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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]).

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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."

AVEO Oncology Announces Receipt of Payments from EUSA Pharma and CANbridge

On September 13, 2017 AVEO Oncology (NASDAQ:AVEO) reported the receipt of a $4 million research and development payment from EUSA Pharma related to the approval of FOTIVDA (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma in Europe, and a $0.5 million milestone payment from CANbridge related to manufacturing development activities for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate (Press release, AVEO, SEP 13, 2017, View Source;p=RssLanding&cat=news&id=2300267 [SID1234520501]).

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"These payments further strengthen our balance sheet while demonstrating the value of our partnerships in advancing AVEO’s pipeline," said Michael Bailey, president and chief executive officer of AVEO. "Additionally, these payments add to our current cash on hand, which was expected to fund operations into the fourth quarter of 2018. We look forward to several additional key milestones in the coming quarters, including the expected presentation of tivozanib-nivolumab combination Phase 1 TiNivo study results this fall, and the anticipated readout of our pivotal Phase 3 TIVO-3 trial in the first quarter of 2018."

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $390 million in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives. In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. With European approval, AVEO will be eligible for up to $12 million in milestones from EUSA based on reimbursement and regulatory approvals. In the territories licensed to EUSA, thirty percent of milestone and royalty payments received by AVEO, excluding research and development payments such as the one announced today, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee. In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

In March 2016, AVEO announced an exclusive collaboration and license agreement, granting CANbridge worldwide rights to AV-203, excluding the United States, Canada, and Mexico. Under the terms of the collaboration and license agreement, AVEO is eligible to receive up to $132 million in future reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in the partnered territories.

AVEO has retained North American rights to tivozanib and AV-203.

Loxo Oncology Announces Initial LOXO-292 Clinical Data to be Presented as Late-Breaking Presentation at the IASLC 18th World Conference on Lung Cancer

On September 13, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that its investigators will present initial clinical data for LOXO-292 at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer to be held October 15-18, 2017, in Yokohama, Japan (Press release, Loxo Oncology, SEP 13, 2017, View Source [SID1234520505]). The oral presentation will include case reports for two patients with RET fusion lung cancer, previously treated with multikinase inhibitors (MKIs), who received LOXO-292, Loxo Oncology’s highly selective RET inhibitor.

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The schedule for the late-breaking oral presentation is as follows:

Presentation Date: October 18, 2017
Title: LOXO-292, a potent, highly selective RET inhibitor, in MKI-resistant RET fusion-positive lung cancer patients with and without brain metastases
Session Title: Emerging Genomic Targets
Presenter: Vamsidhar Velcheti, M.D.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

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.

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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:

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]).

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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.