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Takeda Partners with Twist Bioscience to Expand Biologics Discovery Capabilities

On July 8, 2020 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a partnership with Takeda Pharmaceutical Company Limited (Takeda) for access to proprietary phage display libraries for the discovery, validation and optimization of antibodies in Takeda’s pipeline of biologics for oncology, rare diseases, neuroscience, and gastroenterology (Press release, Takeda, JUL 8, 2020, View Source [SID1234561760]).

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"Twist’s unique ability to generate robust, diverse and cutting-edge libraries through its proprietary silicon platform together with our deep insight into therapeutic drug discovery and development will help us expand a growing pipeline of targeted biologic candidates," said Robert Mabry, Head of Global Biologics Research at Takeda.

Under the terms of the agreement, Twist Biopharma, a division of Twist Bioscience, will license to Takeda its "Library of Libraries," a panel of synthetic antibody phage display libraries derived only from sequences that exist in the human body. Together, the companies will work to discover, validate and optimize new antibody candidates. In return, Takeda will pay Twist annual technology licensing fees, as well as milestones and royalties for all compounds discovered from the Twist phage display libraries.

"We look forward to applying our unique ability to generate robust, diverse and cutting-edge libraries together with Takeda’s deep insight into therapeutic drug discovery and development to truly forge new frontiers in bringing personalized therapies to patients worldwide," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience.

Kinnate Biopharma Appoints Dr. Richard Williams as Chief Medical Officer

On July 8, 2020 Kinnate Biopharma Inc., a precision oncology company focused on the discovery and development of novel kinase inhibitors, reported the appointment of Richard Williams, MBBS, PhD as Chief Medical Officer (Press release, Kinnate Biopharma, JUL 8, 2020, View Source [SID1234561759]). Most recently Chief Medical Officer and Global Head of Oncology Programs at WuXi NextCODE, Dr. Williams brings to Kinnate more than a decade of global clinical strategy and drug development experience in the biopharmaceutical industry. The company has also announced the appointment of Robert Kania, PhD as Senior Vice President, Drug Discovery.

Kinnate is focused on the design and development of best- and first-in-class small molecules targeting atypical mutations and fusions with no coverage from currently available therapeutics. The company’s pipeline portfolio includes a RAF dimer inhibitor targeting Class II and III mutations, an FGFR2/3 inhibitor and a CDK12 inhibitor, as well as other early stage development programs.

"As Kinnate continues to accelerate progress toward clinical testing, we need a leader who shares our vision of developing best- and first-in-class therapies for people with genetically defined and hard-to-treat cancers," said Nima Farzan, Chief Executive Officer of Kinnate. "With extensive clinical development and drug discovery experience over his distinguished career, Richard brings significant precision oncology expertise to the Kinnate team and will play an instrumental role in advancing our lead candidates through clinical trials and regulatory submission."

While at WuXi NextCODE, Dr. Williams was responsible for leading the clinical development of large-scale genomics and target biomarker discovery programs. Previously, he was with cancer detection company GRAIL as Group Medical Director and Program Lead of the Circulating Cell-Free Genome Atlas (CCGA), the largest-ever prospective study of circulating nucleic acids in cancer. He also guided the development of early clinical oncology assets as Head of Early Development Oncology Group and Early Development Leader at Amgen. While Senior Medical Director at Puma Biotechnology, Dr. Williams led the Phase 2 and Phase 3 trials in metastatic breast cancer and lung cancer for the development of the targeted cancer therapeutic Nerlynx (neratinib). He was also a clinical hematology and oncology fellow, and later an NIH-funded faculty member, at St. Jude’s Children’s Research Hospital where he focused on translational biology and therapeutics studies within the molecular oncology and hematological malignancies programs. He has co-authored 60 publications in high impact clinical, translational and basic research journals including NEJM, Nature and Cancer Cell, and is the co-inventor on two patents. Dr. Williams holds an MBBS and PhD as well as a BMedSc from University of Queensland, Australia.

"Currently available therapies don’t provide sufficient clinical benefit to most patients with genetically-defined cancers. Kinnate has developed an impressive platform of kinase inhibitors that could fill this significant unmet need," said Dr. Williams. "I look forward to working with Kinnate’s world-renowned team of drug hunters, life science investors, and scientific advisors to rapidly bring these targeted medicines to the cancer patients who will benefit from these potentially life-saving therapies."

At Kinnate, Dr. Kania will be instrumental in advancing the company’s early-stage development programs. Prior to joining Kinnate, he spent more than 20 years in various senior roles at Pfizer, where he was most recently, Senior Director, Design Chemistry. Other positions he held at the company include Senior Director of Cancer Chemistry, Project Leader and Scientist. While at Pfizer, he was co-inventor for a number of FDA-approved precision oncology therapies including Inlyta (axitinib), Lorbrena (loratinib) and Xalkori (crizotinib). Dr. Kania has published nearly 40 peer-reviewed journal articles and holds 19 patents in drug development-related areas. He holds a PhD and MA in Organic Chemistry from Harvard University and a BS in Chemistry from University of California, Berkeley.

"Kinnate has built an exceptional team with deep expertise across medicinal chemistry, cancer genetics and translational biology and I am pleased to join them in the development of new cancer treatments for people who currently have limited options," added Dr. Kania.

Novocure Announces Over 100 Physicians in the U.S. Now Certified to Prescribe Optune Lua™

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]).

"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.

PharmaCyte Biotech Successfully Completes Three-Month Stability Study

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.

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

Asieris Received China NMPA’s Approval to Start a Global Phase III Clinical Trial for APL-1702 to Treat Cervical Precancerous Lesions (HSIL)

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]).

"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.