On February 9, 2016 AskAt reported that it received a notice of allowance dated February 9, 2016 from Canadian Intellectual Property Office in connection with the Application No. 2,754,702, a use patent of EP4 receptor antagonist for the treatment of Cancer (Press release, AskAt, FEB 9, 2016, View Source [SID1234535064]).

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On February 9, 2016 ADC Therapeutics SA (ADCT), the oncology drug development company, reported that the first patient has been dosed in a Phase I trial to evaluate its lead antibody drug conjugate (ADC) ADCT-301 in Acute Myeloid Leukemia (AML) (Press release, ADC Therapeutics, FEB 9, 2016, View Source [SID:1234513294]).

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The two stage, Phase l open-label trial will evaluate the tolerability, safety, pharmacokinetics and activity of ADCT-301 in patients with relapsed or refractory CD-25 positive AML. The initial dose escalation phase will recruit up to 30 patients at ten clinical sites across the US and will seek to determine the recommended dose of ADCT-301 for the second stage. The second stage, which will begin once an appropriate dose is identified, will be expanded into the UK and Europe with the recruitment of up to 30 additional patients.

ADCT-301 is composed of HuMax-TAC, a monoclonal antibody directed against CD25 (the alpha chain of the IL-2 receptor) conjugated to ADCT’s highly potent proprietary pyrrolobenzodiazepine (PBD) dimer. In preclinical in vivo models, ADCT-301 exhibited strong dose-dependent anti-tumor activity against CD25-positive cell lines at single low doses.

On February 9, 2016 Seattle Genetics, Inc. (NASDAQ: SGEN) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, Seattle Genetics, FEB 9, 2016, View Source;p=RssLanding&cat=news&id=2136905 [SID:1234509024]). The company also highlighted ADCETRIS (brentuximab vedotin) commercialization, regulatory and clinical development accomplishments, vadastuximab talirine (SGN-CD33A; 33A) activities and progress with other proprietary pipeline programs.

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"In 2015, we demonstrated significant progress across our corporate priorities. For ADCETRIS, we achieved record sales in the fourth quarter and for the year, received FDA approval for an expanded label, completed enrollment in two of three ongoing phase 3 trials and continued our efforts to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We also showed substantial progress with our pipeline. We plan to initiate a phase 3 trial with 33A in acute myeloid leukemia later this year, and we are advancing more than a dozen other clinical and preclinical programs in development for a range of hematologic malignancies and solid tumors. With a strong financial position, we are well-positioned to continue delivering on our aggressive commercial, clinical and research goals."

Recent ADCETRIS Highlights

Achieved a $20 million one-time milestone payment from Takeda Pharmaceutical Company Limited (Takeda) triggered by Takeda surpassing ADCETRIS annual net sales of $200 million in its territory. The milestone will be recognized as royalty revenue in the first quarter of 2016.

Reported data from multiple oral and poster sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2015 Annual Meeting highlighting clinical trials with ADCETRIS as monotherapy and as part of combination regimens supporting the company’s goal to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas, including Hodgkin lymphoma (HL), diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphomas (PTCL). Across corporate and investigator studies, there are more than 70 ongoing clinical trials being conducted globally with ADCETRIS.

Completed enrollment of 1,334 patients in the phase 3 ECHELON-1 clinical trial. ECHELON-1 is a randomized trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced classical HL.

Initiated a phase 1/2 clinical trial of ADCETRIS in combination with nivolumab (Opdivo) for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including DLBCL, PTCL and cutaneous T-cell lymphoma (CTCL). This is the second of two trials being conducted under a clinical trial collaboration agreement between Seattle Genetics and Bristol-Myers Squibb Company.

Takeda received approval from the European Commission for a Type II variation of the ADCETRIS label to include retreatment of adult patients with relapsed or refractory HL or systemic anaplastic large cell lymphoma (sALCL) who previously responded to ADCETRIS and who later relapse.

Takeda continues to receive additional marketing approvals for ADCETRIS, which is now commercially available in more than 60 countries worldwide.

Recent Vadastuximab Talirine (SGN-CD33A; 33A) Highlights

Reported phase 1 data with 33A in acute myeloid leukemia (AML) showing activity and tolerability both as a single agent and in combination with hypomethylating agents (HMAs), including azacitidine and decitabine.

Based on the interim data presented at ASH (Free ASH Whitepaper), announced that a phase 3 clinical trial to evaluate 33A in combination with HMAs in previously untreated older AML patients is planned to begin by the third quarter of 2016.

Initiated a phase 1/2 clinical trial in patients with relapsed or refractory AML to evaluate 33A monotherapy as a pre-conditioning regimen prior to an allogeneic stem cell transplant and also for use as maintenance therapy following transplant.

Recent Pipeline and Antibody-Drug Conjugate (ADC) Collaborator Highlights

Reported data at ASH (Free ASH Whitepaper) from a phase 1 trial of denintuzumab mafodotin (SGN-CD19A; 19A) in NHL. The activity and tolerability results from the trial of 19A in relapsed DLBCL patients support the recently initiated phase 2 trial of 19A in combination with a common second-line salvage regimen for patients with relapsed DLBCL.

Reported data at the San Antonio Breast Cancer Symposium on SGN-LIV1A, an ADC targeted to LIV-1 which is highly expressed in breast cancer. Interim data from the phase 1 trial demonstrated antitumor activity in heavily pretreated patients with triple negative disease. The trial has been expanded to enroll an additional cohort of triple negative breast cancer patients. In addition, a cohort was recently opened to evaluate SGN-LIV1A in combination with trastuzumab (Herceptin) in patients with HER2-positive breast cancer.

Received a milestone payment under an ADC collaboration with Genentech upon its initiation of a phase 1 trial with a program utilizing Seattle Genetics technology.

Anticipated Upcoming Activities

ADCETRIS

Report data from the phase 3 ALCANZA trial in patients with relapsed CTCL in the second half of 2016.

Complete enrollment in the phase 3 ECHELON-2 trial in frontline mature T-cell lymphoma (MTCL) during 2016 and report data in the 2017 to 2018 timeframe.

Report phase 2 data in 2016 and define next steps in frontline and relapsed DLBCL.

Based on the robust enrollment rate and total number of patients enrolled, the company is narrowing the expected timeframe for data from the phase 3 ECHELON-1 trial to be in the 2017 through mid-2018 timeframe.

ADCETRIS is not currently approved for use in frontline HL, second-line HL, CTCL, DLBCL or NHL other than sALCL.

Vadastuximab Talirine (SGN-CD33A; 33A)

Initiate a phase 3 registrational trial to evaluate 33A in combination with HMAs in older patients with AML by the third quarter of 2016.

Initiate a phase 1/2 trial with 33A in combination with azacitidine for patients with previously untreated myelodysplastic syndrome (MDS) in the first half of 2016.

Report additional data in 2016 from a phase 1 trial of 33A in combination with HMAs.

Report data in 2016 from a phase 1b trial of 33A in combination with cytarabine and daunorubicin for frontline, younger AML patients.

Report data in 2016 from a phase 1/2 trial of 33A monotherapy as a pre-conditioning regimen prior to an allogeneic stem cell transplant and also for use as maintenance therapy following transplant.

More information about SGN-CD33A and ongoing clinical trials can be found at www.ADC-CD33.com.

Other Pipeline Programs

Initiate a randomized phase 2 trial of SGN-CD19A in frontline DLBCL in the first half of 2016.

Report phase 1 clinical data from ASG-15ME and ASG-22ME (enfortumab vedotin) in the first half of 2016. These programs are in development for solid tumors, notably bladder cancer, under a collaboration with Astellas.

Initiate a phase 1 trial of SGN-CD19B in NHL in the first half of 2016.

Initiate a phase 1 trial of SGN-CD123A in AML during 2016.

Fourth Quarter and Year 2015 Financial Results

Total revenues in the fourth quarter and year ended December 31, 2015 increased to $93.5 million and $336.8 million, respectively, from $74.3 million and $286.8 million for the same periods in 2014. Revenue growth was driven by:

ADCETRIS sales in the fourth quarter were $63.0 million, an increase from $46.5 million in the fourth quarter of 2014. For the year in 2015, ADCETRIS sales were $226.1 million, compared to $178.2 million for the year in 2014, a 27 percent increase.

Royalty revenues in the fourth quarter of 2015 were $12.6 million, compared to $11.9 million in the fourth quarter of 2014. For the year in 2015, royalty revenues were $41.0 million, compared to $40.0 million for the year in 2014. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. Royalty revenues in 2014 included a $5.0 million one-time sales milestone payment from Takeda.

Amounts earned under the company’s ADCETRIS and ADC collaborations totaled $17.9 million in the fourth quarter and $69.8 million for the year in 2015, compared to $16.0 million and $68.6 million for the same periods in 2014.

Total costs and expenses for the fourth quarter of 2015 were $118.6 million, compared to $102.1 million for the fourth quarter of 2014. For the year in 2015, total costs and expenses were $457.8 million, compared to $364.1 million for the year in 2014. The increase in 2015 costs and expenses was primarily driven by investment in Seattle Genetics’ pipeline programs.

Non-cash, share-based compensation cost in 2015 was $41.8 million, compared to $40.6 million in 2014.

Net loss for the fourth quarter of 2015 was $24.9 million, or $0.18 per share, compared to a net loss of $26.7 million, or $0.22 per share, for the fourth quarter of 2014. For the year ended December 31, 2015, net loss was $120.5 million, or $0.93 per share, compared to a net loss of $76.1 million, or $0.62 per share, for the year ended December 31, 2014.

As of December 31, 2015, Seattle Genetics had $712.7 million in cash, cash equivalents and investments, compared to $313.4 million as of December 31, 2014. The increase in cash and investments reflects net proceeds of approximately $526.6 million from the company’s underwritten public offering of common stock that closed on September 16, 2015.

2016 Financial Outlook

Seattle Genetics anticipates 2016 total revenues to be in the range of $390 million to $430 million. This includes ADCETRIS net product sales that are expected to be in the range of $255 million to $275 million and revenues from collaboration and license agreements that are expected to be in the range of $75 million to $90 million. Collaboration revenues will be generated from fees, milestones and reimbursements earned through the company’s ADCETRIS and ADC collaborations. Royalty revenues are expected to be in the range of $60 million to $65 million, which includes a $20 million one-time milestone payment to be reflected in the first quarter of 2016.

Research and development (R&D) expenses are expected to be in the range of $360 million to $400 million. Selling, general and administration (SG&A) expenses are expected to be in the range of $135 million to $145 million. Planned increases in operating expenses will be directed primarily towards commercialization and development of ADCETRIS, expanded 33A development including a planned phase 3 trial and continued investment in the company’s growing pipeline programs. Cost of sales is expected to be in the range of 10 percent to 12 percent of ADCETRIS net product sales for the year in 2016. Non-cash costs are expected to be approximately $65 million to $75 million in 2016, primarily attributable to share-based compensation distributed approximately evenly between SG&A and R&D. Share-based compensation expense is based on several factors, including share price, and is therefore subject to change.

On February 9, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended December 31, 2015 (Press release, Cel-Sci, FEB 9, 2016, View Source [SID:1234509023]).

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Key corporate and clinical developments during first quarter fiscal year 2016 include:

Enrolled an additional 98 patients in the global pivotal Phase 3 head and neck cancer trial. As of January 31, 2016, 697 patients have been enrolled in the study.

Raised net proceeds of approximately $10.6 million to finance the Phase 3 head and neck cancer trial.
Increased Ergomed’s investment in our Phase 3 head and neck cancer trial. Ergomed added another $2 million to its existing $10 million investment for a total investment of $12 million. Ergomed will receive its funds back only from future sales of Multikine* (Leukocyte Interleukin, Injection).

Secured litigation funding for our ongoing arbitration against the former CRO of our Phase 3 trial from Lake Whillans, a firm that specializes in litigation funding. Pursuant to the agreement, CEL-SCI will receive up to $5.0 million in funding and Lake Whillans will get its funds back only from the proceeds derived from the arbitration.

Granted a new European patent on Multikine. The patent is important because it recites a mechanism of action of Multikine by which Multikine changes the type of T cells that enter the tumor microenvironment. This change results in the tumor becoming "visible" to the immune system, resulting in a robust and sustainable anti-tumor immune response.

Received acceptance into a new program for technology commercialization and niche analysis of our LEAPS rheumatoid arthritis vaccine candidate from the U.S. National Institutes of Health (NIH).

Continued patient enrollment in the Phase 1 trial of Multikine in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center and University of California, San Francisco (UCSF). The study in expected to be complete in the second half of 2016.

"During the first quarter of fiscal 2016 we received funding from two strategic sources, Ergomed and Lake Whillans, which we believe affirm the strength of both our Phase 3 trial and our arbitration claims against the former CRO. We are confident in our partners as we move towards the completion of enrollment in our Phase 3 trial," stated CEL-SCI Chief Executive Officer Geert Kersten.

CEL-SCI reported an operating loss of ($5,783,132) for the quarter ended December 31, 2015 versus an operating loss of ($9,995,741) for the quarter ended December 31, 2014. Research and development expenses remained relatively consistent and increased by approximately $286,000 compared to the three months ended December 31, 2014. General and administrative expenses decreased by approximately $4,560,000 compared to the three months ended December 31, 2014. Major components of the decrease include approximately $2,296,000 in a gain on the derecognition of legal fees recognized pursuant to the agreement with Lake Whillans offset by approximately $316,000 net increase in other general and administrative expenses. Also during the quarter ended December 31, 2014, there was approximately $2,620,000 in additional employee compensation costs related to the issuance of shareholder approved shares of restricted stock released upon meeting predetermined milestones.

CEL-SCI’s net income (loss) available to common shareholders for the quarter ended December 31, 2015 was $2,341,813 or $0.02 per basic share, versus ($7,845,318) or ($0.11) per basic share during the quarter ended December 31, 2014. The income was primarily attributable to an unrealized gain on the fair value of warrants, as a result of the change in the stock price between reporting periods.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

On February 9, 2016 Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, reported its fourth quarter and full year 2015 financial results and accomplishments(Press release, Sangamo BioSciences, FEB 9, 2016, View Source [SID:1234509022]).

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"2015 was an important and very productive year for Sangamo, and we enter 2016 poised to initiate the first human clinical trials of in vivo therapeutic genome editing," said Edward Lanphier, Sangamo’s president and chief executive officer. "Our zinc finger nuclease (ZFN) technology leads the therapeutic genome editing field and we have established the core competencies necessary to move our ground-breaking genome editing programs through IND enabling studies and into clinical trials. We believe our IVPRP clinical studies will provide fundamental proof-of-concept data and significantly differentiate the technical advantages of our ZFN platform from other genome editing technologies of bacterial origin as well as conventional gene therapy approaches. In addition to our two new open IVPRP INDs we plan to file six more IND applications in 2016 for our other IVPRP-based programs, and our hemoglobinopathies programs which we are developing in collaboration with Biogen. We began the year with approximately $210 million in cash, which puts Sangamo in a strong financial position and will allow us to accomplish all of our goals in 2016."

Recent Highlights

Announcement of FDA clearance of IND application for Phase 1/2 clinical trial of MPS I (Hurler syndrome) program. In February 2016, Sangamo announced that its Investigational New Drug (IND) application for the Company’s SB-318 program was cleared by the U.S. Food and Drug Administration (FDA) and is now active. SB-318 is an application of the Company’s proprietary In Vivo Protein Replacement Platform (IVPRP) genome editing approach, for the treatment of MPS I. In December 2015, the NIH Recombinant DNA Advisory Committee (RAC) unanimously approved the clinical protocol for SB-318.
Announcement of FDA clearance of IND application for Phase 1/2 clinical trial of hemophilia B program. In December 2015, Sangamo announced that an IND application for SB-FIX, the Company’s IVPRP genome editing approach for the potential cure of hemophilia B, has been cleared by the FDA and is now active.

Presentation of Phase 2 clinical data from SB-728-T HIV studies demonstrating superiority of adenoviral delivery of zinc finger nucleases to T-cells for viral load control and reservoir reduction. In December 2015, Sangamo presented Phase 2 clinical data from ongoing clinical trials of the Company’s SB-728-T HIV program, SB-728-1101 Cohort 3* and SB-728mR-1401. The preliminary comparative data suggest that adenoviral delivery of ZFNs to T-cells may be uniquely immune-stimulatory for both acute viral load control and HIV reservoir reduction. The trial is currently ongoing with the accrual of five additional subjects in ‘1101 Cohort 3*.
Presentation of data at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting (ASH) (Free ASH Whitepaper) highlighting ZFP Therapeutic programs for hemophilia and hemoglobinopathies. In December 2015, Sangamo presented data at ASH (Free ASH Whitepaper) demonstrating the production of therapeutic levels of Factor IX (FIX) clotting protein in non-human primates (NHPs) from its hemophilia B program, and clinical scale manufacturing and engraftment of ZFN-modified hematopoietic stem and progenitor cells (HSPCs) for the treatment of beta-thalassemia.

Publication of improved method for efficient targeted integration in HSPCs and T-cells. In November 2015, Sangamo announced the publication in Nature Biotechnology of data demonstrating efficient ZFN-mediated, targeted gene insertion in HSPCs, as well as a study in Nucleic Acids Research, demonstrating a similarly efficient process in primary human T-cells.
Internal Organization. Sangamo promoted Stewart Craig, Ph.D., from Vice President to Senior Vice President of Technical Operations. Dr. Craig joined Sangamo in May 2014 and has led the development of the Company’s successful and growing manufacturing capabilities. Fyodor Urnov, Ph.D., Senior Scientist, was promoted to Vice President of Discovery & Translational Research. Dr. Urnov is a key contributor to the development of Sangamo’s ZFP Therapeutic technology platform and leads Sangamo’s hemoglobinopathies research collaboration with Biogen Inc. (Biogen). Nathalie Dubois-Stringfellow, Ph.D. was promoted from Senior Director to Vice President of Product Development & Management. Dr. Dubois-Stringfellow, with extensive experience in pre-clinical drug development and project management, established an effective cross-functional team-based culture at Sangamo, enabling the Company’s successful and timely IND submissions.

Upcoming Events in the First Half of 2016

Initiation of Phase 1/2 clinical trials for IVPRP-based SB-FIX-1501 (hemophilia B) and SB-318-1502 (MPS I / Hurler syndrome) programs. The trials will be the first two in vivo clinical studies of genome editing in humans and the first clinical programs based on Sangamo’s IVPRP approach. Sangamo expects to initiate the Phase 1/2 trial for hemophilia B in the first half of 2016, and the Phase 1/2 trial for MPS I in mid-2016.

Presentation of clinical data from Sangamo’s HIV program at the 2016 Annual Conference on Retroviruses and Opportunistic Infections (CROI). Sangamo’s collaborator, Rafick Pierre Sekaly, Ph.D., will present further immunologic and viral reservoir analyses of clinical data from the Company’s SB-728-1101 study, suggesting potential mechanisms of viral control post-treatment with SB-728-T.

Preclinical data presentation from Sangamo’s MPS I and MPS II programs at the 2016 Annual WORLDSymposium Meeting. Sangamo expects to present data from its animal model studies for the Company’s IVPRP-based MPS I and MPS II (Hunter syndrome) programs for lysosomal storage disorders (LSDs). The meeting is being held in San Diego, CA from February 29 to March 4, 2016.
Submission of IND applications for Sangamo’s SB-913 (MPS II) program and beta-thalassemia program. Sangamo expects to file both IND applications in the first half of 2016. SB-913, for the treatment of MPS II, is the second LSD application of the Company’s proprietary IVPRP approach. The beta-thalassemia program, which is being developed in collaboration with Biogen, employs Sangamo’s ZFN-mediated ex vivo genome editing approach to knockout the BCL11A Enhancer.

Fourth Quarter 2015 Results

For the fourth quarter ended December 31, 2015, Sangamo reported a consolidated net loss of $14.0 million, or $0.20 per share, compared to a net loss of $4.3 million, or $0.06 per share, for the same period in 2014. As of December 31, 2015, the Company had cash, cash equivalents, marketable securities and interest receivable of $209.3 million.

Revenues for the fourth quarter of 2015 were $9.1 million, compared to $15.0 million for the same period in 2014. Fourth quarter 2015 revenues were generated from the Company’s collaboration agreements with Biogen, Shire International GmbH (Shire), and Dow AgroSciences, enabling technology agreements and research grants. The revenues recognized for the fourth quarter of 2015 consisted of $9.0 million in collaboration agreements and approximately $0.2 million in research grants, compared to $14.5 million and approximately $0.4 million, respectively, for the same period in 2014.

The decrease in collaboration agreement revenues was primarily a result of an amendment to the Company’s collaboration and license agreement with Shire in the third quarter of 2015, returning the rights to the hemophilia programs to Sangamo. In the fourth quarter of 2015, Sangamo recognized $1.9 million of revenues related to research services performed under the collaboration agreement with Shire, and $1.9 million of revenues related to research services performed under the collaboration agreement with Biogen. In addition, pursuant to the agreements entered into with Shire in January 2012 and Biogen in January 2014, Sangamo received upfront payments of $13.0 million and $20.0 million, respectively. These payments are being recognized as revenue on a straight-line basis over the initial six-year research term for Shire and approximately 40 months for Biogen. The Company recognized $0.5 million of the Shire upfront payment and $1.6 million of the Biogen upfront payment as revenue for the fourth quarter of 2015.

Research and development expenses were $19.9 million for the fourth quarter of 2015, compared to $15.1 million for the same period in 2014. The increase was primarily due to increases in manufacturing expenses, external research expenses associated with our preclinical programs, and personnel-related expenses, including stock-based compensation. General and administrative expenses were $4.9 million for the fourth quarter of 2015, compared to $4.3 million for the same period in 2014.

Total operating expenses for the fourth quarter of 2015 were $24.8 million, compared to $19.4 million for the same period in 2014.

Full Year 2015 Results

For the year ended December 31, 2015, the consolidated net loss was $40.7 million, or $0.58 per share, compared to a consolidated net loss of $26.4 million, or $0.39 per share, for the year ended December 31, 2014. Revenues were $39.5 million for the year ended December 31, 2015, compared to $45.9 million for the same period in 2014. Total operating expenses were $86.4 million for the year ended December 31, 2015, compared to $72.7 million for the same period in 2014.

Financial Guidance for 2016

Cash and Investments: Sangamo expects that its cash, cash equivalents and marketable securities will be at least $150 million at the end of 2016, inclusive of research funding from existing collaborators but exclusive of funds arising from any additional new collaborations or partnerships, equity financings or other new sources.
Revenues: In light of the amendment to our collaboration and licensing agreement with Shire, that returned the rights of the hemophilia programs to Sangamo, the Company expects that revenues will be in the range of $20 million to $25 million in 2016, inclusive of research funding from existing collaborations.
Operating Expenses: Sangamo expects that operating expenses will be in the range of $85 million to $95 million for 2016.