Honeywell partnership aims to improve pharma manufacturing through AI

European Pharmaceutical Manufacturer Magazine | February 17, 2020

Honeywell partnership aims to improve pharma manufacturing through AI
The companies will combine their expertise across process automation and data analytics to aid pharmaceutical companies through a more efficient manufacturing process. Honeywell will utilise Bigfinite’s software-as-a-service (SaaS) to enhance manufacturing process operations by consolidating compliance-related manufacturing data into a single, visual interface for drug manufacturers. By combining data across laboratories, batch management, control, quality management and more, the companies hope pharmaceutical manufacturers will be able to deliver medical therapies more quickly to customers.Through the partnership, pharmaceutical manufacturers will be offered real-time visibility of their operations, assisted by predictive insights through advanced analytics, artificial intelligence, and internet-of-things technologies.

Spotlight

University of South Australia’s Professor Clive Prestidge is just one of our leading researchers in the area of pharmaceuticals. Professor Prestidge is focused on more effectively delivering drugs such as anti-cancer drugs, and runs a very active program to develop the research careers of PhD students.

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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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Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19

Prnewswire | August 18, 2020

Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes. Founded in 2012, Kimera® generated the first publicly available isolated exosome product and has treated over 35,000 thousand patients for a variety of investigational uses. Kimera currently employs 40 PhDs, technicians and staff at its Miramar Florida 27,000 sq. ft. GMP manufacturing facility, the first and only laboratory dedicated solely to exosome R&D and production in the US.

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RESEARCH

Nanoform and Celanese Explore Ways to Improve Drug Delivery

Nanoform, Celanese | May 26, 2021

Nanoform Finland Plc, an innovative nanoparticle medicine enabling company, and Celanese Corporation, a global specialty materials company, announced today plans to investigate potential synergies in the field of nanoparticle-enabled drug delivery. The objective of this research is to determine the utility of combining Nanoform's nanoparticle platform technologies with Celanese's VitalDose® EVA copolymer delivery technology for drug-eluting implants. The objectives are to enable the development of next-generation drug delivery systems that can handle an increased drug load and have better-sustained release properties. Nanoform and Celanese intend to collaborate on formulation development, using each company's formulation expertise. "We are excited to announce our collaboration with Celanese. One of Nanoform's primary goals is to allow next-generation drug therapies through the use of our nanoparticles. Given the inherent difficulty in loading an adequate amount of drug into many medical devices, we see a huge opportunity in employing our nanoparticles to overcome this fundamental challenge. We are excited about the potential to use the combination of these two technologies to provide new therapies to patients "said Nanoform CEO Edward Hggström. "Celanese has a good track record of developing drug-eluting implants for women's health, ophthalmology, and central nervous system disorders by integrating our VitalDose® EVA copolymer delivery technology with proteins, peptides, and small molecules. Exploring Nanoform's nanoparticle technologies offers up new possibilities for enhancing formulation performance with existing products and enabling future products. We are excited to collaborate with Nanoform and hope that our efforts will result in innovations that will benefit patients "Laura Brand, Celanese Vice President of Medical & Pharmaceuticals, said.

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Spotlight

University of South Australia’s Professor Clive Prestidge is just one of our leading researchers in the area of pharmaceuticals. Professor Prestidge is focused on more effectively delivering drugs such as anti-cancer drugs, and runs a very active program to develop the research careers of PhD students.