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Novartis presents new data at SABCS across broad range of breast cancer patient populations, combination treatments and lines of therapy

On November 14, 2017 Novartis reported that it will present data across its breast cancer portfolio and pipeline in a broad range of patient populations, treatment combinations and pathways at the upcoming 40th annual San Antonio Breast Cancer Symposium (SABCS), San Antonio, December 5-9 (Press release, Novartis, NOV 13, 2017, View Source [SID1234522029]).

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"Our presentations at SABCS will address some of the most pressing challenges and questions facing the advanced breast cancer community, including the need to better understand treatment sequencing and biomarkers," said Bruno Strigini, CEO, Novartis Oncology. "At Novartis, we seek to advance scientific understanding of breast cancer with the ultimate goal of improving treatments and outcomes for those affected by the disease. We are pleased to share the latest data from our MONALEESA program, which continues to evaluate the potential of Kisqali treatment in new patient populations."

Results from the Phase III MONALEESA-7 trial in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer will be presented for the first time in a late-breaker oral presentation.

First-line ribociclib vs placebo with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: Results from the randomized phase III MONALEESA-7 trial [Abstract #S2-05; Wednesday, December 6, 4:15 – 4:30 PM CST]
Additional abstracts from across the breast cancer portfolio include:

Kisqali (ribociclib)*

First-line ribociclib + letrozole in hormone receptor-positive, HER2-negative advanced breast cancer: Efficacy by baseline circulating tumor DNA alterations in MONALEESA-2 [Abstract #PD4-06; Thursday, December 7, 7:00 – 9:00 AM CST]
Subsequent treatment for postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received ribociclib + letrozole vs placebo + letrozole in the phase III MONALEESA-2 study [Abstract #P5-21-18; Friday, December 8, 5:00 – 7:00 PM CST]
Efficacy and safety of ribociclib plus letrozole in US patients enrolled in the MONALEESA-2 study [Abstract #P5-21-27; Friday, December 8, 5:00 – 7:00 PM CST]
Quality of life and patient-reported outcomes in US patients enrolled in the MONALEESA-2 study [Abstract #P1-13-12; Wednesday, December 6, 5:00 – 7:00 PM CST]
EarLEE-2: A phase 3 study of ribociclib + endocrine therapy (ET) for adjuvant treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), intermediate-risk, early breast cancer (EBC) [Abstract #OT3-05-06; Friday, December 8, 5:00 – 7:00 PM CST]
Patient-centered initiatives for improving trial participation of diverse patient populations in the open-label phase 3b CompLEEment-1 study of ribociclib plus letrozole in the treatment of HR+/HER2- advanced breast cancer [Abstract #P4-10-07; Friday, December 8, 7:00 – 9:00 AM CST]
Afinitor (everolimus)

Serum activin A and outcomes in HR+/HER2- metastatic breast cancer patients treated with everolimus: Results from BOLERO-2 [Abstract #P1-07-09; Wednesday, December 6, 5:00 – 7:00 PM CST]
Ribociclib in combination with everolimus and exemestane in men and postmenopausal women with HR+/HER2- advanced breast cancer following progression on a CDK4/6 inhibitor: Efficacy and updated safety and pharmacokinetic results from phase 1 of the TRINITI-1 study [Abstract #PD5-11; Thursday, December 7, 5:00 – 7:00 PM CST]
Tykerb (lapatinib)**

Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III trial [Abstract #S1-04; Wednesday, December 6, 10:15 – 10:30 AM CST]
Circulating tumor DNA in HER2 amplified breast cancer: A translational research substudy of the NeoALTTO phase III trial [Abstract #PD3-03; Thursday, December 7, 7:00 – 9:00 AM CST]
Alpelisib (BYL719)

BYLieve: A phase 2 study of alpelisib with fulvestrant or letrozole for treatment of PIK3CA mutant, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (aBC) progressing on/after cyclin-dependent kinase (CDK)4/6 inhibitor therapy [Abstract #OT3-05-02; Friday, December 8, 5:00 – 7:00 PM CST]
Alpelisib plus letrozole in estrogen receptor-Positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (aBC): Safety and preliminary efficacy analysis from a phase 1b trial [Abstract #P5-21-06; Friday, December 8, 5:00 – 7:00 PM CST]
LSZ102

Phase I/Ib study of the SERD LSZ102 alone or in combination with ribociclib in ER+ breast cancer [Abstract #P5-21-04; Friday, December 8, 5:00 – 7:00 PM CST]
Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

For prescribing information, including approved indications and important safety information about marketed products, please visit
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Alpelisib (BYL719), buparlisib (BKM120) and LSZ102 are investigational compounds. Efficacy and safety have not been established. There is no guarantee these compounds will become commercially available.

About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific advancements for breast cancer patients and improving clinical practice in collaboration with the global community. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Myovant Sciences Provides Corporate Update and Reports Financial Results for Second Fiscal Quarter Ended September 30, 2017

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]).

"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.
•
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.
•
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.

Alexo Therapeutics to Present ALX148 Preclinical Data at the 59th American Society of Hematology Annual Meeting (ASH)

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]).

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

Adaptimmune Presents Study Designs for Ongoing MAGE-A4 and NY-ESO SPEAR T-cell Clinical Trials at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

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]).

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

IMMUNOMEDICS APPOINTS MICHAEL PEHL PRESIDENT AND CHIEF EXECUTIVE OFFICER TO LEAD NEXT PHASE OF TRANSFORMATIVE GROWTH

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.

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."