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Company News: ISA Pharmaceuticals obtains broad patent protection in the US for proprietary AMPLIVANT® platform and compounds

– Granted US patent provides market exclusivity until 2032

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced it has been granted a US patent on its AMPLIVANT® technology and compounds (patent no. 9,314,521). The patent ensures market protection in the United States until 2032 and covers the compounds, either as a stand-alone substance or in combination with antigenic peptides, nucleic acids or antibodies. The patent also covers the process for preparing the compounds.

ISA’s AMPLIVANT® technology provides an adjuvant that has been demonstrated to improve the immunostimulatory potency of SLP® immunotherapeutics 100- to 1000-fold. It comprises a synthetic small molecule toll-like receptor 1/2 (TLR1/2) ligand with enhanced immunostimulatory activity that can be used as a stand-alone additive or chemically coupled to immunotherapeutic compounds like synthetic peptides during the SLP® manufacturing process. SLP®-AMPLIVANT® conjugate compounds allow for lower doses at higher efficacy through better dendritic cell antigen processing and presentation as well as enhanced T cell priming. At present, clinical researchers at Leiden University Medical Center are evaluating the safety and immunogenicity of two SLP®-AMPLIVANT® conjugates in patients affected by HPV16+ disease (HESPECTA trial).

“This patent is the first of a family of patents and highly significant for the future development and protection of our next-generation SLP products,” said Ronald Loggers, ISA Pharmaceutical’s Chief Executive Officer. “With market protection in the US until 2032, we have added another level of protection to our products and, potentially, other applications.”

Company News: ISA Pharmaceuticals’ Lead Product ISA101 Efficiently Engages the Immune System Against Virus-Induced Pre-malignant and Malignant Lesions

– ISA101 clinically effective against HPV-induced vulvar / vaginal lesions and cervical cancer

– Optimum immunotherapy window in cancer identified

ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, has announced the publication of two peer-reviewed research manuscripts demonstrating the clinical efficacy of its lead product ISA101 in treating high-grade vulvar intraepithelial neoplasia (VIN), and synergy with chemotherapy in cervical cancer. In cervical cancer, the optimum window for treatment with ISA101 starts two weeks after the second chemotherapy cycle has been completed. The multi-center research was conducted in close collaboration with Leiden University Medical Center (LUMC). Publications appeared in Clinical Cancer Research[1] and Science Translational Medicine[2], respectively.

Infections with HPV are known to cause genital and, head & neck lesions which lead to cancer in a certain percentage of patients. While today selected high-risk HPV infections can be prevented by vaccination, this does not hold true for lesions and cancer formation once an HPV infection has occurred. To treat both pre-malignant (e.g. VIN) and malignant tissue damage (e.g. cervical cancer) in HPV-infected patients, ISA Pharmaceuticals has developed ISA101, a synthetic long peptide (SLP®) immunotherapeutic, to engage the immune system against these lesions.

In a combined analysis of animal and clinical studies in cervical cancer published in Science Translational Medicine, researchers discovered that a timed combination of ISA101 with standard carboplatin and paclitaxel chemotherapy can significantly improve immunity in advanced cervical cancer patients. Researchers also found that the most pronounced effect was seen if ISA101 was administered starting two weeks after the second cycle of chemotherapy.

“We looked into the mechanism of action,” said Kees Melief, CSO of ISA. “In both mice and patients, the presence of a growing tumor was associated with abnormally high frequencies of circulating myeloid-derived suppressor cells. Administration of chemotherapy normalized the abnormal levels of these circulating myeloid cells and this was associated with increased T-cell reactivity to recall antigens. The effect was most pronounced starting two weeks after the second cycle of chemotherapy , providing an optimal immunological treatment window. We also observed that ISA101 treatment at this point resulted in unusually strong HPV16-specific T-cell responses, which were sustained after completing all cycles of chemotherapy. So one should consider chemotherapy as a treatment for the immune system rather than a mere treatment for the tumor.”

The second paper in Clinical Cancer Research features a Phase I/II clinical study of ISA101 in 43 VIN patients demonstrating that advanced stages of VIN can be safely and effectively treated with the compound. All patients displayed drug-induced T-cell responses, which were significantly stronger in patients with complete clinical responses. Importantly, viral clearance occurred in all but one of the patients with complete histological clearance.

“The outcome of the VIN trial demonstrates once again the safety and efficacy of ISA101 in a premalignant setting,” said Melief, who co-authored the study. “This study confirms the correlation between immune response and clinical outcome. It shows complete histopathological regressions and viral clearance, and the data demonstrate that the clinical efficacy of the immunotherapeutic is related to the strength of a drug-induced immune response. Rather than using post-hoc analyses for efficacy, we performed immunological assays and statistical analyses that were predefined.”

“The results of these papers clearly emphasize the importance of our strategy in the cancer immunotherapy field, and prove that we have identified an effective, clinically relevant approach to engage the immune system against virus-induced cell damage,” said Ronald Loggers, CEO of ISA. “They also demonstrate that our lead candidate ISA101 is a very effective treatment for both non-malignant and malignant diseases caused by HPV infections.”

ISA101 is currently explored in two Phase I/II trials in anal intraepithelial neoplasia and HPV-positive cervical cancer, and in a Phase II Nivolumab combination trial in HPV-positive solid cancers. Further details can be found at http://www.isa-pharma.com/clinical-studies.

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[1] Van Poelgeest MIE et al. 2016. “Vaccination against oncoproteins of HPV16 for non-invasive vulvar/vaginal lesions: lesion clearance is related to the strength of the T-cell response.” Clin Cancer Res Published Online First on January 26, 2016; DOI: 10.1158/1078-0432.CCR-15-2594.

[1] Welters MJ et al. 2016. “Vaccination during myeloid cell depletion by cancer chemotherapy fosters robust T-cell responses.” Sci Transl Med 13 April 2016; DOI: 10.1126/scitranslmed.aad8307.

Company News: Curetis Publishes Full-Year 2015 Financial Results and Introduces 2016 Guidance

– Company successfully completed IPO on Euronext Amsterdam and Euronext Brussels, raising EUR 44.3 million
– Accelerated global commercialization lays strong foundation for future growth

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced financial results for the twelve months ended December 31, 2015 and provided details on its outlook for 2016.

2015 Operational Highlights

  • Through its successful IPO on Euronext Amsterdam and Euronext Brussels, raised EUR 44.3 million, including the exercise of the overallotment option.
  • Significantly strengthened commercial capabilities by appointing Dr. Achim Plum as Chief Commercial Officer and expanding its direct sales channels beyond the DACH region (Germany, Austria, Switzerland) to also cover the UK, France and Benelux. Expanded commercial team to 12 members to facilitate broader direct sales efforts as well as marketing and business development support.
  • Entered major Asian markets through partnerships with Beijing Clear Biotech (BCB) for Mainland China, Hong Kong and Taiwan and with Singapore-based Acumen for ASEAN markets, which will initially include Singapore, Malaysia, Thailand and Indonesia.
  • As of the end of 2015, the Company has significantly grown the installed base of Unyvero Analyzers to 103, a 78% increase from an installed base of 58 at the end of 2014.
  • Partnered with an undisclosed major pharmaceutical company for a Phase III Amikacin drug trial. In this trial, Unyvero is being used for pathogen identification and patient inclusion at multiple clinical sites across Europe.

2015 Financial Highlights

  • Revenues: EUR 2.1 million (EUR 0.3 million in 2014).
  • Expenses: EUR 14.3 million total cost of sales, distribution costs, administrative expenses and research & development expenses (EUR 10.5 million in 2014). The increase was mainly due to the increase in valuation of Phantom Stock Options (PSOs).
  • Operating result: EUR 12.1 million (EUR 10.1 million in 2014).
  • Net profit / Net loss: EUR 13.8 million (net loss of EUR 12.4 million in 2014). The difference is mainly due to financial income totaling EUR 25.9 million net, which primarily resulted from a one-time IFRS accounting entry related to the changes in fair value measurement of the preferred and common shares of Curetis AG, which was triggered by the corporate reorganization of the Company.
  • Cash & cash equivalents: EUR 46.1 million as of Dec. 31, 2015 (EUR 3.0 million on December 31, 2014).
  • Net cash burn from operating activities: EUR 8.5 million (EUR 7.4 million in 2014).
  • Net cash burn from investing activities: EUR 1.1 million (EUR 1.6 million in 2014).

Anticipated Milestones

  • Based on current forecasts and expansion plans, Curetis anticipates that the Unyvero Installed Base will grow to 150 to 200 systems at the end of 2016, adding between 50 and 100 new Unyvero Analyzers globally to the installed base during the year.
  • Curetis will add multiple new Application Cartridges to the portfolio of the Unyvero Solution and accelerate its development pipeline in 2016 and 2017. During ECCMID 2016, the Company launched its Unyvero BCU (Blood Culture) Cartridge as a CE-IVD marked product in Europe. Furthermore, the Company expects to launch a second generation of its ITI (implant and tissue infection) Application Cartridge in mid-2016. Toward the end of 2016, the Company anticipates the completion of product development for an IAI panel (intra-abdominal infection) and in late 2017, development of a Sepsis Host Response Application Cartridge.
  • In 2016, Curetis expects its US clinical trial to progress toward completion. With more than 1,600 patient samples already enrolled and successfully tested by the end of March 2016, the Company believes that it will complete enrolment by mid-year and expects to be in a position to submit its application for US FDA clearance of Unyvero in the second half of 2016. The Company aims for FDA clearance of its Unyvero LRT55 product in the first half of 2017, provided that the FDA trial will be successfully completed in 2016.
  • In line with the expected US FDA clearance, the Company intends to build its own direct US marketing and sales organization, beginning with the recruitment of a core team in the second half of 2016. An executive search for the US General Manager / US CEO is currently ongoing.
  • The Company expects that its partner BCB will drive toward completion of its CFDA trial in China by early 2017. BCB has expressed its goal to obtain CFDA clearance in 2017 and to begin commercialization in mainland China thereafter. Commercial efforts in Hong Kong and Taiwan, which are not subject to first obtaining CFDA approval, have already begun with initial installations at major hospitals expected during 2016.

Commenting on Curetis’ 2015 results, Oliver Schacht, CEO of the Company stated: “The year 2015 was extremely successful for Curetis. Based on the three-pronged strategy of expanding Curetis’ commercial presence in Europe, building our own direct US commercial presence and accelerating our Unyvero product development pipeline, we were able to up-size our IPO in November by more than 50% compared to our original target. Throughout 2015 and into 2016 we have begun executing on our strategic plans and further developing our equity story in line with what we communicated during our IPO. Key additions to our commercial team have been made and we expect to continue growing our sales and marketing capabilities. With a very solid cash position of more than 46 million Euros going into 2016, we are well positioned to continue executing this year, and well into the future.”

“At a macro level, Unyvero is beginning to make an impact on how critically ill patients with infectious diseases in hospitals get diagnosed and treated with antibiotics,” Schacht added. “Unyvero contributes to personalizing medicine, and empowers clinicians to make rational antibiotic treatment decisions for patients in life-threatening situations.”

For the twelve months ended December 31, 2015, revenues were EUR 2.1 million, a substantial increase over revenues of EUR 0.3 million in 2014. The strong revenue growth was primarily attributable to a 78% increase in the installed base of Unyvero Analyzers, which totaled 103 at the end of 2015, compared to 58 as of the end of 2014.

Gross loss for the year totaled EUR 0.07 Million, compared with a gross loss of EUR 0.37 Million in 2014. The gross loss was primarily attributable to significant revenues from Unyvero system sales in 2015 at very low or no margins, as well as discounted pricing of Unyvero cartridges sold to distribution partners for clinical trials. Also, under IFRS accounting the cost of goods for the Unyvero cartridges still include significant elements of as-yet unutilized capacity to allow for future expansion in manufacturing output. Full-year 2015 gross margin was -3.5%, compared with -134% for 2014.

Operating loss in 2015 totaled EUR 12.1 million, compared with EUR 10.1 million in 2014. The increased operating loss was mainly related to acceleration of the Company’s commercial expansion and an increase in valuation of the PSOs resulting from the IPO.

Net income for the year was EUR 13.8 million compared with a net loss of EUR 12.4 million in 2014. Full-year 2015 net income included financial income of EUR 25.9 million net, mainly relating to the changes in fair value measurement of the preferred and common shares of Curetis AG, which was triggered by the corporate reorganization of the Company in preparation for its IPO in November 2015.

At the end of 2016, the Company expects a strong cash position of EUR 31 to 32 million cash on hand and a net cash burn of EUR 14 to 15 million throughout the year for all operating and investment activities combined.

 

Company News: COPAL® Knee Moulds Allow to Prepare the Ideal Knee Spacer – Quickly and Easily

For revision operations of artificial knee joints, Heraeus has devised an innovative solution to facilitate the preparation of high-quality knee spacers adapted to individual patients. Infections in knee joint prostheses are a challenge for surgeons and a burden for patients. Out of 1,500,000 knee joint operations annually worldwide there are 125,000 revisions, of which 20% are caused by infections. The two-stage switch procedure, i.e. the removal of the old and implantation of the new prosthesis in two chronologically separate interventions, has established itself as the standard treatment. At the same time, during the waiting period between the two operations, a spacer made of bone cement containing antibiotics assists therapy and the elimination (eradication) of germs from the infection.

With COPAL® knee moulds, Heraeus has developed an innovative solution designed for the simple and rapid preparation of knee spacers. Heraeus is thus expanding its tried-and-tested COPAL® product portfolio for the revision and management of periprosthetic infections (PJI).

Prepare implant-like spacers from bone cement yourself

COPAL® knee moulds are moulds designed for the preparation of implant-like knee spacers with articulating bearings. The range of motion is thereby preserved and the formation of contractures and scar tissue prevented. Spacers made from COPAL® knee moulds have a smooth surface, as a result of which particle wear is reduced and irritations prevented.

Preparation of spacers adapted to individual patients are possible

COPAL® knee moulds are available in three mould sizes (S, M, L) and have a height-adjustable tibia component and an optional stem. This enables spacers individually adapted to patients and their bone situation to be prepared. The shape stability of COPAL® knee moulds means that the high quality spacer design can be easily reproduced.

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