On July 8, 2020 Novocure (NASDAQ: NVCR) reported that over 100 physicians from more than 50 cancer treatment centers in the U.S. are now certified to prescribe Optune Lua, which is approved for the first-line treatment of unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM), in combination with pemetrexed and platinum-based chemotherapy (Press release, NovoCure, JUL 8, 2020, View Source [SID1234561758]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is a disease with a poor prognosis, so being able to offer patients a therapy that results in excellent response rates with minimal toxicity is exciting," said Matthew T. Ballo, M.D., FACR, Professor and Chair, Department of Radiation Oncology, West Cancer Center & Research Institute in Germantown, Tennessee. "We as clinicians can have a big impact on our patients’ lives by making them aware of this important new technology."

"We are proud of the progress we have made in the last year in making Optune Lua accessible to patients," said Pritesh Shah, Novocure’s Chief Commercial Officer. "We continue to work diligently to expand the number of centers that can provide Tumor Treating Fields therapy to patients facing this devastating and aggressive disease."

Of the more than 50 certified centers, 28 are now offering Optune Lua to MPM patients. The remaining centers are in the process of completing all regulatory requirements.

For a complete list of centers where Optune can be prescribed, please visit OptuneLuaCenters.com.

About Optune Lua

Optune Lua is a noninvasive, antimitotic cancer treatment for MPM. Optune Lua delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

Approved Indications

Optune Lua is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

Important Safety Information

Contraindications

Do not use Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of Optune Lua together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Optune Lua can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of Optune Lua include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune Lua treatment.

Do not prescribe Optune Lua for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Lua in these populations have not been established.

On July 8, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed the three-month product stability testing that is required by the U.S. Food and Drug Administration (FDA) for its CypCaps and CypCaps passed all of the FDA-required tests (Press release, PharmaCyte Biotech, JUL 8, 2020, View Source [SID1234561757]). This is the final product that will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed three-month stability study, "We are pleased to announce that our Cell-in-a-Box encapsulated cell product CypCaps has passed all of the FDA-required tests for the first three-months of a 24-month stability study. This is part of an ongoing study to determine the shelf life of the CypCaps final product that the FDA requires for all medical products. The data will be included in our IND. All future longer-term shelf life analyses, such as the next one at six months post-production, will be reported to the FDA but is not required for PharmaCyte to submit an IND."

As based in the ICH guidelines, regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps, as well as live vaccines etc., are particularly sensitive and more prone to inactivation over time, so it is especially important to determine the shelf-life for these products.

A battery of tests was performed on CypCaps that had been frozen post-production for three months of storage at -80C. Samples were thawed to show that the cells inside the CypCaps were still alive and functional as well as free of infectious agents. Some of these tests were performed by Austrianova (cell count, biological activity of the cells, capsule integrity, label integrity), whereas others (sterility, pH measurement) were performed by contract labs.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On July 8, 2020 Asieris Pharmaceuticals (Asieris), a China-based biotech company with global aspirations to discover, develop and commercialize innovative drugs for the treatment of genitourinary tumors and related diseases, reported it has received Clinical Trial Approval (CTA) from China’s National Medical Products Administration (NMPA) for the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira), which is being developed for the non-surgical treatment of high-grade cervical dysplasia (HSIL) (Press release, Asieris Pharmaceuticals, JUL 8, 2020, View Source [SID1234561754]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Receiving the CTA from NMPA for APL-1702 is a significant milestone for the company as it builds and expands its capabilities in the genitourinary disease area," commented Dr. John Zhuang, Asieris’ Chief Operation Officer and APL-1702’s project leader. "APL-1702 has the potential to be the first non-surgical treatment product for cervical precancerous lesions in the world. Female patients of childbearing age have strong desires for a non-surgical treatment that preserves the cervical function, and APL-1702 holds the potential of fulfilling this significant unmet medical need, thereby bringing substantial relief to these patients."

In addition to China, Asieris has concurrently initiated this global pivotal trial in the United States, Germany, Romania, Hungary, Russia, Ukraine and other European countries. Data from this trial will support the market approval applications in China, the United States, the European Union, and other countries.

About Cervical Dysplasia
High grade cervical squamous intraepithelial lesion (HSIL) is a precancerous condition caused by a persistent HPV infection, a highly prevalent sexually transmitted disease. Each year there are approximately 10 million cases with high grade disease and over 50 thousands new cases of cervical cancer worldwide. In China, approximately 2% of the female population develop HSIL each year.
Currently surgical excisions, primarily LEEP/LLETZ and CKC, are the most common treatment options. However, these surgical treatment methods may cause adverse reactions, including bleeding, infection, and damages to the cervix, which may subsequently lead to adverse effects on the reproductive function (such as premature birth, abortion).

About APL-1702 (Cevira)
Cevira is a photodynamic drug-device combination product. Based on the principle of photodynamic therapy, a photosensitizer is combined with light activation of specific wavelength to produce therapeutic effects. APL-1702 is intended for patients of 18 years and older with high-grade cervical dysplasia (HSIL), including all HPV subtype strains.
Cevira is easily placed on the cervix by a gynecologist and removed by the patient at the end of treatment, with no disruption to her normal daily activities during treatment. Only one or two treatments are needed. This breakthrough treatment would provide a new option to both Chinese and overseas patients, allowing them to avoid the pain and adverse reactions associated with surgical procedure, especially avoid the impact of surgery on reproduction.
APL-1702 has received the Fierce Innovation Awards – Life Sciences Edition 2019 in the category of Medical Device Innovation. No non-surgical treatment product has been approved for treating HSIL disease in any country to date.

On July 8, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it and longtime partner, Merck (known as MSD outside the US and Canada) have signed a new license agreement granting Merck the right to develop additional multispecific antibody therapeutic candidates using Zymeworks’ Azymetric and EFECT platforms (Press release, Zymeworks, JUL 8, 2020, View Source [SID1234561753]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the new research and license agreement, Zymeworks will provide Merck a worldwide, royalty-bearing license to research, develop and commercialize up to three new multispecific antibodies toward Merck’s therapeutic targets. In exchange, Zymeworks will receive an undisclosed upfront payment and if each of the three programs yield an approved product, Zymeworks is eligible to receive up to US$411 million in option exercise fees and clinical development and regulatory approval milestone payments and up to US$480 million in commercial milestone payments, as well as tiered royalties on worldwide sales.

Merck will also receive a worldwide, royalty-bearing license to research, develop and commercialize up to three multispecific antibodies in the animal health field in exchange for additional milestone payments and tiered royalties.

"It is an exciting time for the field of bispecific and multispecific therapeutics with candidates like ZW25 demonstrating great promise in clinical trials," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "We are very proud that oncology leaders like Merck recognize the value of our therapeutic platforms and continue to return for expanded access to our technology. We look forward to continuing our relationship with Merck as they advance additional multispecific candidates towards the clinic."

Zymeworks and Merck began working together in 2011 to develop bispecific antibodies in a collaboration that was expanded in 2014. The new agreement does not impact the original agreement.

"Zymeworks’ technology plays a significant role in our efforts to identify and develop multispecific antibody therapies," said Scott Lesley, Ph.D., Vice President of Discovery Biologics, Merck Research Laboratories. "Merck is pleased to continue our collaboration with the Zymeworks team."

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific and multispecific antibodies, allowing simultaneous binding to several different disease targets. This unique technology enables the development of multifunctional therapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering and internalization, and increase tumor-specific targeting. These features are designed to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric therapeutics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes that deliver high yields and purity, potentially reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to activate or suppress the antibody-mediated immune response. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization and optimization of therapeutic responses for different diseases.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Conference Call Information

The call will begin promptly at 16:00 CET. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:

A live webcast of the call can be accessed from the Events and Presentations section of the Company’s website, View Source

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.