On December 1, 2020 Biodesix, Inc. (Nasdaq: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported publication of an analysis of the company’s Nodify XL2 lung nodule test (Press release, Biodesix, DEC 1, 2020, View Source [SID1234572039]). The test supports clinical decision-making for suspicious nodules by more accurately identifying patients with a very low risk of malignancy and shifting those patients into surveillance, thereby minimizing invasive procedures on those with benign nodules.

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In previously published findings from the Pulmonary Nodule Plasma Proteomic Classifier (PANOPTIC) Trial, the Nodify XL2 test was shown to accurately identify patients with lung nodules who have a pre-test risk of malignancy less than 50% as "likely benign." After one year of follow-up, the test demonstrated a sensitivity of 97%, specificity of 44%, and negative predictive value of 98%, which is more accurate than other commonly used lung nodule risk assessment calculators.

The new paper, published in the American College of Chest Physicians (CHEST) Journal, presents findings that all nodules in the study group that were established as benign after one year remained benign after two years of follow-up. This data confirms the performance of the Nodify XL2 test over the guideline-recommended two-year surveillance period to radiologically confirm a benign diagnosis. Additionally, a new analysis suggests that the classifier performs similarly regardless of the whether the nodule of concern was solitary or there were other nodules present.

"This assessment demonstrates our commitment to providing long-term follow-up for patients and to continuously study the performance of our tests," said Scott Hutton, CEO of Biodesix. "Central to our mission is the drive to improve patient outcomes while reducing ineffective and unnecessary treatments and procedures. Nodify XL2 exemplifies this. With this test, part of our Nodify LungTM testing strategy, physicians are equipped with vital and time-sensitive information to help efficiently determine the appropriate course of treatment for each patient."

About Nodify XL2 Lung Nodule Test

The Nodify XL2 blood-based proteomic test helps identify patients who have a suspicious lung nodule that is likely benign or at a reduced risk of being cancerous. Results help physicians to identify patients who may be better candidates for routine CT surveillance to monitor for growth or shrinkage of the nodule over time instead of an invasive diagnostic procedure. The Nodify XL2 test is used for patients who are 40 years or older, have nodules between 8mm and 30mm, and have a pre-test risk of lung cancer of less than or equal to 50%.

The test is performed in Biodesix’s COLA-accredited laboratory in De Soto, Kansas.

On December 1, 2020 MaaT Pharma reported that the company secured an additional €7.35 million ($8.7 million) in an extension of its Series B financing round, bringing the total raised in this round to €25.35 million (Press release, MaaT Pharma, DEC 1, 2020, View Source [SID1234572038]). The new capital from the PSIM Fund managed by Bpifrance on behalf of the French State, with participation from SkyViews Life Science and Celeste Management, underscores the potential of MaaT Pharma’s microbiome restoration biotherapeutics platform and the progress the company has made towards developing drugs that harness the rich diversity of the gut microbiome to improve overall survival in blood cancers and Graft-versus-Host Disease (GvHD). In February, the company announced the initial closing of an €18 Million Series B Financing Round, led by US investor SymBiosis, LLC, with support from Seventure Partners, Crédit Mutuel Innovation, and Biocodex.

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The final closing of the Series B financing round will primarily support the advancement of an innovative fermentation production platform for the development of next-generation, large-scale, fully controlled microbiome ecosystem therapeutics. By leveraging MaaT Pharma’s GutPrint computational data science platform, the new industrial fermentation platform will enable to develop and manufacture both "standard" high-richness, high-diversity fermented product MaaT034, and a pipeline of indication-specific candidates. In particular, the fermentation technology supports pipeline extension towards solid tumors indications, for combination with immunotherapy. The resulting new product candidates will complement the company’s donor-derived lead products MaaT013 (enema) and MaaT033 (oral formulation) for the treatment of GvHD and liquid tumors.

The funding will also support the production of MaaT013 to meet the demand from clinicians wanting to access the product for the treatment of their GvHD patients with no other therapeutic options; this compassionate use is permitted by the French regulator under an "ATUn" program.

"Raising additional capital through an extension of our Series B is a testament to the relevance of our innovative full-ecosystem microbiome therapy approach. We are now supported by a syndicate of seven highly respected investors, enabling us to further advance and expand our portfolio with confidence. Serving patients has always been the cornerstone of our purpose and we look forward to meeting their needs through our microbiome therapeutics development and in our early-access-program," commented Hervé Affagard, CEO and Co-founder of MaaT Pharma. "I would like to thank all of our investors for their trust and for sharing our company’s commitment to improving patients’ lives and treatment outcomes in a variety of cancer indications by restoring gut microbiome function and immune system homeostasis."

"MaaT Pharma has developed an innovative portfolio of microbiome-based biotherapeutics that we believe offers tremendous short-term and long-term potential, addressing the needs of advanced-stage cancer patients with limited options," commented Muriel Prudent, Senior Investment Manager at Bpifrance. "We look forward to working with MaaT Pharma’s team to expand its leadership position and contribute to advancing its innovative pipeline."

Dr Stefan Catsicas, Managing Partner at SkyViews Life Science said: "SkyViews Life Science is delighted to join a strong group of investors collectively committed to supporting MaaT Pharma, a leader in the field of microbiome functionality, as they address severe unmet needs of cancer patients."

"MaaT Pharma has brought together a strong team grounded in scientific and manufacturing excellence with a compelling vision for microbiome-based therapies, which convinced us to support this endeavor," added Dimitri Boulanger, Chief Executive Officer, Celeste Management.

On December 1, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it will host a virtual Investor and Analyst Event on Friday, December 11, 2020, at 1:00 p.m. CT / 2:00 p.m. ET (Press release, Odonate Therapeutics, DEC 1, 2020, View Source [SID1234572037]). The event will follow the presentation of the results of CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer, at the 2020 SABCS, which is scheduled to occur at 8:45 a.m. CT / 9:45 a.m. ET on December 11, 2020 (View Source). Featured speakers will include Lee Schwartzberg, M.D., FACP, Chief Medical Director, West Cancer Center & Research Institute, and Andrew Seidman, M.D., Medical Director, Bobst International Center, Memorial Sloan Kettering Cancer Center and Professor of Medicine, Weill Cornell Medical College.

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Event Information

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA. Odonate recently announced positive top-line results from CONTESSA, and full results are scheduled to be presented at the San Antonio Breast Cancer Symposium in December 2020.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

On December 1, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and Hikma Pharmaceuticals, a multi-national pharmaceutical company and leading licensing partner in the Middle East and North Africa ("MENA") region specializing in the development and commercialization of a broad range of high-quality medicines, reported that the companies have entered into an exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and other types of cancer in MENA (Press release, Sesen Bio, DEC 1, 2020, View Source [SID1234572036]). Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

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"Sesen is committed to saving and improving the lives of patients, and Hikma is an ideal partner to deliver Vicineum to patients with NMIBC in the MENA region," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "As we continue to work toward regulatory approval in the US and Europe, we also continue to execute partnerships outside of the US as part of our mission to deliver this important medicine to patients around the world. Hikma has strong expertise in commercializing innovative products in the MENA region and a successful track record of serving patients worldwide. This partnership represents a further step in realizing the significant global opportunity for Vicineum."

"At Hikma, we believe that partnerships with innovative pharma companies are a key contributor to the success of our business. We are very pleased to enter into an exclusive partnership with Sesen given their expertise in NMIBC and the strong clinical profile of Vicineum," said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. "As a company whose mission is to put better health within reach every day, we regard being the partner of choice to Sesen in MENA as a key collaboration that augments Hikma’s biotechnology and oncology portfolio to deliver on our strategy of bringing innovative products to patients in the region. Vicineum – our first innovative fusion protein – is a highly differentiated product candidate and is positioned to make a meaningful impact on the lives of bladder cancer patients."

Under the terms of the agreement, Sesen Bio granted Hikma an exclusive license to register and commercialize Vicineum in all 19 MENA markets in an arrangement anticipated to deliver equal value share to both parties. Financial terms of the agreement are confidential and include an upfront payment to Sesen Bio, sales related milestone payments and royalties on net sales in the region for the term of the agreement. Sesen Bio retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China and MENA.

Al-Tamimi and Hogan Lovells acted as legal advisors to Sesen Bio for this transaction.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. 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 conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. 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 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
Bladder cancer is the sixth most commonly diagnosed cancer in the United States, 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 more than 60 percent of all 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. 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 December 1, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it will host a key opinion leader (KOL) call on MB-106 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma on Wednesday, December 9, 2020, at 1:00 p.m. EST (Press release, Mustang Bio, DEC 1, 2020, View Source [SID1234572035]).

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The call will feature presentations by KOLs Mazyar Shadman, M.D., M.P.H., Fred Hutchinson Cancer Research Center ("Fred Hutch"), and Brian Till, M.D., Fred Hutch, who will discuss the interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma that the company is developing in collaboration with Fred Hutch. Data from this study have been selected for a poster presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

During the call, Drs. Shadman and Till will also discuss the modified cell manufacturing process that was co-developed by Fred Hutch and Mustang Bio, as well as the correlative science observed in the study to date. The Mustang team will then give a corporate update on its pipeline and future plans. Following the formal presentations, the Mustang team, along with Drs. Till and Shadman, will be available for questions.

To register for the call, please click here.

About Dr. Shadman
Mazyar Shadman, M.D., M.P.H., is an associate professor at the University of Washington (UW) and Fred Hutch. He is a hematologic malignancies expert who specializes in treating patients with lymphoma / chronic lymphocytic leukemia (CLL). He is involved in clinical trials using novel therapeutic agents, immunotherapy (CAR T cell), and stem cell transplant for treatment of lymphoid malignancies with a focus on CLL. He also studies the clinical outcomes of patients using institutional and collaborative retrospective cohort studies. Dr. Shadman received his M.D. from Tehran University in Iran. He finished internal medicine internship and residency training at the Cleveland Clinic in Cleveland, Ohio. He completed his training in hematology and medical oncology fellowships at UW and Fred Hutch. Dr. Shadman also earned an M.P.H. degree from UW and was a fellow for National Cancer Institute’s cancer research training program at Fred Hutch, where he studies cancer epidemiology.

About Dr. Till
Brian Till, M.D., is an Associate Professor in the Clinical Research Division of Fred Hutch and Department of Medicine at UW. His laboratory focuses on developing chimeric antigen receptor (CAR)-based immunotherapies for non-Hodgkin lymphoma and understanding why CAR T cell therapies work for some patients but not for others. He led the first published clinical trial testing CAR T cells as a treatment for lymphoma patients. Dr. Till also has a clinical practice treating patients with lymphoma and attends on the stem cell transplantation and immunotherapy services at the Seattle Cancer Care Alliance.