On January 29, 2018 TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and WindMIL Therapeutics, a clinical stage oncology cell therapy company leveraging a proprietary platform to develop a novel class of cell therapies called MILs (Marrow Infiltrating Lymphocytes), reported they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform to support clinical development of proprietary autologous cell therapies by WindMIL (Press release, TrakCel, JAN 29, 2018, View Source [SID1234553992]).

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The supply chain platform will be used to manage WindMIL’s entire supply chain as WindMIL expands its program of cell therapy clinical trials later this year. This expansion of clinical trials follows WindMIL’s completion of a $32.5 million Series B fundraising in June 2018. WindMIL’s unique expertise in bone marrow immunology includes the only replicable and scalable process to create a cell therapy product from bone marrow-derived T cells, which are naturally tumor specific and of a memory phenotype.

The TrakCel platform will be live in over 100 sites globally by Q1 2019. This will enable WindMIL to leverage clinical site familiarity with the platform, while ensuring connectivity across all organizations and professionals involved. The system will harmonize with all partner internal systems, including those of clinical sites, couriers, CROs and CMOs. This will support an efficient and well controlled supply chain that makes the precision of collection, transportation and manufacturing visible to all involved. It also will encompass a specifically designed
interface for physicians and medical teams.

"We are excited to soon treat more patients with MILs through this expansion of our clinical trial program. MILs harness the power of the body’s own immune system, specifically cells residing in the bone marrow. We are the only company focused on manufacturing and developing this natural source of tumor-targeting, central-memory T cells," said Brian Halak, President and CEO, WindMIL
Therapeutics. "However, developing novel cellular therapies is also about logistics. It is important for us to ensure the supply chain works for each of the individuals involved in the patient’s care and for the oncology patients themselves. We wanted to appoint a company that we saw as a partner, capable of delivering a supply chain solution that is essential for clinical success. TrakCel had the expertise and experience to achieve this."

"The entire cell therapy sector now realizes the importance of managing and tracking the supply chain from an early stage. As a result, TrakCel is now working with a range of companies at the initiation of the clinical stage as well as at the late stage of clinical development," said Ravi Nalliah, CEO of TrakCel. "The opportunity cost of the resources used for managing supply chains is even more important for companies at the earlier clinical stage. This means it is essential for TrakCel to continue to develop our cell therapy supply chain solutions as the cell therapy market continues to evolve."

On January 26, 2018 The U.S. Food and Drug Administration reported the approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (Press release, US FDA, JAN 26, 2018, View Source [SID1234523587]). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.

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"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "This approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment."

GEP-NETs can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately one out of 27,000 people are diagnosed with GEP-NETs per year.

Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

The approval of Lutathera was supported by two studies. The first was a randomized clinical trial in 229 patients with a certain type of advanced somatostatin receptor-positive GEP-NET. Patients in the trial either received Lutathera in combination with the drug octreotide or octreotide alone. The study measured the length of time the tumors did not grow after treatment (progression-free survival). Progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone. This means the risk of tumor growth or patient death was lower for patients who received Lutathera with octreotide compared to that of patients who received only octreotide.

The second study was based on data from 1,214 patients with somatostatin receptor-positive tumors, including GEP-NETS, who received Lutathera at a single site in the Netherlands. Complete or partial tumor shrinkage was reported in 16 percent of a subset of 360 patients with GEP-NETs who were evaluated for response by the FDA. Patients initially enrolled in the study received Lutathera as part of an expanded access program. Expanded access is a way for patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives to gain access to investigational drugs for treatment use.

Common side effects of Lutathera include low levels of white blood cells (lymphopenia), high levels of enzymes in certain organs (increased GGT, AST and/or ALT), vomiting, nausea, high levels of blood sugar (hyperglycemia) and low levels of potassium in the blood (hypokalemia).

Serious side effects of Lutathera include low levels of blood cells (myelosuppression), development of certain blood or bone marrow cancers (secondary myelodysplastic syndrome and leukemia), kidney damage (renal toxicity), liver damage (hepatotoxicity), abnormal levels of hormones in the body (neuroendocrine hormonal crises) and infertility. Lutathera can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception. Patients taking Lutathera are exposed to radiation. Exposure of other patients, medical personnel, and household members should be limited in accordance with radiation safety practices.

Lutathera was granted Priority Review, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. Lutathera also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

On January 26, 2018 AbbVie (NYSE:ABBV) reported financial results for the fourth quarter ended December 31, 2017 (Press release, AbbVie, JAN 26, 2018, View Source [SID1234523584]).

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"2017 reflects another year of top-tier performance, demonstrating the strong momentum in our business," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our guidance for 2018 underscores our confidence in our ability to continue to deliver industry-leading performance. This is an exciting time for AbbVie — we are poised to launch a number of differentiated products over the next 12 to 18 months that will fuel significant growth in the coming years. We remain committed to delivering on our long-term strategic vision for AbbVie.

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Fourth-Quarter Results

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Worldwide net revenues were $7.739 billion in the fourth quarter, up 13.9 percent year-over-year on a GAAP basis. On an operational basis, adjusted net revenues increased 12.6 percent, excluding a 1.5 percent favorable impact from foreign exchange.

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Global HUMIRA sales increased 14.0 percent on a reported basis, or 12.3 percent operationally, excluding a 1.7 percent favorable impact from foreign exchange. In the U.S., HUMIRA sales grew 15.1 percent in the quarter. Internationally, HUMIRA sales grew 6.5 percent, excluding a 5.2 percent favorable impact from foreign exchange.

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Fourth-quarter global IMBRUVICA net revenues were $708 million, with U.S. sales of $585 million and international profit sharing of $123 million for the quarter, reflecting growth of 38.7 percent.

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On a GAAP basis, the gross margin ratio in the fourth quarter was 70.5 percent. The adjusted gross margin ratio was 79.0 percent.

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On a GAAP basis, selling, general and administrative expense was 25.2 percent of net revenues. The adjusted SG&A expense was 21.2 percent of net revenues.

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On a GAAP basis, research and development expense was 18.1 percent of net revenues. The adjusted R&D expense was 17.1 percent, reflecting funding actions supporting all stages of our pipeline.

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On a GAAP basis, the operating margin in the fourth quarter was 23.2 percent. The adjusted operating margin was 40.7 percent.

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On a GAAP basis, net interest expense was $252 million.

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Financial results for 2017 reflected a net charge of $0.77 per diluted share related to the December 2017 enactment of the Tax Cuts and Jobs Act. The net charge included the one-time impact of approximately
$4.5 billion for mandatory taxation on previously unrepatriated earnings, partially offset by the revaluation of tax-related balance sheet items. These amounts have been treated as specified and excluded from adjusted diluted EPS. On a GAAP basis, the tax rate in the quarter was 95.6 percent. The adjusted tax rate was 18.9 percent.

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Diluted EPS in the fourth quarter was $0.03 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.48, up 23.3 percent.

Key Events from the Fourth Quarter

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AbbVie announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial evaluating upadacitinib (ABT-494) as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate. Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20 and low disease activity versus continuing prior stable methotrexate therapy. Both doses also achieved all ranked and all key secondary endpoints. The safety profile of upadacitinib was consistent with previously reported Phase 3 SELECT clinical trials and Phase 2 studies, and no new safety signals were detected. AbbVie expects data from two additional registrational studies in the first half of 2018, supporting regulatory submissions in the second half of 2

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Key Events from the Fourth Quarter (continued)

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AbbVie announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for upadacitinib in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy, supported by positive Phase 2b results. The Phase 3 clinical program for upadacitinib in atopic dermatitis is expected to begin in the first half of 2018.

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AbbVie announced top-line results from the IMMhance study, the fourth pivotal clinical trial evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. Results showed that risankizumab met all co-primary and ranked secondary endpoints in the study. At week 16, nearly half (47 percent) of patients receiving risankizumab achieved complete skin clearance (PASI 100) versus placebo (1 percent), and static Physician Global Assessment (sPGA) score of clear or almost clear skin was achieved by 84 percent of risankizumab patients compared to 7 percent of placebo patients. Among patients who achieved clear or almost clear skin at week 28, 87 percent of patients maintained this response at one year, compared to 61 percent who were switched to placebo at week 28. Risankizumab’s safety profile in IMMhance was consistent with previously reported Phase 3 clinical trials, with no new safety signals detected across the Phase 3 program. The company plans to submit its applications for regulatory approval in the first half of 2018. Risankizumab is being developed in collaboration with Boehringer Ingelheim.

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AbbVie presented results from the Phase 3 MURANO study of VENCLEXTA/VENCLYXTO (venetoclax) in combination with Rituxan at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Results show that patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) achieved significantly prolonged median progression-free survival (PFS) with VENCLEXTA in combination with Rituxan compared with bendamustine in combination with Rituxan. Investigator-assessed twenty-four month PFS estimates were 84.9 percent and 36.3 percent, respectively, with independent review committee (IRC)-assessed PFS showing similar results. Also in the trial, 83.5 percent of patients achieved peripheral blood minimal residual disease (MRD)-negativity with VENCLEXTA in combination with Rituxan, compared to 23.1 percent with bendamustine in combination with Rituxan. At the time of the analysis, safety data were consistent with the known safety profiles of the medicines. Regulatory applications were recently submitted for VENCLEXTA in combination with Rituxan for treatment of patients with R/R CLL. VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group.

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AbbVie presented new and updated IMBRUVICA (ibrutinib) data at the ASH (Free ASH Whitepaper) meeting, including pooled analysis results of the longest follow-up data to-date in Bruton’s tyrosine kinase (BTK) inhibition for R/R mantle cell lymphoma (MCL) patients treated with IMBRUVICA, demonstrating that, at three years, 45 percent of patients were able to achieve overall survival (OS) and 26 percent had PFS. AbbVie also presented new three-year follow-up data from the RESONATE-2 study (PCYC-1115/1116), which found that previously-untreated CLL/SLL patients reported sustained improvements in measures of well-being with IMBRUVICA versus chemotherapy with chlorambucil. At 30 months, IMBRUVICA was also associated with a greater PFS rate of 85 percent versus chlorambucil, which had a PFS rate of 28 percent. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.

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AbbVie announced the Phase 3 iNNOVATE trial evaluating IMBRUVICA in combination with Rituxan in patients with treatment-naïve and previously-treated Waldenström’s macroglobulinemia successfully met its primary endpoint and demonstrated improvement of PFS compared to Rituxan alone. The Independent Data Monitoring Committee recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data. The company expects to submit these data for label augmentation in 2018.

3

Key Events from the Fourth Quarter (continued)

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At the American Society for Reproductive Medicine Scientific Congress & Expo (ASRM), AbbVie, in cooperation with Neurocrine Biosciences, presented detailed results from two replicate Phase 3 extension studies evaluating the long-term efficacy and safety of elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being evaluated for the management of endometriosis with associated pain. In the extension studies, elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain and non-menstrual pelvic pain in women through the 12-month treatment period. The safety and tolerability of elagolix was consistent with the anticipated effects of reduced estradiol levels and no new safety concerns were identified with elagolix use for the 12-month treatment period. Elagolix is currently under priority regulatory review for the management of endometriosis with associated pain.

Full-Year 2018 Outlook, Including Impact of U.S. Tax Reform

GAAP diluted EPS for the full-year 2018 is expected to be between $6.45 and $6.55.

AbbVie is raising its previously announced adjusted EPS guidance range for the full-year 2018 from $6.37 to $6.57 to $7.33 to $7.43 to reflect the impact of U.S. tax reform and stronger operating performance. The midpoint of this guidance reflects year-over-year growth of 32 percent, more than half of which is driven by growth in the underlying business. Relative to the previously issued 2018 guidance provided in October 2017, this guidance includes an increase of $0.08 as a result of stronger operating dynamics.

AbbVie’s adjusted EPS guidance range reflects an effective tax rate of approximately 9 percent in 2018. In 2018, AbbVie will experience a one-time net tax benefit related to the timing of the phase in of provisions of the new legislation on certain subsidiaries. This benefit has been excluded from the adjusted EPS guidance, and included in the GAAP guidance range.

AbbVie anticipates the company’s adjusted effective tax rate to increase to 13 percent over the next five years as a result of increased domestic income and investment.

Increased U.S. Investments

Over the next five years, AbbVie plans to invest approximately $2.5 billion in capital projects in the U.S. and the company is currently evaluating additional expansion of its U.S. facilities. Also, in 2018, the company plans to make a one-time charitable contribution of approximately $350 million to select not-for-profit organizations based in the United States. The company also plans to accelerate pension funding by $750 million, as well as enhance non-executive employee compensation.

Provisional Estimates of the Impact of U.S. Tax Reform

Financial results for 2017 reflect provisional amounts related to the December 2017 enactment of the Tax Cuts and Jobs Act. These provisional estimates are based on AbbVie’s initial analysis and current interpretation of the legislation. Given the complexity of the legislation, anticipated guidance from the U.S. Treasury, and the potential for additional guidance from the Securities and Exchange Commission (SEC) or the Financial Accounting Standards Board, these estimates may be adjusted during 2018.

On January 26, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will present at the Leerink Partners Global Healthcare Conference on Thursday, February 15, 2018 (Press release, Eli Lilly, JAN 26, 2018, View Source [SID1234523585]). Jan Lundberg, Ph.D., executive vice president for science and technology and president of Lilly Research Laboratories, and Dan Skovronsky, M.D., Ph.D., senior vice president of clinical and product development at Lilly, will participate in a fireside chat at 10:30 a.m., Eastern Time.

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the fireside chat will be available for approximately 90 days.

On January 26, 2018 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported that a poster highlighting the synergistic effects of duvelisib in combination with immune checkpoint or co-stimulatory antibodies in preclinical models of B cell lymphoma was presented at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium being held January 25-27, 2018 in San Francisco (Press release, Verastem, JAN 26, 2018, View Source;p=RssLanding&cat=news&id=2328722 [SID1234523588]). Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma that is currently being developed for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL). In addition, duvelisib is being studied in other hematologic malignancies including peripheral T cell lymphoma (PTCL).

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"In patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma, oral duvelisib monotherapy has demonstrated efficacy, along with a consistent and manageable safety profile. However, emerging data suggest that some aggressive lymphomas will likely require combination therapy to improve clinical outcomes," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem. "Our research presented this year at ASCO (Free ASCO Whitepaper)-SITC indicates that the dual PI3K-delta/PI3K-gamma inhibitory activity of duvelisib enables duvelisib to reduce both T-regulatory (Treg) and myeloid immunosuppressive cells in a murine A20 B cell lymphoma model. As a result of these beneficial changes within the tumor microenvironment, we observed a striking enhancement by duvelisib of the anti-tumor efficacy of immune checkpoint or co-stimulatory antibodies in this preclinical B cell lymphoma model. These data support further exploration of duvelisib in combination with immunotherapeutic agents for the treatment of aggressive lymphomas."

Oral duvelisib is the first PI3K inhibitor to show efficacy as an oral monotherapy in a randomized Phase 3 study in patients with relapsed or refractory CLL/SLL (the DUO study). In the Phase 2 DYNAMO study, duvelisib achieved meaningful clinical activity in patients diagnosed with follicular lymphoma (FL), small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL) whose disease is refractory to rituximab and to a chemotherapy regimen or radioimmunotherapy. Verastem plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the first quarter of 2018 requesting 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).

Details for the poster presentation at ASCO (Free ASCO Whitepaper)-SITC 2018 are:

Title: Dual PI3K-δ,γ inhibitor duvelisib reduces immunosuppressive Tregs and myeloid cells enhancing efficacy of checkpoint and co-stimulatory antibodies in a B cell lymphoma model
Session: Developmental Therapeutics – Poster Session B
Abstract #: 33
Location: Golden Gate Hall – B2 Level – Poster Board D1
Date and time: Friday, January 26, 2018; 11:30am to 1:00pm PT and 5:30 to 6:30pm PT
Summary: Prior published research has shown that PI3K-delta inhibition reduces immunosuppressive Tregs and PI3K-gamma inhibition reduces immunosuppressive myeloid cells. As a result, it was hypothesized that duvelisib may augment the efficacy of immune checkpoint or co-stimulatory antibodies. For this study, Verastem researchers administered duvelisib alone, anti-PD-1 alone, anti-OX40 alone, duvelisib + anti-PD-1, duvelisib + anti-OX40, or vehicle control to mice bearing syngeneic A20 B cell lymphoma tumors.

Duvelisib alone, anti-PD-1 alone and anti-OX40 alone each induced tumor growth delay. When duvelisib and anti-PD-1 were combined, strong anti-tumor synergy was observed. When duvelisib and anti-OX40 were combined, tumor regression was observed which correlated with strong reduction of tumor Tregs, M2 macrophages and myeloid-derived suppressor cells. Immune memory was also assessed by injecting mice that had become tumor free with A20 cells following anti-OX40 alone or duvelisib + anti-OX40 with no further treatment. The mice that had received anti-OX40 alone grew new tumors upon A20 re-challenge, however, all mice that had received duvelisib + anti-OX40 did not grow tumors upon re-challenge and showed elevated memory T cells in blood and spleen. These findings indicate that treatment with duvelisib + anti-OX40 established immune memory. The dual inhibition of PI3K-δ and PI3K-γ appears to make duvelisib effective in reducing both lymphoid and myeloid immuno-suppressive populations, consistent with prior data suggesting that PI3K-δ inhibition reduces immunosuppressive Tregs, whereas PI3K-γ inhibition reduces immunosuppressive myeloid cells. We believe these results showing that dual PI3K-δ and PI3K-γ inhibition can enhance the anti-tumor efficacy of immune checkpoint and co-stimulatory antibodies which potentially support the clinical exploration of duvelisib in combination with these agents.

A copy of the poster presentation will be available here following the conclusion of the poster sessions.

About the Tumor Microenvironment

The tumor microenvironment encompasses various cellular populations and extracellular matrices within the tumor or cancer niche that support cancer cell survival. This includes immunosuppressive cell populations such as regulatory T-cells, myeloid-derived suppressor cells, M2 TAMS, as well as tumor-associated fibroblasts and extracellular matrix proteins which can hamper the entry and therapeutic benefit of cytotoxic immune cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s compounds duvelisib and defactinib target the tumor microenvironment as a mechanism of action to potentially improve a patient’s response to therapy.

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 is currently being 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 intends to submit 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.