On January 9, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported its participation at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Kura Oncology, JAN 9, 2020, View Source [SID1234552899]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Thursday, January 16, 2020 at 10:00 a.m. PT / 1:00 p.m. ET, followed by a Q&A session at 10:30 a.m. PT / 1:30 p.m. ET. The conference will be held from January 13-16, 2020 in San Francisco.

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Live audio webcasts of the presentation and Q&A session will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

On January 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it will host a Clinical Data Call on Wednesday, February 19, 2020 at 10:30 am Eastern Time (Press release, Cellectar Biosciences, JAN 9, 2020, View Source [SID1234552921]).

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Members of Cellectar’s senior management team and Dr. Sikander Ailawadhi, M.D., the lead investigator for the company’s Phase 2 study, will provide additional clinical data, as well as an update and analysis of the CLR 131 Phase 1 and Phase 2 hematology focused trials. The team will also provide a summary of the data for patients with relapsed/refractory B-cell malignancies, including patients with multiple myeloma and select non-Hodgkins lymphoma. Additionally, the team will review the current treatment landscape and unmet medical need for treating patients with these cancers, and provide an overview of the market opportunity and its clinical development plan for CLR 131.

Sikander Ailawadhi, M.D., is an Associate Professor, Division of Hematology/Oncology at Mayo Clinic Florida and is the lead investigator for the company’s Phase 2 CLOVER-1 trial of CLR 131 in patients with relapsed/refractory B-cell hematologic cancers. Dr. Ailawadhi was awarded the 2013 NCI CCITLA as an Assistant Professor of Medicine at the Norris Cancer Center, University of Southern California (USC), Los Angeles CA. Subsequently, he joined the Division of Hematology and Oncology at Mayo Clinic in Florida as a Senior Associate Consultant in order to pursue his career goal of clinical, translational and outcomes-based research in B-cell malignancies, especially plasma cell disorders.

Dial-In & Webcast Information

Domestic: 877-705-6003

International: 201-493-6725

Conference ID: 13697717

Webcast: View Source

A replay of the call will be available on the Events section on the Investor Relations page of company’s website following the live event.

About the Phase 2 CLOVER-1 Trial

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study will enroll up to 80 patients. Its primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a fractionated dose of 37.5mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131 administered on day 1 and day 7 (± 1), with the option for a second dose cycle approximately 75-180 days later.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About the Phase 1 R/R MM Trial

The Phase 1 multicenter, open-label, dose-escalation study is designed to evaluate the safety and tolerability of CLR 131 administered as a 30-minute IV infusion, either as a single bolus dose or as two fractionated doses, in patients with relapsed/refractory multiple myeloma. All doses to date have been deemed safe and well tolerated by an independent Data Monitoring Committee (DMC). Based on the data and the recommendation of the DMC, the company is enrolling a Cohort 7 where patients will receive 40mCi/m2 fractionated dose of CLR 131.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission, and was granted U.S. Orphan Drug designation for the treatment of lymphoplasmacytic lymphoma and was granted U.S. Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

On January 9, 2020 Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its CIVO intratumoral microdosing platform, reported that the U.S. Food and Drug Administration (FDA) has approved its first Exploratory Investigational New Drug (IND) application for a Phase 0 study utilizing its CIVO platform (Press release, Presage Biosciences, JAN 9, 2020, View Source [SID1234552931]). The study, which will employ the CIVO platform to evaluate patients’ unique responses to microdoses of cancer drugs, is a collaboration with Takeda Pharmaceutical Company Limited (Takeda), with initiation planned in the first half of 2020.

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"The green light from the FDA for Presage’s first exploratory IND represents a major milestone as we seek to revolutionize early drug development through a superior approach to translational oncology," said Rich Klinghoffer, PhD, Presage CEO. "This latest success reflects our measured approach to building a long-term relationship with the FDA that will support our business model of making Phase 0 trials widely available to companies looking to gain deeper understanding of investigational drug response within the tumor microenvironment."

Takeda has previously partnered with Presage on preclinical mechanism of action and combination studies, including work highlighted by both companies at AACR (Free AACR Whitepaper) last year. "Takeda’s preclinical collaborations with Presage have been foundational to the honing of our translational insights into novel immuno-oncology agents," said Chris Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We are excited to now leverage the CIVO platform in the clinic and we are eager to see what insights this trial can provide and if intratumoral microdosing can enable biomarker studies that enrich and accelerate clinical translation."

"Takeda’s ongoing collaboration and support has enabled Presage to bring the CIVO platform into the clinic. We are very excited for this first trial to begin and demonstrate the possibilities for improving how oncology drug candidates are evaluated," added Klinghoffer.

Earlier this year, Presage announced collaborations with Celgene and BMS for Phase 0 trials with CIVO. Those trials are expected to commence in 2020 following FDA clearance. A recently completed clinical trial to evaluate the safety and feasibility of utilizing the CIVO platform demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

About CIVO and Phase 0 Trials

To address the challenges inherent in cancer drug discovery, Presage is advancing a new approach to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. Exploratory Investigational New Drug studies, also known as Phase 0 trials, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. CIVO is a patented platform that enables intratumoral microdosing and analysis of multiple cancer agents.

On January 9, 2020 Amgen (NASDAQ:AMGN) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference at 8:30 a.m. PT on Tuesday, Jan. 14, 2020, in San Francisco (Press release, Amgen, JAN 9, 2020, View Source [SID1234552947]). Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On January 9, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported its corporate and program priorities for 2020 (Press release, MacroGenics, JAN 9, 2020, View Source [SID1234552968]).

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"Following the submission in 2019 of our first BLA with the FDA, 2020 has the potential to be a transformative year for MacroGenics. As the product candidates in our deep pipeline enter later-stage clinical trials, we are prioritizing certain programs in order to efficiently utilize our financial, human and intellectual capital on programs with the highest commercial and scientific merit and the potential to achieve regulatory approval," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are excited to advance multiple product candidates in registration-directed studies and believe our program prioritization positions us to capitalize on what we hope will be a pivotal year for the Company."

Program Prioritization

The Company’s research and development priorities for its investigational molecules in 2020 are highlighted below.

Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers.

•Biologics Licensing Application (BLA) for Metastatic Breast Cancer. Pending acceptance and review of the BLA submitted in December 2019 to the Food and Drug Administration (FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenics expects a Standard Review process in which the FDA will likely require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.

•Phase 2/3 MAHOGANY Study in Advanced Gastric and Gastroesophageal Junction Cancer. MacroGenics is enrolling patients in this front-line study designed to evaluate the combination of margetuximab with anti-PD-1 based therapies. Initial safety and efficacy data are expected in the second half of 2020 from Module A of this study, which is evaluating a chemotherapy-free regimen. Module A has been designed to support a potential accelerated approval in the U.S. based on evaluation of objective response rate in a single-arm study.

Flotetuzumab is a bispecific CD123 x CD3 DART molecule being evaluated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). MacroGenics intends to define a potential registration path in the U.S. for the treatment of patients with primary induction failure and early relapsed AML in the first half of 2020, pending continued discussions with the FDA.

MGA012 (INCMGA0012) is an anti-PD-1 monoclonal antibody that has been exclusively licensed to Incyte Corporation. There are currently 18 disclosed Phase 1-3 clinical studies evaluating MGA012 in monotherapy and combination regimens across a broad range of tumor types.1

MGD013 is a first-in-class, bispecific PD-1 x LAG-3 DART molecule being evaluated in a Phase 1 dose expansion study. MacroGenics is selecting indications for further development and expects to submit data from the ongoing study for presentation at a scientific conference in the first half of 2020.

Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 monoclonal antibody. To further inform the development
of this molecule, MacroGenics plans to evaluate the activity of both enoblituzumab plus MGA012 and enoblituzumab plus MGD013 as chemotherapy‐free regimens in front‐line patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) before proceeding with the full Phase 2/3 study.

MGC018 is an antibody-drug conjugate (ADC) targeting B7-H3 and MGD019 is a bispecific PD-1 x CTLA-4 DART molecule. The Company expects to complete dose escalation for each of these molecules in early 2020 and then initiate a focused dose expansion in select tumor types.

MGD009 is a B7-H3 x CD3 DART molecule and MGD007 is a gpA33 x CD3 DART molecule. In connection with its strategic prioritization, the Company will discontinue development of these programs.

Cash Balance and Cash Runway

The Company’s estimated cash, cash equivalents and marketable securities balance as of December 31, 2019 was approximately $215 million (unaudited), compared to $232.9 million as of December 31, 2018. Through the prioritization of programs and ongoing realignment of its resources, as well as anticipated and potential collaboration payments, MacroGenics is focused on extending its cash runway through 2021. The Company will provide further guidance in connection with reporting 2019 fourth quarter and annual financial results and company progress in late February 2020.

Slide Presentation

A slide presentation describing these corporate priorities, research and development goals and other information will be available on the Investors page on the Company’s website at www.macrogenics.com after the market close on Friday, January 10, 2020.