Phoenix Molecular Designs Raises $2.7M To Develop PMD-026 for Triple-Negative Breast Cancer (TNBC)

On September 18, 2018 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, reported that the completion of a $2.7M financing effort, which includes an over-subscribed $2M round in venture-backed capital and over $670K in non-dilutive capital (Press release, PhoenixMD, SEP 18, 2018, View Source [SID1234536960]). The venture round is led by Pallasite Ventures and includes new angel investors and existing angel investors from prior funding rounds. PhoenixMD intends to use the proceeds to advance its lead asset PMD-026 through IND-enabling studies and to develop a sophisticated companion diagnostic test to determine which patients have high levels of activated RSK2, the protein that PMD-026 disrupts.

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"This financing is a critical step forward in bringing the first disease-modifying therapeutic treatment to women suffering from TNBC. The PhoenixMD team is committed to innovating in the breast cancer field and we are excited to deploy Pallasite’s investment to such an experienced team to solve an unmet medical need," said Chris Bissonnette, Ph.D., Managing Partner of Pallasite Ventures. In connection with the financing, Dr. Bissonnette has joined PhoenixMD’s Board of Directors.

"We are thrilled to close our first venture-backed round with such high-quality investors, which is a major achievement for the company," said Sandra E. Dunn, Ph.D., CEO of PhoenixMD. "The proceeds from this financing, and the non-dilutive capital from recent research grants will advance PMD-026 through critical IND-enabling studies and will begin planning around our upcoming Phase 1 study, which we are very excited to initiate."

About Triple Negative Breast Cancer (TNBC) and RSK Kinases

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. It is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are still no targeted therapies available for TNBC.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2. Inhibiting RSK2 eliminates TNBC cells completely, including cancer stem cells, which give rise to cancer recurrence. PhoenixMD, with its novel, targeted approach, is focused on creating patented cancer RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Currently, there are no approved targeted therapies for TNBC, although several drugs are subject to research studies and clinical trials. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

BIOGEN TO REPORT THIRD QUARTER 2018 FINANCIAL RESULTS OCTOBER 23, 2018

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.

MediciNova to Present at the Ladenburg Thalmann 2018 Healthcare Conference in New York

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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NewLink Genetics to Participate in the Cantor Global Healthcare Conference

On SEptember 18, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that the Company will present at the 2018 Cantor Global Healthcare Conference on Wednesday, October 3, 2018, at 4:00PM ET in New York, New York (Press release, NewLink Genetics, SEP 18, 2018, View Source [SID1234530679]).

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A live webcast of the presentation will be available on the Company’s website at www.newlinkgenetics.com in the "Investors & Media" section under "Events and Presentations." An archived edition of the presentation will be available on NewLink Genetics’ website later that day.

European Medicines Agency Validates Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma

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.