On March 9, 2021 ImmunityBio, Inc. and NantKwest, Inc. (NASDAQ: NK), reported the completion of their previously announced 100% stock-for-stock merger (Press release, NantKwest, MAR 9, 2021, https://nantkwest.com/immunitybio-and-nantkwest-complete-merger/ [SID1234576320]). This follows the satisfaction of all customary closing conditions, including approval of the merger by a majority of unaffiliated shareholders of NantKwest at its Special Meeting held on March 8, 2021. The combined company will operate under the name ImmunityBio, Inc. ("ImmunityBio") and its shares of common stock will commence trading on NASDAQ on March 10, 2021 under the new ticker "IBRX."

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"ImmunityBio is the culmination of a decades-long quest to orchestrate natural killer cells and T cells to induce what we call ‘immunogenic cell death’. By integrating novel immunotherapy molecules with a state-of-the-art natural killer cell therapy and viral vectors, we are now in the position to transform treatments for patients afflicted with cancer and infectious diseases by activating the host immune system," said Patrick Soon-Shiong, M.D., Executive Chairman of the ImmunityBio Board. "With the merger complete, ImmunityBio has the scale that will allow us to advance our development of more novel therapies in oncology and infectious diseases, and accelerate work on our unique COVID-19 vaccine, which we believe is key to creating long-term immunity to the SARS-CoV-2 virus."

"We are excited to bring together these innovative organizations and talented teams to create a leading immunotherapy and cell therapy company," said Rich Adcock, Chief Executive Officer of ImmunityBio. "Together we expect to deliver important new treatments for patients, as we leverage our best-in-class platforms, expertise and resources to further accelerate our pipeline. We believe that our teams are prepared to seamlessly execute our go-forward strategy. We are excited to deliver on our mission on behalf of our shareholders, partners, and other stakeholders."

Transaction Details

Pursuant to the merger, the former stockholders of ImmunityBio are entitled to receive 0.8190 of a share of NantKwest common stock for each outstanding share of ImmunityBio common stock that they held immediately prior to the merger. Former ImmunityBio stockholders should contact American Stock Transfer & Trust Company, LLC, the exchange agent for the transaction, by calling toll-free at (877) 248-6417 or at (718) 921-8317, if they have any questions regarding the consideration to which they are entitled.

On March 9, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported positive data from its preclinical assessment of dovitinib’s antitumor activity in osteosarcoma, the most common primary malignant bone tumor in children and young adults (Press release, Allarity Therapeutics, MAR 9, 2021, View Source,-Email%20Print%20Friendly&text=by%2050%20%25%20as%20compared%20to%20control%20animals. [SID1234576337]). The purpose of the study was to investigate the capacity of dovitinib alone, and in combination with a specific checkpoint inhibition strategy (anti-PD-1), for slowing the progression of experimental pulmonary metastases in animal models of osteosarcoma.

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Two separate studies, performed contemporaneously in a syngeneic, mouse model of experimental pulmonary osteosarcoma metastases in mice using the K7M2 cell line, generated the following key results:

Treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time by 50 %.
Antitumor growth activity was also observed for dovitinib as a single agent in this model.
In addition, it was found that no significant antitumor activity was observed in mice treated with single-agent anti-PD-1 antibody at the investigated dosage and dosing schedule. Furthermore, the combination of dovitinib and anti-PD-1 antibody did not generate additive or synergistic antitumor activities equal or greater than observed by dovitinib alone in the mouse osteosarcoma model.

Allarity is preparing for the submission of a new drug application (NDA) for marketing approval, by the U.S. FDA, for dovitinib as a treatment for renal cell carcinoma (RCC). In support of its NDA filing, and in accordance with FDA requirements, the company is also planning a clinical trial in pediatric patients with osteosarcoma, where the patients will be selected with the DRP companion diagnostic for Dovitinib. The FDA defines pediatric patients as persons aged 21 or younger.

Allarity Therapeutics has chosen osteosarcoma as the pediatric indication in which to evaluate the efficacy and safety of dovitinib on the basis of the reported preclinical study. A positive preclinical assessment, as announced today, is a part of the normal prerequisites for initiating a clinical trial in pediatric patients with osteosarcoma.

Allarity’s CEO, Steve Carchedi, noted "These data further demonstrates that dovitinib is a therapy that has a potential beyond RCC. We look forward to continuing our work towards regulatory approval of dovitinib, and ultimately realize its potential as a personalized cancer treatment by applying our unique DRP technology."

M.D., D.Sc., Marie Foegh, CMO of Allarity Therapeutics, further stated. "We are now ready to move forward towards initiating a pediatric clinical trial for dovitinib after receiving these excellent preclinical results. If we can show that dovitinib is also a potential treatment for patients with osteosarcoma, it will further strengthen the case for bringing this new therapy to the market."

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

On March 9, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the publication of a review article titled "Therapeutic Targeting of Checkpoint Receptors within the DNAM-1 Axis" reviewing the biology and therapeutic relevance of the DNAM-1 axis in cancer immunotherapy (Press release, Compugen, MAR 9, 2021, View Source [SID1234576356]). The peer-reviewed article, published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), was co-authored by Drew Pardoll, M.D., Ph.D., Professor of Oncology, Johns Hopkins University and Chairman of Compugen’s Scientific Advisory Board.

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Article highlights include:

Detailed overview of the DNAM-1 axis including axis checkpoint molecules: DNAM-1, TIGIT, PVRIG and CD96, along with their ligands PVR and PVRL2
Summary of recent studies outlining the ascendancy of the DNAM-1 axis as a potential new pathway in immuno-oncology, including ongoing clinical trials evaluating therapeutic antibodies directed against TIGIT and PVRIG
Author commentary on the rationale for testing combination regimens of DNAM-1 axis blockers in combination with PD-1/L1 agents and the overall promise of these emerging targets in cancer clinical trials
Author discussion of the potential biomarkers that can define patient populations most likely to respond to the blockade of each checkpoint pathway
"Our discovery of PVRIG as a distinct pathway in the DNAM axis has evolved into a deep and broad understanding of this potentially foundational axis in cancer immunotherapy," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Having spent several years studying PVRIG and TIGIT, the latter of which we discovered along with others, as well as their possible synergy with the PD-1 pathway, we are proud to now share our knowledge with the scientific and healthcare communities through this comprehensive review written with Dr. Pardoll, a world-renowned immuno-oncology thought leader and one of our trusted advisors and long-term collaborators. This article provides an overview of the biology that underlies our clinical strategy addressing the DNAM axis, including evidence that supports PVRIG and TIGIT as important and distinct immunotherapy checkpoints in oncology as well as their potential to expand immuno-oncology treatment options to new patient populations. Importantly, with wholly-owned clinical candidates targeting both PVRIG and TIGIT, we are uniquely positioned to evaluate the role of the DNAM axis in the clinic, specifically with our ongoing Phase 1/2 study, evaluating the triple simultaneous blockade of PVRIG, TIGIT and PD-1."

Dr. Pardoll added, "Our long-standing partnership with Compugen has led to important contributions in the immuno-oncology space, expanding the understanding of the biology of newly discovered immune checkpoints identified by Compugen, including PVRIG and TIGIT. This review highlights the power of these discoveries in the DNAM axis, and the potential of these axis members to translate to new immuno-oncology treatments."

On March 9, 2021 Foundation Medicine, Inc. and InformedDNA, the nation’s largest independent provider of genetics services, reported a collaboration that will enable physicians to refer U.S. patients with possible inherited cancer gene mutations to genetic counseling services and confirmatory genetic testing based on the results of Foundation Medicine’s tumor testing (Press release, Foundation Medicine, MAR 9, 2021, View Source [SID1234576614]).

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For patients who undergo Foundation Medicine’s comprehensive genomic profiling tests and receive a result showing a potential inherited cancer gene variant, genetic counseling and follow up germline (genetic) testing aligns with clinical guidelines and industry best practices, and provides oncologists and their patients with more data to inform treatment decisions.

Cancer can be influenced by many different genetic changes; some are acquired over time, known as somatic mutations, and others are inherited, known as germline mutations. Foundation Medicine’s tests evaluate more than 300 cancer-related genes, including genes with variants that may have potential germline implications. If a potential germline variant is identified via tissue or liquid-based genomic testing, Foundation Medicine’s test report highlights this to the patient’s provider, so that the provider may consider follow up with genetic counseling and confirmatory germline testing.

Through this new collaboration, Foundation Medicine and InformedDNA are helping advanced cancer patients and their physicians navigate the appropriate genetic counseling and confirmatory testing resources available to them should they choose to leverage them to inform treatment plans.

"Both somatic and germline drivers of disease are critical to inform treatment decisions and assess future risk, yet many physicians and health systems do not have a referral process in place or access to internal genetic counseling services and confirmatory germline testing. Further, given the broader implications of this information, responsible communication from a genetic counselor is critical," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "We’re pleased to partner with InformedDNA to create a unique option that enables access to genetic counseling and guidance on confirmatory testing, thereby assisting care teams with obtaining additional information to develop holistic treatment plans for patients and their families."

InformedDNA is a leader in telegenetic counseling, offering services with board-certified genetic counselors across all 50 states. If confirmatory genetic testing is desired and deemed necessary following a potential germline variant finding on one of Foundation Medicine’s reports, InformedDNA’s genetic counselors will guide patients in determining the appropriate test and understanding the benefits, risks, and implications of confirmatory germline testing.

"Together, we’re improving access to an important aspect of tumor testing for cancer patients – the ability to identify patients at risk of carrying inherited genetic mutations," said Rebecca Sutphen, M.D., FACMGG, co-founder and chief medical officer at InformedDNA. "This collaboration aims to make genetic counseling and confirmatory testing more accessible to U.S. patients with potential germline mutations, helping to ensure that physicians have the information needed to develop personalized cancer treatment plans for their patients and implement preventive measures for their families."

Approximately five to 10 percent of all cancers are hereditary.1 In addition to playing a role in diagnosing and treating an individual with cancer, genetic information can be used to help inform health decisions for a patient’s family members.

"We believe it is essential for all advanced cancer patients to have access to the tools needed to understand the hereditary implications of their cancer, if interested," said Sue Friedman, executive director and founder of Facing Hereditary Cancers Empowered (FORCE). "We applaud Foundation Medicine and InformedDNA for embarking on this effort to fill an important gap in cancer care, ensuring people affected by hereditary cancer have the information, support and guidance they need to navigate treatment and prevention."

Foundation Medicine’s reporting of tumor variants does not distinguish between somatic or germline variants and is not intended to replace germline testing or provide information specific to cancer predisposition.

On March 9, 2021 Valo Health LLC (Valo), a technology company transforming the drug discovery and development process and seeking to accelerate the creation of life-changing drugs, reported the final closing of its Series B at $300 million, including a $110 million investment from Koch Disruptive Technologies (KDT) (Press release, Valo Health, MAR 9, 2021, View Source [SID1234577591]). This brings the overall funding of Valo to over $450 million.

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With this investment Valo will continue to scale its Opal Computational PlatformTM, the first-of-its-kind fully integrated end-to-end platform that combines machine learning-driven computational capabilities and patient data to develop first-in-class and best-in-class therapeutic programs across major disease areas.

"We see Valo’s strategy and approach to transforming drug discovery and development as highly disruptive to the industry. Their machine learning and data-centric technology solutions will bring significant value to patients and healthcare practitioners looking for more efficient and enhanced treatment options," said Chase Koch, President of Koch Disruptive Technologies. "The medtech and healthcare markets are currently undergoing dramatic change and accelerated transformation, and our investment in Valo is a testament not only to our belief in their mission but to the importance of this industry in general."

"We are reimagining the process of discovering and developing life-changing drugs in potentially half the time, at half the cost, and with fewer failures, and we are proud that KDT recognizes our paradigm-changing work," said David Berry, Valo founder and CEO. "This investment and their partnership will help us further scale and accelerate our goals and the Opal platform."

The proceeds from the Series B will support the continued discovery and development of therapeutic programs, further build-out the Opal Computational PlatformTM, working capital, and other general purposes. Using Opal, Valo scientists have been able to identify previously unsuspected associations between genetic markers and disease, which identify the specific changes in gene activity with an initial focus on oncology, neurodegenerative, and cardiovascular diseases.

David Berry will discuss Valo’s approach and provide insights into several preclinical programs and the Opal platform at the Barclays Global Healthcare Conference at 8 a.m. EST on March 9, 2021. Following the event, a replay of the Barclays webcast will be available on the Valo LinkedIn page.