On July 8, 2020 Kiadis Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative natural killer cell therapies for patients with life-threatening diseases, reported the exclusive license of Kiadis’ previously undisclosed K-NK004 program to Sanofi (Press release, Kiadis, JUL 8, 2020, View Source [SID1234561751]). The agreement covers Kiadis’ proprietary CD38 knock out (CD38KO) K-NK therapeutic for combination with anti-CD38 monoclonal antibodies, including Sarclisa, Sanofi’s recently approved therapy for patients with multiple myeloma. Additionally, Sanofi has obtained exclusive rights to use Kiadis’ K-NK platform for two undisclosed pre-clinical programs.

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As part of the agreement, Kiadis will receive a €17.5 million up front payment and will be entitled to receive up to €857.5 million upon Sanofi’s achievement of preclinical, clinical, regulatory and commercial milestones. Kiadis will also receive up to low double-digit royalties based on commercial sales of approved products resulting from this agreement.

Natural killer (NK) cells are the human body’s first line of defense against cancer and infections. Antibodies work synergistically with NK cells to kill tumor cells in a process called antibody-dependent cell-mediated cytotoxicity (ADCC). Treatment of multiple myeloma with anti-CD38 antibodies, such as Sarclisa, deplete the patients’ own NK cells, as natural NK cells also express CD38. Kiadis’ CD38KO K-NK cells are NK cells that have been modified to prevent expression of CD38, and are thus resistant to this effect. Therefore, adjunctive infusion of CD38KO K-NK cells will reinvigorate the natural synergy between NK cells and antibodies to kill tumor cells, optimizing efficacy.

Arthur Lahr, chief executive officer of Kiadis, commented, "We are proud to announce this collaboration with Sanofi, which marks the start of the previously undisclosed K-NK004 program and expands the application of our K-NK platform into multiple myeloma. The agreement with Sanofi – with their world-class expertise and approved anti-CD38 monoclonal antibody, Sarclisa, in multiple myeloma and deep understanding of NK-cell biology – is a testament to the groundbreaking potential of our K-NK natural killer cell platform to treat life-threatening diseases."

John Reed, Global Head of Research and Development at Sanofi, commented, "The licensing of Kiadis’ CD38KO K-NK cells is particularly exciting for Sanofi since we will be studying this cell-based therapeutic with our recently FDA approved treatment for patients with difficult-to-treat multiple myeloma, in hopes of bringing even more options to these patients with this hematologic cancer. At Sanofi, we are committed to pioneering treatments that address unmet healthcare challenges. Innovative collaborations, such as this partnership with Kiadis, have the potential to expand the clinical benefits of our medicines by combining them with synergistic partnered therapeutics to deliver improved outcomes for patients."

About the Sanofi-Kiadis License Agreement
Sanofi has received exclusive worldwide rights to research, develop and commercialize K-NK004 based on Kiadis’ CD38KO K-NK cells in combination with CD38-targeting molecules for the treatment of multiple myeloma and other CD38 positive blood cancers. Recently, Sanofi received U.S. Food and Drug Administration (FDA) approval for Sarclisa, a monoclonal antibody that targets CD38, for the treatment of multiple myeloma. Additionally, Sanofi has obtained exclusive rights to use Kiadis’ K-NK platform for two other previously undisclosed pre-clinical programs. The license does not include rights to K-NK002 and K-NK003 or to any other current and future Kiadis programs.

Under the terms of this agreement, Sanofi will be responsible for and bear all costs related to the research and development, manufacturing, regulatory and commercial activities related to the licensed K-NK programs. Kiadis has retained exclusive rights to and will supply PM21 particles and select universal donors for Sanofi, paid for by Sanofi.

About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy,1 affecting more than 130,000 patients in the United States; approximately 32,000 Americans2 are diagnosed with multiple myeloma each year. Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. As patients relapse, they can become refractory to therapies they have received. There is a need for new agents so that patients and physicians can have options as the disease progresses over time.

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Dutch Translation/Nederlandse vertaling
Amsterdam, 8 juli 2020 – Kiadis Pharma N.V. ("Kiadis" of de "Onderneming") (Euronext Amsterdam en Brussel: KDS), een biofarmaceutische onderneming in de klinische fase gericht op ontwikkeling van innovatieve Natural Killer Cell-therapieën voor patiënten met levensbedreigende aandoeningen, heeft een licentieovereenkomst gesloten met Sanofi voor Kiadis’ nog niet eerder bekendgemaakte preklinische K-NK004-programma. De overeenkomst geeft Sanofi het recht om Kiadis’ CD38 knock-out (CD38KO) K-NK-cel medicijn te combineren met Sanofi’s Sarclisa anti-CD38 monoklonale antilichamen. Sarclisa is recentelijk door de FDA goedgekeurd voor patiënten met multipel myeloom (ziekte van Kahler). Bovendien heeft Sanofi de exclusieve rechten verkregen voor het gebruik van Kiadis’ K-NK-platform voor twee niet nader genoemde preklinische programma’s.

Kiadis ontvangt een bedrag ineens van € 17,5 miljoen en heeft het recht op totale betalingen tot potentieel € 857,5 miljoen, zodra Sanofi vooraf vastgestelde mijlpalen heeft behaald. Kiadis zal daarnaast tot lage dubbelcijferige royalty’s ontvangen op de omzet van producten die door Sanofi worden ontwikkeld als onderdeel van de overeenkomst.

Natural killer (NK)-cellen vormen de eerste verdedigingslinie van het menselijk lichaam tegen kanker en infecties. Antilichamen werken in het menselijk lichaam samen met NK-cellen voor het doden van tumorcellen. Anti-CD38-antilichamen voor de behandeling van multipel myeloom (ziekte van Kahler), zoals Sarclisa, doden echter niet alleen de tumorcellen die CD38 tot expressie brengen, maar ook de eigen NK-cellen van de patiënt, aangezien deze ook CD38 tot expressie brengen. Kiadis’ CD38KO K-NK-cellen brengen CD38 niet tot expressie en zijn daarmee resistent tegen dit effect. Een combinatietherapie met zowel anti-CD38 antilichamen als CD38KO K-NK-cellen herstelt daarmee de natuurlijke synergie tussen NK-cellen en antilichamen en optimaliseert de anti-tumor effectiviteit.

Arthur Lahr, CEO van Kiadis, zegt in reactie:
"Het is met trots dat we deze samenwerking met Sanofi bekendmaken. Deze alliantie markeert de start van ons nog niet eerder bekendgemaakte K-NK004-programma en breidt de toepassing van onze K-NK-medicijnen uit naar multipel myeloom. Sanofi heeft het door de FDA goedgekeurde anti-CD38-antilichaam Sarclisa op de markt voor de behandeling van deze ziekte en bezit een diepgaande kennis van NK-celbiologie en synergie met antilichamen. De overeenkomst getuigt daarmee van het baanbrekende potentieel van ons K-NK natural killer cell-platform voor de behandeling van levensbedreigende aandoeningen."

John Reed, MD, PhD, global head of research and development van Sanofi, zegt:
"De licentie van Kiadis ‘CD38KO K-NK-cellen is voor Sanofi bijzonder interessant. We zullen deze celtherapie gaan combineren met ons onlangs door de FDA goedgekeurde medicijn voor patiënten met moeilijk te behandelen multipel myeloom. We hopen zo patiënten met deze bloedkanker meer opties te kunnen bieden. Bij Sanofi zetten we ons in voor baanbrekende behandelingen om grote medische problemen aan te pakken. Innovatieve allianties zoals die met Kiadis kunnen de klinische voordelen van onze geneesmiddelen vergroten, door combinatie met synergetische geneesmiddelen, om resultaten voor patiënten te verbeteren."

De overeenkomst met Sanofi
Sanofi heeft de exclusieve wereldwijde rechten gekregen om Kiadis’ CD38KO K-NK-cellen te ontwikkelen en op de markt te brengen in combinatie met op CD38-gerichte moleculen voor de behandeling van multipel myeloom en andere CD38-positieve bloedkankers. Onlangs ontving Sanofi goedkeuring van de Amerikaanse Food and Drug Administration (FDA) voor Sarclisa, een monoklonaal antilichaam dat zich richt op CD38, voor de behandeling van multipel myeloom (Ziekte van Kahler). Daarnaast heeft Sanofi de exclusieve rechten verkregen om het K-NK-platform van Kiadis te gebruiken voor twee andere niet nader genoemde preklinische programma’s. De licentie omvat geen rechten op K-NK002 en K-NK003 of op andere huidige en toekomstige Kiadis-programma’s.

Conform de voorwaarden van deze overeenkomst is Sanofi verantwoordelijk voor en draagt het alle kosten in verband met onderzoek, ontwikkeling, productie, regulatoire activiteiten en verkoop van de gelicentieerde K-NK-programma’s. Kiadis heeft de exclusieve rechten behouden om PM21-deeltjes aan Sanofi te leveren en universele donoren voor Sanofi te selecteren, bekostigd door Sanofi.

Dit bericht is een vertaling van het originele Engelstalige persbericht. In geval van verschillen ten gevolge van vertaling of verschillen in interpretatie, geldt het originele Engelstalige persbericht als leidend.

About Kiadis’ K-NK-Cell Therapies
Kiadis’ K-NK platform is designed to deliver potent NK cells to help patients. Kiadis’ programs consist of off-the-shelf and haploidentical donor NK-cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies.

The Company’s PM21 particle technology enables improved ex vivo expansion and activation of cytotoxic NK cells supporting multiple high-dose infusions. Kiadis’ proprietary off-the-shelf NK-cell platform is based on NK cells from unique universal donors and can make NK-cell therapy product rapidly and economically available for a broad patient population across a wide range of indications.

Kiadis is developing K-NK002 as an adjunctive immunotherapeutic on top of HSCT, and K-NK003 for the treatment of relapse/refractory acute myeloid leukemia. In addition, Kiadis has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors.

On July 8, 2020 Foghorn Therapeutics Inc. (Foghorn), a company advancing an unprecedented class of therapeutics targeting the chromatin regulatory system in oncology, reported that it has entered into a strategic collaboration with Merck, known as MSD outside the United States and Canada (Press release, Foghorn Therapeutics, JUL 8, 2020, View Source [SID1234561750]). The collaboration will apply Foghorn’s proprietary Gene Traffic Control product platform to discover and develop novel therapeutics against a transcription factor target believed to be relevant to a broad range of cancer patients.

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The target is one of Foghorn’s growing number of programs emerging from the company’s product platform focused on chromatin dysregulation. The chromatin system regulates which genes a cell expresses and when it expresses them. Dysregulation of the chromatin system is implicated in up to half of all cancers.

Under the collaboration agreement, Foghorn will grant Merck exclusive global rights to develop and commercialize drugs that target dysregulation of a single transcription factor. Under the terms of the agreement, Foghorn will receive an upfront payment and research milestones and will be eligible to receive development, regulatory and commercial milestones potentially totaling up to $425 million as well as royalties on sales of any approved product from the collaboration.

"We’re excited to partner with Merck given their world-renowned capabilities in cancer research and development," said Adrian Gottschalk, president and chief executive officer of Foghorn. "Our ability to systematically drug transcription factors using our proprietary product platform opens vast potential to discover and develop novel cancer treatments."

There is broad evidence for the role of dysregulated transcription factors in multiple cancer types, but these have been difficult targets to drug" said Dr Nick Haining, vice president, Discovery Oncology & Immunology, Merck Research Laboratories. "We look forward to working with Foghorn and applying their platform to identify novel candidates to drug transcription factors in cancer."

ABOUT THE CHROMATIN REGULATORY SYSTEM

The chromatin regulatory system regulates gene expression by directing the movement of molecules that turn genes on and off. Disease dependencies associated with the chromatin regulatory system are estimated to impact over 2.5 million cancer patients across the United States, Europe and Japan. This system is further implicated in neurological, autoimmune, and other serious diseases.

On July 8, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of preclinical data describing the unique immunomodulatory effects of umbralisib, the Company’s investigational oral once-daily dual inhibitor of PI3K-delta and CK1-epsilon, in Blood Advances, a Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, TG Therapeutics, JUL 8, 2020, View Source [SID1234561749]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated "We want to thank Dr. Javier Pinilla-Ibarz, and the team at the H. Lee Moffitt Cancer Center & Research Institute for their important preclinical work examining the unique effect of umbralisib on T cells compared to other PI3K inhibitors. We have been encouraged by the safety profile reported in umbralisib clinical trials, and this preclinical data helps us to better understand the potential mechanistic rationale for the differentiated safety profile observed to date."

Dr. Javier Pinilla-Ibarz, Lymphoma Section Head, Director of Immunotherapy, Malignant Hematology Division at the H. Lee Moffitt Cancer Center in Tampa, Florida, and the senior author on the publication stated, "We have long been intrigued by the unique properties umbralisib has exhibited as a PI3K inhibitor. It is evident from the non-clinical work published today and from the clinical data seen thus far, that umbralisib is a novel molecule with differentiated effects on the T cell repertoire. We are pleased to contribute to elucidating the mechanisms of umbralisib and look forward to continuing our research."

The manuscript included preclinical data describing the effects of idelalisib, duvelisib and umbralisib on regulatory T cells (Tregs) on normal human T cells, T cells from CLL patients and T cells in an Eμ-TCL1 adoptive transfer mouse CLL model. While all three inhibitors exhibited anti-tumor efficacy in the Eμ-TCL1 CLL model, idelalisib or duvelisib-treated mice displayed increased immune-mediated toxicities, impaired function and reduced numbers of Tregs, whereas Treg number and function was more sustained in umbralisib-treated, CLL bearing mice. In addition, the manuscript also explored the effects of inhibition of CK1-epsilon on improvements in CLL Treg number and function and suggested the differentiated safety profile of umbralisib may be due to its role as a dual PI3K-delta/CK1-epsilon inhibitor.

These data are described further in the manuscript entitled, "The dual PI3K delta/CK1 epsilon inhibitor umbralisib exhibits unique immunomodulatory effects on CLL T cells," which was published online in the First Edition section of Blood Advances, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The online version of the article can be accessed at View Source

On July 8, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported receipt of a notification from the European Patent Office to grant a patent for Kitov’s application entitled "Humanized antibodies against CEACAM1 (Press release, Kitov Pharmaceuticals , JUL 8, 2020, View Source [SID1234561746])." The patent covers protein and DNA sequences pertaining to humanized antibodies capable of specific binding to human CEACAM1 molecules, including its lead monoclonal antibody, CM24, pharmaceutical compositions comprising these antibodies, as well as methods for their use in treating and diagnosing cancer and other conditions.

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Kitov is currently advancing preparations to initiate a Phase 1/2 clinical trial of CM24 in combination with nivolumab (Opdivo) in patients with non-small cell lung cancer, and in combination with nivolumab in addition to standard of care chemotherapy in patients with pancreatic cancer. The trial will be conducted under a clinical collaboration agreement with Bristol-Myers Squibb (BMS) Company, and is expected to begin in the second half of 2020.

"We are very pleased with this new addition to our patent coverage in the EU, which, together with the corresponding US patent which has been granted earlier this year, strongly positions CM24 as a unique approach for treating cancer patients. We look forward to the anticipated initiation of our planned Phase 1/2 clinical trial with BMS later this year," said Isaac Israel, Kitov’s Chief Executive Officer.

On July 8, 2020 A Health Trends study from researchers at Quest Diagnostics (NYSE: DGX) and the University of Pittsburgh Medical Center (UPMC) reported new evidence that the HPV screening test is significantly less likely to detect cervical cancer and precancer than cotesting, a method which combines HPV and Pap (Papanicolaou test by liquid based cytology) testing using the same specimen (Press release, Quest Diagnostics, JUL 8, 2020, View Source [SID1234561745]).

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The study is significant because it is the largest to date to assess the performance of guideline-recommended cervical cancer screening methods in a diverse population of American women in real-world care settings. It reveals stark differences in the performance of the various recommended methods in detecting cancer and precancers in women 30 years of age and older.

Published online today in the American Journal of Clinical Pathology, the peer-reviewed study assesses sensitivity rates of HPV alone, Pap alone and cotesting (HPV and Pap testing together) in detecting cancer and precancer of the cervix in nearly 19 million de-identified cotest results performed by Quest Diagnostics on behalf of 13.6 million women in the United States from 2010 to 2018. Of these cases, 1,259 were diagnosed with cervical cancer – twice the number of diagnosed cancer cases as the next largest study.v

"This Health Trends analysis of a notably large and diverse population firmly validates the critical role of cotesting as a cancer and precancer screening method for women 30 and older," said R. Marshall Austin, MD, PhD, Emeritus Professor of Pathology, University of Pittsburgh Medical Center (UPMC). "It should put to rest any notion that HPV alone achieves the same bar for quality cancer screening."

HPV testing identifies the genetic material of the human papillomavirus virus, which can cause cervical cancer, while Pap identifies cellular changes on the cervix that may be or become cancer. The United States Preventive Services Task Force (USPSTF) recommends screening in women 30-65 years of age every three years with Pap, every five years with cotesting or every five years with primary HPV testing.

Among the key findings:

HPV and Pap testing alone fails to detect twice as many women who develop cervical cancer as cotesting. Of 1,615 cotests taken at any time prior to a cancer diagnosis, 86.9 percent were positive by cotesting, a non-detection rate (also known as false negative) of about 13.1 percent. By comparison, Pap and HPV testing alone had non-detection rates nearly twice as high: Pap at 26.4 percent and HPV at 28.4 percent.

Cotesting detected significantly more women who developed biopsy-confirmed adenocarcinomas, a typically aggressive form of cervical cancer, identifying 82.3 percent of this cancer compared to only 61.2 percent by HPV and 59.7 percent by Pap.

HPV testing fails to identify one in five women who develop cancer when performed within a year of cancer diagnosis. Among women screened within one year of a cancer diagnosis, the non-detection rate for HPV testing alone was 22.5 percent, nearly 1.5 times higher than Pap (14.9%) and four times higher than cotesting (5.9%).

Cotesting detected more women who developed biopsy-confirmed precancers than HPV or Pap alone, identifying 95.6 percent of these precancers, compared to 92.6 percent by HPV and 77.9 percent by Pap.
According to a report published in January 2020 by the American Cancer Society, cervical cancer is the second leading cause of cancer death nationally in women 20-39 years of age, causing 10 premature deaths per week in this age group.i

"While widespread screening has helped cut cervical cancer mortality by three fourths in the past 80 yearsii, this disease is still far too common," said co-author Harvey W. Kaufman, M.D., Senior Medical Director and Director, Health Trends Research Program, Quest Diagnostics. "Because most cervical cancers develop in the absence of regular screening, ensuring women have access to the most reliable screening method, cotesting, when they are screened is an essential step in lowering mortality from this disease."

Health Trends study builds on prior research

The new findings confirm previous Quest Diagnostics research published in Cancer Cytopathology in 2015, a journal of the American Cancer Society, which found HPV-only cervical screening would not have detected approximately 19 percent of 526 women who developed confirmed cervical cancer. An analysis of data from Magee-Women’s Hospital (MWH) of the University of Pittsburgh Medical Center (UPMC) reported a higher percent of positive Pap than HPV tests among 109 cotesting results within 12 months from cancer diagnosis, similar to the present Quest Diagnostics Health Trends study. iii

By comparison, analysis of a regional dataset from Kaiser Permanente Northern California (KPNC) also found that cotesting outperformed other methods, but the authors of that study concluded that "the contribution of cytology to screening is shown to be very small."iv The KPNC data were also limited in its ability to identify cytological abnormalities associated with confirmed adenocarcinomas, an aggressive cancer, as compared to the Quest and MWH data.v

"It is important to reconcile the similar conclusions of Quest Diagnostics and Magee-Women’s Hospital with the different findings of Kaiser Permanente in Northern California," said Lee H. Hilborne, MD, Professor of Pathology and Laboratory Medicine at UCLA, Senior Medical Director, Quest Diagnostics. "KPNC has an exemplary care model, but this very strength may limit the usefulness of KPNC data for drawing conclusions about the real-world care experience of most American women who receive care in less integrated practice settings."

"For women who may otherwise not be screened at all, there is no question that cytology or HPV primary are useful screening technologies," said Damian P. Alagia, III, MD, Senior Medical Director of Woman’s Health for Quest Diagnostics. "Yet, that should not obscure the fact that cotesting is fundamentally the better screening option for women and is widely available in the U.S."

Study Strengths and Limitations
The strengths of the study include the large, longitudinal, nationally representative sample size and a study population believed to be reflective of adult women in the United States. The study period covers nine years (2010-2018). The study was limited only to women who sought medical care and were referred to laboratory services at Quest Diagnostics. The Quest Diagnostics Health Trends study was deemed exempt by the Western Institutional Review Board.

About Health Trends
Quest Diagnostics Health Trends is a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy. The reports are based on the Quest Diagnostics database of more than 50 billion de-identified laboratory test results, believed to be the largest of its kind in healthcare. Health Trends has yielded novel insights to aid the management of allergies and asthma, prescription drug monitoring, diabetes, Lyme disease, heart disease, influenza and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI), a series of reports on national workplace drug positivity trends based on the company’s employer workplace drug testing data. www.QuestDiagnostics.com/HealthTrends