On January 7, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported several executive promotions. The company also provided corporate updates, including selected fourth quarter 2018 financial results, financial guidance and corporate milestones for 2019 (Press release, Calithera Biosciences, JAN 7, 2019, View Source [SID1234532564]).

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"I am pleased to announce today’s promotions which highlight the talent, skill set and extensive achievements of our executive team," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "It is critical that we have the right leadership in place to reach key clinical milestones as we drive CB-839 towards commercialization with two randomized trials of the glutaminase inhibitor CB-839 for the treatment of patients with advanced renal cell carcinoma. We plan to report data from our Phase 2 ENTRATA trial in 2019, and the global CANTATA trial in 2020. In 2019, we look forward to a number of achievements including the initiation of additional clinical trials of CB-839 in collaboration with Pfizer, and the presentation of data on the arginase inhibitor INCB001158 at a medical meeting in the second half of 2019. Our goal is to have four unique therapeutics in the clinic including CB-280, an oral arginase inhibitor for the treatment of patients with cystic fibrosis, and CB-708, an oral small molecule CD73 inhibitor for the treatment of cancer by the end of 2019."

2019 Milestones

Calithera expects to reach the following milestones in 2019:

CB-839 data from Phase 2 renal cell carcinoma randomized ENTRATA trial 2H19. The ENTRATA trial is a randomized, double-blind trial designed to evaluate the safety and efficacy of CB-839 with everolimus versus everolimus alone in approximately 63 patients with metastatic, clear cell renal cell carcinoma patients who have been treated with at least two prior lines of therapy including a VEGFR-targeting tyrosine kinase inhibitor. The primary endpoint is progression free survival; overall survival will be assessed as a secondary endpoint.

CB-839 enrollment of the Phase 2 renal cell carcinoma CANTATA trial 2H19. The CANTATA trial is a randomized, global, double-blind trial comparing patients treated with CB-839 and cabozantinib to patients treated with cabozantinib alone. The trial will enroll approximately 400 patients with clear cell renal cell carcinoma who have previously received one or two prior lines of therapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population.

CB-839 combination trial initiations in collaboration with Pfizer 1H19. Calithera and Pfizer have two clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib also known as TALZENNA, each in combination with the glutaminase inhibitor CB-839.

INCB001158 arginase inhibitor data presentation at a medical meeting 2H19. INCB001158 is a small molecule immuno-oncology therapeutic being evaluated in multiple clinical trials as a single-agent and in combination with immunotherapies and chemotherapy for the treatment of patients with cancer. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.

CB-280 IND acceptance and Phase 1 trial initiation in healthy volunteers 1H19. CB-280 is an arginase inhibitor for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 is planned for the first half of 2019.

CB-708 IND acceptance and Phase 1 trial initiation 2H19. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019.

Selected Fourth Quarter 2018 Financial Results and Financial Guidance for 2019

Based upon preliminary estimates, cash, cash equivalents and investments totaled $136.2 million at December 31, 2018. Calithera expects to utilize cash and investments between $75 and $85 million in 2019.

Key Executive Promotions

The promotions for its executive leadership team include Curtis C. Hecht, promoted to Chief Business Officer; Keith Orford M.D., Ph.D., promoted to Chief Medical Officer; and Sam Whiting, M.D., Ph.D., promoted to Senior Vice President of Clinical Development.

Mr. Hecht brings over 25 years of broad pharmaceutical experience including business development, strategic planning and commercialization. He has led business and corporate development efforts since joining Calithera in 2014. Key contributions include the Mars in-licensing agreement for arginase inhibitors, clinical collaborations with Bristol-Myers Squibb, Exelixis and Pfizer and the co-development and commercialization agreement with Incyte for INCB001158. He has built strategic portfolio management and lifecycle team functions, and leads commercial planning. Prior to Calithera, Mr. Hecht was Vice President of Business Development for inVentiv Heath Commercial Solutions. Until 2011, Mr. Hecht was at Roche in commercialization and business development roles of increasing responsibility, including the Global Alliance Director of the Roche-Genentech collaboration. Mr. Hecht has a B.S. in Chemistry from California State University, Sacramento, and an MBA from Carnegie Mellon University.

Dr. Orford has over 11 years of experience in pharmaceutical drug development in oncology and immuno-oncology. Since joining Calithera in 2015, he has overseen clinical development activities, including Clinical Operations and Medical Affairs. He has provided strategic development leadership for the company’s oncology and cystic fibrosis portfolio, including CB-839, a glutaminase inhibitor currently in late stage global clinical trials in renal cell carcinoma as well as multiple other clinical studies across a wide range of tumor types. He also serves as strategic development leader for the clinical collaboration between Calithera and Incyte. Prior to joining Calithera, Dr. Orford was the Clinical Development Lead in the Immuno-Oncology and Combinations Development Performance Unit at GlaxoSmithKline, where he oversaw the clinical activities on multiple early stage clinical trials with targeted agents and novel immune-based therapies. Prior to GlaxoSmithKline, Dr. Orford was at Merck, where he worked on early clinical development programs across oncology and other therapeutic areas. Previously, Dr. Orford was a Research Fellow and Instructor at Massachusetts General Hospital and Harvard Medical School, where he completed clinical training in Internal Medicine, as well as postdoctoral work studying the epigenetic regulation of hematopoietic and embryonic stem cell differentiation. Dr. Orford received his undergraduate, M.D., and Ph.D. degrees from Georgetown University.

Dr. Whiting joined Calithera in May 2016. Dr. Whiting’s deep expertise in clinical oncology gained as an academic medical oncologist and in pharmaceutical drug development have helped fuel the growth of the company’s pipeline. Prior to joining Calithera, Dr. Whiting served as Vice President of Research and Clinical Development at Gradalis. Dr. Whiting previously worked in development of small molecule

targeted and immune-oncology agents at VentiRx Pharmaceuticals and Oncothyreon. Previously, Dr. Whiting served as Assistant Professor of Medical Oncology at the University of Washington, Assistant Member of Clinical Research at the Fred Hutchinson Cancer Research Center, and Clinical Head of Gastrointestinal Oncology at the Seattle Cancer Care Alliance. Dr. Whiting completed fellowship training in medical oncology at the Fred Hutchinson Cancer Research Center. His training in internal medicine was at the ABIM Research Pathway at the University of Washington. Dr. Whiting received his B.S. with Honors in Chemistry from Lewis and Clark College, and his M.D. and Ph.D. as part of the Medical Scientist Training Program at the University of Washington Medical Center.

On January 7, 2019 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Dr Reddy’s, JAN 7, 2019, View Source [SID1234532500]).

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The Company’s Senior Management will present on Tuesday, January 8th, 2019 at 1:30 PM PST [3:00 AM IST on January 9 th, 2019].

The live webcast for the presentation can be accessed on company’s website www.drreddys.com. The transcript and the presentation material of the event will be available on the Company’s website as well.

On January 7, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported a new publication demonstrating that the DecisionDx-Melanoma gene expression profile (GEP) test can identify high-risk patients who are likely to recur or die from melanoma within groups of patients often considered low risk based on traditional staging metrics (Press release, Castle Biosciences, JAN 7, 2019, View Source [SID1234532533]). Results from this multicenter study of 690 patients demonstrated that the DecisionDx-Melanoma test is an independent predictor of risk for recurrence, metastasis and melanoma-specific death. The study was published in the January 2019 issue of the Journal of the American Academy of Dermatology (JAAD).

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"In this study of a large, contemporary melanoma population, the GEP test identified patients at high risk for recurrence and death from melanoma among groups that are deemed low risk by traditional staging metrics," commented study co-author John Vetto, M.D., Professor of Surgery, Division of Surgical Oncology and Director of the Cutaneous Oncology Program at the Department of Surgery, Oregon Health & Science University. "The 31-gene GEP test provides independent information that improves risk prediction and enables physicians to develop tailored care for their patients with melanoma."

Study Details:

Patients from three previously published DecisionDx-Melanoma validation studies were combined to enable analysis of test performance in the following three clinically important subgroups that are traditionally considered low risk based on current national melanoma guidelines: (1) patients who had a negative sentinel lymph node (SLN) biopsy; (2) those with American Joint Committee on Cancer (AJCC) Stage I-IIA melanoma; and (3) those with thin (≤1 mm) tumors.

The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1A result indicating the lowest 5-year risk of metastasis and a Class 2B result indicating the highest risk. Study endpoints included recurrence-free survival (RFS; time to local, regional or distant recurrence), distant metastasis-free survival (DMFS; time to any distant metastasis) and melanoma-specific survival (MSS; time to documented death from melanoma).

In this population of 690 unique Stage I-III patients with at least 5 years of follow-up or a metastatic event, median age was 59 years and median Breslow thickness was 1.3 mm. Seventy percent of patients had Stage I or II melanoma.

Key Study Findings:

In the pooled cohort, patients with Class 1A results had significantly higher RFS, DMFS and MSS rates compared to Class 2B (p<0.0001 for all comparisons).
Seventy percent of the patients who were SLN negative and experienced metastasis were identified as Class 2 by the DecisionDx-Melanoma test. Similarly, 79% of melanoma-specific deaths among those who were SLN negative were identified as having a Class 2 result.
Patients with Stage I-IIA melanoma who received a Class 2B DecisionDx-Melanoma test result had significantly worse RFS, DMFS and MSS rates compared to patients with a Class 1A DecisionDx-Melanoma result (p<0.0001 for all comparisons).
Based on Cox multivariate analysis in the Stage I-IIA subgroup that included tumor thickness, ulceration and mitotic rate, DecisionDx-Melanoma test class was found to be the only significant predictor of all three endpoints (RFS, DMFS and MSS; p<0.05 for all).
For patients with thin tumors (≤1 mm), although most patients were low risk Class 1, 15 patients had the highest risk Class 2B result. Those patients with a Class 2B test result had a significantly reduced RFS of 64.6% compared to those with a Class 1A result (96.8%; p<0.0001).
Results of the study extend previous findings of high prognostic accuracy of the DecisionDx-Melanoma GEP test to subgroups of patients at high risk, yet for whom current national melanoma guidelines recommend low intensity follow-up and surveillance. Additionally, the study’s authors suggest that the results could have an important impact on clinical trials evaluating adjuvant treatment of Stage II disease with immunomodulatory or targeted therapies, as the identification of high-risk Stage II patients may guide appropriate patient enrollment in such trials.

The manuscript can be accessed at View Source(18)32328-4/fulltext

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including over 700 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On January 7, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it will be present at the following investor events in the first quarter 2019 (Press release, Innate Pharma, JAN 7, 2019, View Source [SID1234532549]):

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– LifeSci Advisors 1×1 Meetings surrounding the J.P. Morgan Annual Healthcare Conference– San Francisco, January 7-10, 2019

– Oddo BHF Forum – Lyon, January 10-11, 2019

– Degroof Petercam’s Healthcare Seminar – Brussels, January 31, 2019

– Leerink Partners Annual Global Healthcare Conference – NYC, February 27 – March 1, 2019

– Credit Suisse Global Healthcare Conference – London, March 5-6, 2019

– Oppenheimer Annual Healthcare Conference – NYC, March 19-20, 2019

Innate Pharma is committed to meet on a regular basis with the financial community. All corporate information on the Company, such as its financial statements or its corporate presentations, is available on the Company’s websitein the Investors’ section (www.innate-pharma.com/en/investors).

On January 7, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported anticipated 2019 milestones for IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition and provided financial guidance for 2019 (Press release, Infinity Pharmaceuticals, JAN 7, 2019, View Source [SID1234532501]).

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"In the year ahead, we are excited to be moving into earlier lines of therapy, new indications, and novel, potentially transformative immuno-oncology combinations to execute on our strategy to expand the depth and breadth of the development of IPI-549," said Adelene Perkins, Chief Executive Officer of Infinity Pharmaceuticals. "Importantly, we have a cash runway into the second half of 2020, which enables us to advance IPI-549 development in several innovative studies in 2019. We also have the support of tremendous collaborators BMS and Arcus for two of these potentially transformative studies."

"The IPI-549 safety and clinical activity from the MARIO-1 Phase 1b study continues to inform our strategy to expand the depth and breadth of IPI-549 development for cancer patients," said Dr. Sam Agresta, Chief Medical Officer of Infinity. "MARIO-275 is our first global, randomized study of IPI-549 in combination with Opdivo compared to Opdivo monotherapy. This study, in collaboration with BMS, is designed to address an unmet medical need for patients with advanced urothelial cancer and is an important step in advancing IPI-549 development beyond the checkpoint inhibitor refractory setting. In addition, the safety, clinical activity and mechanism of action of IPI-549 allows us to expand the breadth of the program by moving into novel combinations, including in previously treated, advanced triple negative breast cancer patients, with a novel triple therapy study in collaboration with Arcus. And I am particularly excited to initiate our first IPI-549 study in the front-line setting in 2019."

Infinity plans to initiate MARIO-275, a combination study of IPI-549 with Opdivo in I/O naïve urothelial cancer (UC) patients, in the first half of 2019. Opdivo was approved for use by the FDA as a single agent in advanced urothelial cancer based on durable response associated with treatment in CheckMate-275, a Phase 2 single arm clinical trial of Opdivo in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent1. Retrospective analyses of this study showed that patients with higher levels of myeloid derived suppressor cells, or MDSCs, had poor outcomes2. IPI-549 has been shown to reduce MDSCs as both a monotherapy and in combination with Opdivo in MARIO-13-6. MARIO-275 is intended to evaluate the benefit of adding IPI-549 to Opdivo in cisplatin-refractory, I/O-naive urothelial cancer patients. Clinical benefit will be assessed in the overall population as well as in subsets of patients with different baseline levels of MDSCs.

Infinity will also be advancing novel triple combination therapies with Arcus, initially evaluating IPI-549 in combination with AB928, Arcus’s dual adenosine receptor antagonist, and chemotherapy in patients with previously treated, advanced triple negative breast cancer, or TNBC. As both macrophages and high adenosine levels are believed to play critical roles in creating a highly immune-suppressive tumor microenvironment in cancer after chemotherapy, the novel immuno-oncology combination being evaluated in this setting represent a potentially promising approach to treating TNBC.

Infinity’s chair and chief executive officer, Adelene Perkins, will discuss the company’s continued execution on its corporate strategy and 2019 priorities as part of a podium presentation at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, at 9:30 a.m. PST (12:30 p.m. EST). The presentation will be webcast live on Infinity’s website, www.infi.com, and an archived version of the webcast will be available on Infinity’s website for 30 days.

Anticipated Milestones in 2019: Expanding Depth and Breadth of IPI-549 Development

1H2019

Advance into Immuno-Oncology (I/O) Naïve Indications in Combination with Opdivo: Initiate MARIO-275 in I/O naïve UC patients with BMS
Advance into Novel Triple Combinations Beyond CPIs: Initiate Triple Therapy Combination (IPI-549+AB928+Chemo) in previously treated advanced TNBC with Arcus
2H2019

Initiate the first IPI-549 combination study in front-line advanced cancer patients
Complete enrollment of MARIO-1 seven combination expansion cohorts including:
Augmented melanoma expansion cohort (n=40)
TNBC expansion cohort (n=29)
2019 Financial Guidance

Infinity ended 2018 with approximately $58.6 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2018 financial results in March. The company is providing the following financial guidance today:

Net loss: $30 million to $40 million
Year-end cash: $20 million to $30 million
Cash runway: Into 2H 2020
Infinity’s 2019 financial guidance is based on its current operating plans, excludes additional financing or business development activities, and includes a $2 million milestone payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.

IPI-549 is an investigational compound, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.