On September 18, 2018 Rapamycin Holdings, Inc. (RHI), a privately-held drug development company based in San Antonio, Texas, reported that it has treated its first human patient with the company’s pharmaceutical formulation of its eRapaTM compound (Press release, Rapamycin Holdings, SEP 18, 2018, View Source [SID1234529479]). This first in human Phase 1b clinical trial of eRapa focuses on men with early stage prostate cancer.

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The trial will dose an expected twelve to 24 qualified patients to establish safety and explore the optimal biologic dose of eRapa. The trial is led by Michael Liss, M.D., a urologic oncologist at UT Health San Antonio MD Anderson Cancer Center, where the Phase 1b study is being conducted.

"This trial holds tremendous promise, not only for early stage prostate cancer patients but for many people with age-related diseases," commented RHI President and CEO, Dan Hargrove. "In addition to evaluating the safety and optimal dose of eRapa to potentially prevent the progression of prostate cancer, this trial will explore the ways in which eRapa can rejuvenate the body’s immune system, which is one of the strongest weapons against cancer. The final results will help signal our next clinical trials, as well as identify the various opportunities to explore to move eRapa toward becoming a platform therapy to alleviate a number of age-related diseases."

Dr. Liss, the principal investigator of the trial, said, "Early stage prostate cancer is a good target for eRapa because past research has shown that the compound has inhibited the growth of certain types of cancer cells. In this trial, men will be given eRapa in different doses to find the level that provides the biggest benefit with minimal side effects. The therapy has the potential to change how we manage men with early prostate cancer."

Dr. Ruben Mesa, director of UT Health San Antonio MD Anderson added, "This is a great example of the innovative clinical trials that are taking place here. Our cancer center has a long history of testing cancer breakthrough therapies in our world-renowned, early-phase cancer treatment program, the Institute for Drug Development. I am particularly excited about the potential of this new therapy to make an impact on early stage prostate cancer and possibly decrease the chance of recurrence."

RHI anticipates that the trial will conclude in mid 2019, leading the company closer to collaboration with the US FDA toward the expedited 505(b)(2) regulatory pathway. The company is also looking ahead to future clinical trials in potential indications that may expedite marketing authorization and commercialization of eRapa.

For information about participating in the study, please contact Allison Sherrill at (210) 567-1172.

About eRapaTM

Researchers at UT Health San Antonio discovered that an improved formulation of the well-known drug, Rapamycin, extended life span and health span in rodents by mitigating the effects of age-related diseases. Rapamycin Holdings, as the exclusive licensee of this technology, is capitalizing on this discovery by developing a novel proprietary and patented formulation for the treatment of serious unmet medical needs.

On September 18, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Medicines Agency (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy (Press release, Bristol-Myers Squibb, SEP 18, 2018, View Source [SID1234529478]). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

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"Given the need for new treatment options for patients with multiple myeloma, we look forward to working closely with the EMA as they review this application," said Fouad Namouni, M.D., head, oncology development, Bristol-Myers Squibb. "It is our hope that this new Empliciti-based combination will soon become available for patients in the European Union with multiple myeloma, whose disease progressed on lenalidomide and a PI."

The application is based on data from ELOQUENT-3, a randomized Phase 2 study evaluating the EPd combination versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). Data from this study were presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

About ELOQUENT-3

The Phase 2 ELOQUENT-3 trial randomized 117 patients with RRMM who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a PI. Patients were randomized 1:1 to receive either EPd (n=60) or Pd (n=57) in 28-day cycles until disease progression or unacceptable toxicity. Patients in both the EPd and Pd arms received 4 mg of pomalidomide for days 1-21 of each cycle, and the weekly equivalent of 40 mg or 20 mg dexamethasone for patients ≤75 years or >75 years, respectively. In the EPd arm, Empliciti was administered at the dose of 10 mg/kg IV weekly for the first 2 cycles and 20 mg/kg monthly starting from cycle 3. Patients randomized to EPd experienced a 46% reduction in risk of disease progression (HR 0.54; 95% CI: 0.34 to 0.86, p=0.0078) compared with patients randomized to Pd alone, with median PFS, the study’s primary endpoint, of 10.3 months (95% CI: 5.6 to not estimable) compared with 4.7 months (95% CI: 2.8 to 7.2) in Pd patients. The PFS benefit experienced among patients randomized to EPd was consistent among patients who had received two to three prior lines of therapy (HR 0.55; 95% CI: 0.31 to 0.98) and four or more prior lines of therapy (HR 0.51; CI 95%: 0.24 to 1.08).

Rates of treatment-related hematologic adverse events (AEs) were comparable between EPd and Pd groups (38% and 42%, respectively). The most commonly occurring hematologic AEs among patients receiving EPd were neutropenia (13%), anemia (10%), thrombocytopenia (8%) and lymphopenia (8%). AEs led to discontinuation in 18% of patients in the EPd arm, compared with 24% of patients in the Pd arm.

On September 18, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018 at 9:30 am at the Sofitel Hotel in New York City (Press release, MediciNova, SEP 18, 2018, View Source;p=irol-newsArticle&ID=2367994 [SID1234529477]). Management will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Ladenburg Thalmann.

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On September 18, 2018 Biogen Inc. (Nasdaq:BIIB) reported it will report third quarter 2018 financial results Tuesday, October 23, 2018, before the financial markets open (Press release, Biogen, SEP 18, 2018, View Source [SID1234529476]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

On September 18, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the first patient has been dosed in a Phase 2 study evaluating the combination therapy of its cancer immunotherapy, CV301, and Roches’s checkpoint inhibitor, atezolizumab (TECENTRIQ), for the treatment of patients with locally advanced or metastatic urothelial bladder cancer (Press release, Bavarian Nordic, SEP 18, 2018, View Source [SID1234529475]).

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Bavarian Nordic’s CV301 targets tumor-associated antigens, CEA and MUC1, which are overexpressed on multiple solid tumors, including bladder cancer. Preclinical data has shown that vaccination resulted in the induction of tumor specific T-cells that infiltrated the tumor resulting in the upregulation of PD-L1 on tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

CV301 is administered in an innovative manner designed to generate a potent and durable T-cell response. Patients receive an enhanced priming regimen of the highly attenuated, non-replicating vaccinia virus MVA-BN-CV301 in 4 different injection sites on days 1 and 22, followed by boosters of the recombinant fowlpox virus FPV-CV301 at tapering intervals throughout the two years they are receiving atezolizumab.

The Phase 2, single-arm, multi-institutional clinical trial is designed to study the combination of CV301 with atezolizumab as a first-line treatment for patients with urothelial bladder cancer who are not eligible for cisplatin-containing chemotherapy (Cohort 1) and as a second-line treatment for patients who have previously been treated with cisplatin-based chemotherapies. The study is expected to enroll 68 patients, using a two-stage design within each cohort.

Stage 1 is planned to enroll approximately 40% of the subjects, with a threshold of around 25% of the subjects needing to achieve an objective response before enrolling the rest of the patients in Stage 2. Key secondary measures will also be evaluated, including: progression free survival (PFS), overall survival (OS) and duration of response.

"Today represents another large step forward in the development of our CV301 program and understanding its potential in bladder cancer," said Paul Chaplin, President and CEO of Bavarian Nordic. "We are hopeful that the preclinical data demonstrating a synergistic effect of CV301 with checkpoint inhibition will translate into a new, much-needed treatment option for patients living with this disease."

For more information on the trial, please visit: View Source

About CV301
CV301 is an active immunotherapy candidate that targets two tumor-associated antigens, CEA and MUC1, long known to be overexpressed in most solid tumors. The poxvirus-based prime/boost vaccine 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. Preclinical data shows that antigen specific vaccination results in T cell infiltration into areas of antigen expression and upregulation of PD-L1 on antigen expressing tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.