(Press release, Cleveland BioLabs, OCT 23, 2013, View Source [SID:1234503972])

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!

The US Food and Drug Administration (FDA) is withdrawing approval of the indication for treatment of patients with relapsed or refractory, low grade, follicular, or transformed CD20 positive non-Hodgkin’s lymphoma who have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held by GlaxoSmithKline (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing (US FDA, OCT 23, 2013, View Source).

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!

On October 21, 2013 OXiGENE reported the presentation of data from a preclinical study of ZYBRESTAT (fosbretabulin tromethamine/combretastatin A-4 phosphate or CA4P) demonstrating statistically significant differences between the treatment arm and the control arm in a model of pancreatic neuroendocrine tumors (PNETs). The data were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), Boston, MA, in a poster session on October 20, 2013 (Press release OXiGENE, OCT 21, 2013, View Source [SID:1234500303]).

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!

The poster, titled "Combretastatin A-4 Phosphate (CA4P) is effective for the treatment of functional pancreatic neuroendocrine tumors (PNETs) in a transgenic mouse model," was presented by ZiQiang Yuan, MD, Research Assistant Professor, Department of Surgery, Albert Einstein College of Medicine. Steven K. Libutti, MD, FACS, Professor of Surgery and Genetics, Albert Einstein College of Medicine, and Montefiore Medical Center, is the senior author.

This preclinical study was designed to evaluate the efficacy of systemic administration of ZYBRESTAT or CA4P for the treatment of functional insulinomas in a transgenic mouse model of PNETs. PNETs are highly vascularized tumors which originate in the pancreas. Functional PNETs make hormones that can cause a cascade of disease symptoms, resulting in significant morbidity for the patient. An insulinoma is a PNET that causes the over-secretion of the hormone insulin.

The treatment group received ZYBRESTAT three times per week for four weeks, and the control group received a placebo. After four weeks, tumor size, serum insulin levels and other efficacy parameters, including apoptosis (cell death), cell proliferation and effects on tumor vasculature, were assessed. Key results were as follows.

Treatment with ZYBRESTAT resulted in a significant and sustained decrease in circulating insulin, with maximum effect seen by day 17 (p < 0.0001).
The reduction in insulin was accompanied by a significantly reduced tumor size in the treated group compared to the placebo group (p=0.0128).
Treatment with ZYBRESTAT was shown to disrupt tumor vasculature, induce apoptosis (cell death) and inhibit tumor cell proliferation.
ZYBRESTAT was shown to be well tolerated, with no obvious toxicity.

On October 18, 2013 Ablynx reported that it has granted an exclusive,royalty-bearing license to Eddingpharm, a leading Chinese specialtypharmaceutical company, to develop and commercialise its anti-RANKL Nanobody, ALX-0141,in the mainland of the People’s Republic of China, the Hong Kong and MacaoSpecial Administrative Regions, and Taiwan, for all indications, includingosteoporosis and bone metastases (Press release, Eddingpharm, OCT 18, 2013, View Source [SID:1234513851]).

Under the terms of the agreement, Eddingpharm will be responsiblefor the clinical development, registration and commercialisation in GreaterChina of anti-RANKL Nanobody therapeutics. Ablynx will have access to the datagenerated by Eddingpharm to support potential licensing discussions in othergeographic regions.

Ablynx will receive a EUR2 million upfront payment fromEddingpharm and is entitled to receive commercial milestone payments plustiered, double-digit royalties of up to 20%, based on annual net sales ofALX-0141 generated by Eddingpharm in Greater China.

ALX-0141 is a bivalent bi-specific therapeutic molecule composedof two Nanobodies targeting the Receptor Activator of Nuclear factor Kappa-BLigand (RANKL). This bivalent anti-RANKL construct is linked to a Nanobody thatbinds to human serum albumin, extending the drug’s in vivo half-life, and whichmay in turn lead to preferential targeting of diseased tissue. A Phase I studyin healthy post-menopausal women showed that a single administration ofALX-0141 has a strong and very long lasting inhibitory effect on boneresorption biomarkers and was well tolerated with no serious adverse events ordose-limiting toxicity being observed.

Dr Edwin Moses, Chairman and CEO of Ablynx added:
"Eddingpharm is well-positioned to further develop andcommercialise ALX-0141 in Greater China, which represents a rapidly growingarea for bone related disorders. Our Nanobody has strong potential in thismarket, with very good efficacy, as measured by biomarkers, and a clean safetyprofile, and we look forward to collaborating with Eddingpharm and supportingthem to move the programme further in development and beyond."

Mr Ni Xin, Founder, Chairman and CEO of Eddingpharm commented:
"We are very pleased that Ablynx has entrusted Eddingpharmto develop and commercialise its anti-RANKL Nanobody in Greater China. Togetherwith Ablynx, we are committed to bringing this innovative medicine to millionsof patients in the region. This partnership represents a key milestone towardsour goal of establishing Eddingpharm as the partner of choice in China forbiotechnology companies around the world."

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!

On October 16, 2013 Zydus Cadila, an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products, and Pieris AG, a next generation therapeutic protein R&D company, reported that they have entered into an alliance for development and commercialization of multiple novel Anticalin-based protein therapeutics (Press release, Pieris Pharmaceuticals, OCT 16, 2013, View Source [SID:SID1234515597]). The collaboration combines Pieris’ drug discovery and early development capabilities with Zydus’ expertise in biologics development, regulatory affairs and biologics manufacturing. Under the terms of the agreement, Zydus will take the lead in advancing Anticalin drug candidates through formal pre-clinical development and into clinical development, undertaking drug development in accordance with ICH guidelines. Zydus has been granted exclusive marketing rights in India and several other emerging markets, while Pieris retains exclusive marketing rights in key developed markets.

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!

Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus group said, "Collaborating with established biotech companies on differentiated drug candidates is an important component of Zydus’ ongoing transformation into an innovation-led global healthcare provider, and we are pleased to add Anticalins to our novel biologics pipeline." Pieris CEO, Stephen Yoder, added, "With Zydus’ state-of-the-art manufacturing facilities and seasoned drug development team, this collaboration will allow Pieris to unlock value on a global scale in a cost-effective manner, significantly expanding the number of proprietary Anticalin programs we can advance into clinical trials."

The most advanced program in the collaboration is PRS-110, an Anticalin specific for c-Met, a target becoming increasingly validated across a broad spectrum of tumors. PRS-110, which is a pure antagonist due to its monovalent target engagement, has demonstrated the ability to inhibit both ligand-dependent and -independent c-Met activity in a variety of animal models. Through this unique collaborative model, the companies seek to develop candidates to proof-of-concept and will explore out-licensing opportunities in Pieris’ territories at the appropriate time. The companies will share licensing revenues on mutually agreed-upon terms.