On October 31, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that overall survival data from two Phase I clinical trials of its wholly owned, lead programme, IMCgp100, in metastatic uveal melanoma will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting (Press release, Immunocore, OCT 31, 2017, View Source [SID1234521335]). This year’s SITC (Free SITC Whitepaper) is taking place 8 – 12 November, 2017, at the Gaylord National Resort & Convention Center in National Harbor, Maryland in USA.

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Poster Presentation Information:
Title: Safety, efficacy and biology of the gp100 TCR-based bispecific T cell redirector, IMCgp100 in advanced uveal melanoma in two Phase 1 trials
Authors: Richard Carvajal, Takami Sato, Alexander N. Shoushtari, Joseph Sacco, Paul Nathan, Marlana Orloff, Pippa Corrie, Neil Steven, Jeff Evans, Jeffrey Infante, Mario Sznol, Clive Mulatero, Omid Hamid, Leonel Hernandez-Aya, Nicola Little, Cheryl McAlpine, David Krige, Namir J. Hassan, Sanjay Patel, Ann-Marie Hulstine, Christina M. Coughlin, Mark R. Middleton
Category: Clinical Trials (Completed)
Date: Saturday 11 November 2017
Time: 12:30 – 14:00 & 18:30 – 20:00
Abstract Number: P208

The details of the clinical trial can be found on clinicaltrials.gov.

Furthermore, a poster presenting findings from a study mapping the treatment pathway for patients with metastatic uveal melanoma in England will be presented.

Title: Mapping the treatment pathway for metastatic uveal melanoma (mUM) patients in England: A qualitative pilot study
Authors: Elisabeth Adams, Chih-Yuan Cheng, Joseph Sacco, Sarah Danson, Pippa Corrie, Paul Nathan, Peter Szlosarek, Joanne Upton, Abolore Amuludun, Toby Toward
Category: Best Practices for Improving Cancer Immunotherapy Treatment Administration and Polypharmacy Management
Date: Friday 10 November 2017
Time: 12:30 – 14:00 & 18:30 – 20:00
Abstract: P437

To view the posters, please visit the SITC (Free SITC Whitepaper) website at View Source

SITC is the world’s leading member-driven organisation specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.

On October 31, 2017 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will report third quarter 2017 financial results and provide a corporate update on Wednesday, November 8, 2017 at 8:30 am ET (Press release, Protalix, OCT 31, 2017, View Source [SID1234521353]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: (844) 358-6760; International: (478) 219-0004. Conference ID number 6767278.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On October 31, 2017 Minneapolis-based Humanetics Corporation (Humanetics) reported data at the annual meetings of the American Society for Radiation Oncology (ASTRO) and the Radiation Research Society (RRS) (Press release, Humanetics, OCT 31, 2017, View Source [SID1234521342]). The annual ASTRO meeting was held September 24th through the 27th in San Diego, California and the annual RRS meeting was held October 15th through the 18th in Cancun, Mexico. Dr. Zeljko Vujaskovic, M.D., Ph.D., a professor of radiation oncology at the University of Maryland School of Medicine (UMSOM) and director of the school’s Division of Translational Radiation Sciences, and Michael Kaytor, Ph.D., vice president of research and development at Humanetics, respectively, presented data related to Humanetics’s new drug candidate, BIO 300, which is being evaluated as a potential treatment to prevent erectile dysfunction in patients undergoing radiotherapy for prostate cancer.

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Prostate cancer is the most common non-skin cancer affecting men in the U.S. According to the National Cancer Institute (NCI), nearly 162,000 men will be diagnosed with prostate cancer in the U.S. in 2017, representing approximately 20% of all new cancers in men. While survival rates are high, radiation-induced erectile dysfunction (ED) is a common and lingering side effect associated with prostate radiotherapy. Nearly half of all men undergoing radiation treatment for prostate cancer will experience some level of ED.

Data presented included the results of nonclinical studies that were conducted at UMSOM. These studies demonstrated the potential of BIO 300 to both mitigate radiation-induced ED and also to improve the effectiveness of radiation therapy to kill tumors. “These compelling results show the promise of BIO 300 to enhance a prostate cancer patient’s quality of life, while also directly impacting the ability of radiation therapy to kill the tumor,” said Dr. Vujaskovic. “If this result can be translated to the clinical treatment of prostate cancer, it would represent a breakthrough in prostate cancer treatment outcomes.”

At present, there are no FDA-approved drugs to mitigate radiation-induced ED. “BIO 300’s potential to enhance radiation’s killing effect on the tumor while reducing treatment-related side effects is unparalleled,” said Dr. Kaytor. “These findings support the advancement of BIO 300 into a human efficacy study, which is anticipated to begin in 2018.”

BIO 300 is in development for prevention and mitigation of toxicities associated with radiation exposure for the treatment of multiple cancers and is currently in a Phase Ib/IIa clinical trial in patients with non-small cell lung cancer who are receiving chemoradiotherapy.

On October 31, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported an important update on its HuMab-5B1 clinical program as well as presented preclinical data for its HuMab-Tn research program describing a new series of fully-human antibodies targeting ovarian and breast cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) held October 26 – 30, 2017 in Philadelphia, Pennsylvania (Press release, MabVax, OCT 31, 2017, View Source [SID1234521357]).

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

Three posters were presented by Paul W. Maffuid, Ph.D., Executive Vice President of Research and Development, outlining important progress in the Company’s lead fully human antibody programs, HuMab-5B1 currently in Phase 1 clinical development for the treatment of pancreatic cancer and other CA19-9 positive malignancies, and HuMab-Tn currently in preclinical development with potential clinical utility in breast and ovarian cancers.

MVT-5873 in combination with nab-paclitaxel and gemcitabine as first line therapy – The Company reported that newly diagnosed pancreatic cancer patients participating in the Phase 1 clinical trial of MVT-5873, when given in combination with first line nab-paclitaxel and gemcitabine, demonstrated reductions in tumor size after the first two months of therapy. The data reported from this dose escalation safety study included safety data from 7 patients at 1mg/kg and 0.125mg/kg. After the first cohort was treated at 1mg/kg, the MVT-5873 dose was reduced to 0.125 mg/kg in combination with nab-paclitaxel and gemcitabine as the lower dose appears to be generally well tolerated. Two of 3 patients at this lower dose had a partial response (PR) with the remaining patient recording stable disease (SD). One patient continues therapy after six-months. The Company is currently enrolling an additional cohort of patients at the 0.125mg/kg cohort and expects to report on additional data near the end of this year.

Utility of HuMab-5B1 (MVT-5873) in cancers beyond pancreatic cancer – At the AACR (Free AACR Whitepaper)-NCI-EORTC meeting, the Company presented a series of studies examining expression of CA19-9 on tumor microarrays (TMA) and patient derived tumor xenografts (PDX). The results support the expansion of clinical studies of MVT-5873 for the treatment of other CA19-9 positive malignancies, including colorectal, small cell lung and non-small lung cell cancers. Human colorectal (CRC) TMA samples displayed moderate to high levels of positive staining with MVT-5873 in >75% of tumor samples evaluated. MVT-5873 staining of PDX samples was positive in 21% of non-small cell lung cancer (NSCLC), 50% of small cell lung cancer (SCLC), and 69% of CRC cores evaluated. The study included PDX samples from patients with KRAS, BRAF, PIK3CA, or MMR pathway mutations and PDX samples rendered chemoresistant. These results support that expression of CA19-9 in these tumor types is unaffected by mutational status or treatment with chemotherapy. Based on these encouraging data, the Company plans to enroll and treat patients in its ongoing clinical trials with tumor types beyond pancreatic cancer. The Company has previously reported Phase 1a results for MVT-5873 as a single agent in pancreatic cancer patients.

New antibodies focused on the treatment of breast and ovarian cancer – The Company presented data from its lead preclinical development program summarizing the discovery, optimization, and target validation of new series of fully-human antibodies targeting the Thomsen-nouveau (Tn) and the sialyl Tn (sTn) carbohydrate antigens that have potential use for the treatment of patients with ovarian and breast cancers. Tissue microarray data support that these carbohydrate antigens are present on a broad array of tumor types and minimally seen on normal tissues. The results summarized the binding specificity, high affinity, and internalization data that make this series of antibodies attractive as development candidates. Target validation data included screening against multiple patient tumor microarrays of breast, lung, ovarian and colon cancer. 90% of samples from patients with triple negative breast cancer and 50% of samples from patient with ovarian cancer tested positive. A patent application covering this series of antibodies was recently filed by the Company and it is actively advancing the lead series.

On October 31, 2017 Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that third quarter 2017 financial results will be released on Tuesday, November 7, 2017 before the market opens (Press release, Cambrex, OCT 31, 2017, View Source [SID1234521350]).

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The Company will host a conference call to discuss the financial results.

Third Quarter 2017 Earnings Conference Call

When: Tuesday, November 7, 2017 at 8:30 a.m. Eastern Time

Dial-in:

1-866-548-4713 for U.S.
1-323-794-2093 for International
Passcode: 1511082
Dial-in Replay:

1-888-203-1112 for U.S.
1-719-457-0820 for International
Passcode: 1511082
Available through Tuesday, November 14, 2017
Webcast: www.cambrex.com