BeiGene reports positive Phase III interim analysis for lung cancer drug

MedCity News | April 14, 2020

BeiGene reports positive Phase III interim analysis for lung cancer drug
Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Monday. Beijing-based BeiGene reported an improvement in progression-free survival (PFS) among first-line patients with non-squamous non-small-cell lung cancer (NSCLC) receiving tislelizumab along with platinum chemotherapy and pemetrexed, compared with those receiving chemotherapy and pemetrexed alone. However, it did not disclose the data. The company said it plans to file for approval of the drug with Chinese drug regulators and present data from the study at upcoming medical conferences. Shares of BeiGene were up around 6% on the Nasdaq in Tuesday afternoon trading, following the after-hours announcement.

Spotlight

The global Diabetes Attitudes, Wishes and Needs (DAWN2™) study represents the voices of more than 15,000 patients, family members, and health care professionals across 17 countries and 4 continents. DAWN2™ found that the emotional burden of diabetes affects not only patients, but also their families; people living with diabetes are strongly impacted by the negative perceptions of the disease, while family members feel that they do not know how to help their loved ones.

Spotlight

The global Diabetes Attitudes, Wishes and Needs (DAWN2™) study represents the voices of more than 15,000 patients, family members, and health care professionals across 17 countries and 4 continents. DAWN2™ found that the emotional burden of diabetes affects not only patients, but also their families; people living with diabetes are strongly impacted by the negative perceptions of the disease, while family members feel that they do not know how to help their loved ones.

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BUSINESS INSIGHTS

Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor

Xencor, Zenas BioPharma | November 22, 2021

Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and Zenas BioPharma (“Zenas”), a global biopharmaceutical company based in the USA and China committed to the development and delivery of immune-based therapies, today announced that Zenas has acquired from Xencor exclusive worldwide rights to develop, manufacture and commercialize the investigational antibody obexelimab. Obexelimab is a potential first-in-class bifunctional antibody that targets CD19 with its variable domain and uses Xencor's XmAb® Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which are important components in the immune system. Xencor demonstrated through early-stage clinical studies that obexelimab effectively inhibits B-cell function without depleting the cells and generates an encouraging treatment effect in patients with multiple autoimmune diseases. “Zenas is advancing a broad pipeline of differentiated drug candidates that are intended to bring best-in-class innovation to patients with underserved medical needs. Today, we are pleased to add obexelimab to our portfolio, and based on its clinical profile, we believe it is positioned as a first-in-class candidate with the potential to treat numerous autoimmune diseases.” Hua Mu, Ph.D., MD, president and chief executive officer at Zenas “Obexelimab’s highly potent and broad blockade of B-cell activation—without depleting B cells—differentiates it from other B-cell targeting therapies, and it has demonstrated disease-modifying activity in settings where B-cell inhibition is a proven strategy,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “In Zenas BioPharma, we have found a partner committed to broadly and aggressively developing therapeutics like obexelimab for patients with autoimmune diseases, enabling Xencor’s continued focus on the growing opportunities provided by our XmAb bispecific antibody and cytokine pipeline.” Under the terms of the new agreement, Zenas will issue to Xencor a warrant giving Xencor the right to acquire additional Zenas equity, such that Xencor’s total equity in Zenas would be 15% of its fully diluted capitalization following the closing of Zenas’ next round of equity financing, subject to certain requirements. Xencor previously received equity in Zenas under a separate license agreement. Xencor is also eligible to receive up to $480 million based on the achievement of certain clinical development, regulatory and commercialization milestones and is eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography. Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide. About Xencor, Inc. Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. About Zenas BioPharma Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and delivery of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. Xencor Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to the development of obexelimab as a potential treatment for patients with autoimmune diseases; the commercial potential of obexelimab; the safety, tolerability, efficacy and pharmacokinetics of obexelimab; the quotations from Xencor’s president and chief executive officer; and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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BUSINESS INSIGHTS

MHRA Expands Relationship with Commonwealth Informatics to Transform Drug Safety

Commonwealth Informatics, a Genpact company | January 25, 2022

Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom. MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Commonwealth Vigilance Workbench (CVW), to support the MHRA transformation of safety monitoring through a single integrated platform across all medicines, vaccines, blood components and devices. "The MHRA is looking to transform our vigilance services through new ways of working, underpinned by the technology we use and how we operate our services. We see our partnership with CVW enabling us to deliver a more responsive safety surveillance system through innovative technology." Mick Foy, Head of Pharmacovigilance Strategy at MHRA "We are delighted to have the opportunity to build on our longstanding research collaboration with the MHRA and deliver future value through greater efficiencies within signal detection," said Bill Blackwell, Commonwealth VP Safety Science Solutions. "The collaborative partnership will enable us, together with the MHRA, to bring new innovative methodologies to safety surveillance on behalf of patients." Commonwealth's solution will be implemented to perform signal detection and signal management across multiple data sources leveraging advanced automation, such as artificial intelligence, to ensure more accurate multivigilance analysis and processing. CVW is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources. The MHRA is deploying Insife's HALOPV solution for case processing management, advanced automation, and real-time reporting and analytics. Commonwealth Informatics has partnered with Insife, to integrate CVW with HALOPV and to collaboratively deploy the end-to-end multi-vigilance platform in Q2 2022. Insife, headquartered in Denmark, offers specialist consulting services in multivigilance (Medicines and Devices), Regulatory Affairs (RA), and Information Technology (IT) implementation. Insife's services are based on expertise across the life sciences value chain with an understanding of digital transformation and drug safety assurance through process optimisation and automation. About Commonwealth Informatics Commonwealth Informatics is a technology and services company with industry expertise in medical product safety and public health surveillance. Pharmaceutical and biotechnology companies, government agencies, and healthcare providers use Commonwealth's products and services to assemble relevant data and answer complex clinical and safety analysis questions quickly and accurately. Commonwealth is an independently-operated subsidiary of Genpact, a global professional services firm focused on delivering digital transformation. About Medicines and Healthcare products Regulatory Agency MHRA, based in London, is an executive agency sponsored by the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusion in the United Kingdom. Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

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PHARMACY MARKET

Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

Evergreen Theragnostics, Inc. | July 17, 2021

Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility. Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227). Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing. The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment. About Evergreen Theragnostics, Inc. Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. About Tema Sinergie Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.

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