On November 6, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that company management will participate in fireside chats at the following upcoming investor conferences (Press release, Loxo Oncology, NOV 6, 2018, View Source [SID1234530773]):

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Stifel Healthcare Conference in New York City on November 13, 2018 at 8:45 a.m. ET
Piper Jaffray Healthcare Conference in New York City on November 28, 2018 at 10:30 a.m. ET
Live webcasts of the fireside chats will be available at View Source

On November 6, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported a poster presentation of preclinical data by Jonathan Pachter, Ph.D., the Company’s Chief Scientific Officer, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018, in Washington, D.C (Press release, Verastem, NOV 6, 2018, View Source;p=irol-newsArticle&ID=2375552 [SID1234530795]).

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"We have assessed the activity of duvelisib, our orally-administered dual inhibitor of PI3K-delta and PI3K-gamma, in combination with either immune checkpoint or co-stimulatory antibodies in syngeneic antitumor models," said Dr. Pachter. "Results to be presented at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting demonstrated that duvelisib shows strong anti-tumor synergy with PD-1 or OX40 antibodies. As a dual PI3K-delta/gamma inhibitor, duvelisib was found to reduce both immunosuppressive Tregs and myeloid cells in tumors more strongly than PI3K-delta, or PI3K-gamma only inhibitors, suggesting that it could be a highly-differentiated PI3K inhibitor for combination with immuno-oncology therapeutics. These preclinical results support clinical investigation of duvelisib in combination with immunotherapies for treatment of patients with hematological or solid tumor malignancies."

Details for the poster presentation are as follows:

Title: Synergistic efficacy of duvelisib with checkpoint or co-stimulatory antibodies in a B cell lymphoma model: Advantages of dual inhibition of PI3K-delta and PI3K-gamma

Abstract poster number: P373

Date and time: Friday, November 9, 2018 from 12:45-2:15 PM and 6:30 – 8:00 PM ET

Location: Hall E

A copy of the poster will be available here following its presentation at the meeting

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 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