On April 21, 2020 ArcherDX, Inc. and Premier Inc., a leading healthcare improvement company, reported that they have signed a two-part agreement, kicking off a multi-year program. Premier Applied Sciences will identify eight to 10 member institutions that will implement STRATAFIDE – in a research use only (RUO) capacity – to participate in a retrospective study to evaluate its sequencing performance in comparison to other diagnostic tests (Press release, ArcherDX, APR 21, 2020, View Source [SID1234556481]). ArcherDX plans to seek approval from the U.S. Food and Drug Administration (FDA) for STRATAFIDE as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients.

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"Genomic testing has resulted in clear benefit at multiple stages in the fight against cancer. However, there remains a stark need for a kitted IVD solution designed for broader use in any hospital’s molecular diagnostic laboratory," said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. "Premier shares our commitment to providing actionable, accurate information to patients and healthcare providers in a community setting, where clinicians are empowered to control the sample, data and economics. This agreement provides for both a clinical and commercial collaboration, and we are pleased to partner with such a forward-thinking healthcare enterprise dedicated to serving more than 4,000 U.S. hospitals and health systems and approximately 175,000 other providers."

ArcherDX and Premier’s research team will identify retrospective samples from patients with lung, thyroid and colorectal cancer to be analyzed by Archer Clinical Services. The study aims first to evaluate STRATAFIDE as a composite test to identify genomic alterations associated with cancer. The expanded collaboration intends to further understand best practices to implement and utilize a distributed IVD in community hospital settings, which may currently lack advanced molecular genomics tools.

"Our partnership with ArcherDX demonstrates the expanse of Premier’s research portfolio so that it is now engaged in next-generation sequencing for multiple forms of cancer in various provider settings," said Stella A. Safo, M.D., MPH, Chief Clinical Transformation Officer and Vice President for Premier Applied Sciences. "We hope this research will help accelerate appropriate cancer care for hard to reach populations and are thrilled to be working with an innovative team that has the potential to bring accurate and actionable genomic data to patients and their caregivers everywhere. This represents a critical unmet need since so many cancer patients lack access to genomic testing and therapy selection tools in their communities."

On April 21, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE, a therapy for the clinical management of neuroblastoma (Press release, Clarity Pharmaceuticals, APR 21, 2020, View Source [SID1234556447]).

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Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.1

FDA grants ODDs to facilitate the development of investigational therapies intended to treat, diagnose or prevent rare diseases affecting fewer than 200,000 people in the United States. The designation allows Clarity Pharmaceuticals to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; potential tax credits on US clinical costs; exemptions from certain administrative FDA fees; and eligibility for grants to fund future clinical work.

Dr Alan Taylor, Clarity’s Executive Chairman, commented, "At Clarity, we are especially passionate about the development of SARTATE in neuroblastoma. At present, prognosis of high-risk neuroblastoma patients remains unfavourable, despite intensive, multimodal therapy. Also, the effectiveness of current neuroblastoma treatment strategies, such as chemotherapy, radiation, and surgery, is limited in late-stage disease due to patients’ numerous metastases. It is clear that improvements in current treatment approaches are needed to overcome poor outcomes for the patients."

"ODD status will potentially provide a number of advantages for the development of SARTATE for the treatment of neuroblastoma and allow us to progress more swiftly to our ultimate goal of better treatment of children and adults with cancer."

On April 21, 2020 Gilead Sciences, Inc. (Nasdaq: GILD), Kite, a Gilead Company, and oNKo-innate reported the companies have entered into a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells (Press release, Gilead Sciences, APR 21, 2020, View Source [SID1234556484]).

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Current cancer immunotherapy approaches primarily focus on T cell mediated anti-tumor immunity, including checkpoint inhibition and chimeric antigen receptor (CAR) T cell therapy. Like T cells, NK cells are a class of lymphocytes (white blood cells) that play a critical surveillance and effector role in the immune system. NK cells and T cells each have the potential to attack cancer cells, but have different mechanisms for tumor cell killing. Thus, appropriately activated and targeted NK cells may represent a differentiated approach that would be potentially complementary and synergistic with T cell mediated anti-tumor strategies.

"Gilead is pleased to partner with oNKo-innate as a leader in this new and highly promising area of cancer immunotherapy," said William A. Lee, PhD, Executive Vice President, Research, Gilead Sciences. "We have a strategic focus of growing both our expertise and pipeline in immuno-oncology and we believe this exciting collaboration will support each of these objectives as we work to discover and develop novel cancer therapies for patients."

"Kite is committed to building upon our leadership in cell therapy as we seek to meet the needs of patients with cancer," said Peter Emtage, PhD, Senior Vice President of Research at Kite. "Early clinical data utilizing adoptively transferred NK cells has been encouraging and we are excited by the opportunity to scientifically expand our capabilities in this area and to identify novel NK cell therapies to advance toward clinical development."

"With more than 20 years of collective academic expertise in NK cell biology, we have long believed in the potential for NK cells to play a role in cancer immunotherapy," said Jai Rautela, PhD, Co-founder and Chief Executive Officer of oNKo-innate. "We look forward to bringing this NK cell expertise and our unique screening techniques into a collaboration with Gilead and Kite to serve a common goal of discovering new treatments for patients."

Through this research collaboration, oNKo-innate will use genome-wide screening techniques and its proprietary technology platform to discover novel immune cell targets that enhance NK cell anti-tumor immunity and to create NK cell therapies. For Gilead, oNKo-innate will execute screens to identify and validate targets to seed internal Gilead immuno-oncology discovery programs. For Kite, oNKo-innate will create and evaluate NK constructs for Kite’s development of next-generation cell therapies.

Under the terms of the agreement, oNKo-innate will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain clinical, regulatory and commercial milestones, as well as sales royalties across the immuno-oncology and cell therapy programs.

On April 21, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company") reported that it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) in an underwritten public offering (Press release, Actinium Pharmaceuticals, APR 21, 2020, View Source [SID1234556502]). The Company expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of the securities to be sold in the offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Actinium intends to use the net proceeds from the offering to complete its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate, Iomab-B, and progress Phase 1 trials from its refocused CD33 program to the proof of concept stage. Net proceeds from this offering will also be used to support its AWE Technology Platform, Iomab-ACT program, research and development and general working capital needs.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on October 24, 2017. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 21, 2020 Roche (SIX: RO, ROG; OTCQX:RHHBY) reported US Food and Drug Administration (FDA) approval for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems (Press release, Hoffmann-La Roche, APR 21, 2020, View Source [SID1234556448]). The cobas HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into precancerous lesions and, if left untreated, these lesions can progress to cervical cancer.

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"The approval of our HPV test for the cobas 6800 and 8800 Systems enables molecular laboratories to achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs," said Thomas Schinecker, CEO Roche Diagnostics. "This is critical as most healthcare providers in the US have adopted HPV testing as part of their cervical cancer screening protocol, with the ultimate goal of preventing cervical cancer in all women."

The goal of cervical cancer screening is to find and treat precancer early to help stop the progression of disease. The cobas HPV test helps to protect women from the potential harms of undetected and untreated cervical disease by detecting the virus that causes nearly all cervical cancers.

The cobas HPV test, previously approved for the cobas 4800 System, is now part of the growing menu of clinically validated, FDA approved tests for use on cobas 6800/8800 Systems. Laboratories now have the ability to run HPV DNA tests simultaneously with other previously released cobas tests on these high-throughput systems.

The FDA considered data from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled almost 35,000 women in the US to clinically validate cobas HPV for use on the cobas 6800/8800 Systems. Study data will be broadly shared, pending publication of the key findings.

About cobas HPV test
cobas HPV is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer.

The cobas 4800 HPV Test, originally introduced in 2011 and supported by the ATHENA trial (Addressing the Need for Advanced HPV Diagnostics), helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers – and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. Roche received the first FDA approval to use an HPV test for primary cervical cancer screening without accompanying Pap cytology for the cobas HPV 4800 Test in 2014. More information about the cobas HPV tests is available at www.hpv16and18.com

About the Roche Cervical Cancer Portfolio
The Roche Cervical Cancer Portfolio enables healthcare professionals to better screen, triage and diagnose women, based on the confidence and clarity of results across a continuum of patient care. The unique combination of molecular, cellular and tissue-based tests provides healthcare professionals powerful information to make patient care decisions and minimize unnecessary treatment.

The Roche cobas 4800 HPV Test, used in combination with CINtec PLUS Cytology and CINtec Histology, offers clinicians and labs in the US powerful support they have not had before. The dual-stain biomarker technology included in the CINtec PLUS Cytology test, which was FDA approved in March 2020, detects the simultaneous presence within a single cell of the two biomarkers — p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease. The ability of CINtec PLUS Cytology to distinguish those women who are at higher risk for cervical disease provides labs, clinicians and women, in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines information, to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money.

CINtec Histology is the only FDA-cleared test used as an aid to confirm the presence of cervical disease in women who have had a tissue biopsy. The CINtec Histology test uses the p16 biomarker for a more conclusive diagnosis to provide distinctive visual confirmation of precancerous cervical lesions that may be missed by hematoxylin and eosin (H&E) interpretation alone. Both CINtec assays are fully automated on the VENTANA BenchMark IHC/ISH instruments.

About human papillomavirus and cervical cancer
Persistent infection with high-risk human papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. It can take 10 to 15 years or longer for cervical cancer to develop, so knowing a woman’s individual risk and finding disease early, before cancer develops, is an important prevention strategy. Globally, the World Health Organization estimates there are more than 570,000 new cases of cervical cancer annually, and 311,000 deaths4.

About cobas 6800/8800 Systems
Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Like the cobas 4800 System, each system is based on Nobel Prize-winning polymerase chain reaction (PCR) technology. The cobas 6800/8800 Systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity validated for molecular testing, providing users with greater flexibility to consolidate their in vitro diagnostic (IVD) and laboratory developed testing (LDT) to a single system while increasing overall workflow efficiencies.

The cobas 6800/8800 Systems menu for sexual health includes Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG),Trichomonas vaginalis/ Mycoplasma genitalium (TV/MG), and Herpes simplex virus (HSV-1, HSV-2). Additionally, the broad and expanding menu covers other infectious diseases such as a Mycobacteria assay portfolio, Hepatitis B and C (HBV and HCV), Human immunodeficiency virus (HIV), and Cytomegalovirus (CMV). For more information about the tests and systems, please visit www.diagnostics.roche.com.