On December 16, 2016 Aptevo Therapeutics Inc. (Nasdaq:APVO) a biotechnology company focused on developing novel oncology and hematology therapeutics, reported the publication of positive data from a Phase 2 clinical trial evaluating its proprietary humanized monospecific anti-CD37 protein therapeutic, otlertuzumab (Press release, Aptevo Therapeutics, DEC 16, 2016, View Source;p=irol-newsArticle&ID=2230353 [SID1234517094]). The results were recently published in the British Journal of Haematology (BJH).

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"We’re very encouraged by the Phase 2 data, which demonstrated a significant increase in median progression free survival, from approximately 10 to 16 months in patients receiving combination otlertuzumab/bendamustine therapy," said Marvin L. White, President and Chief Executive Officer. "These data, coupled with additional results from ongoing studies of otlertuzumab used in combination with current CLL therapies should help position otlertuzumab for a potential partnership to advance into Phase 3 clinical development."

The publication, entitled, "Randomized Phase 2 Study of Otlertuzumab and Bendamustine Versus Bendamustine in Patients with Relapsed Chronic Lymphocytic Leukemia," discusses the results of a multi-center Phase 2 clinical trial comparing the efficacy and safety of otlertuzumab in combination with bendamustine to bendamustine alone in patients with relapsed chronic lymphocytic leukemia (CLL). The data show an improved overall response rate and progression free survival with combination otlertuzumab/bendamustine therapy.

"While substantial advances in the treatment of CLL have been made over the last several years, there is still a significant unmet medical need for safe and effective new combination therapies to treat the many CLL patients that eventually will experience a relapse or discontinue therapy due to adverse events," remarked Dr. Scott Stromatt, Chief Medical Officer for Aptevo. "These latest data show the combination of otlertuzumab and bendamustine is well tolerated and significantly increases the response rate and PFS in patients with relapsed or refractory CLL. Consequently we are now exploring the utility of otlertuzumab in combination with additional CLL therapies to evaluate clinical benefit in distinct CLL patient subgroups."

The data published in BJH suggest that combination therapy with otlertuzumab may improve outcomes for CLL patients. In previous studies Aptevo has shown that otlertuzumab in combination with rituximab, obintuzumab or idelalisib is clinically active and appears to have a good safety and tolerability profile. Based on this promising body of data, Aptevo is further exploring its utility in subgroups of CLL patients who have either (i) not achieved a complete response after one year of therapy with ibrutinib, or (ii) in patients who are developing a resistant clone to ibrutinib but have not yet experienced a clinical relapse.

About the Phase 2 Clinical Trial
A total of 65 patients participated in the study with 32 receiving a combination of otlertuzumab and bendamustine and 33 receiving bendamustine alone. The primary endpoint in the clinical trial was overall response rate (ORR), as measured by the 2008 International Workshop on CLL. Secondary endpoints included an assessment of progression free survival (PFS) and safety.

Phase 2 Clinical Trial Results
The study demonstrated that otlertuzumab combined with bendamustine significantly increased overall response rate, which was 69% for the combination compared to 39% for bendamustine alone (p=0.025). In addition, the combination showed an improvement in median progression free survival, which was 15.9 months in the otlertuzumab/bendamustine combination treatment arm compared to 10.2 months in the bendamustine treatment arm (p=0.0192). Otlertuzumab in combination with bendamustine was generally well tolerated, although there was a higher incidence of pyrexia (34% vs. 12%) and neutropenia (59% vs. 39%) with the combination, however, this did not result in a higher incidence of severe (grade 3 or 4) infections.

The full publication in the British Journal of Haematology can be accessed online at View Source

On December 16, 2016 Celsion Corporation (NASDAQ:CLSN) reported an update on its Phase III OPTIMA program for ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, DEC 16, 2016, View Source [SID1234517095]). The Phase III OPTIMA Study is expected to enroll up to 550 patients at up to 75 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone.

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The Company recently met with the China Food and Drug Administration (CFDA) to discuss the ongoing Phase 3 OPTIMA program and regulatory pathway for ThermoDox in China. During the meeting, Celsion presented the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox plus optimized RFA versus optimized RFA alone. The CFDA informed Celsion that if the ongoing Phase 3 OPTIMA trial is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected.

"We are building momentum with our efforts for ThermoDox in the Asia Pacific region, particularly China, which represents a significant market opportunity with over 50% of new diagnosed cases of this devastating cancer," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "All Chinese sites will be fully activated by early 2017, enrollment is on pace to meet our objective of fully enrolling the trial by the first quarter of 2018, and we have advanced our manufacturing in China with Hisun to support a potential future launch in this region with impressive gross margins. We believe that the remarkable data from the Chinese cohort of the HEAT study underscores the potentially curative nature of ThermoDox in patients with primary liver cancer, and we are pleased that the CFDA has both recognized its potential and offered a straightforward path to a regulatory filing in China."

In support of its efforts in China, Celsion reported that recent bioequivalence studies of ThermoDox produced in China by Hisun are equivalent to batches of ThermoDox produced at its United States manufacturing site.

In addition, Celsion reported that the Company’s management team recently met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA study in the country. Celsion expects to have approximately 5 additional clinical trial sites in Vietnam activated by early 2017. Vietnam represents a significant market for ThermoDox where HCC incidence rates are among the world’s highest.

About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 75 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

On Dec 15, 2016 Progenra, Inc. announced a new immune-oncology drug whose mechanism differs from available cancer immunotherapies Opdivo and Keytruda (Press release, Progenra, DEC 15, 2016, View Source [SID1234517432]). The findings, published by Progenra with Dr. Wayne Hancock, University of Pennsylvania School of Medicine, support a new immune-oncology antitumor strategy by inhibiting USP7, an enzyme that prevents immune activity against cancer in addition to supporting the growth of cancer cells . According to a commentary on this publication, inhibiting USP7 works on T cells to diminish immunosuppression, permitting the patient’s own immune system to eliminate cancer ("the data by Wang and colleagues proposes a potential immunotherapy against tumors by targeting USP7, which … breaks the immune tolerance in the tumor microenvironment"… "these preclinical findings suggest that USP7 targeting … as well as directly induce tumor cell apoptosis, could have practical significance in clinical applications").

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"We are pleased that Progenra’s unique UbiPro Drug Discovery Platform is gaining traction outside the US and that a major pharmaceutical company such as Ono has agreed to collaborate with Progenra on the ubiquitin and ubiquitin-like protein pathways"

"We are pleased that Progenra’s USP7 inhibitors, tested in several laboratories worldwide, can eradicate cancers by both tumoricidal and immunological mechanisms," said Tauseef Butt, President of Progenra. "We are excited to move USP7 inhibitors into clinical trial as single agents or combined with marketed immunological agents such as Opdivo and Keytruda."

Dr. Hancock added," Immunotherapy must do more than affect a single target, since those approaches help only about 20% of patients. Pharmacologic inhibition of USP7 allows direct targeting through the immune system, in a graded manner that has antitumor efficacy used alone or combined with one or more biologic agents.".

Progenra (www.progenra.com) aims to develop high value medicines exploiting protein regulatory pathways. Its early product portfolio addresses unmet needs in cancer, inflammation, and neurodegeneration. Utilizing its drug discovery platform, Progenra identifies novel modulators of its protein regulatory targets for drug development; the company’s discovery platform is complemented by internal target validation, cell proof of concept, and medicinal chemistry.

Dr. Wayne Hancock is Professor of Pathology/Laboratory Medicine at The University of Pennsylvania School of Medicine and Chief, Division of Transplant Immunology at the Children’s Hospital of Philadelphia. His multidisciplinary team focuses on improving outcomes of organ transplantation and cancer immunotherapy by modulating immune cell production and function.

On December 15, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported the successful closing of the acquisition of 100% shares in Cyprotex PLC ("Cyprotex", AIM: CRX-GB), a specialist pre-clinical contract research organisation in ADME-Tox and DMPK headquartered in the UK (Press release, Evotec, DEC 15, 2016, View Source [SID1234517081]). The proposed acquisition was announced in detail on 26 October 2016.

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Following a scheme of arrangement regulated by the UK takeover code, all shares of Cyprotex have been acquired by and transferred to Evotec AG effective 14 December 2016 and the shares will this morning be cancelled from AIM. Evotec is paying £ 55.7 m (EUR 66.3 m; at an assumed £/EUR exchange rate of 1.19) in cash for the acquisition of all 26.1 million issued and to be issued Cyprotex shares and the funding of company debt mainly in the context of loan notes. The offer of 1.60 £ per Cyprotex share reflects a 9.4% premium to the VWAP of the past 30 trading days at AIM prior to the offer on 26 October 2016. MCF Corporate Finance, led by Ian Henderson, acted as Evotec’s exclusive financial adviser throughout the acquisition process.

Cyprotex, headquartered in the UK, was founded in 1999 and is publicly traded on AIM (CRX). The company currently has 136 employees working from sites at Macclesfield and Alderley Park, both of which are located near Manchester in the UK, and at Watertown, MA, and Kalamazoo, MI, in the USA. Cyprotex will continue to operate and serve its loyal client base in all currently existing segments under its brand name "Cyprotex" whilst employees and capabilities will be integrated into Evotec’s global drug discovery group, thereby leveraging both companies’ extensive partner networks and identifying further commercial synergies.

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: "We are pleased the acquisition has closed and we can now approach the exciting phase of welcoming Cyprotex’ employees and clients to our global drug discovery services platform. The addition of the market’s most industrialised ADME-Tox platform and proven expertise in in vitro ADME screening, mechanistic and high-content toxicology screening and predictive modelling to our offering substantially improves our ability to provide our alliance partners with access to the most comprehensive drug discovery platform. Cyprotex’ proven technology platform and its expert and dedicated employees perfectly augment Evotec’s business strategy and offering."

Dr Werner Lanthaler, Chief Executive Officer of Evotec, added: "The highest quality and completeness of our drug discovery platform is key to improve the efficiency in the process for our partners. With Cyprotex we make here an important next step. We warmly welcome the Cyprotex employees to the Evotec Group and look forward to working with them."

Evotec confirms its liquidity guidance for 2016. The Company expects liquidity to be at a similar level to the prior year, excluding any potential cash outflow for M&A or similar transactions. Based on current estimates, it is expected that the Cyprotex business will add approx. EUR 18-20 m in revenues in 2017 and will be accretive to Evotec’s 2017 EBITDA.

On December 15, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has submitted its pre-Investigational New Drug (pre-IND) meeting package to the U.S. Food and Drug Administration (FDA) for PharmaCyte’s therapy in inoperable locally advanced pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, DEC 15, 2016, View Source [SID1234517091]). PharmaCyte’s pre-IND submission follows its recent announcement that the FDA has granted PharmaCyte a pre-IND meeting for its pancreatic cancer therapy.

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The package provides the FDA with a full history of PharmaCyte’s therapy, including information on the previous preclinical studies and the clinical trials that were performed using the Cell-in-a-Box live-cell encapsulation technology combined with low doses of the chemotherapy drug ifosfamide. That combination makes up PharmaCyte’s pancreatic cancer therapy. The package also provides detailed information on the manufacturing process used to produce the Cell-in-a-Box capsules and a synopsis of the structure of the clinical trial that PharmaCyte plans to conduct in the U.S. and Europe in patients with inoperable LAPC.

The FDA’s response to the pre-IND submission will be provided after the pre-IND meeting. The regulatory agency’s response will serve as a roadmap in guiding PharmaCyte as it prepares the full IND application that must be deemed acceptable to the FDA before the clinical trial can begin.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "The submission of the pre-IND package is yet another major step that PharmaCyte has completed in its efforts to develop its pancreatic cancer therapy. We are looking forward to the pre-IND meeting and the FDA’s guidance as we prepare for our clinical trial in patients with inoperable LAPC where there is an unmet medical need we plan to address."