On October 20, 2016 Synaffix BV reported it has entered into a Commercial License Agreement with ADC Therapeutics for its proprietary GlycoConnect and HydraSpace site-specific antibody-drug conjugate technologies (Press release, Synaffix, OCT 20, 2016, View Source [SID1234522092]).

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Under the terms of the agreement, ADC Therapeutics has been granted a single-target license for one of its preclinical programs and has also been granted an option to take a limited number of additional single-target licenses for potential future programs.

Floris van Delft, CSO at Synaffix said,

"We are delighted that ADC Therapeutics has recognized the value of our proprietary antibody-drug conjugate technologies and has elected to incorporate Synaffix technology into one of its preclinical programs."

"The experience of Synaffix and its partners has consistently confirmed that, in preclinical models, our proprietary GlycoConnect and HydraSpace technologies significantly improved both efficacy and safety as compared to other mainstream site-specific conjugation approaches."

"We look forward to working closely with the ADC Therapeutics team to advance these promising therapeutics to the patients who need them."

Synaffix is eligible to receive upfront, milestone and royalty payments on a per-target basis.

About GlycoConnect and HydraSpace

The Synaffix technology platforms include GlycoConnect, the site-specific and stable antibody conjugation technology that involves proprietary enzymes and metal-free click conjugation reagents, and HydraSpace, the antibody-drug conjugate enhancing spacer technology.

GlycoConnect was shown to be capable of significantly enhancing the therapeutic index of an antibody-drug conjugate on its own. The highly polar properties of HydraSpace improve the solubility and stability of the payload and the resulting antibody-drug conjugate product, thus enhancing further the therapeutic index of the antibody-drug conjugate.

Both technologies have demonstrated compatibility with all antibody-drug conjugate payload classes and all IgG isotypes without requiring antibody engineering.

On October 20, 2016 NBE Therapeutics AG and SOTIO a.s. reported that the companies have entered into a collaboration for the development of next-generation antibody-drug conjugates (ADCs) for improved cancer therapy (Press release, NBE Therapeutics, OCT 20, 2016, View Source [SID1234573379]). Under the agreement, NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of novel ADC products against undisclosed targets. The ADC products will be based on NBE’s proprietary antibody discovery and conjugation platforms, including NBE’s Transpo-mAb antibody platform, its site-specific SMAC conjugation technology and its novel ultra-potent toxin platform. SOTIO will have global responsibility for clinical development, registration and commercialization of the ADC products.

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Upon exercise of the target options, NBE will be eligible for an option exercise fee, as well as milestone payments and royalties based on global net sales of the products. In addition, NBE will be reimbursed for its R&D expenses incurred in connection with the development of the product in collaboration with SOTIO.

As part of the deal, PPF Group, the owner of SOTIO, has committed to invest CHF10m in the next financing round of NBE.

Dr Ulf Grawunder, CEO of NBE Therapeutics commented: "We are excited about entering a strategic collaboration with SOTIO. This partnership validates our ADC platform and will allow us to further expand our ADC product pipeline. SOTIO’s proven clinical development expertise will help us to develop our ADC platform to the next level."

Ladislav Bartonicek, CEO of SOTIO and shareholder of PPF commented: "NBE’s product platform addresses the key issues of today’s antibody-drug conjugates. With the very strong preclinical data generated by NBE that show superiority in terms of potency, safety and product homogeneity, as well as strong immunotherapeutic effects, this platform has the potential to provide new superior treatment options for cancer patients."

On October 20 2016 Servier, headquartered in France, and Vernalis (R&D), a company based in the UK, reported that a new compound, discovered jointly by international pharmaceutical company has been shown by researchers at the Walter and Eliza Hall Institute and Servier to block a protein that is essential for the sustained growth of up to a quarter of all cancers (Press release, Servier, OCT 20, 2016, View Source [SID1234515950]).

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The research presents a new way to efficiently kill these cancerous cells and holds promise for the treatment of blood cancers such as acute myeloid leukaemia, lymphoma and multiple myeloma, as well as solid cancers such as melanoma and cancers of the lung and breast. It is published online today in the journal Nature.

The Servier compound – S63845 – targets a protein of the BCL2 family, called MCL1, which is essential for the sustained survival of these cancer cells.

Institute scientist Associate Professor Guillaume Lessene, who led the Walter and Eliza Hall Institute’s research team in Melbourne, Australia, said the work provided the first clear preclinical evidence that inhibiting MCL1 was effective in targeting several cancer types.
"MCL1 is important for many cancers because it is a pro-survival protein that allows the cancerous cells to evade the process of programmed cell death that normally removes cancer cells from the body," Associate Professor Lessene said. "Extensive studies performed in a variety of cancer models have shown that S63845 potently targets cancer cells dependent on MCL1 for their survival."

The institute team of Associate Professor Lessene worked with haematologist Associate Professor Andrew Wei and Dr Donia Moujalled from The Alfred Hospital and Servier scientists, to demonstrate that not only was S63845 effective against several cancer types, but that it could also be delivered at doses that were well tolerated by normal cells.

Dr Olivier Geneste, Director of Oncology Research at Servier, said: "This preclinical research and the identification of drug candidates confirm the potential of MCL1 as a therapeutic target in cancers. S63845 was discovered through collaboration with the fragment and structure based discovery expertise at Vernalis. As part of the ongoing Servier / Novartis collaboration on this target class, clinical development of a MCL1 inhibitor should be launched in the near future."

Associate Professor Lessene said the research provided further evidence of the usefulness of a new class of anti-cancer drugs called BH3 mimetics. "BH3 mimetics inhibit a group of proteins known as the ‘pro-survival BCL-2 proteins’," he said. "MCL1 is a member of this protein family, and inhibiting it activates the process of programmed cell death. Walter and Eliza Hall Institute researchers revealed the role of BCL-2 in cancer more than 28 years ago and the essential role of MCL1 for the survival of malignant cells four years ago."

The research was supported through a research collaboration with Servier and through funding from the National Health and Medical Research Council of Australia, the Leukemia and Lymphoma Society (US), Cancer Council Victoria, the Kay Kendall Leukemia Fund, Victorian Cancer Agency, Australian Cancer Research Foundation, the Victorian Government Operational Infrastructure Scheme and the estate of Anthony Redstone.

The Walter and Eliza Hall Institute is the research powerhouse of the Victorian Comprehensive Cancer Centre, an alliance of leading Victorian hospitals and research centres committed to controlling cancer.

On October 20, 2016 Cantargia AB ("Cantargia") reported that it will be presenting new data at the Protein & Antibody Engineering Summit ("PEGS (View Source)"), an international scientific conference to be held in Lisbon, Portugal, from October 31st to November 4th 2016 (Press release, Cantargia, OCT 20, 2016, View Source [SID1234515952]). The company will be presenting data from preclinical studies in non-small cell lung cancer, where the product candidate CAN04, a humanised antibody against the IL1RAP target molecule, has been investigated. The presentation will take place on October 31st 2016.

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With the ambition of developing a new cancer therapy, Cantargia has developed a fully humanised antibody, CAN04, which binds with high affinity to Interleukin-1 Receptor Associated Protein ("IL1RAP"). The antibody blocks signalling from the inflammatory cytokine IL-1, which in turn reduces signals that promote tumour growth and survival. Cantargia has previously shown that antibodies against IL1RAP can stimulate killing of tumour cells in various preclinical PDX-models of leukemia.

In the new study Cantargia shows that high levels of IL1RAP are expressed also in several different solid tumours, including non-small cell lung cancer. CAN04 treatment of various solid tumour cell lines with IL1RAP on the cell surface led to a reduced secretion of the inflammatory and tumorigenic cytokines IL-6 and IL-8. CAN04 also stimulated cells from the immune system to directly destroy these tumour cells. In a PDX model, mice were transplanted directly with tumour cells from a patient with non-small cell lung cancer. In this model a microenvironment is developed in the tumour that is not obtained in classical cell line-based models. A statistically significant treatment effect was obtained with CAN04 in the study.

"We are very pleased to present new data on CAN04 at an important scientific conference. In addition to the documented effect in various models of non-small cell lung cancer, including a very aggressive PDX model, these results constitute an important base for continued studies of CAN04 both as monotherapy and in combination with other drugs", Göran Forsberg, CEO, says.

The poster, The CAN04 antibody targets IL1RAP and inhibits tumor growth in a PDX model for NSCLC, will be available at www.cantargia.com after the presentation.

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on 20 October 2016, at 08.30.

On October 20, 2016 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter of 2016 (Press release, Pain Therapeutics, OCT 20, 2016, View Source [SID1234515931]). Net loss in Q3 2016 was $3.5 million, or $0.08 per share, compared to a net loss in Q3 2015 of $3.7 million, or $0.08 per share.

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At September 30, 2016, cash and investments were $21.8 million, compared to $24.6 million at June 30, 2016. The Company has no debt.

"We continue to evaluate the comments recently raised by the FDA with regards to REMOXY," said Remi Barbier, President and Chief Executive Officer. "We are encouraged by the preliminary feedback we have received from external experts in the field and look forward to announcing a new strategy after further consultation with external advisors."

Financial Highlights for Q3 2016

Research and development expenses increased to $2.7 million in Q3 2016 from $2.4 million in Q3 2015, primarily due to increased activities related to REMOXY ER (oxycodone capsules CII). Research and development expenses included non-cash stock-related compensation costs of $0.3 million in both Q3 2016 and Q3 2015.
General and administrative expenses decreased to $0.9 million in Q3 2016 from $1.3 million in Q3 2015, primarily due to lower compensation costs. General and administrative expenses included non-cash stock-related compensation costs of $0.5 million in both Q3 2016 and Q3 2015.
Net cash used in Q3 2016 was $2.8 million.