On October 2, 2018 PharmAbcine, Inc, a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications reported that the company received "Study May Proceed Letter " from the US Food and Drug Administration (FDA) for the Investigational New Drug ("IND") application of its flagship antibody, TTAC-0001 (Press release, PharmAbcine, OCT 2, 2018, View Source [SID1234529710]). This enables the Company to begin opening US clinical trial sites for phase II clinical trial with bevacizumab (Avastin) refractory recurrent GBM patients.

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Recurrence of GBM is inevitable and recurrent GBM (rGBM) is one of the most aggressive and has the worst prognosis. The treatment options are limited with modest activity for rGBM. Therefore, there is no universally held standard of care available till now.

Patients with rGBM are suffering under cerebral edema and partially responded to bevacizumab. However, patients responded to bevacizumab ultimately become non-responder during the treatment and once patients become bevacizumab non-responder, unfortunately, there are no more therapeutic options.

Cerebral edema comes from excessive secretion of VEGF-A, B, C and D from brain tumors. While bevacizumab traps VEGF-A only, TTAC-0001 binds to VEGFR2 specifically and interferes the activation of VEGFR2 by VEGF-A, C and D.

TTAC-0001 has completed its phase IIa in recurrent GBM in Australia last year with clear safety profile (all DAE maintain within grade 2) and 25% disease control rate. rGBM patients in the study responded to TTAC-0001 for cerebral edema (>40%). No hypertension, hemorrhage, gastric/lung perforation or proteinuria have been observed.

Jin-San Yoo, CEO of PharmAbcine, Inc., commented: "As part of the study design, it was always planned that US trial sites would become part of our Bevacizumab refractory recurrent GBM Phase II clinical trial. We are pleased with today’s IND approval from the FDA as it will accelerate patient enrolment into the global bevacizumab recurrent GBM phase II trial. Moreover, the FDA’s decision is positive news for eligible American sufferers under this devastating condition who can now participate in the study."

This research was supported by Korea Drug Development Fund (KDDF) funded by MSIT, MOTIE and MOHW (Grant No. KDDF201509-07, Republic of Korea)

On October 2, 2018 Quentis Therapeutics, Inc., a biotechnology company developing therapies that target endoplasmic reticulum (ER) stress pathways, reported that FierceBiotech has named the company to its "Fierce15" list for 2018, designating Quentis as one of the most promising private emerging biotechnology companies (Press release, Quentis Therapeutics, OCT 2, 2018, View Source [SID1234529833]). Quentis also announced the appointment of industry veteran, Mark Murcko, PhD, to its Board of Directors.

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"Quentis is thrilled to be recognized by FierceBiotech at this stage in the company’s growth and development. The science and understanding of the role of ER stress in disease has advanced significantly, providing a path to develop new therapies with the potential to treat cancer and other diseases in a meaningful way. Our lead program has the potential to overcome suppression and restore normal immune-cell function in the tumor micro-environment leading to increased tumor killing and improved patient outcome," said Michael Aberman, MD, President and CEO of Quentis Therapeutics.

The endoplasmic reticulum (ER) is a structure within cells that is responsible for multiple functions, including serving as a sensor of cellular stress. Many diseases, including cancer, neurodegenerative, and autoimmune diseases, can cause persistent ER stress, triggering aberrant responses that disrupt normal cellular functions. The company’s lead program is a first-in-class IRE1α inhibitor designed to boost anti-tumor immunity in cancer. Quentis plans to advance a pipeline of programs designed to address ER stress in multiple diseases.

Sponsored by FierceBiotech, an internally recognized provider of life science news and analysis, Fierce15 is an annual award bestowed upon 15 privately held-life science companies that embody the word "fierce" – championing innovation and creativity in the face of intense competition. Now in its 16th year, recipients are selected from hundreds of private companies from around the world based on the strength of their technology and science, partnerships, investors and competitive market position.

New Appointment to Board of Directors

Quentis also announced that Dr. Murcko has joined its Board of Directors providing deep experience in drug discovery and development. Dr. Murcko is a Founder, Board member, and served as interim chief scientific officer of Relay Therapeutics. He is a senior lecturer in the Department of Biological Engineering at MIT and has served on scientific advisory boards and corporate boards of directors for a diverse range of organizations. Prior to co-founding Relay Therapeutics, Dr. Murcko was chief technology officer and chair of the Scientific Advisory Board of Vertex Pharmaceuticals. He previously worked at Merck Sharpe & Dohme, where he helped discover multiple drug candidates. Dr. Murcko has directly contributed to the development of seven marketed drugs over his career, is a co-inventor on more than 50 issued and pending patents, and has co-authored more than 85 scientific articles. He holds a PhD in organic chemistry from Yale University.

"I am excited to join the Board of Directors at this important time and look forward to collaborating with the talented Quentis team to realize the promise of ER stress in cancer and beyond," said Dr. Murcko

On October 2, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer of Synlogic, effective immediately (Press release, Synlogic, OCT 2, 2018, View Source [SID1234529712]). Dr. Brennan joined Synlogic as chief medical officer in 2016 and has served as interim president and chief executive officer since May 2018.

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"After conducting a thorough search process, it was clear to the board of directors that Aoife is the right person to lead Synlogic at this time in the company’s evolution," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife stepped into the interim role and rapidly demonstrated her effectiveness. Her broad experience across multiple stages of drug development and therapeutic areas, her demonstrated leadership abilities, and her ambitious vision for Synlogic, make her uniquely qualified for the job. We are confident that under her leadership, Synlogic will be well-positioned to deliver Synthetic Biotic medicines to patients."

"I appreciate the confidence and support of the board of directors and am thrilled to be selected to lead Synlogic as we pioneer the development of a completely new class of living medicines," said Dr. Brennan. "We have made great progress to date, advancing two Synthetic BioticTM programs into the clinic. I look forward to continuing to execute on our plans for the clinical development of our lead candidates while capitalizing on the broad applicability and potential of our novel platform to build a pipeline of therapies for patients with serious and life-threatening diseases."

Prior to joining Synlogic, Dr. Brennan spent six years at Biogen in roles of increasing responsibility, most recently as vice president and head of the Rare Disease Innovation Unit, which included programs ranging from pre-clinical to commercial. She has also led programs across multiple therapeutic areas including the late-phase development of nusinersen for spinal muscular atrophy and treatments for Hemophilia B and Hemophilia A, ALPROLIX and ELOCTATE. Earlier, Dr. Brennan was director of clinical development at Tolerx, a start-up biotech company focused on immunotherapy for Type 1 diabetes. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland and completed her post-graduate training in internal medicine, endocrinology and metabolism at the Royal College of Physicians in Ireland. Additionally, she completed post-doctoral training in clinical research and metabolism at the Beth Israel Deaconess Medical Center in Boston and is a graduate of the Harvard Medical School Scholars in Clinical Science Program.

On October 2, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported that the U.S. Congress urges the Centers of Medicare & Medicaid Services (CMS) to consider coverage of colorectal cancer screening blood tests as part of the approved 2019 Health and Human Services (HHS) Appropriations Bill (Press release, Epigenomics, OCT 2, 2018, View Source [SID1234530237]).

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According to the Appropriations report issued in concert with the Appropriations Bill signed into law on September 28, 2018 the U.S. Congress stated its intent by urging CMS to provide "…coverage of blood tests…(which) could serve to deter or immediately recommend the need for colonoscopy so as to increase the number of patients that go in for testing and decrease the amount of late-stage colon cancer diagnoses."

"We are very pleased that the U.S. Congress has urged CMS to cover FDA approved blood tests for colorectal cancer screening. We believe this is a positive step towards legislative approval," said Greg Hamilton, Chief Executive Officer of Epigenomics AG. "Colorectal cancer remains the second-leading cause of cancer death in the United States as still 1 in 3 or approximately 30 million Americans are not screened. CMS coverage of blood tests could help to increase screening participation rates and ultimately save lives."

In March 2018, Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM) introduced the "Colorectal Cancer Detection Act of 2018" to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) "Donald Payne Sr. Colorectal Cancer Detection Act" introduced by Congressman Donald M. Payne, Jr. (D – NJ) in 2017. These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood tests.

About colorectal cancer (CRC)

The American Cancer Society projects there will be over 140,000 new diagnosed cases of colorectal cancer, and over 50,000 deaths, from colorectal cancer in 2018 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened. While the 5-year survival rate for early colorectal cancer (stage I) is 90%, only four- out-of-ten cases are diagnosed at this early stage. According to the American Cancer Society, this is in part due to the underuse of screening.

About Epi proColon

Epi proColon is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

On October 2, 2018, Immunomedics, Inc. (the "Company") entered into privately negotiated exchange agreements (the "Exchange Agreements") with a limited number of holders ("Noteholders") of its outstanding 4.75% Convertible Senior Notes due 2020 (the "Convertible Notes"), pursuant to which the Company agreed to exchange, in a private placement in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended (the "Exchanges"), approximately $12.9 million in aggregate principal amount of the Convertible Notes held by the Noteholders for approximately 2.57 million newly issued shares of the Company’s common stock, par value $0.01 per share (Filing, 8-K, Immunomedics, OCT 2, 2018, View Source [SID1234530614]).

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The Company anticipates that the Exchanges will be completed on or about October 5, 2018. Upon completion of the Exchanges, the aggregate principal amount of the Convertible Notes is expected to be reduced to approximately $7.1 million.

The Company expects to file the form of Exchange Agreement as an exhibit to its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2018. The foregoing description is qualified in its entirety by reference to the complete text of the form of Exchange Agreement when filed.

This Current Report does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.