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ImmunityBio Begins Trading Today on Nasdaq as Large Cap Biotechnology Company

On March 10, 2021 ImmunityBio, Inc. (NASDAQ: IBRX) reported it has begun trading as a large cap company with approximately 398 million fully diluted shares outstanding following its merger with NantKwest (Press release, ImmunityBio, MAR 10, 2021, View Source [SID1234576365]). The combined company begins trading today on the Global Select Market of the Nasdaq exchange under the IBRX ticker.

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ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."

The company’s broad-based platforms are based on the foundation of four separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, second-generation human adenovirus (hAd5) and yeast vaccine technologies, and state-of-the-art, off-the-shelf natural killer cells, including autologous and allogenic cytokine-enhanced memory NK cells.

ImmunityBio has a broad immunotherapy clinical pipeline of over 40 clinical trials in Phase I, II and III development across 19 indications in solid and liquid cancers and infectious diseases. The clinical-stage pipeline and intellectual property portfolio spans 17 first-in-human antibody cytokine fusion proteins, chemo immuno-modulators, vaccine vectors, and cell therapies in 25 Phase II and III clinical trials. Anktiva (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

SIR-Spheres® Y-90 Resin Microspheres Obtains Recommendation from NICE and Approval from the FDA

On March 9, 2021 Grand Pharmaceutical and Healthcare Holdings Limited ("GP (HK)" or the "Company", together with its subsidiaries, the "Group", stock code: 00512) reported that the Group’s associate Sirtex Medical Pty Ltd core anti-tumor drug SIR-Spheres Y-90 resin microspheres obtained recommendation from the National Institute for Health and Care Excellence ("NICE") in the treatment of unresectable advanced hepatocellular carcinoma ("HCC") in adults, and obtained an approval from the US Food and Drug Administration ("FDA") to conduct clinical trials on primary liver cancer (Press release, Grand Pharmaceutical, MAR 9, 2021, View Source [SID1234653970]).

SIR-Spheres Y-90 resin microspheres are used in selective internal radiation therapy for malignant liver tumors. The SIR-Spheres Y-90 resin microspheres are delivered to the vasculature of liver tumor via a worldwide leading interventional technology, and then emit high doses of beta radiation to destroy tumor cells, which are the only radioactive microspheres around the world approved by the FDA.

NICE is an important organization of National Health Service ("NHS") in England, and is one of the recognized premier health technology assessment organizations in the world. More than 75% of the governments and health technology assessment agencies in the world regard NICE’s recommendations as an important decision-making basis for bringing products into their own medical insurance reimbursement. As recommended by NICE, the use of selective internal radiation therapy ("SIRT") using SIR-Spheres Y-90 resin microspheres in England and Wales will be a fully funded and reimbursed option for adult patients with HCC, on the conditions that it is used for patients with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate. This approval opens the potential to treat thousands of patients who would apply to treat with SIR-Spheres Y90 resin microspheres, annually, in the UK. Besides, SIR-Spheres Y-90 resin microspheres obtaining recommendation from NICE is a milestone for its global medical insurance reimbursement access, which is expected to accelerate its access to medical insurance reimbursement in other emerging markets (such as Brazil), further expand its market shares, and help more liver cancer patients worldwide to receive the treatment of SIR-Spheres Y-90 resin microspheres.

In addition, SIR-Spheres Y-90 resin microspheres have been approved by the FDA to conduct clinical trials on primary liver cancer in order to apply for marketing license of primary liver cancer in the United States. The clinical trial is a single arm trial and patients will be recruited in the near future.

The results of clinical studies prove that SIR-Spheres Y-90 resin microspheres can significantly increase tumor response rate, reduce tumor burden and achieve tumor downstaging, so that patients can gain the chances to undergo surgical resection. It can also significantly prolong the progression-free survival, control tumor progression and increase the waiting time for liver transplantation. In the meantime, SIR-Spheres Y-90 resin microspheres bring less side effects and higher quality of life for patients. With its remarkable clinical efficacy, SIR-Spheres Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. It is recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). It is also covered by medical insurance in places such as the United States and Europe. In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition).

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "Two important developments demonstrate the clinical efficacy and competitive advantages of SIR-Spheres Y-90 resin microspheres, helping more liver cancer patients worldwide receive treatment. The NICE recommendation proves that the treatment of SIR-Spheres Y-90 resin microspheres has positive effects on the quality of life and economic benefits of HCC patients."

"Sticking to patients-centered and innovation-driven, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including United Stated based OncoSec, Australia based Sirtex and Telix Pharmaceuticals Limited (ASX: TLX), the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich 3product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and Immunotherapy platform integrating diagnostics and treatment. The Group adopts the strategy of ‘global expansion and dual-cycle operation’, forming a new pattern of domestic and international cycles that synergize with each other. The Group makes full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization processes for innovative products and provide cancer patients with more advanced and diverse treatment options in the world."

Cue Biopharma to Host Business Update Call and Webcast

On March 9, 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will host a conference call and webcast to provide a business update on Tuesday, March 16, 2021 at 4:30 p.m. EDT (Press release, Cue Biopharma, MAR 9, 2021, View Source [SID1234608284]). Live and archived versions of the event can be accessed via the Company’s website.

Members of the Cue Biopharma executive management team will provide clinical updates on the Company’s ongoing CUE-101 Phase 1 dose escalation monotherapy trial, which will include new patient data, and on the combination trial KEYNOTE-A78, where CUE-101 will be evaluated in combination with KEYTRUDA (pembrolizumab) as first-line treatment for HPV+ recurrent/metastatic head and neck squamous cell carcinoma. Management will also provide an update on the Company’s most recent technology platform developments and pipeline progress as well as updates on its strategic objectives and anticipated milestones.

Valo Health Receives $110 Million In Funding From Koch Disruptive Technologies To Close Series B

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.

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.

Foundation Medicine and InformedDNA® Collaborate to Improve Access to Genetic Counseling for Advanced Cancer Patients

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]).

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.