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Artiva Biotherapeutics Announces Exclusive Worldwide Collaboration and License Agreement with Merck to Develop Candidate CAR-NK Cell Therapies

On January 28, 2021 Artiva Biotherapeutics, Inc., an oncology company focused on developing and commercializing primary allogeneic natural killer (NK) cell therapies to treat cancer, reported that it has entered into an exclusive worldwide collaboration and license agreement with Merck, known as MSD outside the United States and Canada, to develop novel chimeric antigen receptor (CAR)-NK cell therapies targeting solid tumor-associated antigens (Press release, Artiva Biotherapeutics, JAN 28, 2021, View Source [SID1234574386]). The collaboration will leverage Artiva’s off-the-shelf allogeneic NK cell manufacturing platform, along with its proprietary CAR-NK technology. The collaboration initially includes two CAR-NK programs with an option for a third, none of which are in Artiva’s current or planned pipeline. The agreement provides that Artiva will develop the CAR-NK programs through the first GMP manufacturing campaign and IND preparation, followed by transfer to Merck for clinical and commercial development.

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Under the terms of the agreement, Artiva will receive a $30 million upfront payment for the first two programs and an additional $15 million payment if Merck exercises its option for a third program. Artiva is also eligible to receive future development and commercial milestones of up to $612 million per program and royalties are payable by Merck on worldwide sales of any product derived from the collaboration. Merck agreed to provide research funding to Artiva for each of the programs under the collaboration.

"Our NK platform has been developed to be truly off-the-shelf and we believe it will be further validated by this exclusive collaboration with Merck, as we work together to bring cell therapies to all patients who may benefit," said Dr. Peter Flynn, COO of Artiva. "This collaboration will combine Merck’s leading immuno-oncology expertise and capabilities with our highly scaled and optimized CAR-NK platform," added Dr. Fred Aslan, CEO of Artiva.

"At Merck, we continue to explore new ways to transform the most innovative science into better therapies for patients who need them most," said Dr. Nick Haining, Vice President, Head of Discovery Oncology and Immunology, Merck Research Laboratories. "We look forward to working with the team at Artiva with the hope of developing new NK cell-based treatments for cancer."

Artiva’s targeted NK cell therapies leverage the innate anti-tumor biology and safety features of NK cells. The therapies are optimized for enhanced efficacy through CARs, therapeutic antibody combination therapy, and genetic engineering. The Merck CAR-NK collaboration programs will leverage Artiva’s novel NK-specific CAR costimulatory structures and highly scaled, proprietary NK cell manufacturing platform. Artiva’s manufacturing platform supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies and proprietary CAR-NK and NK-specific gene-editing technologies to augment therapeutic activity.

Ultimovacs Announces NIPU Trial Design Poster Presented at World Conference of Lung Cancer Singapore 2020

On January 28, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI), reported that the lead investigator of the Company’s NIPU Phase II clinical trial, Åslaug Helland from Oslo University Hospital, has presented a poster with an overview of the NIPU trial at the 2020 World Conference on Lung Cancer in Singapore (Press release, Ultimovacs, JAN 28, 2021, View Source [SID1234574385]). For more information on the NIPU trial and the poster that was presented today, please refer to Ultimovacs corporate website.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. UV1 has been tested in four phase I clinical trials which enrolled a total of 82 patients and has maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

Universal Diagnostics Presents Promising Data on Lung Cancer Detection using Blood-Based Methylation Test at the IASLC 2020 World Conference on Lung Cancer

On January 28, 2021 Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, reported promising new data for its investigational blood-based lung cancer test (Press release, Universal Diagnostics, JAN 28, 2021, View Source [SID1234574384]). The data, presented at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC20), held virtually 28th-31st January 2021, used methylation status measurement of the tumour-derived portion from cell-free DNA (cfDNA) in plasma for patient classification. Results of the study show the potential of the test to detect different lung cancer sub-types early, with high sensitivity and specificity, and indicate the potential of using blood-based screening for wider population regardless of the smoking-status of the patient.

"Cell-Free DNA (cfDNA) Methylation Assay Allows for Early Detection and Identification of Lung Cancer"

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"These initial results from our lung cancer test study are promising, particularly for detecting cancer at the early stages. With current methods for lung cancer screening being limited, with the majority of patients being detected too late, we believe there is a significant opportunity to improve outcomes for lung cancer patients using a simple and accurate blood-based test for early detection through mass screening," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "We will now build on these preliminary results and plan to move forward with test development, including starting clinical sample collection studies and further improving the panel and its performance. Beyond this, the results demonstrate our ability to leverage our technology for other cancer tests. "

In the study (P46.06 – "Cell-Free DNA (cfDNA) Methylation Assay Allows for Early Detection and Identification of Lung Cancer"), plasma samples of 37 lung cancer patients and 71 asymptomatic age, gender and smoking-history matching controls were assessed using UDX’s 10 methylation marker panel. The panel exhibited good lung cancer detection potential, with sensitivity for detecting lung cancer of 73% (27/37) at 90% (64/71) specificity. A total of 82% of adenocarcinoma (9/11), 80% of squamous cell carcinoma (8/10), 73% of small cell lung cancer (8/11) and 40% of other rare lung cancer subtypes (2/5) were correctly identified. Notably, the sensitivity for stage I cancers was 73% (11/15).

ImmunityBio Announces Positive Phase 2 Results Showing that Anktiva Restores the Activity of Checkpoint Inhibitors in Patients Who Have Relapsed Checkpoint Immunotherapy in Non-Small Cell Lung Cancer

On January 28, 2021 ImmunityBio, Inc., a privately-held immunotherapy company, reported the presentation of encouraging data in non-small cell lung cancer (NSCLC) from the company’s ongoing Phase 2b study, QUILT-3.055 (ClinicalTrials.gov: NCT03228667) at the International Association for the Study of Lung Cancer (IASCL)’s 2020 World Conference on Lung Cancer, Singapore, being held virtually January 28 – 31, 2021 (Press release, ImmunityBio, JAN 28, 2021, https://ir.nantkwest.com/news-releases/news-release-details/immunitybio-announces-positive-phase-2-results-showing-anktiva?field_nir_news_date_value[min]= [SID1234574383]).

The presentation, titled "QUILT 3.055: a phase 2 multi-cohort study of N803 (IL-15 superagonist) in combination with checkpoint inhibitors in NSCLC", highlighted safety and efficacy data from NSCLC patients in Cohort 1 of the study (N=78), which is evaluating patients with initial response on single-agent checkpoint inhibitor therapy who subsequently progressed on or after that therapy in multiple tumor types. The study is designed to evaluate combination immunotherapy regimens that include ImmunityBio’s lead cytokine infusion protein, a novel interleukin-15 (IL-15) superagonist complex (AnktivaÔ, also called N-803) in patients who have previously received treatment with PD-1/PD-L1 immune checkpoint inhibitors. Anktiva has been engineered to exhibit a longer half-life and more potent trans-presentation relative to endogenous IL-15 to promote natural killer (NK) cell and T cell expansion to control cancer.

Key presentation results include:

Clinical benefit was demonstrated in a majority of the NSCLC patients, as measured by reduction of target lesion size and cessation of progression in the target lesion over time (with follow-up of up to 13 months).
Clinical benefit was observed in patients with immediate prior progression on checkpoint inhibitors when Anktiva was combined with the checkpoint inhibitor, regardless of PD-L1 status or use of chemotherapy with checkpoint inhibitors
The combination regimen of Anktiva and checkpoint inhibitors was well tolerated, with low incidence of treatment-related severe adverse events in second- and third-line NSCLC patients who had progressed on checkpoint inhibitor therapy at the time of study enrollment.
Among 78 participants, nine (12%) exhibited grade 3 or higher treatment-emergent adverse events (AEs). Common low-grade AEs observed included injection site reactions (72%), chills (30%), fatigue (27%), fever (26%) and nausea (12%).
These results suggest that a combination regimen with Anktiva has the potential to restore and or enhance responsiveness to checkpoint inhibitors including in patients with low PD-L1 expression, which typically is a robust predictor of checkpoint inhibitor failure.
"These encouraging safety and efficacy data suggest that the addition of Anktiva to checkpoint inhibitors has the potential to restore and/or enhance sensitivity to checkpoint inhibitors. While immunotherapy has been transformative for many NSCLC patients, particularly those with high PD-L1 expression, the majority will not experience durable response to these treatments," said lead investigator John Wrangle, M.D., Associate Professor, Division of Hematology/Oncology at Hollings Cancer Center at the Medical University of South Carolina. "Strikingly, we see clinical benefit in patients with immediate prior progression on checkpoint inhibitors and low PD-L1 expression, groups which historically are less likely to respond to checkpoint inhibitors, without the need for interval chemotherapy or radiation therapy and their attendant toxicities."

Tumor resistance to checkpoint therapy occurs when T cells are unable to recognize the tumor cell antigen. NK cells can overcome this resistance as indicated by Allen, et al., "Mechanisms of resistance to T cell-based immunotherapy in head and neck cancer" (DOI: 10.1002/hed.26158), who show that NK cells can improve the efficacy of T-cell activated immunotherapy such as checkpoint inhibitors.

Sandeep Bobby Reddy, M.D., Chief Medical Officer at ImmunityBio, commented, "This Phase 2 study demonstrates that activation of NK cells through administration of Anktiva, reactivates and restores the activity of checkpoint inhibitor therapy even in patients who relapsed on the same checkpoint therapy. Thus, the potential exists that Anktiva could be the combination backbone to all checkpoint therapy by activating both NK and T cells. We believe that our particular approach in using an engineered IL-15 superagonist to coordinate T cell and natural killer cell-mediated responses may elicit tumor response regardless of the type and extent of prior checkpoint inhibitor therapy, PD-L1 status, and tumor type. The data presented are from the NSCLC cohort of a multi-cohort ongoing trial in 11 checkpoint inhibitor indications. Much excitement has been generated with targets such as TIGIT, OX40, TIM3, LAG3 and many others. We are particularly excited that our approach is independent of a particular biomarker and may have a broader applicable patient population."

Lung cancer is the second most common cancer in men and women (excluding skin cancer) and non-small cell lung cancer accounts for 80% to 85% of all lung cancers, according to the American Cancer Society. In 2021, more than 235,000 people will be diagnosed with lung cancer and more than 131,000 people will die from the disease.

NantKwest Transaction

As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest (NASDAQ: NK). The combination, which is expected to close in the first half of 2021, will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.

Bavarian Nordic Reports Preliminary Financial Results for 2020

On January 28, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported preliminary, unaudited financial results for 2020 in line with or better than the Company’s most recent guidance (Press release, Bavarian Nordic, JAN 28, 2021, View Source [SID1234574382]).

Revenue for the full year is expected at approximately DKK 1,852 million, comprised of DKK 1,082 million from combined sale of Rabipur/RabAvert and Encepur, DKK 704 million from US Government sale, including JYNNEOS revenue and contract work, and finally DKK 66 million from the milestone payment from Janssen (Ebola vaccine approval).
The operating result (EBITDA) is expected at approximately DKK 740 million, including other operating income of DKK 628 million from the sale of Priority Review Voucher.
Cash position at year-end was approximately DKK 1,670 million, excluding unutilized credit facilities of DKK 244 million.

Revenue in 2020 significantly increased over 2019 as a result of the commercial transformation of Bavarian Nordic following the acquisition of two commercial vaccines, Encepur and Rabipur/RabAvert. COVID-19 negative impact on Encepur and Rabipur/RabAvert revenue was limited to approximately DKK 200 million by strong brand performance in key markets and largely off-set by better than originally expected JYNNEOS revenue. A USD weakening against DKK had some negative impact on RabAvert revenue in the last two months of 2020.

EBITDA came in slightly better than guided due to continued tight focus on cost and profitability.

The year-end cash position exceeded guidance due to phasing of ongoing investments and working capital movements. This was achieved without draw-down of existing credit facilities of DKK 244 million. Due to the strong cash position the draw-down was deferred to 2021.

"We are very pleased to deliver results in line with or better than the original guidance from February 2020 when no-one really understood the full-scale dramatic effect of COVID-19 on the world. These results have been achieved by good market performance in key markets, by the governmental business performing better than originally anticipated and by keeping a tight focus on profitability and cash," said Paul Chaplin, President and CEO of Bavarian Nordic.

Bavarian Nordic will publish its annual report for 2020 on March 12, 2021, including financial guidance for 2021.