On November 13, 2017 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for women’s health and endocrine diseases, reported corporate updates and financial results for the second fiscal quarter ended September 30, 2017 (Press release, Myovant Sciences, NOV 13, 2017, View Source [SID1234522028]).

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"We made significant clinical and corporate progress this quarter as we continue to build Myovant into a leading women’s health company. The positive results from Takeda’s two Phase 3 studies evaluating the efficacy and safety of relugolix for the treatment of uterine fibroids provide strong support for Myovant’s ongoing Phase 3 studies of relugolix for the treatment of heavy menstrual bleeding associated with uterine fibroids," stated Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "In addition, we secured flexible financing commitments of up to $140 million, which puts us in a strong financial position to support the Phase 3 development of relugolix in uterine fibroids, endometriosis and advanced prostate cancer."

Recent Business Progress
Positive results in two Phase 3 clinical studies conducted by Takeda Pharmaceutical Company Limited ("Takeda") to evaluate the efficacy and safety of relugolix for the treatment of uterine fibroids.
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On October 2, 2017, Myovant announced that Takeda reported positive top-line results from a Phase 3 study in Japan evaluating the efficacy and safety of relugolix compared with leuprorelin for the treatment of women with heavy menstrual bleeding associated with uterine fibroids. Relugolix met the study’s primary endpoint, achieving an 82.2% response rate, and was observed to be statistically non-inferior to leuprorelin (p = 0.0013) in meeting the study’s primary endpoint, the proportion of patients achieving a pre-defined reduction in menstrual bleeding. The incidence of adverse events in the study was generally similar between treatment groups and consistent with the mechanism of action of the study medications.
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On November 9, 2017, Myovant announced that Takeda reported positive top-line results from a Phase 3 study in Japan evaluating the efficacy and safety of relugolix compared with placebo for the treatment of pain associated with uterine fibroids. Of the women treated with relugolix, 57.6% achieved a marked improvement in pain symptoms compared to 3.1% treated with placebo (p< 0.0001). Adverse events in the study were consistent with the mechanism of action of relugolix and adverse events observed in previous clinical studies.
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Takeda plans to submit the data from both studies to regulatory authorities in Japan for marketing authorization of relugolix for the treatment of uterine fibroids. Myovant will be solely responsible for obtaining FDA approval for relugolix in the United States.
Secured flexible financing commitments of up to $140 million. On October 16, 2017, Myovant announced that it had secured up to $140 million in flexible financing commitments from NovaQuest Capital Management ("NovaQuest") and Hercules Capital, Inc. ("Hercules"). The NovaQuest financing is comprised of a note purchase commitment of up to $60 million and an equity purchase commitment of up to $40 million. An additional $40 million of debt financing capacity is committed in the form of a term loan facility from Hercules. Myovant plans to use the net proceeds from both financings to fund the ongoing Phase 3 development of relugolix in uterine fibroids, endometriosis and advanced prostate cancer. Pursuant to the agreements, upon closing, Myovant received net cash proceeds of approximately $32 million under the financing commitments.

Second Fiscal Quarter 2017 Financial Summary
Research and development (R&D) expenses for the quarter ended September 30, 2017 were $24.2 million, compared to $3.8 million for the comparable period in 2016. The increase over the prior year period is primarily due to costs associated with the five ongoing Phase 3 clinical trials of relugolix which were initiated in 2017. R&D expenses for the three months ended September 30, 2017 consisted primarily of clinical trial and clinical drug supply costs of $19.7 million, personnel expenses of $3.0 million, share-based compensation expense of $0.7 million, and costs billed to us under the services agreements with Roivant Sciences, Ltd. and Roivant Sciences, Inc. ("the Services Agreements") of $0.5 million, including personnel expenses and third-party costs associated with the preparation of our clinical and other research programs. R&D expenses were $3.8 million for the three months ended September 30, 2016, and consisted primarily of costs billed to us under the Services Agreements of $2.7 million, including personnel expenses and third-party costs associated with the preparation of our clinical and other research programs and share-based compensation expense.

General and administrative (G&A) expenses for the quarter ended September 30, 2017 were $6.1 million, compared to $3.0 million for the same period in 2016. G&A expenses for the three months ended September 30, 2017 consisted primarily of personnel-related and general overhead expenses of $2.3 million, share-based compensation expense of $2.1 million, legal and professional fees of $1.2 million and costs of $0.5 million billed to us under the Services Agreements, including personnel expenses, overhead allocations and third-party costs. G&A expenses were $3.0 million for the three months ended September 30, 2016, and consisted primarily of share-based compensation expense of $1.3 million, legal and professional fees of $1.0 million and costs of $0.3 million billed to us under the Services Agreements, including personnel expenses, overhead allocations and third-party costs.
Net loss for the quarter ended September 30, 2017 was $29.9 million, or $0.50 per share, compared to $34.7 million or $0.82 per share for the same period in 2016. The decrease in net loss was driven by the change in the fair market value of the previously outstanding Takeda warrant liability during the second quarter of 2016, which did not recur in the second quarter of 2017 due to its expiry on April 30, 2017. This was offset by an increase in costs associated with the ongoing LIBERTY 1 and LIBERTY 2, SPIRIT 1 and SPIRIT 2, and HERO Phase 3 clinical studies which were initiated in 2017 as well as increased personnel expenses to support Myovant’s growing operations.
Cash totaled $129.3 million on September 30, 2017.

About Relugolix
Relugolix is an oral, once-daily, small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that has been evaluated in over 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects are consistent with suppression of these hormones. In the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain and the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids, relugolix will be evaluated with and without low-dose hormonal add-back therapy, the addition of which is expected to decrease potential side effects such as bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix in men with advanced prostate cancer.

On November 13, 2017 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint mechanism exploited by cancer cells to evade the immune system, reported that ALX148 preclinical results have been selected for an oral presentation at the 59th ASH (Free ASH Whitepaper) Annual Meeting & Exposition, Dec. 9-12, 2017 in Atlanta, Georgia (Press release, Alexo Therapeutics, NOV 13, 2017, View Source [SID1234522015]).

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Oral Presentation Information
Title: ALX148 Is a High Affinity SIRPα Fusion Protein That Blocks CD47, Enhances the Activity of Anti-Cancer Antibodies and Checkpoint Inhibitors, and Has a Favorable Safety Profile in Preclinical Models
Session Name: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: New Tools and Emerging Immune-Modulatory Approaches for Non-Hodgkin’s Lymphomas
Session Date: Saturday, December 9, 2017
Presentation Time: 10:15 am ET
Room: Georgia World Congress Center, Building C, Level 1, C101 auditorium
Publication Number: 112

On November 13, 2017 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported that it is presenting two trials in progress posters summarizing study designs for ongoing clinical trials with MAGE-A4 and NY-ESO SPEAR T-cells at the 2017 SITC (Free SITC Whitepaper) annual meeting at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, United States (Press release, Adaptimmune, NOV 13, 2017, View Source [SID1234521993]).

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Overview of Study Designs:

· MAGE-A4 SPEAR T-cells targeting multiple solid tumors(1):

· Open-label, non-randomized pilot study evaluating the safety, tolerability, and antitumor activity of MAGE-A4 SPEAR T-cells in patients with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumor(s)

· This dose escalation study utilizes a modified 3+3 design:

· Group 1: to enroll 3-6 patients; dose of 100 million transduced SPEAR T-cells, 21-day interval for safety review

· Group 2: to enroll 3-6 patients; dose of 1 billion transduced SPEAR T-cells, 7-day interval for safety review(2)

· Group 3: to enroll 3-6 patients; dose of 1-5 billion transduced SPEAR T-cells, 7-day interval for safety review(2)

· Study allows for expansion at optimal dose range up to 20 patients across tumors

· Patients must be: > 18 yrs old; HLA-A*02 positive; have MAGE-A4 positive inoperable locally advanced or metastatic tumor(s) at >1+ intensity in > 10% of tumor cells MAGE-A4 expression by immunohistochemistry (IHC); have ECOG status 0 or 1; and adequate organ function

· Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days

· Efficacy assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression

· The study is open and enrolling

· NY-ESO SPEAR T-cells with or without KEYTRUDA(pembrolizumab) in multiple myeloma:

· Open-label, randomized pilot study evaluating the safety, tolerability, and antitumor activity of NY-ESO SPEAR T-cells with or without KEYTRUDA in patients with multiple myeloma

· Eligible patients will be randomly assigned to a treatment arm: NY-ESO SPEAR T-cells alone (Arm 1) or NY-ESO-1 SPEAR T-cells in combination with KEYTRUDA (Arm 2)

(1) Urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer

(2) If, in Group 1 or Group 2, 1 out of 3 patients experiences a dose limiting toxicity (DLT) requiring expansion of an additional 3 patients (n=6), the subsequent observation periods in Group 2 or Group 3 will be increased from 7 days to 14 days for the respective groups.

· Target enrollment is 20 patients with 10 in each arm; eligible patients who do not receive the T-cell infusion may be replaced.

· Patients must be: > 18 yrs old; HLA-A*02:01, *02:05, or *02:06 positive; have histologically confirmed diagnosis of multiple myeloma with either primary refractory or relapsed/refractory disease expressing NY-ESO-1 and/or LAGE-1a; have received prior therapies including IMiD and a proteasome inhibitor as separate lines or a combined line of therapy; have ECOG status 0 or 1; and adequate organ function

· Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days, followed by granulocyte-colony stimulating factor

· For patients in Arm 2, KEYTRUDA will be administered every 3 weeks, starting at week 3 following T-cell infusion until week 108

· Target dose of 1 – 8 × 109 transduced SPEAR T-cells

· Efficacy will be assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Overall response rate, time to response, duration of response, progression-free survival, and overall survival will be determined.

· The study is open and enrolling

On November 13, 2017 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company") reported that its Board of Directors has voted to appoint Michael Pehl as President and Chief Executive Officer ("CEO"), effective December 7, 2017 (Press release, Immunomedics, NOV 13, 2017, View Source [SID1234522004]). He has also been appointed to the Board, effective as of the commencement date of Mr. Pehl’s employment. Immunomedics also announced that Brendan Delaney has been appointed Chief Commercial Officer ("CCO") at Immunomedics, effective as of November 10, 2017. Michael Garone, current Chief Financial Officer ("CFO") and Interim CEO, will resume his role as CFO.

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Discussing the addition of Mr. Pehl, Dr. Behzad Aghazadeh, Chairman of the Board of Immunomedics, stated, "Today’s announcement represents the culmination of an intensely thorough – but ultimately extremely rewarding – search process for the right leader to guide the next phase in the transformation of Immunomedics. As we undertook this task, the Board and I were focused on finding a best-in-class talent with a proven ability to successfully navigate the approval and commercialization of ground-breaking drugs in the oncology space – which we are confident IMMU-132 and other products in our pipeline will be. While Michael’s track record in this area speaks for itself, it was his less tangible qualities that made it clear he was the right choice. As we did our diligence, we repeatedly heard Michael lauded for his strategic vision, operational expertise and confident execution ability. Perhaps most importantly, we time and again heard him singled out for his unique capacity to effectively and compassionately communicate across a spectrum of audiences including patients, KOLs, investors, regulators and fellow team members. This is the type of singular leader we were looking for and are thrilled to have found for Immunomedics."

Mr. Pehl brings to Immunomedics a history of success as a global pharmaceutical leader. Most recently, he served as President, Hematology & Oncology, at Celgene Corporation ("Celgene"), and prior to that was the company’s Head of Global Marketing, Head of Hematology Europe and the first General Manager of Celgene in Germany. Over the course of his 11 years at Celgene, Mr. Pehl has launched multiple blockbuster drugs in the areas of hematology and oncology, including Revlimid, Pomalyst, and Abraxane.

Notably, he has demonstrated an exceptional acumen for realizing lifecycle opportunities and developing pipeline drugs, reflected by the steep revenue growth of Celgene’s Hematology and Oncology business. Under his leadership, Celgene developed and launched the Acute Myeloid Leukemia (AML) drug IDHIFA in industry-record time, and also built an industry-leading pipeline of late and early stage products to treat multiple high-unmet need conditions. Prior to his time as Celgene, Michael served in a number of commercial leadership positions at Amgen in Europe.

Michael Pehl, Immunomedics CEO-designee, stated, "This chance to lead Immunomedics represents a uniquely exciting point-in-time opportunity. Based on the public data on IMMU-132 and available information regarding the Company’s pipeline, I believe the antibody-drug conjugates of Immunomedics have a high likelihood of improving the lives of countless patients with significant unmet medical needs. Now more than ever, this is an absolute priority for me in my career."

Pehl continued, "I was also attracted to this role by the chance to help develop and instill a science based and patient centric culture of performance excellence at Immunomedics. The technology, science and talent the Company has at its disposal are world-class, and I am honored that Behzad and the Board have turned the reins over to me. While the U.S. and global approval and commercialization of IMMU-132 for metastatic triple negative breast cancer are a key goal for me and my team, we simultaneously will be focused on developing IMMU-132 in multiple solid tumor indications, thereby laying the foundation to transform Immunomedics into a recognized leader in the field of antibody-drug conjugates."

Immunomedics also announced today that Brendan Delaney has joined the Company as Chief Commercial Officer. Brendan was most recently Vice President, U.S. Commercial Hematology Oncology at Celgene. In this role, Brendan oversaw a team of roughly 400 professionals across sales, marketing and strategic alliances. Notably, under Brendan’s leadership, the revenue for the group grew to over $7 billion annually, representing a significant proportion of Celgene’s global revenue. Prior to this role, Brendan held a series of other senior-level marketing roles at Celgene. Before coming to Celgene he was at Novartis for five years, serving in a number of U.S. and global marketing roles within the Company’s oncology business unit. Over the course of his 22-year commercial career Brendan has been involved in the launch of nine new oncology products and indications.

In his role as CCO at Immunomedics, Brendan will be responsible for building out the Company’s commercialization team including sales, marketing, market access and pricing. He will report directly to Michael Pehl.

Dr. Aghazadeh said, "Brendan is one of the top commercial leaders in oncology, with deep experience managing cross-functional teams and successfully launching high-value oncology drugs. We believe he is the ideal candidate to lead the launch of the IMMU-132 franchise. Further, Brendan is a truly collaborative and strategic leader who understands how to optimally organize and deploy the commercial function of a top-tier biotech company, making him an excellent fit for where we are at Immunomedics – and more importantly – where we are going as we become a commercial organization ourselves."

Brendan Delaney, Chief Commercial Officer, Immunomedics, stated, "I am thrilled to take on the challenge of building a commercial unit from the ground up at Immunomedics. What makes the opportunity even more exciting is my belief that IMMU-132 will truly address a high unmet need for patients and potentially serve as foundational therapy for multiple solid tumor indications. Additionally, I have deep respect for Michael Pehl from our time working together at Celgene and cannot wait to collaborate to define and execute the commercial strategy at Immunomedics."

On November 13, 2017 Pfizer Inc. (NYSE: PFE) reported that Albert Bourla has been named Chief Operating Officer effective January 1, 2018 (Press release, Pfizer, NOV 13, 2017, View Source [SID1234522007]).

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"The naming of a Chief Operating Officer comes at a time when our business is strong as we continue to advance our strategy while also managing a dynamic and challenging external environment, said Ian Read, Pfizer Chairman and CEO.

"The addition of a COO will enable me to spend more time focusing on the company’s long term strategic direction, ensuring continued R&D productivity and engaging with government policy and industry leaders on key issues facing the future of the healthcare industry."

Albert Bourla, 56, has been the Group President of Pfizer’s Innovative Health Business since the beginning of 2016. Under his leadership revenues for the Pfizer Innovative Health business grew 11% operationally in 2016 and in the first nine months of 2017 have grown 9% operationally. Prior to his current position Dr. Bourla was the Group President for Pfizer’s Vaccines, Oncology and Consumer Healthcare businesses where he was instrumental in building a strong and competitive position in Oncology and expanded the company’s leadership in vaccines.

Over the course of his career Dr. Bourla has held a number of senior global positions across a range of businesses and geographies.

Read continued, "Albert is a proven and trusted leader with over two decades of leadership experience and a demonstrated track record for delivering strong business results. He possesses the right combination of skills, knowledge, strengths and a deep commitment to Pfizer’s culture that make him the clear choice to become Pfizer’s COO."

As General Manager of the company’s Established Products Business Unit he advanced the company’s efforts to build a strong post-patent business by spear-heading efforts that maximized the lifecycle of key brands following loss of exclusivity.

Prior to leading the Established Products business, Dr. Bourla was the Area President for Pfizer’s Animal Health business across Europe, Africa, and Asia Pacific where he successfully managed the integration of Wyeth’s Animal Health Business (Fort Dodge) with Pfizer in these global markets.

Dr. Bourla has significant scientific expertise. He is a Doctor of Veterinary Medicine and holds a PhD degree in the Biotechnology of Reproduction from the Veterinary School of Aristotle University.

Effective January 1, 2018 John Young, Group President, Pfizer Essential Health becomes Group President, Pfizer Innovative Health. Angela Hwang, Global President and General Manager for Pfizer Inflammation & Immunology will succeed John Young as Group President, Pfizer Essential Health.

Mr. Young has held a number of senior leadership positions across Pfizer including as President of the Primary Care Business. He is a scientist by training and has deep knowledge of the company’s innovative biopharmaceutical portfolio having led the commercial and clinical development of medicines in key therapeutic areas including cardiovascular disease, diabetes and pain.

Mr. Young received a BSc in Biological Science from Glasgow University and an MBA from Strathclyde Graduate Business School. He will report to Dr. Bourla and will continue to be a member of the company’s Executive Leadership Team.

Ms. Hwang joined the company in 1997 in the company’s Corporate Strategic Planning and Policy Group. Her experience includes leadership roles within the Innovative Health and Essential health businesses as Global President Pfizer Inflammation and Immunology, Regional head for U.S. Vaccines, Vice President of Emerging Markets for the Primary Care business and Vice President of the U.S. Brands business within Essential Health. In her current role she has been responsible for the growth of products such as Xeljanz and Eucrisa and building a strong pipeline around rheumatology, gastroenterology and dermatology.

Ms. Hwang received her Bachelor of Science in Microbiology and Biochemistry from the University of Cape Town and a Masters of Business Administration from Cornell University. She will become a member of the company’s Executive Leadership team and will report to Dr. Bourla.

Additional members of the Pfizer Executive Leadership team reporting to Dr. Bourla will be:

Kirsten Lund-Jurgensen – Executive Vice President and President Pfizer Global Supply

Rod MacKenzie – Executive Vice President, Chief Development Officer

Laurie Olson – Executive Vice President, Strategy and Commercial Operations

In addition to Dr. Bourla, the following members of Pfizer’s Executive Leadership team will continue to report to Ian Read:

Frank D’Amelio – Executive Vice President, Business Operations and Chief Financial Officer

Mikael Dolsten – Executive Vice President and President, Worldwide Research & Development

Chuck Hill – Executive Vice President, Worldwide Human Resources

Rady Johnson – Executive Vice President, Chief Compliance and Risk Officer

Doug Lankler – Executive Vice President, General Counsel

Freda Lewis-Hall – Executive Vice President and Chief Medical Officer

Sally Susman – Executive Vice President, Corporate Affairs