1stOncology™: Cancer Intelligence Service – Page 14467 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ONXEO GRANTS EXCLUSIVE WORLDWIDE LICENSE OF VALIDIVE® DEVELOPED FOR THE TREATMENT OF ORAL SEVERE MUCOSITIS TO MONOPAR THERAPEUTICS

On September 13, 2017 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or the "Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported the Company has granted a global exclusive license of its product Validive (clonidine mucoadhesive buccal tablet) developed for the treatment of severe oral mucositis induced by radiotherapy or chemotherapy in patients suffering from head and neck cancer to Monopar Therapeutics (Chicago, Illinois, USA), a biopharmaceutical company focused on developing innovative drug combinations to improve clinical outcomes in advanced cancer (Press release, Onxeo, SEP 13, 2017, View Source [SID1234570545]).

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!

Following the phase II trial, the company had announced that it would not initiate the next clinical steps on its own for this asset but would actively look for an industrial partner to further its development.

Under the agreement, Monopar Therapeutics Inc. receives an exclusive worldwide license to develop, register, commercialize and manufacture Validive. Monopar Therapeutics will drive and fund all remaining development and regulatory activities, the first of these activities being a phase III registration study.

"Severe oral mucositis occurs in the majority of patients treated with radiotherapy/chemotherapy for head and neck cancer but there is no effective prevention or treatment available to date," said Chandler D. Robinson, MD, MBA, MSc, CEO of Monopar Therapeutics Inc. "We are pleased with this agreement and strongly believe in the potential of Validive to answer this large unmet need. The acquisition of a phase III-ready asset is fully aligned with our strategy to build a strong and diversified portfolio of oncology products that will improve clinical outcomes in patients with advanced cancer."

Onxeo is entitled to an immediate $1.0m license fee and to future milestone payments that could reach up to $108m subject to the achievement of the agreed upon milestones, including $15.5m related to regulatory milestones, from phase III to registration. Escalating royalties on sales up to a 2-digit percentage are also part of the agreement.

" It was our stated intention after its successful Phase II to partner Validive prior to initiating any remaining development steps, as it was the best strategy to maximize its value for Onxeo," said Judith Greciet, CEO of Onxeo. "This licensing transaction with Monopar Therapeutics is fully in line with this strategy and further demonstrates our capacity to execute such value-creating deals. We are pleased that Validive will get the opportunity to one day serve the unmet needs of many patients affected with severe oral mucositis, while, on our end, we are focusing all our energy on our pipeline of unique breakthrough compounds in orphan oncology."

Alligator Bioscience signs immunotherapy research collaboration agreement for 4-1BB

On September 13, 2017 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that a research collaboration agreement has been signed with Professor Ignacio Melero, MD, PhD, Center for Applied Medical Research (CIMA) and Clínica Universidad de Navarra, Spain, to further investigate the biology of 4-1BB (CD137) as a target in cancer immunotherapy (Press release, Alligator Bioscience, SEP 13, 2017, View Source [SID1234538686]).

Alligator has two pipeline programs targeting 4-1BB, the fully owned monospecific antibody ATOR-1017, and the bispecific antibody ALG.APV-527, co-developed with Aptevo therapeutics.

Under the collaboration agreement, the team led by Professor Melero primarily will investigate the biological effects of 4-1BB activation in various pre-clinical cancer immunotherapy models. Professor Melero has acted as a scientific advisor and collaboration partner for Alligator since 2014.

Professor Melero, principal investigator at the Immunology and Immunotherapy Program of CIMA and codirector of the Immunology Department of Clínica Universidad de Navarra, has contributed extensively to the understanding of the anti-tumor properties of 4-1BB antibodies in cancer. His landmark studies have opened the field of 4-1BB-targeted immunotherapy, and this is now generally considered to be one of the most promising approaches within immuno-oncology.

4-1BB belongs to the so-called TNF receptor superfamily and plays a critical role in immune responses and immunological memory to cancer. CIMA is the University of Navarra’s biomedical research institute. Its mission is to carry out translational research to a high standard of excellence, based on novel biological knowledge and aimed at finding therapeutic solutions to unsolved medical’s needs.

"I am very enthusiastic about the extended collaboration with Alligator. Its 4-1BB drug candidates provide great new treatment opportunities within immuno-oncology", said Professor Ignacio Melero. "The fact that 4-1BB is upregulated on tumor-specific T cells, together with its capacity to promote survival, expansion and functional activity of several immune cells involved in tumor eradication, makes 4-1BB a uniquely appealing target for immunotherapy of cancer."

"We are very fortunate to have Professor Melero as a research collaborator", said Per Norlén, CEO of Alligator Bioscience. "He is a world leading expert in the field of 4-1BB and immuno-therapy and his scientific guidance will be extremely valuable both for our pipeline projects, and to help fulfill our ambition to deliver first and best-in-class products to patients."

For further information:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

This information is information that Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CEST on 13 September 2017.

Transgene: Availability of the Half-Year Financial Report as Of June 30, 2017

On September 13, 2017 Transgene reported that it has made available to the public and filed with the Autorité des marchés financiers its half-year financial report as of June 30, 2017 (Press release, Transgene, SEP 13, 2017, View Source [SID1234520890]). This report comprises the following documents:

1. 2017 interim financial statements
2. Financial highlights and management discussion and analysis
3. Statutory Auditors’ report on the 2017 interim financial statements
4. Declaration by the person responsible for this interim financial report

The report can be consulted on the company’s website at www.transgene.fr under the heading “Investors – Financial information”.

Eos Biosciences Announces Issuance of U.S. Patent for Novel Oncology Theranostic

On September 13, 2017 Eos Biosciences, Inc., a bio-targeted nanomedicines company developing a novel nanoparticle drug delivery platform, with a proprietary oncology pipeline, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,757,386, which covers Eos Biosciences’ theranostic product Eos-002, a HER3-targeted Eosome for the treatment and imaging of solid tumors (Press release, Eos Biotechnology, SEP 13, 2017, View Source [SID1234520531]). HER3 is over-expressed on many types of HER2+ metastatic and drug-resistant solid tumors, as well as Triple Negative Breast Cancer (TNBC).

This newly issued patent, further enhances the Company’s intellectual property portfolio, which includes U.S. Patent No. 9,078,927, covering Eos Biosciences’ first proprietary product in preclinical development, Eos-001, with Doxorubicin payload. The clinical development of Eos-001 is intended to address TNBC and HER2+ breast cancer resistant or nonresponsive to first line therapies. Both patents are owned by Cedars-Sinai Medical Center and exclusively licensed to Eos Biosciences.

Omar Haffar, Ph.D., Founder, President and Chief Executive Officer, commented, "The allowance of this patent represents a significant milestone for Eos Biosciences, as we continue to build and strengthen our intellectual property portfolio." He continued, "We anticipate additional exciting IP developments in 2017, as we deepen our oncology presence and widen our therapeutic delivery coverage."

About Eos-002 and Corroles

Eos-002 is a HER3 targeted theranostic with a manganese corrole payload for treating and imaging solid tumors. Corroles are pophyrine-like macrocyclic compound that can incorporate metal ions. Corroles alter the function of mitochondria leading to increased production of free radicals and subsequent cell death. When packaged into Eosomes, corroles were shown to have impressive effects on killing cancer cells in vitro and resolving tumor xenografts in vivo.

About Eosomes

Eosomes are self-assembling nanobiologic particles composed of a recombinant polypeptide and a therapeutic payload. The recombinant polypeptide is designed to incorporate three functional domains for cell targeting, active endosomal escape, and therapeutic payload binding. The modular design of the polypeptide provides significant versatility in adapting the application of the Eosomes to multiple disease areas and therapeutic modalities.

MOLOGEN’s presentations well received at ESMO 2017

On September 13, 2017 The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN)reported two sets of data on its lead compound, the immunotherapeutic agent lefitolimod, at the European Society for Medical Oncology (ESMO 2017) in Madrid (8 – 12 September 2017) (Press release, Mologen, SEP 13, 2017, View Source [SID1234520530]). The coordinating investigator Prof. Dr. Michael Thomas, MD, Head of the Department Oncology/Internal Medicine at the Thorax Clinic at University of Heidelberg, Germany, gave an oral presentation on the top-line data from the exploratory, signal-seeking phase II IMPULSE trial in extensive-disease small-cell lung cancer in a Proffered Paper Session with the session’s co-chair, Prof. Sanjay Popat, The Royal Marsden Hospital, London, acting as invited discussant. Furthermore, data on lefitolimod as modulator of the tumor microenvironment (TME) alone and in combination with immune checkpoint inhibitors in pre-clinical tumor models were presented in the Translational Research Poster Session.

Promising overall survival signal in pre-defined subgroups of IMPULSE

The exploratory randomized IMPULSE study which evaluates the efficacy and safety of lefitolimod in patients with extensive-disease small-cell lung cancer (SCLC) showed noteworthy results in the primary analysis regarding overall survival (OS) in two clinically relevant subgroups of patients in comparison to the control group (standard therapy). A signal for an OS benefit was seen in patients with reported Chronic Obstructive Pulmonary Disease (COPD), a frequent underlying disease.

Notably, a strong OS signal was observed in patients with a low count of activated B cells, an important immune parameter, at baseline. This contributes to the hypothesis that activated B cells may serve as a valid biomarker in the further development of lefitolimod in this relevant subgroup of extensive-disease SCLC patients. The invited discussant Prof. Popat interpreted IMPULSE as a signal-generating study with an interesting hypothesis which merits further evaluation.

"To our knowledge IMPULSE is the first randomized controlled clinical study of a maintenance therapy following first-line chemotherapy in extensive-disease SCLC showing a promising overall survival signal in a pre-specified subgroup. The study provides important guidance for defining patient populations most likely to benefit from treatment with lefitolimod in further clinical trials," said Dr. Matthias Baumann, Chief Medical Officer of MOLOGEN AG. "I am also delighted that the European Thoracic Oncology Platform (ETOP) asked Prof. Thomas for permission to publish his presentation on their website which, in our view, underlines the interest of the scientific community in our approach."

Lefitolimod-induced modulation of the tumor microenvironment supports its potential as ideal partner for immune-oncology combination therapies

The lefitolimod-induced pathway provides the rationale for combining lefitolimod with checkpoint inhibitors (CPI). First combination data of lefitolimod with checkpoint inhibitors in mouse tumor models have been presented at the Annual 2017 Gastrointestinal Cancers Symposium in San Francisco, USA (January 19-21, 2017). The data showed that lefitolimod can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine colon carcinoma and lymphoma tumor models.

Response rates to checkpoint inhibitor immunotherapy vary between different tumor entities and depend on the nature of the tumor microenvironment (TME). Hot tumors with a T cell-infiltrated TME show better responses. Therefore, modulation of the TME is a crucial requirement for the response to immunotherapeutic approaches.

MOLOGEN’s current data showed that monotherapy with lefitolimod resulted in a modulation of the TME in a colon carcinoma tumor model after intra-tumoral injection. An increased infiltration of T cells, especially cytotoxic T cells, into the tumor was shown, which was associated with reduced tumor growth. This beneficial modulation of the TME by lefitolimod supports its potential in cancer immunotherapy. Hence, lefitolimod may be an ideal partner for immune-oncology combination approaches, i.e. with checkpoint inhibitors.

Background to the IMPULSE small-cell lung cancer (SCLC) study

The trial titled "Randomized Clinical Study of Maintenance Therapy with Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy" (IMPULSE study) is an explorative study and has overall survival as the primary endpoint. It compares lefitolimod (MGN1703) versus standard therapy (chemotherapy). The study included 102 patients suffering from extensive-disease small-cell lung cancer and showing at least partial response to four cycles of first-line chemotherapy. They were randomized at a ratio of 3:2 to switch-maintenance therapy with lefitolimod (60mg injected subcutaneously twice weekly) or standard therapy until disease progression.

There will be a final read-out probably in the first quarter of 2018, approximately 24 months following the recruitment of the last patient.

Further information can be found on MOLOGEN’s website: