On November 30, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported the establishment of its Scientific Advisory Board (SAB) (Press release, Oncolytics Biotech, NOV 30, 2017, View Source [SID1234522318]). The SAB will provide Oncolytics with significant clinical expertise and experience in breast cancer drug development in both the U.S. and Europe with the following initial members:

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Dr. Mattine Piccart, M.D., Ph.D., Professor of Oncology, Université Libre de Bruxelles, Director of the Medicine Department, TRANSBIG and Jules Bordet Institute, Brussels, Belgium, Member, BCRF Scientific Advisory Board
Dr. Aleix Prat, M.D., Ph.D., Head, Medical Oncology Department, Hospital Clinic of Barcelona & Associate Professor, University of Barcelona, SOLTI – Breast Cancer Research Group
Dr. Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
"As we continue to expand our collaborative third-party expertise to build on the momentum of our phase 3 program in metastatic breast cancer, we are delighted to introduce a strong Scientific Advisory Board comprised of world-renowned clinical and medical oncologists," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Drs. Piccart, Prat and Sharma will provide crucial guidance based on their specializations in breast cancer drug development and cancer immunotherapy, which parallel the development plan we have established for REOLYSIN."

Dr. Mattine Piccart is a Professor of Oncology at the Université Libre de Bruxelles and a member of the Breast Cancer Research Foundation (BCRF) SAB. She is a member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale Working Group and co-founder and Chair of the Breast International Group (BIG), an international group that includes more than 56 cooperative groups, more than 10,000 experts and links more than 3,000 hospitals. Dr. Piccart was President of ESMO (Free ESMO Whitepaper) from 2012 to 2013 and the European Cancer Organization (ECCO) from 2014 to 2015. She is a former president of the European Organisation for Research and Treatment of Cancer (EORTC) and served on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Board. Author or co-author of more than 470 peer-reviewed publications, she has received numerous prestigious awards, including the Jill Rose Award, the William L. McGuire Award, the Umberto Veronesi Award for the Future Fight against Cancer, and 2013 David A. Karnofsky Memorial Award, Dr. Piccart obtained both her M.D. and Ph.D. degrees from the Université Libre de Bruxelles.

Dr. Aleix Prat is the Head of Medical Oncology of the Hospital Clinic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS). Dr. Prat designs and leads clinical trials for novel drugs and approaches, and has a particular interest in the clinical implications of different subtypes of breast cancer. He is currently the scientific coordinator of SOLTI, a Spanish breast cancer cooperative group, and was recently named as a Member of the Executive Committee of BIG. In 2008, Dr. Prat became a postdoctoral research associate at the Lineberger Comprehensive Cancer Center (University of North Carolina), and in 2012, returned to Barcelona as the Head of the Translational Genomics Group at Vall d´Hebron Institute of Oncology (VHIO). Dr. Prat obtained his M.D. degree in 2003 from the University of Barcelona and completed a medical oncology fellowship in 2008 at VHIO.

At the University of Texas MD Anderson Cancer Center, Dr. Padmanee Sharma is a Professor at the Department of Genitourinary Medical Oncology, the Co-Director of the Parker Institute for Cancer Immunotherapy and Scientific Director of the Immunotherapy Platform at the Department of Immunology. She has participated in 54 research outputs since 1996, focusing primarily on immunotherapy, and is principal investigator of several immunotherapy clinical trials that study immune and anti-tumor responses in cancer patients. Dr. Sharma has served as a member of the BMS Immuno-Oncology Network, a Member of the SAB at Kite Pharma, Inc. and also recently became a member of Constellation Pharmaceuticals, Inc.’s SAB. Dr. Sharma holds a Ph.D. in immunology and an M.D. from Pennsylvania State University.

On November 30, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and I-Mab reported that they have entered into an exclusive regional licensing agreement to develop and commercialize MOR202 in China, Taiwan, Hong Kong and Macao (Press release, MorphoSys, NOV 30, 2017, View Source [SID1234522310]). MOR202 is MorphoSys’s proprietary investigational antibody against CD38, for which recruitment of a European Phase 1/2a clinical study in relapsed/refractory multiple myeloma has been concluded.

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Under the terms of the agreement, I-Mab Biopharma will assume exclusive responsibility for all subsequent development and commercialization of MOR202 in the agreed territory. MorphoSys receives an immediate upfront payment of USD 20 million. MorphoSys will be entitled to receive additional success-based clinical and commercial milestone payments from I-Mab of up to approximately USD 100 million, as well as tiered double-digit royalties on net sales of MOR202 in the territory.

In connection with the license agreement with I-Mab, MorphoSys has increased its financial guidance. For the year 2017, MorphoSys now expects revenues in the range from EUR 63 to 66 million (up from previously EUR 46 to 51 million) and earnings before interest and taxes (EBIT) of EUR -66 to -71 million (up from previously EUR -75 to -85 million). Guidance for revenues and EBIT includes royalty income on Tremfya(R) sales in Q3 2017, but does not include any royalty income on Tremfya(R) sales in Q4 2017. Following the partnering of MOR202, proprietary R&D expenses will be in the range from EUR 96 to 100 million (previously EUR 85 to 95 million).

I-Mab Biopharma intends to start clinical development of MOR202 to treat patients with multiple myeloma in China next year.

"Our deal with I-Mab is the first step in our plan to secure the development and commercialization of MOR202. In I-Mab, we have found an ideal partner with a highly dedicated and experienced team who are committed to developing MOR202 as fast as possible for the Chinese market", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.

"We are very excited to partner with MorphoSys to develop this highly differentiated investigational oncology medicine for unmet needs in China. This partnership marks a latest addition to our China portfolio of clinical stage assets, which parallels with our global immuno-oncology portfolio of innovative biologics", said Jingwu Zang, founder and CEO of I-Mab Biopharma.

About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a human HuCAL antibody directed against CD38, a highly expressed and validated target in multiple myeloma. Preclinical findings also support an anti-CD38 approach in other therapeutic fields beyond multiple myeloma including solid tumors and autoimmune diseases. MOR202 is currently in a phase 1/2a, open-label, multi-center, dose-escalation clinical study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 with low dose dexamethasone and in combination with the immunomodulatory drugs (IMiDs) pomalidomide (POM) and lenalidomide (LEN) plus DEX in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 with DEX and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.

About Multiple Myeloma:
Multiple myeloma (MM), a cancer derived from plasma cells, ranks second among hematological malignancies in many countries. In China, there would be an estimated 27,800 new cases each year and a total of 200,000 cases. With the acceleration of the aging process in China, it is predicted that MM, with a rapid growth in incidence, will become one of the more significant diseases that affect people’s health. Patients who are refractory to the existing treatments have a very poor prognosis. MOR202 could be a highly differentiated innovative medicine for the treatment of multiple myeloma.

On November 30, 2017 Pfizer Inc. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, reported they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole) (Press release, Pfizer, NOV 30, 2017, View Source [SID1234522326]). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis1, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

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Under the terms of the agreement, Pfizer will have exclusive rights to develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific countries and China (including Hong Kong and Macao). These rights do not include Japan. In addition, Pfizer will become the marketing authorization holder for the Asia Pacific Region and China. The specific financial terms of the agreement remain confidential. The agreement is subject to customary regulatory approval.

In July 2017, Pfizer completed an agreement with Basilea to obtain the exclusive commercialization rights to CRESEMBA in Europe (with the exception of the Nordic countries). Since that time, Pfizer has assumed responsibility for the commercialization of CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom and successfully launched CRESEMBA in Spain with additional launches expected in 2018 and beyond.

CRESEMBA was developed in response to the urgent medical need for antifungal medicines for the treatment of invasive fungal infections, which are naturally resistant to many antifungal therapies and have become increasingly resistant to other available therapies. Today, invasive aspergillosis is the most frequently reported fungal infection in immunocompromised individuals within the Asian Pacific region.

"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, global president of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China, together with our expertise in successfully commercializing innovative medicines, will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."

"CRESEMBA is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections," said Ronald Scott, chief executive officer of Basilea. "We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.

About invasive aspergillosis and mucormycosis

Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection and those with cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. Today, there are limited treatment options available for patients diagnosed with invasive aspergillosis and mucormycosis.

About CRESEMBA (isavuconazole)

CRESEMBA is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.

On November 30, 2017 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that new data on the Company’s first FDA-approved anticoagulant, betrixaban, and its two investigational hematologic compounds – the anticoagulant reversal agent andexanet alfa and the oral, dual Syk/JAK kinase inhibitor cerdulatinib – will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 9-12 in Atlanta, Georgia (Press release, Portola Pharmaceuticals, NOV 30, 2017, View Source;p=RssLanding&cat=news&id=2319373 [SID1234522319]). The Company also will present outcomes-based research on prophylaxis of venous thromboembolism in two real-world settings.

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Oral Presentation Details:

• Presentation Title: Effect of Andexanet-TFPI Interaction on in Vitro Thrombin Formation and Coagulation Markers in the TF-Pathway

Session: 332 (Antithrombotic Therapy: Anticoagulation in Cancer and Beyond)
Presenter: Genmin Lu, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 at 11:30 a.m. ET
Location: Building B, Level 2, B207-B208 (Georgia World Congress Center)
Poster Presentation Details:

• Poster Title: Physiologically-Based Pharmacokinetic (PBPK) Modeling for Betrixaban and the Impact of P-glycoprotein Inhibition on Betrixaban Pharmacokinetics

Poster Session: 321 (Blood Coagulation and Fibrinolytic Factors: Poster III)
Presenter: Janet M. Leeds, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Impact of D-Dimer Assays Performed at Local Labs vs. Central Laboratory in the Evaluation of APEX Trial Outcomes

Poster Session: 332 (Antithrombotic Therapy: Poster II)
Presenter: Lisa Jennings, Ph.D., CirQuest Labs, Memphis, Tennessee
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Did Patients with Renal Disease Receive Sufficient Prophylaxis for Venous Thromboembolism in the Real-World Settings?: A Study Among Hospitalized Acutely Medically Ill Patients

Poster Session: 903 (Outcomes Research—Non-Malignant Conditions: Poster II)
Presenter: Donna Hesari, R.N., Portola Pharmaceuticals
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: The Frequency of Venous Thromboembolism (VTE) Prophylaxis Among Patients Hospitalized for Cancer in the US

Poster Session: 903 (Outcomes Research—Non-Malignant Conditions: Poster III)
Presenter: Andrea Hafeman, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Cerdulatinib Pharmacodynamics and Relationships to Tumor Response Following Oral Dosing in Patients with Relapsed/Refractory B Cell Malignancies: Results from a Phase I Dose Escalation Study

Poster Session: 623 (Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II)
Presenter: Greg Coffey, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)

Important U.S. Safety Information for Bevyxxa (betrixaban) capsules

INDICATION
Bevyxxa is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

LIMITATIONS OF USE
The safety and effectiveness of Bevyxxa have not been established in patients with prosthetic heart valves because this population has not been studied.

SELECT IMPORTANT SAFETY INFORMATION

___________________________________________________________________________________________________________________________________________________

WARNING: SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS TREATED WITH BEVYXXA WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THE RISK OF THESE EVENTS MAY BE INCREASED BY THE USE OF IN‑DWELLING EPIDURAL CATHETERS OR THE CONCOMITANT USE OF MEDICAL PRODUCTS AFFECTING HEMOSTASIS. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
___________________________________________________________________________________________________________________________________________________

CONTRAINDICATIONS

Active pathological bleeding
Severe hypersensitivity reaction to Bevyxxa

WARNINGS AND PRECAUTIONS
Risk of Bleeding

Bevyxxa increases the risk of bleeding and can cause serious and potentially fatal bleeding
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs)
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room
Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement
Discontinue Bevyxxa in patients with active pathological bleeding
There is no established way to reverse the anticoagulant effect of Bevyxxa, which can be expected to persist for at least 72hours after the last dose
It is unknown whether hemodialysis removes Bevyxxa
Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of Bevyxxa

Spinal/Epidural Anesthesia or Puncture

When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis
Do not remove an epidural catheter earlier than 72hours after the last administration of Bevyxxa. The next Bevyxxa dose is not to be administered earlier than 5hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Bevyxxa for 72hours
Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary
Prior to neuraxial intervention, consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis

Use in Patients with Severe Renal Impairment

Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault) taking Bevyxxa may have anincreased risk of bleeding events
Reduce dose of Bevyxxa, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients

Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors

Patients on concomitant P-gp inhibitors with Bevyxxa may have an increased risk of bleeding
Reduce dose of Bevyxxa in patients receiving or starting concomitant P-gp inhibitors, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients
Avoid use of Bevyxxa in patients with severe renal impairment receiving concomitant P‑gp inhibitors

ADVERSE REACTIONS

The most common adverse reactions with Bevyxxa were related to bleeding (> 5%)

USE IN SPECIFIC POPULATIONS
Hepatic Impairment

Bevyxxa has not been evaluated in patients with hepatic impairment, because these patients may have intrinsic coagulation abnormalities
Bevyxxa is not recommended in patients with hepatic impairment

On November 30, 2017 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that enrollment has opened in its open-label, Phase 1 study of CDX-1140 in patients with advanced solid tumors. CDX-1140 is a fully human antibody targeted to CD40, a key activator of immune response that is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells (Press release, Celldex Therapeutics, NOV 30, 2017, View Source [SID1234522315]).

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"CD40 has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses; however, balancing systemic dosing and safety has proven elusive to date for CD40 targeted activating therapeutics. CDX-1140 is a unique, potent CD40 agonist that we believe has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "We look forward to characterizing CDX-1140 in this Phase 1 study and rapidly moving into combination studies with other anti-tumor agents."

Study Overview
This study, which is expected to enroll up to approximately 105 patients with recurrent, locally advanced or metastatic cancers, is designed to determine the maximum tolerated dose during a dose-escalation phase and to recommend dose(s) for further study in a subsequent expansion phase. During the dose-escalation phase, patients will receive CDX-1140 at dose levels ranging from 0.01 mg/kg to 3.0 mg/kg once every four weeks until disease progression or intolerance. The expansion phase is designed to further evaluate the tolerability and biologic effects of selected dose(s) of CDX-1140 in specific tumor types. Secondary objectives of the study include analyses of safety and tolerability, pharmacodynamics, pharmacokinetics, immunogenicity and assessment of anti-tumor activity across a broad range of endpoints, such as objective response rate, clinical benefit rate, duration of response, progression-free survival and overall survival. More information about this study is available on www.clinicaltrials.gov (Identifier: NCT03329950).

About CDX-1140
CDX-1140 is a fully human antibody targeted to CD40, a key activator of immune response that is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40L binding is not blocked, leading to potential synergistic effects of agonist activity near activated T cells in lymph nodes and tumors; and the antibody does not promote cytokine production in whole blood assays. CDX-1140 has shown direct anti-tumor activity in preclinical models of lymphoma. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.