On June 14, 2018 Apexigen, Inc., and Yale Cancer Center reported a clinical trial collaboration to evaluate Apexigen’s APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors (Press release, Apexigen, JUN 14, 2018, View Source [SID1234591001]). The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary activity of APX005M in combination with cabiralizumab and Opdivo in metastatic NSCLC, metastatic melanoma and RCC patients whose disease has progressed on prior anti-PD-1/PD-L1 therapy (www.clinicaltrials.gov: NCT03502330). In addition to providing funding, Bristol-Myers Squibb will supply Opdivo and cabiralizumab, an investigational antibody being developed in partnership with Five Prime Therapeutics.

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APX005M is an investigational compound that is designed to activate CD40, a key immune co-stimulatory receptor essential to regulating the activation of both innate and adaptive immune responses against cancer. Cabiralizumab (FPA008) is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R) and depletes immunosuppressive tumor associated macrophages (TAMs). Preclinical data from Yale researchers and others have demonstrated that treatment with a combination of CD40 activation and inhibition of CSF-1R modifies tumor-associated macrophages and activates T cells in tumors. This results in converting a "cold" into an "inflamed" tumor microenvironment capable of eliciting protective T cell responses in tumors that are either unresponsive or insensitive to immune checkpoint blockade.

"There is an urgent need to find effective therapies for the growing number of patients who have not responded to checkpoint inhibitors," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "CD40 has a fundamental role in the activation of both innate and adaptive immunity, and we believe that CD40 activation by APX005M will become a key component of a number of promising new I-O therapeutic regimens for treating cancer patients."

"This most exciting collaboration between Apexigen and Yale is a result of studies with tumor bearing mice that are poorly responsive to inhibitors of PD-1/PD-L1. Based on these studies, we believe that activation of the innate immune system by APX005M in combination with cabiralizumab will enhance the activity of nivolumab, leading to a novel therapeutic approach for the increasing population of cancer patients who progress on currently approved immune checkpoint inhibitors. This is the first time this combination of drugs has been given to patients and we are eager to initiate this new clinical trial," said Harriet Kluger, M.D., Professor of Medicine at Yale Cancer Center and Principal Investigator of the trial.

On June 14, 2018 AIVITA Biomedical reported the randomization of its first patient in the Company’s Phase II clinical trial for newly diagnosed advanced ovarian cancer (Press release, AIVITA Biomedical, JUN 14, 2018, View Source [SID1234527445]). The double-blind study will enroll approximately 99 patients who will receive AIVITA’s patient-specific ovarian cancer vaccine, or a control agent. This milestone achievement is the first application of AIVITA’s new ROOT OF CANCER technology, a revolutionary immunotherapy that targets cancer-initiating cells.

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AIVITA has received seven patient tumor specimens from a single clinical site, and has successfully generated a treatment for each patient, yielding a 100% manufacturing success rate. Given the success of patient recruitment and manufacturing, AIVITA will now expand the clinical study to multiple centers.

"I’m very proud that our AIVITA team has so clearly demonstrated feasibility and reproducibility in manufacturing these patient-specific treatments," said Dr. Robert Dillman, AIVITA’s Chief Medical Officer. "Quick, reliable and cost-effective production is critical for the viability of both patient and company."

AIVITA’s ROOT OF CANCER technology may soon be applied to both melanoma and glioblastoma multiforme patients. The Company is seeking approval to commercialize the treatment of melanoma patients in Japan and was recently approved to conduct a Phase 2 clinical study in glioblastoma multiforme by the US FDA.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,240 new diagnoses in 2018 and 14,070 deaths. The median age at diagnosis is 63, with a 5-year survival rate of less than 50% for all, and about 35% for the two thirds who have advanced disease (stage III or IV) at the time of initial diagnosis. Current standard of care includes surgical debulking and several courses of chemotherapy.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

The ovarian Phase II double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).

For additional information about AIVITA’s AVOVA-1 trial patients can visit www.clinicaltrials.gov/ct2/show/NCT02033616

On June 13, 2018 BioCryst Pharmaceuticals, Inc. ("BioCryst") (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), reported that they will be presenting at the JMP Securities Life Sciences Conference on Thursday, June 21, 2018 at 10:00 A.M. E.T (Press release, BioCryst Pharmaceuticalsa, JUN 13, 2018, View Source [SID1234527289]).

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Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com and in the Investors and Media section of Idera’s website at View Source

On June 13, 2018 Nordic Nanovector ASA (OSE: NANO) reported that it has received approval from the Regional Committees for Medical and Health Research Ethics (REK) in Norway with regard to the Clinical Trial Application (CTA) for the Archer-1 Phase 1b trial with Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab in second-line follicular lymphoma patients (2L FL) (Press release, Nordic Nanovector, JUN 13, 2018, View Source [SID1234553498]).

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Nordic Nanovector has now received all necessary approvals to begin Archer-1 in Norway and will commence start-up activities immediately. Archer-1 is a Phase 1b clinical trial designed to investigate the safety, tolerability, pharmacokinetic and preliminary efficacy of the Betalutin/rituximab combination in approx. 20 2L FL patients, and the study will initially be conducted in Norway. Further countries are expected to be added later. The first patient is expected to be dosed in the second half of 2018.

On June 13, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that its Chief Executive Officer, Philip Serlin, will participate in a panel discussion at JMP Securities 2018 Life Sciences Conference on Wednesday, June 20, 2018 at 3:30 p.m. (EDT) (Press release, BioLineRx, JUN 13, 2018, View Source;p=RssLanding&cat=news&id=2354358 [SID1234527290]). The conference will be held at St. Regis New York, NY.

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Details of the panel discussion are as follows:

Title: Combination Strategies in Immuno-Oncology

Description: Recent clinical and commercial success with immune checkpoint blockade and cell-based therapy approaches has resurrected intense scientific interest in cancer immunotherapy. With approaches ranging from immune cell mobilization to epigenetic modulation and metabolic conditioning, panel participants will discuss the opportunities afforded by the field as well as the challenges posed by it, and how their individual development strategies have been designed to maximize the chances of ultimate success in immuno-oncology.

Key topics slated for discussion include: Next-generation immuno-oncology therapeutics, novel targets (e.g., inhibitory checkpoints, co-stimulatory molecules, etc.), biomarker strategies, the future of combination therapies, and challenges associated with drug cost and coverage.