On October 30, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported financial results for the third quarter ended September 30, 2018 (Press release, Aduro Biotech, OCT 30, 2018, View Source;p=RssLanding&cat=news&id=2374236 [SID1234530366]). Net loss for the third quarter of 2018 was $23.1 million, or $0.29 per share, and for the nine months ended September 30, 2018 net loss was $69.0 million, or $0.88 per share, compared to net loss of $24.5 million, or $0.33 per share, and net loss of $65.7 million, or $0.92 per share, respectively, for the same periods in 2017.

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Cash, cash equivalents and marketable securities totaled $278.6 million at September 30, 2018, compared to $349.7 million at December 31, 2017.

"Our strong cash position enables us to advance our lead STING agonist, ADU-S100, and novel anti-APRIL antibody, BION-1301, toward maturing data from ongoing clinical studies. We look forward to presenting preliminary data on ADU-S100 at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C.," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro.

Revenue was $3.1 million for the third quarter of 2018 and $12.3 million for the nine months ended September 30, 2018, compared to $3.8 million and $13.5 million, respectively, for the same periods in 2017. The decrease in revenue for both periods was primarily due to the adoption of the ASC 606 accounting standard on January 1, 2018, which resulted in a change in revenue recognition methodology for our Novartis collaboration revenue.

Research and development expenses were $18.7 million for the third quarter of 2018 and $58.2 million for the nine months ended September 30, 2018, compared to $24.5 million and $66.5 million, respectively, for the same periods in 2017. The decrease in research and development expenses for both periods was primarily due to lower expenses for our antibody programs, including contingent consideration and contract manufacturing related to ADU-1604 and BION-1301, respectively.

General and administrative expenses were $9.1 million for the third quarter of 2018 and $27.0 million for the nine months ended September 30, 2018, compared to $8.5 million and $25.0 million, respectively, for the same periods in 2017. The increase in general and administrative expenses for both periods was primarily due to outside professional services and consulting costs as well as higher stock-based compensation expense.

On October 30, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Patent Application titled "Encapsulated Cells Producing Cytochrome P450 and Methods of Use Thereof," which covers a targeted therapy to treat solid cancerous tumors, was published in the United States on September 27, 2018, (Publication No. US 2018/0271794 A1) (Press release, PharmaCyte Biotech, OCT 30, 2018, View Source [SID1234530350]). Unlike the previously announced PCT Application, which was international in nature, this Patent Application is specific to the United States.

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PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, stated, "This patent application in concert with the previously announced PCT application (Publication No. WO 2018/175576) that was filed to gain protection in most major markets worldwide, if granted, will provide protection for PharmaCyte’s technology for 20 years without a gap in patent protection – until March 2038.

"Publication of this U.S. Patent Application by the U.S. Patent and Trademark Office (USPTO) is significant in allowing us to protect our unique complex cancer therapy for many years in this country. This development becomes more and more important as we progress with our clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

"As described in the Patent Application, through use of the Cell-in-a-Box live-cell encapsulation technology, PharmaCyte may be able to develop unique therapies for other forms of solid tumors, particularly where safety and efficacy are of major concern."

This Patent Application also includes methods of treating cancerous tumors other than pancreatic cancer, such as those of the liver, breast and colon. This could be accomplished by using cancer prodrugs such as ifosfamide and its "sister" drug cyclophosphamide together with encapsulated live human cells that overexpress a form of the cytochrome P450 enzyme system normally found in the liver (the same encapsulated cells used in PharmaCyte’s pancreatic cancer therapy). The patent application also includes using PharmaCyte’s platform technology with other cancer chemotherapy prodrugs against a variety of tumors other than those noted above. In all cases, the Cell-in-a-Box cellulose-based-live-cell encapsulation technology will be used to prepare the "biologic" part of any of the cancer treatments.

The original Provisional Patent Application that preceded the current application was filed with the USPTO on March 21, 2017, well before the Bavarian Nordic patents expired. The current application was filed with the USPTO on March 21, 2018. There should be no gap in patent protection assuming PharmaCyte’s patent application is granted

On October 30, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the third quarter ending September 30, 2018 on Wednesday, November 7, 2018, before the U.S. financial markets open (Press release, Alnylam, OCT 30, 2018, View Source;p=RssLanding&cat=news&id=2374231 [SID1234530367]).

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Management will provide an update on the Company and discuss third quarter 2018 results as well as expectations for the future via conference call on Wednesday, November 7, 2018 at 8:30 am ET. To access the call, please dial 800-667-5617 (domestic) or 334-323-0509 (international) five minutes prior to the start time and refer to conference ID 7650424. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to conference ID 7650424.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

On October 30, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that its abstract describing new data from the Company’s adaptive Phase 1 clinical trial for ZW25 has been selected for a plenary session presentation at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held in Dublin, Ireland from November 13-16, 2018 (Press release, Zymeworks, OCT 30, 2018, View Source [SID1234530386]).

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The abstract (No. 6), entitled, "Single agent activity of ZW25, a HER2-targeted bispecific antibody, in HER2-expressing gastroesophageal and other cancers," is scheduled for presentation on November 14, 2018 at 2:45pm GMT during plenary session 2 in the auditorium at the Convention Centre. These data will be presented by Dr. Murali Beeram, a haematologist-oncologist and clinical investigator at the START Center for Cancer Care, San Antonio, United States.

About ZW25

ZW25 is being evaluated in a Phase 1 clinical trial in the United States and Canada. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function and has led to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2.

On October 30, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 trial with the initial goal to evaluate safety, tolerability and pharmacokinetics of the Company’s KRAS G12C inhibitor, MRTX849, in patients with advanced solid tumors (Press release, Mirati, OCT 30, 2018, View Source [SID1234530351]). The trial will utilize an accelerated titration design with single patient cohorts and intra-patient dose escalation to rapidly achieve an active dose level for MRTX849. Phase 2 expansion cohorts will enroll patients whose tumors are driven by KRAS G12C positive mutations. The Phase 2 portion of the trial in patients with non-small cell lung cancer (NSCLC) or colorectal cancer (CRC) may provide proof of concept and the basis for accelerated approval.

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"MRTX849, is a potent, highly selective inhibitor of G12C positive mutations. These mutations occur in large patient populations with NSCLC and CRC tumors, and are also present in patients with other solid tumors, such as pancreatic cancer. We submitted the IND on October 29th, 2018 and plan to begin enrolling patients soon after FDA approval is received. The trial is designed to enable early clinical efficacy data in 2019," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer, Mirati Therapeutics, Inc. "KRAS has long been one of the most difficult targets in all of oncology and this program has the potential to be a breakthrough for patients with G12C positive mutations."

"KRAS has been an elusive target for researchers for more than 30 years. It’s exciting to see an IND filing that would potentially provide a therapy for patients with G12C mutations, which were once considered undruggable and who have had no viable treatment options," said Channing J. Der, Ph.D., the Sarah Graham Kenan Professor of Pharmacology at the University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center.

About MRTX849

MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C-positive pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.