CEL-SCI REPORTS MONTHLY PATIENT ENROLLMENT IN MAY FOR ITS PHASE 3 HEAD AND NECK CANCER TRIAL

On June 1, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of May it has enrolled 19 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, JUN 1, 2016, View Source [SID:1234512946]). Total patient enrollment for the trial is now 816 as of May 31, 2016.

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About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

Xcovery to Present at the ASCO Annual Meeting 2016

On June 1, 2016 Xcovery, a developer of targeted therapeutics for cancer, reported that data on the plasma genotyping of patients enrolled in its expansion Phase I/II trial of ensartinib (X-396), the Company’s lead ALK inhibitor drug candidate, in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016, which is being held from June 3 – 7, 2016 in Chicago, Illinois (Press release, Xcovery, JUN 1, 2016, View Source [SID:1234512947]). The presentation details are as follows:

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Poster Title: Plasma genotyping of patients enrolled on the expansion phase I/II trial of X-396 in patients (pts) with ALK+ non-small cell lung cancer (NSCLC)
Poster Session: Lung Cancer – Non-Small Cell Metastatic
Poster Time: Sunday, June 5, 2016 from 8:00am – 11:30am CDT
Session Location: McCormick Place, Hall A
Poster Board Number: 379
Abstract Number: 9056
Presented by: Leora Horn, MD, MSc, Vanderbilt University Medical Center
Additional abstract details can be found at abstracts.asco.org.

About Ensartinib (X-396)

Xcovery’s lead asset is Ensartinib (X-396), a small molecule, anaplastic lymphoma kinase (ALK) inhibitor. It is being studied in the eXalt2 Study, a Phase II trial for the treatment of ALK-positive non-small cell lung cancer (NSCLC). The eXalt2 Study is currently enrolling patients. To learn more, visit: www.xalt2study.com or ClinicalTrials.gov under trial identifier NCT01625234.

About NSCLC and ALK

Lung cancer is the second most common type of cancer identified in the United States with an estimated 221,000 new diagnoses expected in 2015. Non‐small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for an estimated 85‐90% of the lung cancer cases. The anaplastic lymphoma kinase (ALK) gene is located on chromosome 2 and rearrangement of the ALK gene can lead to its activation or expression, therefore increasing a person’s chance of developing certain types of cancer, including NSCLC. Between three and seven percent of patients with NSCLC have the ALK rearrangement, making this a molecular target warranting investigation for NSCLC patients.

Baxalta and Award-winning Photographer Debut Unique Exhibition Showcasing Perspectives of Those Impacted by Rare Cancers

On May 31, 2016 Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported the unveiling of an initiative that illustrates the perspectives of those impacted by rare cancers, created in partnership with photographer Rick Guidotti of Positive Exposure (Press release, Baxalta, MAY 31, 2016, View Source [SID:1234512924]). The photo exhibit, Rare Cancer Illuminated: a View From Within, debuts on June 2 in Chicago as part of The Atlantic’s "The Search for Answers: Fighting Rare Cancers," which Baxalta is underwriting.

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"The Search for Answers: Fighting Rare Cancers"
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This press release has an accompanying Smart Marketing Page providing further details about the organization, products and services introduced below. You can access the Smart Marketing Page via the following link: View Source

People living with rare and underserved cancers often experience difficulty with disease recognition, late or inaccurate diagnosis,1 limited treatment options, and scarcity of clinical trial availability or registries.2 Through photography, Guidotti and Baxalta aim to raise awareness and understanding of the unique challenges that rare cancer communities face and encourage greater collaboration to achieve more efficient diagnoses, treatment, access, and support.

The exhibit gathers individuals connected by various types of rare adult, pediatric, and adolescent cancers, such as pancreatic cancer, myelodysplastic syndromes (MDS), and acute lymphoblastic leukemia (ALL), and aims to illuminate the passion that drives them daily. While there is no international consensus on the definition of rare cancer, it is defined as fewer than 15 per 100,000 cases per year in the U.S.3 In Europe, rare disease is defined as those with a prevalence of fewer than 50 per 100,000 cases.3 Underserved cancers are typically referred to as those receiving inadequate physical or emotional resources.

"At Baxalta, our mission is to improve the lives of individuals affected by rare cancers through the use of innovative technologies and approaches, such as harnessing the body’s immune system," said David Meek, Executive Vice President and President, Oncology, Baxalta. "Our collaboration with Positive Exposure aims to raise awareness of rare cancers and to unite the community to drive action."

Guidotti founded the not-for-profit organization, Positive Exposure, in 1998, to celebrate and understand human diversity. Using photography, Guidotti aims to change public perception by helping people to see beyond standard definitions of beauty and arrive at their own interpretation. Rare Cancer Illuminated: a View From Within features photographs by Guidotti of rare cancer community members including those who have been diagnosed with cancer, their family and friends, advocacy organizations, and healthcare professionals. The exhibit will travel to Europe later this year.

"Baxalta’s commitment to serving rare cancer communities aligns with my vision to see beyond disease or diagnosis and celebrate our shared humanity," said Guidoitti, Founder, Positive Exposure. "We hope that people who experience this exhibit are able to take away a greater sense of understanding and compassion for communities that are up against these challenges, and feel empowered to learn more and become part of the effort to bring solutions."

The exhibit includes representation from leading advocacy organizations including: American Cancer Society Cancer Action Network; Austrian Childhood Cancer Organization; the Myelodysplastic Syndromes (MDS) Foundation, Inc.; PAN-Austria (Patient Advocacy for Adolescents and Young Adults with Neoplasia); Pancreatic Cancer Action; Stupid Cancer, Inc.; and TEB e.V. Germany (translated to Tumors and Diseases of the Pancreas). Together, their stories focus on the need for improved delivery and access to critical resources and support worldwide.

The Atlantic’s "The Search for Answers: Fighting Rare Cancers," underwritten by Baxalta, will take place on June 2 from 2:00-5:00 p.m. CDT in Chicago ahead of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The event will focus on topics such as the fight against rare cancer, the role of advocacy organizations, the White House’s Moonshot Initiative, patient access, and support networks. Confirmed speakers include: Richard Schilsky, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Chief Medical Officer and co-author of Value Framework; American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld; and Kim Thiboldeaux, President and Chief Executive Officer of the Cancer Support Community.

This event is open to media; please RSVP directly to The Atlantic’s Sydney Simon ([email protected]; 202-266-7338) to attend. A live stream of the afternoon’s conversations will be available beginning at 2:30 p.m. CDT on June 2 on AtlanticLIVE’s website where it will be archived for later viewing.

ASLAN003

ASLAN003 is a small molecule inhibitor of DiHydroOrotate DeHydrogenase (DHODH), an enzyme which catalyses the key rate-limiting step in the synthesis of pyrimidines in mammalian cells (Company Pipeline, ASLAN Pharmaceuticals, MAY 31, 2016, View Source [SID:1234512877]). In studies conducted to date, ASLAN003 has generated promising emerging preclinical data in oncology indications where the mechanism is linked with induction of p53 and apoptosis. ASLAN plans to develop ASLAN003 in several oncology indications as monotherapy and in combination with other targeted agents.

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ASLAN004

ASLAN004 is a fully human therapeutic monoclonal antibody that neutralises both interleukin 4 (IL-4) and interleukin 13 (IL-13) by binding to the IL-13Rα1 (Company Pipeline, ASLAN Pharmaceuticals, MAY 31, 2016, View Source [SID:1234512886]). The IL-13Rα1 is a key component of the type II receptor dimer that is expressed in epithelial cells, airway smooth muscle, alternatively activated (M2) macrophages, NKT cells, mast cells, eosinophils and basophils. In allergic diseases such as asthma and atopic eczema, IL-4 and IL-13 play a pivotal role in causing airway hyperresponsiveness, pulmonary inflammation, mucus hypersecretion, lung oeosinophilia and increases in allergen specific circulating IgE.

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In oncology, IL-13 signaling is emerging as a key driver of proliferation in cutaneous T-cell lymphoma. More generally in oncology, agonsim of IL-13Rα1 via IL-13 is recognised as a key driver in a shift from an M1 (proinflammatory) to M2 (regulatory/repair) macrophage phenotype that is used by tumour cells to evade killing via host immune surveillance. IL-13Rα1 is a specific marker for the M2 macrophage and mouse studies demonstrate that bone marrow cells from IL-13Rα1 knockout mice preferentially differentiate to an M1 macrophage phenotype. Similarly, knockout of IL-13 or knockdown of IL-13Rα1 via miRNA-155 triggers a switch to an M1 macrophage phenotype (Dhakal et al, 2014, Martinez-Nunez et al, 2011). Consequently, inhibition of IL-13 signalling is emerging as an immune checkpoint for tumour evasion of host immune surveillance and hence an important mechanism for enhancing the immune infiltrate in the tumour microenvironment.

ASLAN004 is the only therapeutic antibody that targets IL-13Rα1, and is progressing into a range of allergic disorders and oncology indications as both monotherapy and in combination with existing immunotherapies.