Year: 2016

Apollo Endosurgery Completes Merger with Lpath; Initiates Trading on NASDAQ as ‘APEN’

On December 29, 2016 Apollo Endosurgery, Inc. ("Apollo"), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that it has completed its merger transaction with Lpath, Inc. ("Lpath", Nasdaq: LPTN) (Filing, 8-K, Lpath, DEC 30, 2016, View Source [SID1234517278]).

With the completion of the merger today, Lpath was renamed Apollo Endosurgery, Inc. and will begin trading on the NASDAQ Global Market under the symbol ‘APEN’ on December 30, 2016.

Following the closing of the merger and a 1-for-5.5 reverse stock split, the combined company has approximately 10.7 million shares of common stock outstanding. The stockholders of Apollo received common stock representing approximately 95.9% of the outstanding shares and the stockholders of Lpath retained approximately 4.1% of the combined company. Concurrent with the closing of the merger, certain stockholders of Apollo invested $29 million of new equity in the combined company, which is included in the 95.9% ownership of previous Apollo stockholders.

"Apollo has an exciting product and technology portfolio from which to advance the interventional treatment of obesity through less invasive procedures. We are grateful for the continued confidence and support of Apollo’s stockholders as we take this next step in the development of our company," commented Todd Newton, Chief Executive Officer of Apollo.

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BeiGene Announces First Patient Dosing in China Phase I Trial with Investigational Anti-PD-1 Monoclonal Antibody BGB-A317

On December 30, 2016 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a Phase I clinical trial of BGB-A317, an anti-PD-1 monoclonal antibody, in mainland Chinese patients with advanced solid tumors (Press release, BeiGene, DEC 30, 2016, View Source [SID1234517240]).

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"We are pleased to report that BGB-A317 is now in Phase I clinical evaluation in mainland China. To date, all four of our clinical-stage molecules are active in the clinic in China. We are enthusiastic about the agent’s therapeutic potential, with promising data from an ongoing Phase I study of BGB-A317 in Australia, New Zealand, the United States, and Taiwan recently reported at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. We are committed to developing BGB-A317 for patients in China, where this exciting class of immuno-oncology agents is still not approved," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

The Phase I open-label, multi-center study of BGB-A317 is designed to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-A317 in Chinese patients with advanced solid tumors. Professor Yilong Wu from Guangdong General Hospital is the lead principal investigator of the study. The co-lead investigators are Professor Lin Shen and Professor Jun Guo, both of Beijing Cancer Hospital.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.

Aptose Biosciences Provides Update on APTO-253 Development

On December 29, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported an update on the development of APTO-253, its investigational compound for acute myeloid leukemia (AML) (Press release, Aptose Biosciences, DEC 29, 2016, View Source [SID1234539166]). The company has successfully manufactured multiple batches of a new drug product formulation for APTO-253, including a batch that has been stable and soluble for over six months. However, Aptose will have to repeat the production of the fourth batch, a 40L batch that was the intended clinical supply, because of a correctable engineering design incompatibility during the filling process. Aptose expects the batch records and release specifications from such a new batch, along with the stability and sterility data, to be provided to the FDA during the first quarter of 2017.

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The need to strengthen the filling process is not a reflection on the drug substance or new formulation, both of which continue to perform favorably. Indeed, the new formulation demonstrates an increase of three times plasma drug exposure as compared to the prior formulation and may have the potential to create additional intellectual property for the company. Aptose also demonstrated that APTO-253 acts by inhibiting expression of the c-Myc oncogene without toxicity to normal bone marrow and blood cells, thereby potentially increasing the likelihood of application to additional cancer indications.

"We remain committed to the development of APTO-253, a small molecule agent that may provide benefit to an important patient population," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "While we have encountered delays in manufacturing activities, we also have continued mechanistic and pharmacokinetic testing of APTO-253 which heighten its viability. In parallel, we also continue to advance the development of CG’806, an exciting preclinical compound for patients with FLT3-driven AML and certain B-cell malignancies."

In November of last year, Aptose’s phase 1b trial of APTO-253 was temporarily suspended because of the report of an operational difficulty with an IV infusion pump at a clinical site. The company has spent the year identifying the root cause of the clogging issue and actively evaluating multiple formulation and production methodologies in order to improve solubility and stability characteristics and select the best approach to optimizing the delivery of the product to patients with the goal of re-entering the clinic. Aptose is currently working on submitting information requested by the FDA as a result of the development of a new drug product that does not cause filter clogging or pump stoppage during simulated infusion studies.

argenx announces publication of seminal data supporting the therapeutic potential of ARGX-110 for acute myeloid leukemia in the Journal of Experimental Medicine

On December 29, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported the publication of new preclinical data on the CD70/CD27 pathway that provide further rationale for ARGX-110 therapy for the treatment of acute myeloid leukemia (AML) (Press release, arGEN-X, DEC 29, 2016, View Source [SID1234517235]). ARGX-110, a SIMPLE Antibody(TM) targeting CD70, is currently being evaluated in a Phase I/II study in combination with azacitidine in newly diagnosed AML patients.

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Data published by argenx collaborator Prof. Adrian Ochsenbein at the University of Bern, demonstrate that CD70/CD27 is highly expressed on AML blasts and leukemic stem cells in newly diagnosed AML patients, regardless of cytogenetic factors, or the patient’s risk class. The published data show the CD70/CD27 pathway to be critical in the biology of leukemic stem cells, and therapeutic intervention using a CD70-targeted antibody to enable selective targeting of leukemic stem cells without impacting hematopoietic stem cells, resulting in a survival benefit in preclinical AML models.

"The published data from Prof Ochsenbein’s lab continue to support our rationale to evaluate ARGX-110 in newly diagnosed AML patients based on the important presence of the CD70 target in the disease pathogenesis and its demonstrated role in survival," commented Nicolas Leupin, MD, Chief Medical Officer of argenx. "We are very committed to our recently initiated Phase I/II study of ARGX-110 in combination with standard of care azacitidine as we believe this target represents an innovative and differentiated approach to the disease, further proven by this seminal data underscoring the role of CD70 in acute myeloid leukaemia (AML)."

A link to the abstract can be accessed at: View Source

About ARGX-110
ARGX-110 is a SIMPLE Antibody(TM) targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) restores immune surveillance against tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). ARGX-110 is currently being evaluated in hematological and solid tumors. Preclinical work on ARGX-110 in AML was done in collaboration with the Tumor Immunology Lab of Prof. A. F. Ochsenbein at the University of Bern. Prof. Ochsenbein won the prestigious 2016 Otto Naegeli Prize for their breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients.

About AML
AML is a neoplasia of the myeloid line of blood cells, characterized by the rapid growth of abnormal white blood cells that build up in the bone marrow and interfere with the production of normal blood cells. AML has the lowest 5-year survival rate of all blood malignancies (~5-20%) and primarily affects the eldery. Patients above 65 years old are unfit for stem cell transplantation and are often put on palliative treatment. Around 40% of these patients receive azacitidine, as it has been shown to improve the overall survival rate.
-Azacitidine (Vidaza, Celgene)-

BAVARIAN NORDIC INITIATES TRIAL OF CV301 IN COMBINATION WITH NIVOLUMAB IN PATIENTS WITH LUNG CANCER

On December 29, 2016 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the initiation of a clinical trial combining its proprietary cancer immunotherapy candidate, CV301, with the anti-PD-1 drug, OPDIVO (nivolumab) from Bristol-Myers Squibb (Press release, Bavarian Nordic, DEC 29, 2016, View Source [SID1234517234]). The study is enrolling patients with non-small cell lung cancer (NSCLC) who have failed prior therapy.

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The trial will begin with a Phase 1 safety component, enrolling up to 40 patients; the Phase 2 portion of the study will enroll 120 patients who will be randomized to receive either nivolumab (monotherapy) or a combination of CV301 and nivolumab. The study will enroll patients from up to 20 clinical sites throughout the United States. Detailed information on the trial can be found at View Source

The rationale for this combination approach is for the vaccine to generate a tumor specific T cell response and allow the checkpoint inhibitor to maintain that immune effect by preventing the tumor from turning that response off.

While the primary endpoint of the study is overall survival, numerous secondary endpoints including response rate, progression free survival and duration of response will be evaluated and offer the potential for an early efficacy signal, prior to an overall survival endpoint.

"We are pleased to announce the initiation of this study, which marks the entry for Bavarian Nordic into lung cancer. While CV301 has shown the ability to generate immune responses to tumor-associated antigens in a variety of cancers, this study is the first seeking proof-of-concept for a promising combination approach and we look forward to the results as well as to advance CV301 as combination therapy in additional indications over the next years," said Paul Chaplin, President & CEO of Bavarian Nordic.

About CV301
CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI).

CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in multiple solid tumors, including lung, bladder and colorectal cancer. Similar to PROSTVAC, CV301 uses a prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.

A precursor version of CV301 has been tested in six NCI-sponsored clinical trials in various cancers, and a Phase 2 study in bladder cancer is currently ongoing. More than 300 patients have been treated with the product candidate.

About OPDIVO (nivolumab)
Marketed by Bristol-Myers Squibb, OPDIVO is an immune checkpoint inhibitor (anti-PD-1 therapy) approved for treatment of patients with advanced NSCLC in the second line setting, among other indications. OPDIVO has demonstrated superior overall survival across histologies, versus chemotherapy, in two pivotal Phase 3 trials in patients with advanced NSCLC.