On November 6, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that the company will host and webcast an investor event on Friday, November 9, 2018 at 6:30 p.m. Eastern Time in Washington, D.C (Press release, Aduro Biotech, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375696 [SID1234530875]). The event will feature special guest speaker Jason J. Luke, M.D., FACP, Assistant Professor of Medicine at the University of Chicago and a principal investigator for the Phase 1 dose-finding studies of ADU-S100 (MIW815), a novel STING (stimulator of interferon genes) pathway activator. ADU-S100 is currently being evaluated as a single agent and in combination with spartalizumab (PDR001), an investigational anti-PD-1 compound in patients with advanced/metastatic solid tumors or lymphomas.

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcast will remain available for replay on Aduro’s website for 30 days.

Aduro’s posters will be on display on Friday, November 9, 2018 from 8 a.m. – 8 p.m. ET and Saturday, November 10, 2018 from 8 a.m. – 8:30 p.m. ET in Hall E. at the Walter E. Washington Convention Center. Details of Aduro’s posters and oral presentations are as follows:

P309 Phase I dose-finding study of MIW815 (ADU-S100), an intratumoral
STING agonist, in patients with advanced solid tumors or lymphomas
Session: Rapid Oral Abstract Presentation Session
Date: Saturday, November 10, 2018, 1:00 p.m. ET
Location: Room 204ABC, Walter E. Washington Convention Center

P351 ADU-S100 (MIW815) Synergizes with Checkpoint Inhibition to Elicit an
Anti-Tumor CD8+ T Cell Response to Control Distal Tumors

P516 SIRPα blockade increases the activity of multiple myeloid lineage cells,
enhances dendritic cell cross-presentation, and aids in remodeling the
tumor microenvironment
Session: Concurrent Session 104: Immune Checkpoints – Beyond PD-1
Date/Time: Friday, November 9, 2018, 4:30 p.m. ET
Location: Hall D, Walter E. Washington Convention Center

P517 Pan-allele anti-SIRPα antibodies that block the SIRPα–CD47 innate
immune checkpoint

On November 6, 2018 Fortis Therapeutics, Inc., an immuno-oncology biotech developing a novel antibody-drug conjugate (ADC) against CD46, reported the U.S. Food and Drug Administration (FDA) has cleared two investigational new drug (IND) applications for the company’s lead candidate, FOR46, for the treatment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma (Press release, Fortis Therapeutics, NOV 6, 2018, View Source [SID1234530937]). The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second program, in late-stage multiple myeloma, is expected to move into clinical trials in early 2019.

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FOR46 targets a novel immune modulatory receptor, CD46, which is highly expressed in multiple tumor types and is part of the tumor’s immune defense shield. While CD46 is expressed throughout the body, preclinical studies show that FOR46 activity is primarily restricted to prostate and other tumor tissue types, as opposed to normal tissue.

"CD46 is an attractive target for a number of cancers but has yet to be exploited due to its role in healthy tissues," said Jay Lichter, Ph.D., President and CEO of Fortis Therapeutics. "FOR46 cracks the code, in a sense, by binding a specific conformational epitope of CD46, that appears to be specific to tumor cells. This results in targeted tumor killing, while not impacting the natural role of CD46 in the complement system."

Discovery of FOR46

The FOR46 program originated at the University of California, San Francisco, in the laboratory of Bin Liu, Ph.D. It was identified through an antibody selection process that uses living tumor cells residing in their tissue microenvironment, thereby preserving the natural range of surface antigens present on the cells.

"It’s really a testament to the work of our scientists and the scientists at UCSF. By generating antibodies against tumor cells in situ, we developed a drug that readily translates to animal studies and, soon, human trials," said Marc Nasoff, Ph.D., Chief Scientific Officer of Fortis Therapeutics. "We’re confident in the science and in our therapeutic, which builds upon decades of innovation and refinement of antibody-drug conjugates."

To create FOR46, the fully human antibody was conjugated to a potent payload using a proven chemistry platform with well-characterized in vivo properties. Early in vitro studies of FOR46 have demonstrated its potential to kill tumor cells with no effect on normal cells. In rodents with human prostate cancer, it eliminated the tumor and led to long-term survival.

Fortis Therapeutics exclusively licensed rights to the antibody in 2016, and the company maintains a strong intellectual property position.

On November 6, 2018 Nordic Nanovector ASA (OSE: NANO) reported its third quarter 2018 results (Press release, Nordic Nanovector, NOV 6, 2018, View Source [SID1234553487]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Eduardo Bravo, CEO, commented: "The latest updated clinical results from a once-only administration of Betalutin, to be presented at ASH (Free ASH Whitepaper) in December, highlight the very promising clinical profiles of the two dosing regimens that are being evaluated in patients with relapsed/refractory indolent NHL. We are working hard to advance the PARADIGME study to confirm these results in a trial with 130 patients and to enable the selection of the best dosing regimen for our regulatory submissions. We are also pleased that Betalutin has received PIM designation in the UK reflecting the high unmet medical need of the FL patient population as well as the potential of Betalutin to offer therapeutic benefits to these patients. Both the PIM and Fast Track designations (granted by the FDA in June) provide opportunities for enhanced dialogue with health authorities and a route to bring Betalutin to patients quicker. We have a clear focus on delivering results from PARADIGME in 1H 2020 and in building further value in Nordic Nanovector from our CD37-targeting approach to treating patients with NHL."

Operational Highlights
• Abstract reporting promising clinical results from LYMRIT 37-01 trial with Betalutin published ahead of poster presentation at ASH (Free ASH Whitepaper)
o Overall response rates of 69% in Arm 4 (100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin) and 64% in Arm 1 (40 mg lilotomab followed by 15 MBq/kg Betalutin) in relapsed/refractory follicular lymphoma patients
o Median duration of response of 13.3 months for all patients (20.5 months for those with a complete response)
o Well tolerated with predictable and manageable safety profile

• Site activations and patient recruitment progressing for pivotal Phase 2b PARADIGME trial
o As of 5 November, 51 (of 80-85) sites in 16 (of 20) countries are open for enrolment
o First US site in Long Beach, CA open for enrolment

Betalutin granted Promising Innovative Medicine (PIM) Designation in the UK for the treatment of advanced relapsed/refractory FL

• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients

• Promising results from a collaborative R&D project to develop a CD37-targeted alpha therapy published in abstract ahead of ASH (Free ASH Whitepaper) presentation
o Next-generation targeted alpha therapy comprises Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) linked to lead-212 for treating B-cell malignancies

Financial Highlights Third Quarter 2018

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the third quarter amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the third quarter were NOK 76.9 million (NOK 72.7 million). Total operating expenses for the first nine months of 2018 amounted to NOK 243.7 million (NOK 214.9 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 73.0 % of total operating expenses (71.0 %) for the first nine months of 2018.

• Comprehensive loss for the third quarter amounted to NOK 75.4 million (loss of NOK 85.9 million). Comprehensive loss for the first nine months of 2018 was NOK 249.1 million (loss of NOK 207.9 million)

• Cash and cash equivalents amounted to NOK 499.7 million at the end of September 2018 (NOK 570.1 million at 30 June 2018 and NOK 756.6 million at 31 December 2017)

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin has been granted Fast Track and PIM designations in the US and UK, respectively, for the treatment of patients with R/R FL.
Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities across other stages of FL, NHL and other haematological cancer indications.
The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Third Quarter 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: HOLMENKOLLEN

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media
The results report and the presentation are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.

On November 6, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that a presentation of new data from the ongoing Phase 2 lifileucel metastatic melanoma trial (C-144-01) will occur at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C. from November 7-11, 2018 (Press release, Iovance Biotherapeutics, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375545 [SID1234530754]). Dr. Amod Sarnaik, from H. Lee Moffitt Cancer Center, the lead investigator in the C-144-01 study, will discuss the new data as an oral presentation on Sunday, November 11, 2018. These results will also be presented as a poster beginning November 9, 2018. The company will also host a live webcast of its melanoma program at an event for analysts and investors on Friday, November 9, 2018 from 6:30 – 8:30pm ET during the SITC (Free SITC Whitepaper) meeting.

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Highlights from the oral and poster presentations include:

An ORR of 38% from 47 consecutively dosed metastatic melanoma patients, including one complete response and 17 partial responses, four of which are unconfirmed as of October 25, 2018, pending these patients’ upcoming second assessments
A median duration of response (DOR) of 6.4 months with a range of 1.3+ to 14+ months
All patients were unsuccessfully treated with prior anti-PD-1 treatment
Mean prior systemic therapies for all patients was 3.3
The most common treatment emergent adverse events observed in this cohort to date include chills, febrile neutropenia, anaemia, decreased platelet count, pyrexia, and hypophosphataemia. Two grade 5 events occurred. One was deemed not related to lifileucel by the investigator and the other possibly related.

"The ORR from the ongoing study in post PD-1 metastatic melanoma patients treated with lifileucel continues to be well above the outcomes from the current standard of care for late-stage melanoma patients. In particular, the DOR of greater than six months is very encouraging," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We are pleased that Dr. Sarnaik can share updated data from the C-144-01 study with the oncology community at SITC (Free SITC Whitepaper)."

As previously reported, an End of Phase 2 meeting with the FDA was held. During this meeting, the FDA acknowledged the potential acceptability of a single-arm cohort for registration. FDA has further acknowledged that conduct of a randomized Phase 3 trial may not be feasible in its intended population of advanced melanoma patients who have been treated with at least one systemic therapy including a PD-1 blocking antibody and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not required for initial registration of lifileucel. Literature suggests that available care for these patients offers approximately 10% ORR. A new cohort of 80-100 patients in C-144-01 will be enrolled with a prospective definition of the primary endpoint of ORR to be read out by a Blinded Independent Review Committee to support registration of lifileucel. This new cohort, which the company refers to as Cohort 4, will be initiated in early 2019 and is expected to be fully enrolled by late 2019/early 2020. BLA submission to FDA is expected in the second half of 2020.

The details of the SITC (Free SITC Whitepaper) presentations are as follows:

Concurrent Session 302: Clinical Trials Session, Oral Presentation

Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients following progression on checkpoint inhibitors
Author: Amod Sarnaik, MD – H. Lee Moffitt Cancer Center & Research
Presentation date: Sunday, November 11, 2018
Presentation time: 8:10 am ET

Poster Presentation

Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients following progression on checkpoint inhibitors
Author: Amod Sarnaik, MD – H. Lee Moffitt Cancer Center & Research
Dates and times: The poster will be displayed both on Friday, November 9, 2018 from 8 a.m. – 8 p.m. ET and Saturday, November 10, 2018 8:00 a.m. – 8:30 pm ET.
Location: Hall E
Poster number: 022
Presentation: Dr. Sarnaik will moderate the poster presentation on Saturday, November 10, 2018 from 12:20 pm – 1:50 pm and 7:00 pm – 8:30 pm, local time

On November 6, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Advaxis, NOV 6, 2018, View Source [SID1234530796]). The poster, entitled "Natural killer (NK) cells orchestrate the antitumor activities of Listeria monocytogenes (Lm)-based immunotherapy," evaluated the impact of Lm-based immunotherapy on the activation of NK cells in a murine model of human papillomavirus (HPV)-associated tumors.

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Poster Number P520 will be presented by Sandy Hayes, Ph.D., Sr. Director, Research – BioMarkers and Immune Monitoring, on Saturday, November 10, 2018 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m. Eastern time at the 2018 SITC (Free SITC Whitepaper) 33rd annual meeting at the Walter E. Washington Convention Center in Washington, D.C.

"The results demonstrate that AXAL can induce changes in the tumor microenvironment that promote NK cell activation, establish cross-talk between dendritic cells (DC cells), NK cells, and can facilitate trafficking of tumor antigen-specific T cells into the tumor core which we believe contribute to the antitumor activity of AXAL," said Robert G. Petit, Ph.D., Executive Vice President and Chief Scientific Officer of Advaxis. "The critical role of NK cells and NK-DC crosstalk is part of the broad-based immunologic profile associated with Advaxis Lm vectors and their favorable alteration of the microenvironment for immunotherapy of solid tumors."

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack that is currently in Phase 3 clinical testing. In a Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38% in 50 patients. This is a 52% improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.