On February 7, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it has been able to show promising tumor suppression activity with its inhibitor of glycolysis, WP1122 (Press release, Moleculin, FEB 7, 2018, View Source [SID1234523798]).

"We have previously announced that our glycolysis inhibitors have shown a remarkable affinity for concentrating in the pancreas," commented Walter Klemp, Chairman and CEO of Moleculin. "And, we know that pancreatic cancer is highly glycolytic. Now, we have solid data showing the ability of WP1122 to inhibit pancreatic tumor growth in mice."

Mr. Klemp continued, "This is the indicator we were looking for to support our going after pancreatic cancer as a primary target for the WP1122 portfolio. We couldn’t be more excited given the intense unmet need in pancreatic cancer."

On February 7, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the United States Patent and Trademark Office has issued a notice of allowance for U.S. Patent Application No. 15/095,641, entitled "Alkylphosphocholine Analogs for Multiple Myeloma Imaging and Therapy," which covers a method of use for CLR 131, the company’s lead radiotherapeutic Phospholipid Drug Conjugate (PDC) in multiple myeloma (MM) (Press release, Cellectar Biosciences, FEB 7, 2018, View Source [SID1234523792]).

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CLR 131 is Cellectar’s investigational compound under development for a range of orphan designated cancers. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver the cytotoxic radioisotope iodine-131 directly to tumor cells. CLR 131 is currently being evaluated in a Phase 1 clinical trial in patients with relapse or refractory MM, as well as in a Phase 2 clinical trial for relapsed or refractory MM and select relapsed or refractory lymphomas. The U.S. Food and Drug Administration has granted orphan drug designation for CLR 131 in the treatment of MM.

"This patent allowance enhances our intellectual property estate and underscores the novelty of CLR 131 for the treatment of multiple myeloma, a life-threatening disease with high unmet medical need," said James Caruso, chief executive officer of Cellectar Biosciences. "Importantly, upon issuance, this patent will extend our coverage into the mid-2030s."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

On February 7, 2018 Xcovery, a developer of targeted therapeutics for cancer, reported the initiation of its Phase 2 clinical trial of ensartinib (X-396), the company’s lead anaplastic lymphoma kinase (ALK) drug candidate, in patients with advanced malignant melanoma harboring alterations in ALK, including ALKATI (Press release, Xcovery, FEB 7, 2018, View Source [SID1234523776]). The trial is being conducted by the renowned Memorial Sloan Kettering Cancer Center (MSK) and led by MSK’s Dr. Alexander Shoushtari.

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"We hope that ensartinib will be a viable treatment option for these patients."

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The primary objective of the study is to determine the clinical benefit rate (CBR) of ensartinib in this patient population. CBR is defined as any confirmed objective response by Response Evaluation in Solid Tumors (RECIST) 1.1 or stable disease until the 24-week assessment. This is an open label, single arm Phase 2 study, enrolling patients with melanoma either currently or previously having received a PD-1 based therapy and, if BRAF V600 mutated, a BRAF-based therapy. The study is comprised of two portions: the screening phase and treatment phase. In the screening phase, archival tumor tissues from patients deemed to be current or future candidates for this trial will be tested for the ALKATI alteration using a Nanostring-based RNA assay at MSK. Patients whose tumors express ALKATI will be eligible for the treatment phase.

"While there has been significant clinical advancements in the treatment of advanced malignant melanoma, 30 to 40 percent of patients do not respond to immune-based therapy or will develop therapeutic resistance. This is a promising trial that uses an RNA-based assay to identify an epigenentically-regulated tumor growth mechanism and if deemed favorable for further study, this trial could represent a new treatment option for patients who currently have few options," said Alexander Shoushtari, M.D., Department of Medicine/Melanoma and Immunotherapeutics Services and principal investigator of the study at MSK.

"We are honored to collaborate with the distinguished scientists and investigators at MSK who were the first to discover this novel ALK alternation in melanoma patients," said Lieming Ding, M.D., Chairman of Xcovery. "We hope that ensartinib will be a viable treatment option for these patients."

For more information on the ensartinib clinical trial, please visit clinicaltrials.gov.

About Ensartinib
Ensartinib (X-396) is a potent anaplastic lymphoma kinase (ALK) inhibitor currently in a global Phase 3 trial in ALK positive non-small cell lung cancer patients. Besides ALK, ensartinib also potently inhibits TRKA fusions, TRKC, ROS1, EphA2, and c-MET.

On February 7, 2018 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking full approval for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL) (Press release, Verastem, FEB 7, 2018, View Source;p=RssLanding&cat=news&id=2330853 [SID1234523775]). Duvelisib has received Fast Track Designation from the FDA for patients with CLL or peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.

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"The submission of our first NDA for duvelisib is a major milestone for Verastem and is the culmination of substantial effort by our employees and the investigators who have dedicated themselves toward developing a potential treatment option for patients who are in need of additional therapies. We are immensely grateful to all of the patients that participated in the duvelisib clinical trial program over the last few years," said Robert Forrester, President and Chief Executive Officer of Verastem. "Oral duvelisib is the first PI3K inhibitor to show efficacy as a monotherapy in a randomized Phase 3 study in patients with relapsed or refractory CLL/SLL. Duvelisib monotherapy has also demonstrated significant clinical activity in patients with double-refractory FL. We believe duvelisib will offer a convenient oral treatment alternative. We look forward to working with the FDA during the review process and to a potential U.S. approval decision for duvelisib in early 2019."

The NDA is supported by clinical data from the randomized Phase 3 DUO study demonstrating significant efficacy, along with a consistent and manageable safety profile, of duvelisib monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study met its primary endpoint with oral duvelisib monotherapy achieving a statistically significant improvement in progression-free survival (PFS) compared to ofatumumab in patients with relapsed or refractory CLL/ SLL (median PFS of 13.3 months versus 9.9 months, respectively; HR=0.52; p<0.0001), representing a 48% reduction in the risk of disease progression or death. The NDA is also supported by results from the Phase 2 DYNAMO study in patients with indolent non-Hodgkin’s lymphoma that are double-refractory to both rituximab and chemotherapy or radioimmunotherapy, which also achieved its primary endpoint with an objective response rate (ORR) of 46% (p<0.0001). In the subset of patients enrolled in DYNAMO with double-refractory FL (n=83), duvelisib demonstrated an ORR of 41%.

About Duvelisib

Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints and Verastem has submitted a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On February 7, 2017 Sanofi reported financial results for the fiscal year ended December 31, 2017 (Press release, Sanofi, FEB 7, 2018, View Source [SID1234523887]).

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Q4 2017 sales reflect strong Dupixent launch offset by anticipated declines in U.S. diabetes and Renagel

Net sales were €8,691 million, down 2.0% on a reported basis and up 4.1%(3) at CER. At CER/CS(3), net sales were down 1.6%.
Strong Sanofi Genzyme sales growth (up 16.8%) driven by contribution from new immunology franchise.
Sanofi Pasteur sales increased 1.2% at CER/CS impacted by order phasing effects and Dengvaxia.
CHC sales grew 2.5% at CER/CS.
Diabetes and Cardiovascular GBU sales down 19.1%.
Emerging Markets(4) sales increased 2.1% at CER/CS, driven by Pharmaceuticals which increased 4.0% at CER/CS.
Sanofi Genzyme, Sanofi Pasteur and Emerging Markets sales growth more than offset Diabetes sales decline in 2017

Net sales in 2017 were €35,055 million, up 3.6% on a reported basis and 5.6%(2) at CER. Net sales were up 0.5% at CER/CS.
Sanofi Genzyme grew 15.1% to €5,674 million while Sanofi Pasteur increased 8.3% (at CER/CS) to €5,101 million.
Emerging Markets sales were up 6.0% at CER/CS supported by strong performance in China (up 15.1% at CER/CS).
Diabetes and Cardiovascular GBU sales declined 14.3% to €5,400 million.
Sanofi meets its full-year 2017 business EPS guidance

Q4 2017 business EPS(1) decreased 8.8% at CER to €1.06, including financial impact from Dengvaxia (-€0.10).
2017 business EPS(1) of €5.54 (-0.4% at CER) and IFRS EPS of €6.71 (+83.3% on a reported basis).
Net debt was €5,229 million at the end of 2017, a decrease from €8,206 million at the end of 2016.
Board proposes dividend of €3.03, an increase of 2.4%.
2017 business net income (BNI) effective tax rate unaffected by the U.S. tax reform. In 2018, Sanofi expects the BNI effective tax rate to be around 22% primarily as a result of U.S. tax reform(5).
Sanofi progresses on its strategic priorities

Sanofi to acquire Bioverativ(6) for $11.6 billion to expand in specialty care and strengthen its leadership in rare diseases.
Sanofi to acquire Ablynx(6) for €3.9 billion to strengthen its R&D strategy with innovative Nanobody technology platform.
Agreement signed with Regeneron to accelerate and expand investments for the development of cemiplimab and dupilumab.
FDA supplemental BLA submission for dupilumab in uncontrolled persistent asthma for adults and adolescents.
2018 financial outlook

Sanofi expects 2018 business EPS(1) to grow between 2% and 5%(7) at CER, including the anticipated contribution from the recently announced acquisitions, barring unforeseen major adverse events. Applying the average December 2017 exchange rates, the currency impact on 2018 business EPS is estimated to be -3% to -4%.