On May 8, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that an abstract highlighting X4P-001-IO, the company’s CXCR4 antagonist, has been selected for poster and oral presentation at the 16th Annual Meeting of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), taking place May 15-17 in Mainz, Germany (Press release, X4 Pharmaceuticals, MAY 8, 2018, View Source [SID1234526276]). The presentations will describe clinical results from a pilot study of X4P-001-IO in combination with Opdivo (nivolumab) in patients with clear cell renal cell carcinoma (ccRCC), expanding the range of combination treatment settings in which X4P-001-IO has been studied.

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Details of the presentations on X4P-001 are as follows:

Title: The safety, tolerability, and preliminary clinical activity of the CXCR4 inhibitor X4P-001 and nivolumab in renal cell carcinoma patients that are refractory to nivolumab monotherapy

Author: David F. McDermott, M.D., Beth Israel Deaconess Medical Center, Harvard Medical School

Abstract #: 77

Poster Session: Tumor Biology and Interaction with the Immune System, May 15th, 3:00 – 5:00 PM CET

Oral Presentation Session: Clinical Trials, May 17th, 11:45 AM – 1:00 PM CET

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule antagonist of C-X-C receptor type 4 (CXCR4). CXCR4 is a chemokine receptor present in abundance on certain immune cells and cancer cells and it plays a critical role in immune cell trafficking, infiltration and activation in the tumor microenvironment. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment. X4P-001-IO has the ability to help restore immunity within the tumor microenvironment and has the potential to enhance the anti-tumor activity of approved and emerging oncology agents, such as checkpoint inhibitors and targeted therapies. X4P-001-IO is being investigated in several clinical studies in solid tumors.

On May 8, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, and Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, reported the presentation of new preclinical data supporting ALG.APV-527 as a promising new immunotherapeutic candidate for the treatment of a variety of 5T4-expressing solid tumors (Press release, Alligator Bioscience, MAY 8, 2018, View Source [SID1234538677]).

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ALG.APV-527 is designed to simultaneously target 5T4 and the co-stimulatory receptor 4-1BB (CD137) to promote potent, tumor-directed immune T-cell activation. 5T4 is a well-defined tumor antigen expressed on many different types of malignancies including, non-small cell lung, renal, pancreas, prostate, breast, colorectal, gastric, ovarian and cervical cancers. Conversely, 5T4 has limited expression on normal tissues, making it an attractive target for cancer immunotherapy.

New ALG.APV-527 preclinical data show that ALG.APV-527 has the potential to selectively activate and enhance tumor specific T cell responses at the tumor site without triggering systemic immune activation. Notably, the preclinical in vitro and in vivo data show that ALG.APV-527:

Stimulates increased T cell activation in the presence of 5T4-expressing cells
Localizes to the site of 5T4 positive tumors in an in vivo melanoma tumor model
Inhibits tumor growth in a 5T4 expressing in vivo human colon carcinoma model
Has an extended, antibody-like serum half-life of 9 days in an experimental model
The data were recently presented at the PEGS Summit 2018 and American Association of Immunologists (AAI) annual meeting and will be presented next week at the Annual Meeting of Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper).

"Taken together, the accumulating preclinical data package for ALG.APV-527 support its potential to provide effective tumor-directed immune activation with reduced systemic side effects. We are continuing to advance this candidate and look forward to commencing clinical development in 2019," said Christina Furebring, Senior Vice President Research at Alligator.

"Our collaboration with Alligator Bioscience continues to yield encouraging data supporting the advantages of this novel pathway for targeted immunotherapy of cancer," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "As a first-in-class molecule, ALG.APV-527 showcases the versatility of our ADAPTIR platform in generating bispecific antibodies with unique mechanisms of action and a therapeutic profile that is more consistent with traditional antibodies, including an extended half-life, desirable antibody-like manufacturing characteristics and increased potency and stability."

Aptevo and Alligator believe that the precise targeting of 4-1BB within the tumor microenvironment can overcome some of the limitations seen with other 4-1BB therapies. ALG.APV-527 employs a novel mechanism of action, 4-1BB x 5T4 binding, to direct the therapeutic immune response towards the tumor, thereby potentially reducing the harmful side effects of systemic immune stimulation while providing a strong tumor directed immune activation.

About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo’s ADAPTIR bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD human scFV library. The ALG.APV-527 bispecific antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other part binding to the 5T4 protein expressed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.

On May 8, 2018 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 the Company has expanded its collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop the next generation of genetically engineered chimeric antigen receptor T-cell (CAR T) immunotherapies (Press release, Atara Biotherapeutics, MAY 8, 2018, View Source [SID1234526196]). This agreement is the next step in Atara’s strategy to leverage the potential of the Company’s technology platform to develop genetically modified off-the-shelf, allogeneic T-cell immunotherapies to transform the lives of patients with serious medical conditions.

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Under the agreement, Atara will gain access to several of MSK’s innovative enabling technologies, including a novel CAR T construct that Atara believes has physiologic T-cell activation properties, as well as methods for designing CAR T immunotherapies. Atara is also entering into an exclusive research collaboration for multiple targets with Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering at MSK, to employ next-generation technologies in developing novel CAR T immunotherapies with applications in oncology, autoimmune and infectious diseases.

Dr. Sadelain stated, "We are eager to work with Atara to continue advancing promising allogeneic T-cell immunotherapy technologies that originated at MSK. The new CAR T technologies seek to overcome persistent therapeutic challenges, such as safety and tolerability, durability of treatment response, and activity in areas of significant unmet medical need that are underserved by the current generation of CAR T immunotherapies."

"Our earlier MSK collaboration has been highly productive, highlighted by tab-cel, Atara’s off-the-shelf, allogeneic T-cell immunotherapy currently in Phase 3 development," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "The deepening of our collaboration with MSK allows us to rapidly advance novel gene-edited CAR T development programs leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities. Going forward, we plan to continue to assemble complementary genetic engineering technologies to grow our pipeline and realize the full potential of our platform."

On May 8, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that MediciNova will present a corporate overview at the UBS Global Healthcare Conference on Monday, May 21, 2018 at 9:00 am at the Grand Hyatt New York in New York City (Press release, MediciNova, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347957 [SID1234526227]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through UBS.

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On May 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported first quarter 2018 financial results and provided a corporate update (Press release, OncoMed, MAY 8, 2018, View Source [SID1234526243]). As of March 31, 2018, cash, cash equivalents, and short-term investments totaled $88.4 million.

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"The Company is encouraged by ongoing clinical progress on its two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, and preclinical data on these programs were recently highlighted in multiple poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We also continue to dose patients in two Phase 1b studies of navicixizumab, our anti-DLL4/VEGF bispecific antibody. We look forward to delivering on numerous near-term catalysts, including the initiation of the Phase 1b portion of the anti-TIGIT study in combination with anti-PD1 in the second quarter of this year, the publication of the navicixizumab Phase 1a manuscript and the presentation of the navicixizumab Phase 1b ovarian cancer data in the second half of 2018, and the planned presentation of the anti-TIGIT Phase 1a data in the fourth quarter of 2018," stated John Lewicki, Ph.D., President and CEO of OncoMed.

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate dosing of the Phase 1b portion of its Phase 1a/b anti-TIGIT (OMP-313M32) trial, in combination with anti-PD1, in the second quarter of 2018. The Phase 1b portion of the open-label clinical trial is designed to assess the safety, tolerability, preliminary efficacy, and pharmacodynamic biomarkers of escalating doses of OMP-313M32 in combination with anti-PD1 for the treatment of patients with solid tumors who have progressed after prior treatment with anti-PD1 or anti-PD-L1.
OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses of anti-TIGIT. Biomarkers will be assessed in this study which includes a single-agent dose expansion cohort.
The company currently expects to present data from the Phase 1a portion of the Phase 1a/b study in the fourth quarter of 2018.
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.
To date, OncoMed has enrolled approximately 100 patients across the Phase 1a and Phase 1b trials of navicixizumab.
The Phase 1a data are expected to be published in the second half of 2018, and interim data from the ongoing Phase 1b ovarian cancer study are also expected to be reported in the second half of 2018.
GITRL-Fc (OMP-336B11)

Robust enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.
The Phase 1a data are expected to be presented in 2019.
New product discovery

OncoMed continues to make strong progress in its pursuit of novel immune-oncology agents, including emerging opportunities from the TNF superfamily of ligands, using the company’s proprietary linkerless fully human trimer technology.
First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $88.4 million as of March 31, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $7.8 million for the first quarter of 2018, an increase of $1.6 million, compared to $6.2 million for the same period in 2017. The change in revenue was due to the effect of the adoption of the new revenue recognition standard in the first quarter of 2018. For further discussion regarding our adoption of the new revenue recognition standard and its effects, see page 12 of our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 8, 2018.

Research and development (R&D) expenses were $8.4 million for the first quarter of 2018, a decrease of $15.6 million, compared to $24.0 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and reduced headcount following the restructuring actions in April 2017.

General and administrative (G&A) expenses were $5.4 million for the first quarter of 2018, an increase of $0.4 million, compared to $5.0 million for the same period in 2017. The increase in G&A expenses was primarily due to an increase in personnel cost, including retention bonus and severance expenses in the first quarter of 2018, offset by a decrease in headcount as a result of restructuring actions in April 2017.

Net loss for the first quarter of 2018 was $5.6 million ($0.15 per share), compared to $22.6 million ($0.61 per share) for the same period of 2017. The change in year-over-year net loss was primarily due to lower operating expenses in the first quarter of 2018.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestone or opt-in payments.