On November 8, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas"), and Seattle Genetics, Inc. (NASDAQ: SGEN) reported dosing of the first patient in EV-103, a phase 1b clinical trial evaluating the safety and tolerability of enfortumab vedotin in combination with pembrolizumab or atezolizumab, two types of immune checkpoint inhibitor (CPI) therapies, for first- or second-line treatment of patients with locally advanced or metastatic urothelial cancer (Press release, Astellas, NOV 8, 2017, View Source [SID1234521788]). Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver the cell-killing agent monomethyl auristatin E (MMAE) to the target Nectin-4.

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"The initiation of EV-103 is an important step in investigating the utility of enfortumab vedotin in earlier lines of therapy, including the first-line setting, for locally advanced and metastatic urothelial cancer, where patients ineligible for cisplatin-based chemotherapy continue to have limited treatment options," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "This study represents Seattle Genetics’ third ADC under clinical evaluation in combination with CPIs, highlighting our vision that ADCs could be the preferred partners for immuno-oncology agents for patients with solid tumors and hematological cancers."

The EV-103 study is a single arm, open label multicenter trial that will enroll up to 85 patients with locally advanced or metastatic urothelial cancer who are ineligible for first line cisplatin-based chemotherapy or have progressed following treatment with a regimen containing platinum-based chemotherapy. Enfortumab vedotin will be administered during weeks one and two of every three-week cycle, and pembrolizumab or atezolizumab will also be administered during week one of this period. The primary objective of the trial is to assess the safety and tolerability of enfortumab vedotin in combination with CPI therapy. Secondary endpoints include the recommended dose in combination with CPIs, overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS), among other measures.

"We are pleased to be moving forward with evaluating enfortumab vedotin in combination with CPI therapy, as we look to further investigate the potential of this agent in some of the hardest-to-treat cancers," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "Many patients do not respond to or relapse after treatment with CPIs, and we are committed to exploring additional ways to potentially address the unmet needs of the urothelial cancer community."

Enfortumab vedotin is also being studied as monotherapy in a pivotal clinical trial for patients with advanced urothelial cancer who have received prior CPI therapy, called EV-201 (NCT03219333), to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

For more information about the EV-103 clinical trial, please visit www.clinicaltrials.gov.

Innovation Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Innovation Pharmaceuticals, 2017, NOV 8, 2017, View Source [SID1234521807]).

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Myriad Genetics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Myriad Genetics, 2017, NOV 8, 2017, View Source [SID1234521833]).

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On November 8, 2017 Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) reported its third quarter 2017 financial results for the period ended September 30, 2017 (Press release, Merrimack, NOV 8, 2017, View Source [SID1234521746]).

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"The third quarter marked continued execution on our 2017 goals as we delivered on the promise of a refocused Merrimack with a seasoned team built around our efficient, biomarker-driven approach and refined corporate strategy," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "With the potential to emerge from the fourth quarter with a clean balance sheet and three upcoming data readouts from our lead clinical candidates, MM-121, MM-141 and MM-310, we look towards 2018 with great anticipation and are poised to deliver on our corporate goals with a strong infrastructure and disciplined approach."

Third Quarter and Recent Highlights

Key events from the third quarter and more recently include:

Received orphan drug designation from the U.S. Food and Drug Administration (FDA) for MM-121 in heregulin positive non-small cell lung cancer, which would potentially provide Merrimack with up to seven years of market exclusivity in this indication, among other benefits, if approved; and
Rounded out executive team with two key additions:
Jean Franchi, a 30-year industry veteran with rich leadership experience in the biotechnology and life sciences sectors, hired as Chief Financial Officer. Most recently, Ms. Franchi served as Chief Financial Officer at Dimension Therapeutics, with time previously spent as Chief Financial Officer at Good Start Genetics and 16 years at Genzyme, including as Senior Vice President of Corporate Finance.
Thomas Needham, an experienced dealmaker with 25 years in corporate strategy and business development, hired as Chief Business Officer. Most recently, Mr. Needham served as Senior Vice President of Business Development at C4 Therapeutics. Previously, he was Managing Director at Synthesis Capital, where he helped manage two healthcare venture funds, a Principal at the global private equity firm Advent International and Vice President of Business Development at both GPC Biotech and Mitotix.
Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

First patient dosed by the end of 2017 in the SHERBOC study, a Phase 2 randomized, double-blind, placebo-controlled clinical trial of MM-121 added to standard of care in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer;
Top-line results in the first half of 2018 from the CARRIE study, a Phase 2 randomized clinical trial of MM-141 added to standard of care in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1;
Top-line results in the second half of 2018 from the SHERLOC study, a Phase 2 randomized clinical trial of MM-121 added to standard of care in patients with heregulin positive non-small cell lung cancer; and
Safety data and recommended Phase 2 dose in the second half of 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.
Third Quarter 2017 Financial Results

The following summarizes Merrimack’s financial results for the three months ended September 30, 2017:

In October, Merrimack reached a settlement with participating convertible noteholders to resolve litigation associated with the asset sale to Ipsen S.A., agreeing to pay $0.90 per $1.00 of 4.50% convertible senior notes due in 2020 held by the noteholder plaintiffs, plus accrued interest and an amount towards the plaintiffs’ legal fees. In conjunction with the settlement, Merrimack commenced a tender offer, set to expire November 10, 2017, to purchase all remaining convertible notes at the same rate of $0.90 per $1.00 of convertible notes, plus accrued interest, with the potential to eliminate remaining debt if all noteholders participate. Together, the settlement payout, the amount Merrimack expects to pay to acquire the remaining convertible notes and Merrimack’s expenses related to this litigation will approximate the $60.0 million that Merrimack placed into an escrow account as security for the plaintiffs’ claims;
Research and development expenses for the three months ended September 30, 2017 from continuing operations were $13.6 million, compared to $28.2 million for the three months ended September 30, 2016. This represents a decrease of $14.6 million, primarily due to Merrimack’s refocused clinical and preclinical pipeline;
General and administrative expenses for the three months ended September 30, 2017 from continuing operations were $3.4 million, compared to $6.4 million for the three months ended September 30, 2016. This represents a decrease of $3.0 million, primarily due to the transition following the asset sale which led to a decrease in corporate expenses related to headcount and stock-based compensation;
Net loss attributable to Merrimack’s continuing operations for the three months ended September 30, 2017 was $5.4 million, or $0.40 per share, compared to a net loss attributable to Merrimack’s continuing operations of $26.6 million, or $2.06 per share, for the three months ended September 30, 2016;
During the quarter, Merrimack deconsolidated Silver Creek Pharmaceuticals’ financial statements from Merrimack’s consolidated financial statements effective July 14, 2017. As a result of the deconsolidation, Merrimack recognized a non-cash gain of approximately $10.8 million; and
As of September 30, 2017, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.
Updated Financial Outlook

Merrimack continues to believe that its unrestricted cash and cash equivalents of $107.2 million as of September 30, 2017 and potential net milestone payments anticipated from Shire will be sufficient to fund its planned operations into the second half of 2019.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Wednesday, November 8, 2017 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 6187659. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

Annual Meeting Date

Merrimack will hold its 2018 Annual Meeting of Stockholders on June 12, 2018.

On November 8, 2017 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and financial results for the quarter ended September 30, 2017 (Press release, MacroGenics, NOV 8, 2017, View Source [SID1234521800]).

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"We continue to be encouraged by data we’ve seen across multiple product candidates in our diverse pipeline. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting later this week, we will have five posters relating to our various PD-1-based programs, including MGA012 (anti-PD-1) and our two PD-1-based DART molecules," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also, in addition to the Phase 1 flotetuzumab data presented recently at the European Society for Medical Oncology Annual Congress (ESMO) (Free ESMO Whitepaper), we look forward to having two posters and an oral presentation with updated clinical data, at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December. Finally, we are thrilled to work with our new collaboration partner, Incyte, to expand the current development efforts for MGA012 and accelerate our own efforts to investigate combinations of MGA012 with multiple molecules in MacroGenics’ portfolio."

Key Pipeline Highlights
Flotetuzumab. Enrollment of the Phase 1 dose expansion study of flotetuzumab, a bispecific DART molecule that recognizes both CD123 and CD3, is ongoing in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Recent highlights include:
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In September, MacroGenics presented clinical data from its ongoing Phase 1 study of flotetuzumab in an oral session at ESMO (Free ESMO Whitepaper). Flotetuzumab demonstrated acceptable tolerability in the dose escalation portion of the study with encouraging initial anti-leukemic activity observed in AML patients. As of the data cut-off date of August 1, of the 14 response-evaluable patients treated at the threshold dose, six (43%) experienced an objective response. This included four (28%) patients who achieved a CR/CRi, with one patient who had a molecular CR.
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MacroGenics will present updated clinical data in an oral presentation at ASH (Free ASH Whitepaper) in December 2017.
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which are designed to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:
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MGA012. Enrollment in the dose escalation portion of the Phase 1 study of this anti-PD-1 antibody has been completed and the data have been accepted for poster presentation at the upcoming SITC (Free SITC Whitepaper) meeting. MGA012 is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the Phase 1 study. In October 2017, MacroGenics entered into an exclusive global collaboration and license agreement with Incyte Corporation for MGA012, in which Incyte obtained exclusive worldwide rights for the development and commercialization of MGA012. MacroGenics retains the right to pursue its core strategy to develop its pipeline assets in combination with MGA012. The Company plans to initiate the first study of MGA012 in combination with another internal program by year end 2017.

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MGD013. MacroGenics is developing MGD013, a DART molecule, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company is enrolling the dose escalation portion of the Phase 1 study and will present a preclinical data poster as well as a Trials-in-Progress poster describing the Phase 1 study at SITC (Free SITC Whitepaper).
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MGD019. MacroGenics continues to advance a preclinical bispecific DART molecule that provides co-blockade of PD-1 and CTLA-4, resulting in enhanced T-cell activation. The Company is conducting activities to support the potential submission of an Investigational New Drug (IND) application for MGD019 in 2018 and will present a preclinical data poster at SITC (Free SITC Whitepaper).

B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:
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Enoblituzumab: The Company and collaborators continue to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a combination study with an anti-PD-1 antibody and a neoadjuvant prostate cancer study.
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MGD009: This DART molecule targets B7-H3 and CD3 and is being evaluated in a Phase 1 study across multiple solid tumor types. The Company continues to explore the dose and schedule for MGD009 administration.
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MGC018: The Company is conducting activities to support the potential submission of an IND application for this anti-B7-H3 antibody drug conjugate in 2018.
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:
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Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics believes it is on track to complete and announce the results of an interim futility analysis by year-end 2017 or early 2018 and to complete enrollment of this study by late 2018.
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Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. MacroGenics expects to complete enrollment of two 30 patient expansion cohorts in 2017 and present clinical data during the first half of 2018.
Additional DART Clinical Programs. Other DART molecules being led by MacroGenics in Phase 1 clinical development include MGD007 (gpA33 x CD3) for colorectal cancer and MGD014 (HIV x CD3) for HIV. Updates on these programs include:
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MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study and is evaluating various expansion cohorts to define a recommended dose and schedule.
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MGD014. MacroGenics’ IND submission for MGD014 was cleared by FDA and the Company anticipates that a first patient will be dosed in early 2018.
Corporate Update

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Incyte Collaboration. In October 2017, MacroGenics and Incyte Corporation entered into an exclusive global collaboration and license agreement for MGA012. Under this agreement, MacroGenics will receive an upfront payment of $150 million and could receive up to $750 million in potential development, regulatory and commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte. The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.
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GMP Manufacturing. Construction progress on MacroGenics’ GMP manufacturing suite remains on track. The Company anticipates that the 5 x 2,000 liter single-use bioreactor facility will be operational in 2018. As part of the MGA012 collaboration with Incyte, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012.
Third Quarter 2017 Financial Results
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Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2017, were $203.6 million, compared to $285.0 million as of December 31, 2016. MacroGenics anticipates receipt of the $150 million upfront payment from Incyte upon closing of the transaction in the fourth quarter of 2017.
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Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $1.7 million for the quarter ended September 30, 2017, compared to $3.3 million for the quarter ended September 30, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the period.
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R&D Expenses: Research and development expenses were $41.0 million for the quarter ended September 30, 2017, compared to $30.3 million for the quarter ended September 30, 2016. This increase was primarily due to the initiation of the MGA012 Phase 1 study and continued enrollment in multiple ongoing clinical trials.
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G&A Expenses: General and administrative expenses were $8.4 million for the quarter ended September 30, 2017, compared to $7.2 million for the quarter ended September 30, 2016. This increase was primarily due to increased professional fees, including consulting expenses, and increased employee compensation and benefit expense to support our overall growth.
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Net Loss: Net loss was $47.0 million for the quarter ended September 30, 2017, compared to net loss of $33.8 million for the quarter ended September 30, 2016.
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Shares Outstanding: Shares outstanding as of September 30, 2017 were 36,807,112.