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.

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 [SID1234530532]). 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 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a paper published in a major cancer journal detailed results of a patient with head and neck cancer treated with MEDI0457 achieved a sustained complete response (full remission) on treatment with a subsequent PD-1 checkpoint inhibitor (Press release, Inovio, OCT 2, 2018, View Source [SID1234530271]). In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma the company reported 91% (20/22) showed T cell activity in the blood or tissue. MEDI0457­ – formerly called INO-3112 – was in 2015 licensed to MedImmune, the global biologics research and development arm of AstraZeneca. These immune data as well as the financial terms of the license agreement have been previously reported by Inovio.

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We are buoyed by the study as it lends support to all of our HPV and oncology programs. These data demonstrated that Inovio’s technology based in MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. The study supports our belief that this approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated head and neck and other types of cancer to improve therapeutic outcomes. Inovio is collaborating with MedImmune (w/ MEDI0457) as well as Genentech and Regeneron (w/ INO-5401) in efficacy trials coupling Inovio’s DNA-based cancer immunotherapies with checkpoint inhibitors designed to increase response rates with data expected in 2019."

An article in the most recent edition of Clinical Cancer Research highlights data from an Inovio-sponsored trial that demonstrated that after a cancer progressed a patient was subsequently given a PD-1 checkpoint inhibitor. The patient achieved a complete response, which has sustained for over two years and counting. Increasing evidence suggests that response rates from checkpoint inhibitors can be enhanced when used in combination with cancer vaccines like MEDI0457 that generate tumor-specific T cells. Interim data from a MEDI0457 monotherapy study of head and neck cancer patients demonstrated that MEDI0457 generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples.

Charu Aggarwal, MD, MPH, the study’s principal investigator and an assistant professor of Hematology-Oncology at the University of Pennsylvania’s Perelman School of Medicine, said, "We wanted to know if this vaccine (MEDI0457) can boost the immune systems of patients with HPV-related head and neck cancer, potentially opening the door for better response rates to other existing therapies, and our findings show that we can."

The article notes that researchers administered four doses of MEDI0457 to 21 patients separated into two different groups. One group received a dose before surgery, followed by three doses after surgery. The second group received four doses following chemotherapy and radiation. Eighteen out of the 21 patients showed elevated T cell activity that lasted at least three months after the final vaccine dose, meaning the immune effect persisted for at least six months from the start of immunotherapy. Five tumors were biopsied both before and after one dose of the vaccine, and there was evidence of T cells infiltrating into tumors and expressing proteins associated with cell killing potential.

"We have not seen that kind of T cell infiltration with just one dose of a vaccine before," Dr. Aggarwal added. "These findings open the door for utilizing targeted immunotherapy approaches against specific cancer-causing targets like HPV."

Overall the characteristics of these immune response data mirrored those previously observed in a Phase 2b clinical study of VGX-3100 for HPV-associated cervical dysplasia. In that study, strong CD8+ T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints. VGX-3100, which is currently in global REVEAL 1 Phase 3 trial, is the first therapy to demonstrate that activated killer T cells induced in the body have the power to clear neoplastic lesions as well as the virus which caused the disease.

About MEDI0457 and VGX-3100

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which MedImmune in-licensed from Inovio) is under evaluation by MedImmune to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, currently infecting about 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2018 an estimated 48,330 persons will get oral cavity or oropharyngeal cancer in the U.S. New cases of head and neck cancer occur nearly three times more often in men as in women. Incidence rates of head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing.

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 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported its updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Cellectar Biosciences, OCT 2, 2018, View Source [SID1234530173]).

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The results to date show that OS is currently at 19.4 months. Cellectar continues to monitor these patients and intends to update OS results as data become available. All 15 patients from the Phase 1b, single-dose cohorts were heavily pretreated, receiving an average of 5 previous lines of multidrug therapy including anti CD38, immunomodulating drugs and proteasome inhibitors. All patients were relapsed or refractory to at least one proteasome inhibitor and IMiD. Most patients presented with advanced stage 2 or 3 disease and 67% had previously received at least 1 stem cell transplant.

"We are extremely pleased to announce that CLR 131 has achieved OS of 19.4 months in our Phase 1b trial in R/R MM. We view this outcome as impressive considering all patients were heavily pretreated and presented with high tumor burden," said James Caruso, president and chief executive officer of Cellectar Biosciences. "Most drugs currently approved for third-line or later R/R MM average approximately 12 months of survival, including several recent approvals. We believe extending OS to beyond 19 months with a more patient-friendly dosing regimen provides both a unique product profile and potential for beneficial patient outcomes."

The objective of this multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 administered as a single-dose, 30-minute infusion in patients with R/R MM. Patients received doses of 12.5 mCi/m2 up to 31.25 mCi/m2. All doses were deemed safe and well tolerated by an independent data monitoring committee.

Data from a fifth cohort, released in August, evaluated a split or fractionated dose of 31.25 mCi/m2 for tolerability and safety. The dosing schedule provided higher average drug exposure but lower peak serum levels than non-fractionated dosing potentially reducing adverse events and improving efficacy. The independent Data Monitoring Committee (DMC) determined the fractionated dose used in Cohort 5 to be safe and well tolerated and recommended advancement to a higher dose cohort.

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in R/R MM and a range of B-cell malignancies and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2. All study doses have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.