Vaccinex to Participate in the LifeSci Partners 10th Annual Healthcare Corporate Access Event

On January 5, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that it will participate in the 10th Annual LifeSci Partners Corporate Access Event, January 6-8 and 11-14, 2021 (Press release, Vaccinex, JAN 5, 2021, View Source [SID1234573492]).

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Maurice Zauderer, Ph.D., President and CEO, will host 1×1 meetings and will present a corporate update on Wednesday, January 6th at 11am EST.

To register to listen to the presentation or to request a meeting, visit: View Source

Tmunity to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 5, 2021 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported that President and CEO, Usman "Oz" Azam, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 3:10 pm ET (Press release, Tmunity Therapeutics, JAN 5, 2021, View Source [SID1234573509]).

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A live webcast of the presentation will be available on the "Events and Presentations" page of the Tmunity website at View Source Tmunity will maintain an archived replay of the webcast on the website for 30 days after the conference.

MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing Authorization Application for Tafasitamab

On January 5, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) reported that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted the marketing authorization application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody (Press release, MorphoSys, JAN 5, 2021, View Source [SID1234573457]). The MAA seeks approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). The MAA will now enter the formal review process by Swissmedic.

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The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food and Drug Administration’s (FDA) modified Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries.

"Currently about 40% of DLBCL patients do not respond to initial therapy or relapse thereafter leading to a high medical need for new, effective therapies," said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review by Swissmedic is a pivotal step towards bringing tafasitamab in combination with lenalidomide to eligible patients in Switzerland."

"Tafasitamab in combination with lenalidomide may represent an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development, MorphoSys. "We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients with a high unmet medical need."

The Swissmedic application, submitted by Incyte in collaboration with MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL and data from the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.

Incyte has exclusive commercialization rights for tafasitamab outside the United States.

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide[1], characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter[2]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[3],[4],[5].

About L-MIND
The L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study’s primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit View Source

About RE-MIND
RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and the EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

For more information about RE-MIND, visit View Source

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.

Researchers aim artificial intelligence at rising oral cancers with $3.3 million grant from National Cancer Institute

On January 5, 2021 Researchers at Case Western Reserve University and partners in the United States and India are applying the investigative and predictive capabilities of artificial intelligence (AI) to help physicians customize treatments for patients with oral squamous cell carcinomas (Press release, Case Western Reserve University, JAN 5, 2021, View Source [SID1234573476]).

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Research shows that oral squamous cell carcinomas cancer is already the eighth-most common type worldwide and numbers are steadily increasing in the United States, India and other parts of Asia.

The National Cancer Institute awarded a five-year, $3.3 million grant to a group led by Anant Madabhushi, the Donnell Institute Professor of Biomedical Engineering at Case Western Reserve and head of the Center for Computational Imaging and Personalized Diagnostics (CCIPD), and James Lewis Jr., a professor of pathology, microbiology and immunology at Vanderbilt University Medical Center.

The CCIPD has become a global leader in AI-driven precision medicine research. Madabhushi and his research team at the CCIPD hold more than 60 patents, many tied to their work in various cancers.

In this work, researchers will use advanced computer vision and machine learning techniques to identify cancer and immune cells on digitized images of oral squamous cell carcinoma tissue slides and then recognize spatial patterns among those cells.

This technology allows computerized vision to recognize patterns and quantify features that simply are beyond the human visual system but are powerful indicators of tumor biology. These algorithms will help oncologists and pathologists to then better determine which cancers are more versus less aggressive.

James Lewis, MD
This, in turn, will then enable them to identify which patients with early-stage disease could safely receive surgery alone, versus who might need postoperative radiation. In addition, it could help identify which patients with advanced stage disease might need chemotherapy with radiation after initial treatment versus who may be adequately treated with radiation alone.

"We have known for a long time that pathologic features of oral cavity squamous cell carcinomas correlate with tumor behavior and prognosis, but human visual systems cannot extract these features consistently or quantitatively," Lewis said. "AI now allows us to do just that, and we are hopeful that the extracted information can be turned into clinically available algorithms that drive better patient care decisions."

Madabhushi and Lewis will work with a number of partners—Cleveland Clinic and University Hospitals in Cleveland, the San Francisco VA Health System, and Tata Memorial Centre in Mumbai, India—in a national and global endeavor to improve oral cavity squamous cell carcinoma patient care with advanced technology and data sharing.

The clinical partners will provide glass slides to be digitized or will directly provide digitally scanned whole slide images, which will be used to train the AI algorithms for predicting outcomes as well as treatment benefit.

The team will also have access to unique datasets from completed prospective, randomized, clinical trials of oral squamous cell carcinoma patients at the Tata Memorial Center as well as from the cancer clinical cooperative group NRG Oncology. The datasets that will allow for validation of the AI tools.

Seeking precise, personal predictions
Currently, physicians place oral carcinoma patients into one of three categories: those who require just surgery; those who should have surgery plus radiation therapy; or those who will need surgery, followed by radiation and chemotherapy.

"That’s the gold standard right now: a system that puts patients in those very broad categories," Madabhushi said. "For clinicians and pathologists, this is limiting because it relies on a limited number of parameters. But our machines are looking at the appearance of cells, their spatial architecture and interplay between different cell types, to parse out those patients who should actually be in another category."

For example, Madabhushi said, their AI research has already shown that there is a subset of early-stage patients now placed in the first category—surgery alone—who are actually at a much higher risk and would do poorly with surgery alone.

"Instead, they should be offered radiation therapy as well, but under the current parameters, that is not called for," Madabhushi said.

The group also will look at anticipated differences in the appearance of oral cancer among patients of different races, a fast-developing aspect of Madabhushi’s AI-based investigations.

Previous research by the lab used AI to reveal apparent tissue-level cellular distinctions between Black and white men with prostate cancer, enabling the development of population-specific risk prediction models.

Oral cancers rising
Oral carcinomas include cancers of the mouth, tongue, gums, and lips. According to the National Institutes of Health (NIH), these cancers can develop on the mobile tongue, the tissue lining the gums and hard palate, and on the underside of the tongue and floor of the mouth,

Oral carcinoma accounts for roughly 3% of all cancers diagnosed annually in the United States, with nearly 400,000 new cases being diagnosed annually worldwide.

Oral carcinoma most often occurs in people over age 40 and affects more than twice as many men as women. Most oral cancers are related to tobacco use, alcohol use, or both. Infection by the human papillomavirus (HPV), which is very common in oropharyngeal carcinomas, is a less common cause of oral carcinomas.

Other members of the research team include: Shlomo Koyfman, David Adelstein, and Deborah Chute at the Taussig Cancer Center, Cleveland Clinic; Ted Teknos, president of Seidman Cancer Center, University Hospitals; Stephen Connelly, San Francisco VA Health System; and Sarbani Ghosh-Laskar and Swapnil Rane, Tata Cancer Center.

Myovant Sciences Announces U.S. Availability of ORGOVYX™ for the Treatment of Advanced Prostate Cancer

On January 5, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that ORGOVYX (relugolix), the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer, is now available through authorized specialty distributors (Press release, Myovant Sciences, JAN 5, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-us-availability-orgovyxtm-treatment [SID1234573493]).

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"Myovant has been focused on ensuring access to ORGOVYX for men with advanced prostate cancer as quickly as possible following approval, and we are delighted to announce that it is now available," said David Marek, chief executive officer of Myovant Sciences, Inc. "As part of our commitment to redefine care for women and for men, this is a critical step as we work to bring about a new standard of care for men with advanced prostate cancer."

ORGOVYX was approved by the FDA on December 18, 2020. Myovant is committed to ensuring that men in the U.S. who are prescribed ORGOVYX can achieve fair and timely access and receive the support they may need throughout their treatment journey. As part of this commitment, Myovant has launched the ORGOVYX Support Program which provides insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to two months of therapy, and patient assistance for qualifying uninsured patients. For more information, please contact 833-ORGOVYX (833-674-6899), 8 a.m.–8 p.m. Eastern Time, Monday–Friday.

About ORGOVYX (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

For full prescribing information, including patient information, please click here.

Indication

ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information

Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily.