On September 15, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM), reported that the final results of its SM-88 Phase II Prostate Cancer study designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with non-metastatic biochemical recurrent prostate cancer, was published on September 13th, 2020 in the peer-reviewed journal Investigational New Drugs (Press release, TYME, SEP 15, 2020, View Source [SID1234565184]). The article, titled "Phase II Trial of SM-88, a Cancer Metabolism Based Therapy, in Non-Metastatic Biochemical Recurrent Prostate Cancer," is available online at View Source

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The study demonstrated that SM-88 had promising efficacy and safety outcomes for prostate cancer patients while sparing testosterone. The study also demonstrated a reduction of CTCs, an important prognostic indicator, that may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88.

"Oral SM-88 has demonstrated potential efficacy and a well-tolerated safety profile that may represent a new treatment option for more than 450,000 prostate cancer patients in the U.S. alone seeking a non-cytotoxic, non-hormonal therapy," said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. "We are encouraged by the clinical results of our unique proprietary approach using cancer metabolism-based therapies that we believe attack the cancer cells from within, interrupting the cancer metabolic processes."

From September 2016 to April 2019, twenty-three evaluable patients with non-metastatic pancreatic cancer with rising PSA levels, detectable circulating tumor cells and no radiographically detectable metastases were assessed in a Phase II trial. All patients received 230 mgs twice per day of SM-88 orally. Patients also received oral doses of methoxsalen (10 mg), phenytoin (50 mg), and sirolimus (0.5 mg) once per day. Most patients had previously received androgen-deprivation therapy (ADT) after radiation therapy or surgery, but ADT treatment changes were not permitted during the trial.

From the initial diagnoses of PSA rise, 100% of patients (23/23) remained free of metastatic progression (MFS) and 87% of patients (20/23) have maintained radiographic progression-free survival (rPFS) with a median duration of therapy of 6.5 months since starting SM-88 treatment. All patients who have maintained meaningful reductions in circulating tumor cells (CTCs) on SM-88 were 100% free of any radiographic progression.

At baseline, the median PSA for patients with radiographic progression was 13.4 compared to 5.6 for patients with no radiographic progression (p=0.02). Among evaluable patients, PSA stabilized in 83% of patients (19/23). Importantly, 52% of evaluable patients (12/23) experienced an improvement in median PSA doubling time (DT), a positive prognostic indicator. In all patients who completed three cycles of therapy, the median DT improved nearly 34.4% from 6.1 to 8.2 months (n=20). After 12 weeks, or three cycles of therapy, 78.2% of patients (18/23) demonstrated a decrease in CTC from baseline, with a median decrease of 65.3%.

Patients without local progression (20/23) had slightly higher testosterone levels at baseline and throughout treatment on SM-88 as compared to those who experienced local radiographic progression (3/23). According to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, patients generally reported stable cognitive and sexual function domain measures, with no detectable worsening in any domain. Patient weight, EKG QTc, glucose and hematocrit and other measures, which are often side effects of ADT, did not appear affected while receiving SM-88.

The SM-88 therapy was well tolerated in all patients. There were no treatment-related serious adverse events. No adverse events resulted in dose delay, discontinuation, or reduction. The majority of Grade 1 AEs possibly or probably related to the SM-88 investigational therapy were gastrointestinal in nature.

The Phase II prostate cancer trial results are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition.

About Advanced Prostate Cancer

Prostate cancer is the most common malignancy in men, accounting for approximately 31,620 deaths in the United States in 2019.1 Approximately 15% of men with prostate cancer present with metastatic disease, and 20% to 30% of men with localized disease treated with definitive local therapy subsequently develop metastatic disease. While the vast majority of patients with metastatic disease demonstrate a transient response to androgen deprivation, eventually all patients develop hormone refractory prostate cancer (HRPC) and virtually all prostate cancer deaths are due to the development of metastatic HRPC.2 While chemotherapy regimens have shown a modest survival advantage in HRPC patients, median survival remains approximately 19 months,3,4 and not all patients are candidates for chemotherapy. Novel agents and new approaches such as oral cancer metabolic-based therapies are needed.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

On September 15, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), reported that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") solely by means of remote communication (i.e., a virtual-only stockholder meeting) (Press release, Avid Bioservices, SEP 15, 2020, View Source [SID1234565216]). This change is to protect the safety, health and well-being of its stockholders, directors, employees and the public during the COVID-19 pandemic. As previously announced, the Annual Meeting will be held on Tuesday, October 20, 2020 at 10:00 a.m. PDT.

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Stockholders will not be able to attend the Annual Meeting in person at a physical location. However, the virtual Annual Meeting will provide stockholders of record as of the close of business on August 24, 2020, the ability to participate, vote their shares and ask questions during the meeting via audio webcast.

Despite the change to a virtual-only meeting, the proxy card or voting instruction form, as applicable, included with previously-distributed proxy materials will not be updated to reflect the change from an in-person meeting to a virtual-only meeting and may be used to vote shares in connection with the Annual Meeting.

As provided in the company’s proxy materials, an online portal is available to stockholders at www.proxyvote.com where stockholders can view and download the company’s proxy materials and fiscal year 2020 Annual Report and vote their shares in advance of the Annual Meeting. Stockholders may vote their shares during the Annual Meeting (up until the closing of the polls) by following the instructions available at www.virtualshareholdermeeting.com/CDMO2020 during the meeting.

To be admitted to the virtual-only Annual Meeting, stockholders should visit www.virtualshareholdermeeting.com/CDMO2020 and enter the 16-digit control number found on their Important Notice Regarding the Availability of Proxy Materials, their proxy card or the instructions that accompanied their proxy materials.

Below are additional details on how stockholders can participate in the virtual-only Annual Meeting:

Access the meeting platform beginning at 9:45 a.m. PDT on October 20, 2020.

Vote during the Annual Meeting by following the instructions available on the meeting website during the meeting.

Submit a question during the meeting by visiting www.virtualshareholdermeeting.com/CDMO2020 and entering the stockholder’s 16-digit control number and submitting the question in the "Ask a Question" field.

If any difficulties are encountered while accessing the virtual meeting, contact the technical support number that will be posted on the Virtual Shareholder Meeting log-in page. Technical support will be available beginning at 9:45 a.m. PDT on October 20, 2020 and will remain available until the meeting has ended.

A list of stockholders entitled to vote will be available for inspection by stockholders of record for any legally valid purpose related to the Annual Meeting during the Annual Meeting by following the link provided when stockholders login to www.virtualshareholdermeeting.com/CDMO2020 and for a period of ten days prior to the Annual Meeting by sending a request to [email protected].
Whether or not stockholders plan to attend the virtual-only Annual Meeting, the company urges stockholders to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials

On September 15, 2020 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a scientific collaboration with Brigham and Women’s Hospital, a world-class academic medical center and a major teaching hospital of Harvard Medical School based in Boston, Massachusetts (Press release, BostonGene, SEP 15, 2020, View Source [SID1234565190]).

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In this collaboration, BostonGene provides the analysis of whole transcriptome sequencing (RNA seq) data sets generated from tumor and blood samples from patients with recurrent glioblastoma (GBM) treated with an oncolytic virus as part of a Phase I clinical trial. As part of the effort, BostonGene correlation analysis aims to identify novel biomarkers of response to therapy. The collaboration will further demonstrate the powerful advantages of transcriptomic data analysis for prediction of the response to novel therapies for malignant brain tumors.

"We are very excited to enter into this collaboration with BostonGene in our efforts to fully understand the molecular underpinnings of responses to novel engineered viruses-based therapies," said Ennio Antonio Chiocca, MD, PhD, Neurosurgeon-in-Chief and Chairman, Department of Neurosurgery at Brigham and Women’s Hospital. "This collaboration is another step in allowing us to make better individual treatment decisions for patients with GBM."

"We’re honored to collaborate with Brigham and Women’s Hospital to demonstrate the clinical utility of BostonGene’s analytical tools that have been designed to improve diagnosis and treatment decisions for cancer patients," said Andrew Feinberg, President & CEO at BostonGene. "We firmly believe that advanced computational analytics will better equip physicians as they identify personalized treatment plans."

On September 15, 2020 Carina Biotech and Sydney-based immuno-oncology company Glytherix reported a co-development agreement that could result in a promising new CAR-T therapy that is effective in killing a range of cancers (Press release, Carina Biotech, SEP 15, 2020, View Source [SID1234565138]).

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Glytherix is developing its proprietary antibody Miltuximab for the targeted treatment of a number of cancers. Miltuximab is specific for GPC-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue.

The agreement with Glytherix will see Carina use its CAR-T development platform to create and optimise a library of CAR-T cells targeted at GPC-1, creating jointly owned IP.

This is the second recent commercial deal for Carina, after it sold the IP rights to its first successful CAR-T cell to UK-based biopharmaceutical company Biosceptre in July 2020.

Deborah Rathjen, PhD, CEO of Carina Biotech says: "We are delighted to have partnered with Glytherix, a company that shares our vision of defeating cancer. Carina Biotech has substantial experience in creating potent, targeted CAR-T cell-based therapies. Combining our knowledge and expertise, we believe will lead to the identification of a GPC-1-targeted CAR-T cell that is effective in killing a range of cancers."

Brad Walsh, PhD, CEO of GlyTherix Ltd, commented: "We are excited to commence our CAR-T development program with Carina Biotech, whose expertise, track record and experienced management made it an easy choice. We are looking forward to working together on this unique target with a view to making a difference in the lives of cancer patients, particularly those with currently limited treatment options."

ABOUT GLYTHERIX Glytherix, is an Australian immuno-oncology company specialising in therapeutics for solid tumours expressing Glypican-1 (GPC-1), the basis for its proprietary antibody Miltuximab. Glytherix are investigating multiple mechanisms of action including radioimmunotherapy, bi-specific antibodies and immune cell engagement and activation. They have completed a ‘first-in-human’ clinical trial of 12 patients with advanced prostate, bladder and pancreatic cancer using Miltuximab, with no drug-related adverse events observed. Glytherix are based in Sydney, adjacent to Macquarie University and the Macquarie University Hospital, one of their key collaborators.

On September 15, 2020 Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported the appointment of Mark Rothera as President and Chief Executive Officer (CEO) and Board member, effective immediately (Press release, Silence Therapeutics, SEP 15, 2020, View Source [SID1234565163]). Iain Ross, who has been Executive Chairman since December 2019, has today assumed his previous position of Non-Executive Chairman.

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Mr. Rothera brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of commercial and operational leadership, including driving the successful build of multiple biotech companies, predominantly in the field of rare or specialty diseases.

Prior to joining Silence, Mr. Rothera served as CEO of Orchard Therapeutics (Orchard), where he oversaw its transformation from a small U.K.-based, privately held company with two clinical-stage programmes into a leading gene therapy company with seven clinical-stage programmes and fully integrated capabilities. Under his leadership, Orchard completed an initial public offering of American Depositary Shares on the Nasdaq Global Market and during his tenure that company secured more than $600 million in financing and grew from a market capitalization of $250 million to more than $1.7 billion at its peak. Prior to Orchard, Mr. Rothera served as Chief Commercial Officer of PTC Therapeutics (PTC), where he helped transition that company from a privately held R&D biotechnology company to a publicly traded, commercial-stage company with a global footprint, including the successful launch of two rare disease therapies. He also previously served as Global President of Aegerion Pharmaceuticals Inc. and Vice President and General Manager of commercial operations at Shire Human Genetic Therapies for Europe, Middle East and Africa. Mr. Rothera received an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

Based out of Silence’s New York City office, Mr. Rothera will lead the continued global expansion of the Company. His appointment follows the completion of Silence’s Nasdaq listing on 8 September 2020 and aligns with the strategy of increasing the Company’s presence in the United States.

Iain Ross, Chairman of Silence Therapeutics plc, said: "On behalf of the Silence Board and the entire Silence team, I welcome Mark to the Company. Following a thorough search, Mark’s appointment reflects his proven leadership skills and strong track record in growing successful biotechnology companies and building shareholder value. I believe he will now provide the leadership necessary to grow Silence into a leading international biotechnology company built upon our innovative siRNA technology platform, proprietary product pipeline and validating industry partnerships.

"On a personal note, and on behalf of the Board, I would like to thank the management team and staff at Silence for theirsupport, hard work and tremendous resilience during the current COVID-19 pandemic and over the past nine months whilst I have been Executive Chairman. The Company has made great strides during this period, and is now in a strong position, both operationally and financially, and ready for Mark to take the helm.

" Mark Rothera, President and CEO of Silence Therapeutics plc, added: "It is an honour to take the role of leading Silence at this time in the Company’s history. I believe the Company is poised to capitalise on its important siRNA technology platform, pipeline and research capabilities built over 18 years, and position itself as a leader in the RNAi field. The Company has made great strides under Iain’s leadership and I look forward to working with the Board, the management team and Silence employees to build upon this momentum."