On March 26, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the Needham 17th Annual Healthcare Conference, being held at the Westin Grand Central Hotel, in New York City (Press release, TG Therapeutics, MAR 26, 2018, View Source [SID1234524996]). The presentation is scheduled to take place on Wednesday, March 28, 2018 at 4:00pm ET.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com.

On March 26, 2018 Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI) (Press release, Seattle Genetics, MAR 26, 2018, View Source;p=RssLanding&cat=news&id=2339635 [SID1234525388]).

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This press release features multimedia. View the full release here: View Source
Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
"The FDA Breakthrough Therapy Designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "Seattle Genetics is an emerging multi-product oncology company, advancing a robust pipeline with the goal of improving outcomes for cancer patients. Enfortumab vedotin is at the forefront of our late-stage clinical pipeline, and we are working closely with our partner and the FDA to bring this potential new treatment to patients as quickly as possible."

"Achieving Breakthrough Therapy Designation for enfortumab vedotin is another step forward in our goal to bring an additional treatment option to patients who need it most," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "With the enfortumab vedotin registrational phase 2 trial and CPI-combination trial actively underway, Astellas looks forward to expanding development of enfortumab vedotin and its oncology pipeline, including treatments that would target some of the hardest-to-treat cancers."
The Breakthrough Therapy Designation was granted based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs. Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). The companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.

More information about the ongoing trials can be found at www.clinicaltrials.gov.
About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at View Source

Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)–Mar. 26, 2018– Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).
This press release features multimedia. View the full release here: View Source
Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
"The FDA Breakthrough Therapy Designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "Seattle Genetics is an emerging multi-product oncology company, advancing a robust pipeline with the goal of improving outcomes for cancer patients. Enfortumab vedotin is at the forefront of our late-stage clinical pipeline, and we are working closely with our partner and the FDA to bring this potential new treatment to patients as quickly as possible."
"Achieving Breakthrough Therapy Designation for enfortumab vedotin is another step forward in our goal to bring an additional treatment option to patients who need it most," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "With the enfortumab vedotin registrational phase 2 trial and CPI-combination trial actively underway, Astellas looks forward to expanding development of enfortumab vedotin and its oncology pipeline, including treatments that would target some of the hardest-to-treat cancers."
The Breakthrough Therapy Designation was granted based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs. Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). The companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.
More information about the ongoing trials can be found at www.clinicaltrials.gov.
About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at View Source

About Seattle Genetics
Seattle Genetics is an innovative biotechnology company dedicated to improving the lives of people with cancer through targeted therapies. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Seattle Genetics commercializes ADCETRIS (brentuximab vedotin) for the treatment of several types of CD30-expressing lymphomas. The company is also advancing a robust pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information can be found at www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

On March 26, 2018 Bayer reported that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO) has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion (Press release, Bayer, MAR 26, 2018, View Source [SID1234525481]). The rolling submission was initiated in December 2017. NTRK gene fusions are genetic alterations present across a wide range of tumors resulting in uncontrolled tropomyosin receptor kinase (TRK) signaling and tumor growth.

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"This NDA submission in the U.S. marks an important milestone in bringing us one step closer to providing larotrectinib as a potential treatment option for patients with TRK fusion cancer," said Scott Fields, MD, Bayer’s senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. "NTRK gene fusions, while rare, are present in various pediatric and adult cancers. We are committed to working with the FDA and the oncology community to bring larotrectinib to patients as soon as possible."

Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients across a wide range of cancers that harbor a NTRK gene fusion. Bayer plans to submit a Marketing Authorization Application (MAA) in the European Union in 2018.

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is an investigational oral and selective drug in clinical development for the treatment of patients across a wide range of cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for tropomyosin receptor kinases (TRKs), can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov or visit www.loxooncologytrials.com. Larotrectinib has not been approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor in clinical development. Bayer and Loxo Oncology will jointly develop the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Bayer and Loxo Oncology will co-promote the products.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes four oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On March 24, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported encouraging efficacy and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (EOC) (Press release, ImmunoGen, MAR 24, 2018, View Source [SID1234525455]). These data are being presented at the Society of Gynecologic Oncology (SGO) Annual Meeting, March 24-27, 2018 in New Orleans, LA.

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Key findings in 14 heavily pre-treated patients are as follows:

In the subset of 8 patients with medium or high folate receptor alpha (FRα) expression levels, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median progression-free survival (PFS) of 8.6 months (95% CI 1.6, upper bound not yet reached).
For all patients, the confirmed ORR was 43 percent (95% CI 18, 71), with a median PFS of 5.2 months (95% CI 1.6, 9.5); patients in this cohort had received a median of 4.5 prior lines of systemic therapy, with 64% of patients receiving 4 or more prior lines.
As previously reported, at full dosing, the combination of mirvetuximab (6 mg/kg) and pembrolizumab (200 mg, supplied by Merck) demonstrates favorable tolerability, consistent with the known safety profiles of each agent, with primarily mild to moderate (≤ grade 2) adverse events observed.
Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study.

"We are encouraged by the early evidence of anti-tumor activity with durable responses and the tolerability profile of mirvetuximab in combination with pembrolizumab, particularly among the subset of patients with medium or high folate receptor alpha expression where we saw the greatest benefit," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "Across multiple combinations, we’ve demonstrated that our Phase 3 single agent dose level for mirvetuximab combines readily with other therapies. The consistency of these findings further underscore the potential of mirvetuximab for ovarian cancer – both as monotherapy, and in combination with other therapies in earlier lines of treatment."

Featured Poster Presentation Details

Title: "Initial safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in platinum-resistant epithelial ovarian cancer (EOC) patients" (abstract #74)

Lead author: Ursula Matulonis, M.D., Director and Program Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, MA

The findings will be presented during featured poster presentation discussion sessions:

Sunday, March 25 at 3:30pm CT
Monday, March 26 at 3:30pm CT
Additional information can be found at www.sgo.org

About FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), pegylated liposomal doxorubicin, or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant EOC, primary peritoneal, or fallopian tube tumors, as well as a doublet combination of mirvetuximab with carboplatin and a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On March 24, 2018 Barricade Therapeutics reported a study conducted at The Wistar Institute in collaboration with The University of Texas Southwestern Medical Center which has demonstrated the efficacy of targeting aberrantly active telomerase to treat therapy-resistant melanoma (Press release, Barricade Therapeutics, MAR 24, 2018, View Source [SID1234524977]).

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A hallmark of several cancer types, including melanoma, is increased telomerase activation. Telomerase is an enzyme responsible for elongating telomeres which protect the integrity of chromosome ends during cell replication. While absent in most normal cells, telomerase is highly active in cancer cells, driving continuous cell divisions.

"Telomerase is an almost universal oncology target. In the present study, we provide a scientific rationale for the development of new clinical cancer treatments based on targeting telomeres in cancer cells," said Jerry W. Shay, co-author of the study, and professor of Cell Biology at UT Southwestern Medical Center.

Meenhard Herlyn, D.V.M., D.Sc., Caspar Wistar Professor in Melanoma Research and director of The Wistar Institute Melanoma Research Center, and his collaborators used a modified telomerase substrate they had previously described, 6-thio-2’-deoxyguanosine or 6-thio-dG (THIO), to utilize telomerase to induce telomere dysfunction. They demonstrated that THIO induced cell death in melanoma cells harboring BRAF gene mutations and impaired tumor growth in several BRAF-mutant mouse melanoma models without affecting the viability of normal skin cells.

The team also studied the ability of THIO treatment to stop proliferation and tumor growth of therapy-resistant melanoma cells. They created a large panel of human melanoma cell lines with acquired resistance to targeted therapy and immunotherapy and showed a general sensitivity of these cells to THIO both in vitro and in vivo.

"These exciting results add to a substantial amount of scientific data on THIO supporting our development program," said Frank Perabo, CEO of Barricade Therapeutics. "The data suggest that THIO could be studied in future clinical trials in a first- and second-line therapy setting, or in combination with other agents to overcome intrinsic resistance."

This work was supported by grants from NIH, DoD, Dr. Miriam and Sheldon G. Adelson Medical Research Foundation and the Melanoma Research Foundation