On May 22, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for CX-2029, a first-in-class CD71-directed Probody drug conjugate being co-developed by CytomX and its partner AbbVie (Press release, CytomX Therapeutics, MAY 22, 2018, View Source [SID1234527069]). CD71, also known as the transferrin receptor 1, is a highly expressed protein present in a number of solid and hematologic cancers that possess attractive molecular properties for the efficient delivery of cytotoxic payloads to tumor cells. The achievement of this milestone triggers a $25 million payment to CytomX from AbbVie.

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"CD71 has long been considered a high potential but challenging target for antibody drug conjugates given its high expression in tumors but ubiquitous expression in normal tissues. However, we see CD71 is an attractive candidate for a Probody drug conjugate approach, since our technology can potentially localize treatment directly to tumor tissue," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With CX-2029 now clear to advance into Phase 1, CytomX and our partners now have four clinical-stage Probody programs with anticipated initial data readouts later this year from our two wholly-owned programs, CX-072 and CX-2009. It is also noteworthy that this milestone comes just two years following the signing of our agreements with AbbVie, reflecting the efficiency of this collaboration."

"The IND clearance of CX-2029 marks an important step in our partnership with CytomX," said Steve Davidsen, Ph.D., vice president, oncology drug discovery, AbbVie. "Our partnership has the potential to advance emerging areas of science with the hope of providing additional options for people living with cancer."

About the Collaboration
AbbVie and CytomX are co-developing CX-2029, a Probody drug conjugate against CD71, with CytomX leading pre-clinical and early clinical development. AbbVie will lead later development and commercialization, with global late-stage development costs shared between the two companies. CytomX is eligible to receive up to $470 million in development, regulatory and commercial milestones, pending the achievement of pre-determined outcomes. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S.

AbbVie also received exclusive worldwide rights to develop and commercialize Probody drug conjugates against up to two additional, undisclosed targets. Should AbbVie ultimately pursue these targets, CytomX is eligible to receive additional milestone and royalty payments per target on any resulting products.

On May 22, 2018 Lupagen, Inc. (www.lupagen.com), a medical device company developing first-in-class cell and gene therapy delivery technologies for CAR-T, gene editing and immunotherapy products, reported the intent to explore the development of a bedside, point-of-care delivered CAR-T therapy with Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments (Press release, Lupagen, MAY 22, 2018, View Source;humanigen-to-explore-point-of-care-car-t-therapy-300652016.html [SID1234573190]).

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Lupagen and Humanigen are planning work to investigate the potential of a bedside CAR-T therapy created from Humanigen’s Ifabotuzumab, a first-in-class, monoclonal antibody targeting the EphA3 receptor tyrosine kinase.

"We are excited to support Humanigen’s strategic objectives to deliver safer, more effective and more routine CAR-T treatments, including one with the novel EphA3 target," said Nipon Das, M.D., chief executive officer and co-founder of Lupagen. "A bedside, closed-loop, point-of-care patient-connected system allows patient cells to be harvested, reprogrammed or modified, then reinfused at the bedside. The potential positive impact on CAR-T and other ex-vivo autologous cell and gene therapies is enormous through lower treatment costs, increased patient access and enhanced safety and control of these powerful new therapies."

On May 21, 2018 Galecto Biotech AB, the leading developer of galectin modulators for the treatment of severe diseases, including fibrosis and cancer, reported the appointment of Richard Marshall, MD, PhD, as Chief Medical Officer (Press release, Galecto Biotech, MAY 21, 2018, View Source [SID1234526811]). Dr Marshall joins Galecto with more than 15 years of experience across drug discovery, clinical development and business development in various positions at Glaxo Smithkline (GSK). Most recently, he was Vice-President and Head of the Fibrosis & Lung Injury Discovery Performance Unit. During his tenure at GSK, Dr Marshall led the early clinical development for NucalaTM, anti-IL-5 mAb in asthma and nasal polyposis. He is a visiting Professor at Newcastle University and an Honorary Consultant in Thoracic Medicine at Royal Brompton & Harefield NHS Foundation Trust. Dr Marshall earned his undergraduate, medical and doctorate degress at University College London.

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"Richard is a great addition to the Galecto management team as we move towards late-stage clinical studies with our lead program, TD139, a potent and selective inhibitor of galectin-3, in Idiopathic Pulmonary Fibrosis (IPF) and advance other candidates in fibrosis, inflammation and cancer through clinical development," said Hans Schambye, CEO of Galecto Biotech. "His career at GSK has seen him deliver on all aspects of drug discovery and development within the respiratory and fibrosis field, making him ideal to help take Galecto to the next level."

"Galecto’s unique approach to targeting galectin-3 has shown very promising results, so far, in clinical studies. This exciting mechanism has the potential to bring new medicines to patients, treating fibrosis and inflammation across a range of severe, often life threatening, diseases. I look forward to working with the superb team at Galecto to help steer the next stage of clinical development for Galecto’s portfolio of candidate drugs," said Dr Marshall.

On May 21, 2018 Immedica Group reported that it has entered into an exclusive supply and distribution agreement with German based Oncoscience GmbH regarding the distribution, marketing and sale of CIMAher (Nimotuzumab) in the Nordics (Press release, Immedica Pharma, MAY 21, 2018, View Source [SID1234555254]). Under the agreement, Medical Need AB gains the rights to distribute CIMAher in Denmark, Finland, Iceland, Norway and Sweden, and will initially do so on a named patient basis in the territories.

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Tomas Gloveus, the Head of Marketing and Sales at Medical Need AB said, "CIMAher addresses a significant unmet medical need for many patients with severe cancers, who are currently left to treatment alternatives with severe side-effects and we look forward to making CIMAher available in the Nordic countries."

Dr. Dirk Reuter, the Managing Director of Oncoscience GmbH added, "The niche focus combined with their capabilities within oncology, makes Medical Need a very suitable partner for us in the Nordics, and we look forward to working together to improve the access of CIMAher in the Nordic region."

Nimotuzumab is a well-established monoclonal antibody within oncology that targets the epidermal growth factor receptor (EGFR) on cancer cells and inhibits their signalling pathway which stops cancer cells from growing and proliferating. To date, Nimotuzumab has been administered to more than 65,000 patients globally and has undergone 82 clinical studies. Nimotuzumab is already approved in 25 countries around the world for a variety of cancers, such as head & neck cancer, oesophageal cancer, highly malignant brain tumours and pancreatic cancer.

Nimotuzumab has an EU orphan designation for the treatment of pancreatic cancer and glioma and has been used in EU under named patient basis, following special individual approvals from a national regulatory authority as it does not yet hold a EU marketing authorization.

About CIMAher (Nimotuzumab)
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Nimotuzumab’s capacity to bind to EGFR is strongly dependant on cell receptor density and it’s bivalent binding mechanism. EGRF is overexpressed in many cancer cells as compared to normal tissue and nimotuzumabs bivalent binding mechanism results in more specific bonds and therefore, potentially increases anti-tumor activity with decreased toxicity in normal tissue (i.e. skin and healthy organ toxicity).

Nimotuzumab is currently available as a registered treatment in 25 countries around the world for a variety of cancers, including head & neck cancers in advanced stages, nasopharyngeal carcinoma, oesophageal cancer, high-malignant glial cancers (glioblastoma multiforme and anaplastic astrocytoma), and locally advanced or metastatic pancreatic cancer (adenocarcinoma). Nimotuzumab has also been approved in a number of countries for high-grade gliomas in children and adolescents (newly diagnosed, recurrent and refractory).

On May 21, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that management will present at the UBS Global Healthcare Conference in New York, NY, on Monday, May 21st, at 3:00 pm EST (Press release, Athenex, MAY 21, 2018, View Source;p=RssLanding&cat=news&id=2349986 [SID1234526816]).

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The presentation will be webcasted, and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until August 19, 2018.