On March 8, 2021 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported that the Company, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy (PICI) and The University of Texas MD Anderson Cancer Center, has voluntarily discontinued further enrollment in the Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) study evaluating the safety and drug activity of SER-401 or fecal microbiota transplant (FMT) in combination with nivolumab in patients with metastatic melanoma (Press release, Seres Therapeutics, MAR 8, 2021, View Source [SID1234576247]).

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"While we are disappointed to discontinue enrollment, we are encouraged by the opportunity to apply the learnings from this study towards future development programs at Seres that can directly benefit the oncology community in search of new treatment options," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. "We want to thank the patients, their care partners, our collaborators and the medical professionals who participated in this study, despite the COVID-19 pandemic, and helped further advance our understanding of the role microbiome therapeutics play in the treatment of cancer."

A preliminary analysis of results from 10 subjects who received either SER-401 or placebo in combination with nivolumab indicated that SER-401 was safe and well-tolerated. There were no patients enrolled in the FMT portion of the study. Subjects currently enrolled in the study will complete the study protocol. Given challenges in enrollment due to the COVID-19 pandemic, subsequent anticipated time to study completion, and progress in its preclinical oncology pipeline, Seres has decided to deprioritize further development of SER-401. The Company will continue to advance its research and development efforts in cancer, applying learnings from the SER-401 trial.

Evidence continues to emerge that suggests gut microbiome modulation may augment responses to cancer immunotherapy, including improving responses in PD-1 refractory patients1.

Seres and its collaborators continue to be excited about the opportunity to develop next-generation therapeutics targeting gut microbes for the treatment of individuals living with cancer. Seres will continue to engage with MD Anderson and PICI to advance the development of medicines in this field, and maintains a robust preclinical program in oncology as well as a collaboration with Memorial Sloan Kettering Cancer Center centered on advancing microbiome therapeutics in various settings of oncology. Seres’ immuno-oncology patent portfolio includes the option to exclusively license foundational intellectual property from MD Anderson, based upon the work of Jennifer Wargo, M.D., professor of Surgical Oncology and Genomic Medicine.

On March 8, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported the advancement of its ongoing Phase 1 clinical study of Radspherin in ovarian cancer patients suffering from peritoneal carcinomatosis to the third level dose cohort following approval from the trial Safety Monitoring Committee (Press release, Oncoinvent, MAR 8, 2021, https://www.oncoinvent.com/press-release/oncoinvent-announces-progression-of-radspherin-to-third-dose-level-cohort-in-ongoing-rad-18-001-phase-1-trial-in-platinum-sensitive-recurrent-ovarian-cancer-patients-with-peritoneal-carcinomatos/?utm_source=mailpoet&utm_medium=email&utm_campaign=oncoinvent-announces-progression-of-radspherin-r_32 [SID1234576246]). In this cohort, patients will receive 4MBq of Radspherin, and enrollment is expected to begin imminently. Radspherin, a versatile α-emitting radionuclide therapy, is also being evaluated in an ongoing Phase 1 study in colorectal cancer patients with peritoneal carcinomatosis.

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"Peritoneal carcinomatosis is a very serious complication of ovarian cancer, often leaving patients with a poor prognosis, and we believe that Radspherin represents a potentially safe and transformative product candidate, offering patients a new treatment option," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "Radspherin leverages the unique properties of alpha-emitting microparticles to safely deliver localized radiation to cancer cells, while also minimizing off-target effects and the killing of healthy tissue. We are excited by our continued progress, and look forward to reporting dose-ranging data in the second quarter of 2021."

"I am pleased to see how, when administered, Radspherin is well tolerated and seems quite evenly distributed in the abdominal cavity of the patients that have been recruited to the RAD-18-001 study here at the Radium Hospital. With the safety results that have been seen in both the RAD-18-001 and RAD-18-002 studies, I am looking forward to initiating treatment of patients at the 4 MBq dose level." Said Dr. Yun Wang, Principle Investigator for the RAD-18-001 study at the Radium Hospital.

About RAD-18-001
RAD-18-001 is an ongoing phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin
Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

On March 8, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., Chief Executive Officer, will participate in a fireside chat at the 33rd Annual Roth Conference on Monday, March 15 at 2:00 p.m. ET (Press release, Merus, MAR 8, 2021, View Source [SID1234576245]).

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The live webcast of the presentation will be available on the Investors page of the Company’s website, View Source An archived presentation will be available on the Merus website for a limited time.

On March 8, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on Friday, March 5, 2021 the Company submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum1 for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) under the EMA’s centralized procedure (Press release, Sesen Bio, MAR 8, 2021, View Source [SID1234576243]).

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The MAA is supported by the pivotal Phase 3 VISTA trial data, which the Company believes demonstrates a strong risk-benefit profile. In addition, the Company believes the chemistry, manufacturing and controls (CMC) data confirms the analytical comparability between clinical and commercial supply.

"Europe represents one of the largest regions in terms of unmet need for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The submission of the MAA in Europe marks an important milestone as we continue toward the goal of making this potential best-in-class treatment available to patients globally. I would like to thank the Sesen Bio team and our regulatory partners for their execution excellence and tireless dedication to help save and improve the lives of the patients we serve. We will continue working collaboratively with the EMA to move Vicineum through the regulatory process as expeditiously as possible."

In Europe, bladder cancer is the fifth most commonly diagnosed cancer with about 124,000 new cases per year, and it ranks ninth in cause of death with approximately 40,000 deaths per year. Approximately 80% of these patients are diagnosed with NMIBC, of which many will initially be treated with BCG and at least 50% of patients will experience disease recurrence. If BCG is not effective or a patient can no longer receive BCG, the recommended treatment option is radical cystectomy, the complete removal of the bladder. If approved in Europe, Vicineum would be the first product approved for patients with high-risk, BCG-unresponsive NMIBC in over 20 years.

1The proprietary brand name, Vicineum is a corporate trademark which has been conditionally approved by the FDA. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox. Sesen Bio is currently going through the tradename approval process with the EMA for oportuzumab monatox.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk, BCG-unresponsive NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer

There are approximately 440,000 new cases of bladder cancer each year globally, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and many patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. Additionally, there is an ongoing chronic, global shortage of BCG, which puts a tremendous pressure on doctors, patients and the FDA. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

On March 8, 2021 Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), reported that Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics, will participate in two virtual investment conferences during the month of March, as follows (Press release, Oragenics, MAR 8, 2021, View Source [SID1234576242]):

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The H.C. Wainwright Global Life Sciences Virtual Conference with one-on-one meetings being held March 9-10, 2021
The Virtual 33rd Annual Roth Conference with one-on-one meetings being held March 15-17, 2021
The Roth Capital Partners presentation will be prerecorded and available in the Investors section of the Company’s website beginning March 9, 2021. Institutional and other investors interested in scheduling a one-on-one meeting with Oragenics during any of these conferences should contact their sales representative at the sponsoring investment bank.