On Berlin-based biotechnology company MOLOGEN (ISIN DE0006637200; Frankfurter Stock Exchange Prime Standard: MGN) reported its "Next Level" program which is based on a strategic portfolio review and envisages greater product and market orientation (Press release, Mologen, JUN 9, 2016, View Source [SID:1234513167]).

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The realignment and associated further development of the company’s organization structure is intended to help MOLOGEN reach the next level of its development from a research-focused biotech company toward a product oriented one. The company will be focused more strongly than before on products which are no longer at the basic research stage and are already closer to reaching the market. The strategy program includes a concentration of the further development activities centered on the lead product, the cancer immunotherapy lefitolimod and next-generation molecules EnanDIM, along with an acceleration of the commercialization of these products.

In contrast, MOLOGEN plans to shelve any further development of the compound MGN1601, a cell-based therapeutic vaccine against renal cancer, for the time being. In the event of lefitolimod products or the entire lefitolimod product group being successfully out-licensed, MGN1601 would be a suitable foundation from which to continue the business model based on an attractive next-generation clinical product which has moved beyond the basic research stage. The non-viral vector system MIDGE is to be sold or spun off, along with the corresponding compounds.

In addition, the new strategy includes the adjustment of the organization structures to the company’s new stage of development. In particular, preconditions for a potential market entry will be created, initially of the lead product lefitolimod. These include, for example, ensuring sufficient production capacity by outsourcing production to subcontractors and consequently closing internal production capacity. In view of the focusing and resulting reduction of the preclinical product portfolio, research activities previously carried out within the company will mostly be discontinued. By implementing this strategy, MOLOGEN will reduce its complexity and focus much more on the advanced product portfolio in order to promptly generate greater added value for its shareholders. The implementation of the new structure is expected to be completed by the end of 2016.



Dr. Mariola Söhngen, CEO of MOLOGEN AG: "The ‘Next Level’ strategy will define the goalposts for MOLOGEN’s continued successful development. We will focus on the company’s value drivers, especially on the promising cancer immunotherapy lefitolimod, for which we now plan to press on with approval and market preparation activities in view of the mature stage of development reached by the product. These are also important and value-driving activities as regards the out-licensing of the product which we are pursuing as a top priority. We are convinced that we will create real added value for our shareholders with the implementation of this strategy."

Clear focus on lead product lefitolimod (MGN1703)

The target of the portfolio review was the analysis and evaluation of MOLOGEN’s product pipeline with regard to potentials and fit to the new strategy. The main focus of MOLOGEN’s activities in future will be on continuing the four clinical trials with the immune surveillance reactivator ("ISR") lefitolimod (MGN1703): the IMPALA, IMPULSE and TEACH studies in the indications colorectal cancer, small-cell lung cancer and HIV, and a combination study which is due to start shortly with the immunotherapy Yervoy (ipilimumab) in patients with advanced solid tumors. In the case of lefitolimod, the focus is on completing patient recruitment in the IMPALA study and, with a view to approval and market preparation activities, on preparing to upscale production so that large quantities of the compound can be produced in order to meet market demand. There are plans to work with a specialist contract manufacturer for production.

Lefitolimod (MGN1703) is part of the family of TLR9 agonists. In order to be able to exploit the potential of this product group fully and to tap additional market potential, MOLOGEN will also continue to invest in the next-generation, currently still pre-clinical molecule of lefitolimod (MGN1703), EnanDIM, which is also aimed at the indications cancer and infectious diseases. As such, the bulk of available financial resources will go into the further development of lefitolimod (MGN1703) and EnanDIM.

In addition, MOLOGEN has the MIDGE platform technology, which has been in particular developed for the treatment of infectious diseases. Two compounds are in the preclinical phase: the prophylactic and therapeutic vaccines against leishmaniasis (MGN1331) and against hepatitis B (MGN1333). In addition, the compound is being tested in a phase I study in malignant melanoma (MGN1404). These projects cannot be taken forward significantly because of limited financial resources and the company’s concentration on lefitolimod (MGN1703). MOLOGEN is now seeking to sell the technology along with all the compound candidates. Alternatively, a spin-off is a possibility.

Increasing efficiency and flexibility

As part of the strategy of concentrating on products which are close to market, the Executive Board of MOLOGEN AG has decided to streamline the company’s organization structure significantly. Production along with large parts of the research will therefore be discontinued and outsourced to subcontractors and cooperation partners. The company’s growing "virtualization" is making its development activities more efficient and is linked with a variabilization of costs. All research and production activities will continue to be initiated, controlled and monitored by internal experts. The results of outsourced research work will remain the property of MOLOGEN AG. Implementation of the new structure is expected to be completed by the end of 2016.

Stepping up marketing activities

The company plans to commission a consultancy firm specialized in biotechnology to evaluate strategic alternatives, arising from the portfolio review, and to comprehensively search for potential partners for lefitolimod.

Walter Miller, CFO of MOLOGEN AG: "By outsourcing our production and research activities, we create structures which are more flexible and geared to products and the market. This will lead to less complexity, a reduction in fixed costs and increasing operating flexibility, which in turn should also contribute to increasing the value of our product portfolio."

The realignment is not expected to have any major impact on the guidance given for the full year 2016.

On June 9, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, reported the biopsy results from all 18 patients enrolled in the Phase 2a proof of concept study of topsalysin in localized prostate cancer (Press release, Sophiris Bio, JUN 9, 2016, View Source [SID:1234513165]).

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The one-time administration of topsalysin was well tolerated with no serious adverse events and no new safety signals being reported. Topsalysin demonstrated an ability to ablate tumor cells in 50 percent of patients (9/18 patients) six months after treatment in a patient population with pre-identified, clinically significant prostate cancer. The results support advancing topsalysin into a Phase 2 study to confirm dose and optimize delivery.

"These promising early results open up the possibility of treating early prostate cancer by the simple administration of an injection into the prostate – something that could be done in an office setting," according to Dr. Mark Emberton, Investigator, Dean, Faculty of Medical Sciences, University College London and Honorary Consultant Urologist at University College London Hospital NHS Foundation Trust.

All 18 patients enrolled completed the study. Biopsy data at six months following treatment showed that:

Two men experienced complete ablation of their targeted tumor with no evidence of any tumor remaining at 6 months;
Seven men experienced a partial response, defined as either a reduction in the maximum cancer core length or a reduction in Gleason pattern;
Nine patients had no response to treatment.
"It was impressive to observe complete tumor ablations in this proof of concept study. We have demonstrated that topsalysin can safely ablate prostate tumor cells, so these responses increase our confidence that topsalysin could obviate or prolong the time to the need for radical therapy in this patient population," stated Dr. Hashim Ahmed, Principal Investigator for the study, Division of Surgery and Interventional Sciences, University College London. "With the experience from this study, we believe we can further improve responses by optimizing dosing topsalysin based on the size of the tumor and not the prostate and optimizing the delivery of topsalysin, which we will confirm in a larger Phase 2 study."

Allison Hulme, Ph.D., chief operating officer and head of research and development at Sophiris, added: "The breakthrough for us is the ability to inject topsalysin, an enzymatically-activated ablative agent, directly into the identified tumor using imaging technology. Topsalysin has been engineered to be activated only by enzymatically-active PSA, which is only found in the prostate tissue. We believe that with the favorable side effect profile observed to date, topsalysin has the potential to become a focal targeted therapy for the ablation of localized prostate cancer while avoiding many of the complications and side effects associated with radical treatments that are aimed at the entire prostate."

The Phase 2a proof of concept study was a single-center, open-label study at University College London, which is well known for the focal treatment of prostate cancer in the UK. In this study, previously obtained multiparametric magnetic resonance images (mpMRIs) of each patient’s prostate tumor lesions are mapped to real-time three-dimensional transrectal ultrasound using an elastic image-fusion software. These images are used to guide the injection of topsalysin to treat a single, histologically-proven, clinically significant prostate cancer lesion. The primary objective of the study was to evaluate the safety and tolerability, and the key efficacy variable was the change in the treated lesion on targeted biopsy after 6 months. The study was designed to assess whether topsalysin has the potential to provide patients with clinically significant, localized, low to intermediate risk prostate cancer a tissue-sparing cancer treatment that carries little in the way of side effects. A total of 18 patients were enrolled and treated in this study. Detailed results from this study will be presented at a future medical conference.

Webcast scheduled for today at 2:00 p.m. Pacific Time

The Sophiris management team will host a conference call and webcast today, June 9, at 2:00 p.m. Pacific Time to review the topsalysin prostate cancer data. Dr. Hashim Ahmed, University College London and Principal Investigator of the prostate cancer study will also participate in the call.

A live audio webcast will be accessible on the "Investor Relations" page of the Sophiris corporate website at www.SophirisBio.com. A replay will be available at the same location.

About Localized Prostate Cancer

Prostate cancer is the second most common form of cancer in men in the US with an estimated 220,800 new cases in 2015. Approximately 80 percent of patients in the US are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence, and rectal toxicity.

Topsalysin for the Targeted Treatment of Localized Prostate Cancer

Topsalysin (PRX302) has the potential to provide a focal targeted therapy for the ablation of localized prostate cancer while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in mapping previously obtained mpMRI images with real-time three-dimensional ultrasound images enables physicians to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.

Topsalysin, an inactivated pore-forming protein, was engineered to be activated only by enzymatically-active PSA, which is present only in prostate tissue. The targeted focal treatment of prostate cancer is in line with current treatments for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ as possible.

On June 9, 2016 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing antibodies including checkpoint inhibitors and other checkpoint modulators (CPMs) and cancer vaccines, reported the selection of a lead product candidate under its license and research collaboration with Merck (Press release, Agenus, JUN 9, 2016, View Source [SID:1234513159]).

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Merck, known as MSD outside the United States and Canada, has selected a lead antibody candidate and several backup antibodies, discovered by Agenus, to an undisclosed Merck checkpoint target. Based on this milestone and under the terms of the agreement, Agenus received a $2 million milestone payment from Merck.

As previously announced, Merck will be responsible for all future product development expenses for the selected antibody candidate and Agenus is eligible to receive up to $100 million in milestone payments, as well as royalties on worldwide product sales.

"We are pleased that in collaboration with Merck scientists, our research team has successfully identified antibody candidates to advance into preclinical studies," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This is an important validation of our discovery platform and expertise and adds to our successes in discovering antibodies for a broad range of targets, including challenging ones."

"Our integrated monoclonal antibody discovery platforms have successfully identified unique antibodies for a wide range of therapeutic targets," said Robert B. Stein, M.D., Ph.D., Agenus’ President, Research & Development. "This discovery engine provides Agenus the opportunity to bring innovative single-agent and combination immuno-oncology therapies to patients whose cancers are not adequately treated with current approaches."

On June 9, 2016 Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, reported results from two key studies comparing its biosimilar etanercept and rituximab candidates with the originator products – Enbrel*** and MabThera**** respectively (Press release, Novartis, JUN 9, 2016, View Source [SID:1234513158]). In both studies, the primary endpoints of achieving PK bioequivalence were met. The studies were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.[1],[2] Etanercept and rituximab are indicated to treat autoimmune diseases such as rheumatoid arthritis. Rituximab is also indicated to treat hematological cancers like follicular lymphoma.

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"Findings from these studies, along with additional data in our development programs, demonstrate that our biosimilar etanercept and rituximab candidates are highly similar to their originators," said Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz. "Access to biological therapies remains a challenge for many patients with immunological disorders such as rheumatoid arthritis and blood cancers like follicular lymphoma. If approved, our biosimilars could help broaden access to these vital therapies."

The Phase I etanercept trial demonstrated PK bioequivalence and no clinically meaningful differences in safety, tolerability and immunogenicity between the biosimilar candidate and the etanercept originator product (Enbrel).[1] No major safety signals were observed during the study.[1]

The Phase II rituximab trial demonstrated PK bioequivalence and similar PD, safety, efficacy and immunogenicity between the biosimilar candidate and the rituximab originator product (MabThera).[2] Adverse events related to both products were similar for both medicines.[2]

Sandoz’ biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.

Its biosimilar rituximab candidate was accepted by the EMA for regulatory review in May 2016. Sandoz is seeking approval for the same indications as the reference product with the same presentations which is used to treat autoimmune diseases such as rheumatoid arthritis as well as a number of hematological cancers.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Sandoz has a leading biosimilar pipeline and plans to make 10 regulatory filings over a three-year period (2015-2017), having already submitted six and had one approved. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

About the Phase I etanercept study
(Annual European Congress of Rheumatology (EULAR 2016) ref: THU0145)
This study was a randomized, two-way crossover trial comparing the PK and safety of Sandoz’ biosimilar etanercept candidate with originator etanercept (Enbrel) in 54 healthy subjects, with a washout period of at least 35 days between administration of the two study drugs.[1] Follow-up was undertaken for four weeks after the final study drug administration.[1]

About the Phase II rituximab study
(Annual European Congress of Rheumatology (EULAR 2016) ref: FRI0222)
This was a prospective, randomized, double blind study in 173 patients with active rheumatoid arthritis not responsive to conventional therapies (disease-modifying antirheumatic drugs or TNF inhibitors).[2] Primary analysis was performed at week 24 with efficacy and PD data collected to week 52, with safety follow-up ending 24 weeks after the last administration of study medication.[2]