreement"), effective immediately (Press release, Valo Health, NOV 15, 2021, View Source [SID1234595734]).

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Both parties decided to terminate the Business Combination based on current market conditions, particularly in the biotechnology area.

"We formed KVSA to merge with companies that are impactful to the world as we recently did with KVSB when we merged with Nextdoor," said Samir Kaul, Founding Partner and Managing Director at Khosla Ventures. "Valo Health is a strong company and we wish them continued success as they move forward on a very solid plan. We will continue to look for other high-impact targets across a range of industries to deliver maximum shareholder value."

"We made this decision to ensure that Valo continues to be in an optimal position of strength to pursue our growth strategy and to deliver on our mission to transform drug discovery and development," said David Berry, Founder & CEO. "Our team has worked hard to ensure that all of the fundamentals of our business are strong. As we move closer to launching our first Phase 2 trial this year, our second Phase 2 trial in the first half of next year, and continue to aggressively build out the additional unique capabilities of our platform, we have tremendous momentum going into 2022 and beyond."

On November 15, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Alan Fuhrman, Interim CEO and President, will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference (Press release, Checkmate Pharmaceuticals, NOV 15, 2021, View Source [SID1234595709]). The pre-recorded webcast will be available on-demand beginning on Monday, November 22 at 10:00am ET through Thursday, December 2, 2021. Checkmate will also host 1×1 investor meetings during the conference.

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The webcast can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 90 days after the event.