On April 28, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study NKX019 in patients with relapsed or refractory B cell malignancies (Press release, Nkarta, APR 28, 2021, View Source [SID1234578663]).

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NKX019 is an off-the-shelf cancer immunotherapy candidate that uses NK cells engineered with a CD19-directed chimeric antigen receptor (CAR). The CAR is designed to target cancer cells expressing CD19, a clinically validated target, and to enhance the innate anti-tumor activity of NK cells. In addition, NKX019 is engineered with a membrane-bound form of IL-15, an important cytokine for NK cell survival, which has been shown in preclinical models to enhance NK cell proliferation, persistence and activity.

Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies, including non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia, is planned for the second half of 2021.

"Academic studies have highlighted the ability of donor-derived NK cells, when collected from healthy donors, to effectively target and kill cancer cells without some of the safety risks commonly associated with T cell therapies," noted Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. "We look forward to evaluating NKX019 in our trial as a planned multi-dose, multi-cycle treatment regimen to determine its potential for enhanced anti-tumor activity with a beneficial safety profile."

"This IND clearance, our second in less than 10-months time, builds on the strong track record of the Nkarta team to deliver on challenging goals," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "Thanks to their outstanding efforts, Nkarta will soon have two differentiated co-lead programs, NKX101 and NKX019, in clinical trials as we look forward to the continued progress of our best-in-class, healthy donor-derived NK cell platform and pipeline of novel cell therapy candidates for cancer patients."

About NKX019
NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a CD19-directed chimeric antigen receptor (CAR) and a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. Via its CAR, NKX019 targets and binds to CD19 and eliminates CD19-expressing cells via a robust immune response in preclinical studies. Preclinical models also demonstrate enhanced proliferation, persistence and activity of NK cells with the membrane-bound IL-15, an important cytokine for NK cell survival. Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies in multiple centers in the United States and Australia is planned for the second half of 2021.

About Nkarta’s Platform and Natural Starting Materials
Nkarta’s engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells endowed with inherent tumor-recognizing ability and potent cytotoxic function. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells, providing Nkarta with the potential to capitalize on the inherent diversity of the innate immune system in selecting donors or NK cell populations with optimal characteristics.

About Nkarta’s NK Cell Technologies
Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to identify and kill tumor cells. To enhance the inherent anti-tumor activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to cancer cells through recognition of specific surface proteins. This receptor is fused to co-stimulatory and signaling domains, which amplify cell signaling and NK cell cytotoxicity. Upon target binding, NK cells activate and release cytotoxic granules for target cell killing as well as cytokines that enhance the cumulative immune response. All of Nkarta’s current NK cell therapy candidates are also engineered with a membrane-bound IL-15, a proprietary version of an activating cytokine important for NK cell growth and enhancement of NK cell persistence.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for extended periods and is designed to enable immediate, off-the-shelf administration to patients at the point of care.

On April 28, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI) reported that an abstract on the Company’s Phase I trial evaluating its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab in patients with metastatic malignant melanoma has been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting to be held virtually Friday, June 4, 2021 through Tuesday, June 8, 2021 (Press release, Ultimovacs, APR 28, 2021, View Source [SID1234578685]).

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The abstract, titled "A Phase I Clinical Trial Investigating the Telomerase Vaccine UV1 in Combination with Pembrolizumab in Patients with Advanced Melanoma", will provide an overview of the open-label, single-arm study investigating the safety and tolerability for the UV1/pembrolizumab combination.

Details of the virtual poster presentation are as follows:

Title: A Phase I Clinical Trial Investigating the Telomerase Vaccine UV1 in Combination with Pembrolizumab in Patients with Advanced Melanoma

Abstract Number: 2620

Session: Developmental Therapeutics—Immunotherapy

The corresponding abstract will be published by ASCO (Free ASCO Whitepaper) on Wednesday, May 19th at 5:00 pm EDT / 11:00 pm CEST. The poster presentation will be available on demand for all conference attendees starting on Friday, June 4th at 9:00 am ET / 3:00 pm CEST. The poster will also be made available on the Company’s website at the same time on June 4th.

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. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

On April 28, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour-infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status (Press release, Hoffmann-La Roche, APR 28, 2021, View Source [SID1234578627]). Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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"Today’s positive vote reaffirms that Tecentriq fills a significant unmet need for people with previously untreated metastatic bladder cancer, many of whom cannot tolerate standard of care chemotherapy and need additional options," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Having now received positive ODAC recommendations in both bladder cancer and triple-negative breast cancer, we will continue to work with the FDA on next steps for Tecentriq in these indications."

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in 2017 for the treatment of adults with locally advanced or mUC who are not eligible for cisplatin-containing chemotherapy based on the positive overall response rate and duration of response results from the IMvigor210 study. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival. IMvigor130 continues for overall survival (OS). Roche looks forward to sharing the final OS results once available.

Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine approved for particularly difficult to treat cancers. Tecentriq’s extensive development programme includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.

Yesterday, on 27 April, the ODAC voted 7 to 2 in favour of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive, metastatic triple-negative breast cancer.

About bladder cancer
In 2020, there were over half a million new cases of bladder cancer diagnosed globally, with around 212,500 deaths from the disease.1 Urothelial carcinoma, which develops in the cells of the bladder lining, is the most common type of bladder cancer, accounting for about 90% of all cases.2 In total, 30% of cases are considered advanced based on muscle-invasive or metastatic disease.3 There remains a high unmet need for people facing previously untreated advanced bladder cancer. Despite improvements in tolerability, there have been no efficacy improvements for more than 30 years with chemotherapy as standard of care, and patients continue to experience poor outcomes.4,5

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

On April 28, 2021 seqWell reported the appointment of Dan Calvo as its President and Chief Executive Officer, effective as of April 19th, 2021 (Press release, Research Corporation Tech, APR 28, 2021, View Source [SID1234578643]). Dan brings over 30 years of leadership experience, most recently serving as President and CEO of Gyros Protein Technologies AB from 2013 through its acquisition by Mesa Labs in 2019. Prior to this role, Dan served as President and CEO of Oncimmune (USA) LLC, a leading early cancer detection company from 2009 thru 2013. He also brings strategic insights from earlier CEO roles at Cellomics and Assay Designs, having led both companies through acquisition by Fisher Scientific and Enzo Biochem, respectively.

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With accelerated growth of its core product offerings, seqWell welcomes Dan at a critical inflection point in the company’s commercial strategy. The recent release of seqWell’s first single-cell solution, plexWell Rapid scRNA, for single-cell RNA-seq applications, alongside strategic OEM partnerships, continues to broaden the company’s collaborative opportunities. According to seqWell Founder and Chief Scientific Officer, Joe Mellor, "Dan’s commercial leadership skills are essential and valuable at this stage of seqWell’s growth and development. I look forward to working closely with Dan as we build on our core capabilities to further meet the needs of the genomics market and build upon our strategic partnerships."

"The outlook for our business is exceptional," said Dan Calvo. "I am excited to work with the tremendous team at seqWell to accelerate development and commercialization of critical tools to meet the increasing global demand for workflow improvements in a wide variety of NGS applications."

Chad Souvignier, Vice-President and Investment Lead at RCT, added "seqWell’s progress this past year has been exceptional. The board worked cooperatively with management over this past year to recruit a CEO who could lead the company through its next stage of growth. We are fortunate to have found Dan and confident in his ability to aggressively move the company forward."

On April 28, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported their plan to add a blood-based 52-gene next generation sequencing (NGS) test to their portfolio of molecular testing based on a recent publication (Press release, Biodesix, APR 28, 2021, View Source [SID1234578664]). Of critical importance, the publication, "Targeted Next-Generation Sequencing of Liquid Biopsy Samples from Patients with NSCLC," in Diagnostics showed that the rapid liquid biopsy testing was able to detect actionable genomic alterations in patients with non-small cell lung cancer (NSCLC) with an unmatched turnaround time of only 72 hours.

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The test has been in use for biopharma research testing and is performed in Biodesix’s ISO 13485-certified, New York Clinical Laboratory Evaluation Program (CLEP)-approved, College of American Pathologists (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA)-high complexity certified clinical testing laboratory. With the turnaround time for existing, on-market liquid biopsy NGS tests ranging from 7-14 days, improving turnaround time to three days can be critical for patients with advanced NSCLC who are unable to undergo biopsy or whose biopsies have yielded insufficient test results.

"We observed significant agreement (95.7%–100%) with an orthogonal, high-sensitivity Droplet Digital Polymerase Chain Reaction (ddPCR) test," said Gary Pestano, Ph.D., Chief Development Officer at Biodesix. "This method offers a valuable supplement to assessing targeted mutations from blood while conserving specimens and maintaining sensitivity, with rapid turnaround time to actionable results."

The NGS test will complement the now 36-hour turnaround time that GeneStrat ddPCR and VeriStrat tests currently offer with the expanded coverage of 52-genes and broader molecular markers. The 52-gene NGS test will be used for advanced, late-stage, or recurrent cancer mutation detection, and the targeted 6-gene GeneStrat test can be used for identification of the select mutations for treatment guidance, recurrence monitoring, and detection of the development of resistance mutations over time. The company expects to begin offering this testing strategy in the first half of 2022.

"This test allows Biodesix to offer comprehensive molecular test results, with small and large genomic testing panels in combination with our immune profiling test for early and advanced NSCLC," said Scott Hutton, CEO of Biodesix. "We believe that by adding this NGS test to our current portfolio and multi-omics approach, we can enable physicians to make critical treatment decisions for their patients across the continuum of care in the shortest amount of time available today."