On January 4, 2019 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Isaac Ciechanover, M.D., the Company’s President and Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 10:30 a.m. Pacific Standard Time (Press release, Atara Biotherapeutics, JAN 4, 2019, View Source [SID1234532447]). The conference will be held at the Westin St. Francis in San Francisco, California.

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A live audio webcast of the presentation will be available by visiting the Investors and Media section of the Atara website. An archived replay of the webcast will be available on the Company’s website for 14 days following the live presentation.

On January 4, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Sanjiv Patel, M.D., president and chief executive officer, is scheduled to present an overview of the company’s business and scientific objectives at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 10, 2019 at 11:00 a.m. PT (2:00 p.m. ET) (Press release, Relay Therapeutics, JAN 4, 2019, View Source [SID1234532466]).

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On January 4, 2019 OncoNano Medicine, Inc. reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ONM-100, an intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery (Press release, OncoNano Medicine, JAN 4, 2019, View Source [SID1234532467]). In addition, OncoNano received Fast Track designation from the FDA for ONM-100.

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ONM-100 is the first product from a platform based upon the OncoNano’s library of unique micelles that respond to pH variability. Specifically, ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which will allow surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras. The OncoNano micelle platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. OncoNano is currently concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.

"These two positive responses from the FDA reflect the progress that we have made on ONM-100," said Kathy Rath, Vice President, Regulatory Affairs at OncoNano Medicine. "The Fast Track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time."

"We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day," said Yalia Jayalakshmi, Vice President, Clinical Development at OncoNano Medicine. "With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a Phase 2 clinical study in 2019."

On January 4, 2019 Triumvira Immunologics Inc., reported that it will present at Biotech Showcase 2019, to be held January 7–9, during the most important week for healthcare investors at the Hilton San Francisco Union Square (Press release, Triumvira Immunologics, JAN 4, 2019, View Source [SID1234532484]).

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Paul Lammers, MD, MSc, President and Chief Executive Officer, will present at Biotech Showcase as follows:

Date: Monday, January 7, 2019
Time: 1:45PM (PST)
Room: Franciscan D, Level Ballroom
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San
Francisco, CA (United States)
Presentation: Triumvira Immunologics Company Overview and Progress in Key Programs/Technology

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

"We are delighted that Triumvira Immunologics will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is the perfect platform for life science companies to showcase their innovation and seek out their next deal. We are thrilled to, once again, be hosting what we believe will be the great strategic networking opportunity of 2019."

About Biotech Showcase
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year. Now in its eleventh year, this rapidly growing conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.

On January 4, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-301 (camidanlumab tesirine) in patients with selected solid tumors that are locally advanced or metastatic (Press release, ADC Therapeutics, JAN 4, 2019, View Source [SID1234596069]).

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ADCT-301 is already being evaluated in relapsed and refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, ADC Therapeutics presented interim data on 113 patients dosed in its Phase Ia/Ib clinical trial in lymphoma. In HL patients with a median of five prior lines of therapy and no other approved therapy options, the overall response rate was 86.5 percent, including a 43 percent complete response rate, at the dose being considered for a pivotal Phase II clinical trial that the Company anticipates initiating in 2019.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We continue to be very encouraged by the anti-tumor activity of ADCT-301 in Hodgkin lymphoma and non-Hodgkin lymphoma. In addition, based on the immune-oncology potential ADCT-301 has demonstrated in preclinical studies, we are excited to be starting this clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple difficult-to-treat solid tumor cancers."

ADCT-301 in Solid Tumors

At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, ADC Therapeutics presented preclinical data showing that an engineered version of ADCT-301 demonstrated highly potent anti-tumor activity, both as a monotherapy and in combination with a checkpoint inhibitor, in multiple solid tumor models with infiltrating CD25-positive regulatory T cells (Tregs).

Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics, said, "ADCT-301 targets CD25, which is expressed on Tregs that infiltrate the local tumor environment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25-negative solid tumors with infiltrating Tregs both as a monotherapy and in combination with a checkpoint inhibitor. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity."

The Phase Ib trial of ADCT-301 in patients with advanced solid tumors has both dose escalation and cohort expansion parts. The dose escalation part is designed to establish a safe and tolerated dose and dosing schedule of ADCT-301 in these patients. The identified dose and dosing schedule will be studied in the dose expansion part. Approximately 50 patients will be enrolled in the trial.

For more information about this Phase Ib clinical trial in solid tumors, please visit www.clinicaltrials.gov (identifier NCT03621982).

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. In addition to the Phase Ib clinical trial in solid tumors, ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235).