On October 27, 2021 Monteris Medical, the leader in MR-guided laser interstitial thermal therapy (LITT or laser ablation), reported that Cigna, a global health services company and one of the largest commercial payors in the United States, has released a national coverage policy supporting the use of LITT for people with brain tumors and drug-resistant epilepsy (Press release, Monteris Medical, OCT 27, 2021, View Source [SID1234592020]).

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The medical coverage policy by Cigna considers LITT medically necessary in the treatment of drug-resistant epilepsy and symptomatic brain tumors and radiation necrosis when medical necessity is met, and the patient is not suitable for open brain surgery.

"Many patients with brain tumors face situations in which traditional, open surgery is neither possible, nor the preferred approach. This policy decision by Cigna offers appropriate patients greater access to a targeted, minimally invasive technology that can positively impact their care and improve their quality of life," said Dr. Peter Fecci, director of the Brain Tumor Immunotherapy Program and the Center for Brain and Spine Metastasis at Duke University School of Medicine in Durham, N.C.

A growing body of peer-reviewed clinical evidence continues to show medical advantages of minimally invasive, MR-guided laser ablation technology due to decreased morbidity, faster recovery time, shorter hospital and intensive care stay, and an ability to access lesions not amenable to open surgery. Laser ablation also represents an alternative to surgery for patients with significant comorbidities.

"Cigna and other national payors have progressively widened access to care for the patients we serve. This policy announcement is the latest in a continuum of advancements for LITT, establishing its position in the care pathway for patients and their families afflicted by brain tumors and epilepsy," said Martin J. Emerson, president and chief executive officer of Monteris Medical.

The Cigna coverage policy follows recently issued position statements on the use of LITT for epilepsy and brain tumors, respectively, by the major neurosurgical societies, inclusion of LITT in guidelines issued by the National Comprehensive Cancer Network, and Category Level 1 CPT codes approved by the American Medical Association with an effective date of January, 2022.

On October 27, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported a collaboration that will power A.I.-driven computational research for oncology-focused drug discovery and development with Code Ocean, the leading computational research environment for sharing scientific discoveries (Press release, Lantern Pharma, OCT 27, 2021, View Source [SID1234593961]). By leveraging Code Ocean’s Compute Capsule technology, the strategic approach is expected to further power Lantern Pharma’s RADR platform for faster, more collaborative discoveries from billions of RADR data points, as well as data and insights from Lantern’s network of collaborators.

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Computational researchers today are challenged with analyzing big data due to too many disparate tools, lack of specialized coding experience, and challenging, cumbersome DevOps processes required to organize and securely share research. Through this collaboration, Lantern Pharma is expected to benefit from significant efficiencies in development time and cost, as well as increased reproducibility from Code Ocean’s platform. The Code Ocean platform will offer an easy to use, collaborative research experience with an integrated development environment, secure repository, and portable Compute Capsule technology for guaranteed reproducibility.

"I’m thrilled to be working with a leading-edge technology partner like Lantern Pharma," said Simon Adar, Co-Founder and CEO of Code Ocean. "This collaboration truly enables large-scale, high-throughput collaboration both internally at Lantern and also with their leading research partners to accelerate the pace of oncology drug discovery."

"It’s clear that science and discovery need to be fully integrated using the latest tools and technologies to reduce costs, speed-up development, and increase probability of success," said Panna Sharma, President & CEO of Lantern Pharma. "We selected Code Ocean as we believe this collaboration will provide our scientists, researchers, data engineers and collaborators with a best-in-class, reproducible and highly secure platform environment to maximize the power and usability of our RADR A.I. platform to improve and enhance the research experience. Bringing together our proprietary A.I. with Code Ocean’s Compute Capsule technology we believe will allow us and other researchers to take collaborative drug development further and faster than ever before."

Lantern leverages advances in machine learning, genomics and artificial intelligence to develop oncology therapies by using its proprietary A.I. platform, RADR, to discover biomarker signatures aimed at helping identify patients more likely to respond to its pipeline of cancer therapeutics. Working within the Code Ocean platform is expected to help increase team productivity and enhance Lantern Pharma’s ability to collaborate more rapidly with industry leading partners, such as the National Cancer Institute, Georgetown University, Johns Hopkins and Fox Chase Cancer Center, within a secure and agile research environment.

The Code Ocean platform does not require the user to be an IT expert to utilize the software properly. By integrating the essential triplet– code, data and a computing environment– Code Ocean offers the most complete platform for computational research that’s on the market. Code Ocean’s unique Compute Capsules provide a fundamentally easier and more efficient way for researchers to create and safely share their work, which is essential to moving science forward. This, combined with Lantern Pharma’s billions of data points and growing library of algorithms designed for oncology drug development, will allow researchers to have faster access to more data than ever before, without being overwhelmed by massive amounts of data management or computational structure.

On October 26, 2021 Alkermes plc (Nasdaq: ALKS) reported the initiation of ARTISTRY-7, a global phase 3, open-label, randomized trial evaluating the anti-tumor activity and safety of intravenously administered (IV) nemvaleukin alfa (nemvaleukin), in combination with pembrolizumab, compared to investigator’s choice chemotherapy, in patients with platinum-resistant ovarian cancer. Nemvaleukin, Alkermes’ lead immuno-oncology candidate, is a novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy (Press release, Alkermes, OCT 26, 2021, View Source [SID1234591943]). As previously announced, ARTISTRY-7 is being conducted in collaboration with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA), which is providing KEYTRUDA (pembrolizumab) for the study. In addition, Alkermes is working with The GOG Foundation, Inc. (GOG) and the European Network of Gynaecological Oncological Trial groups (ENGOT) to conduct the study. The U.S. Food and Drug Administration recently granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.

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"The initiation of our phase 3 study of nemvaleukin in platinum-resistant ovarian cancer is an important milestone for the nemvaleukin clinical development program and reflects our commitment to focusing on the high unmet need of patients living with difficult-to-treat cancers such as platinum-resistant ovarian cancer," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "ARTISTRY-7 is designed to build upon the durable and deepening responses observed in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study. We look forward to sharing updates from ARTISTRY-7 as the study progresses and as we advance toward potential registration."

ARTISTRY-7 is a global phase 3, open-label, randomized study designed to evaluate the anti-tumor activity and safety of IV nemvaleukin in combination with pembrolizumab compared to investigator’s choice chemotherapy, with additional nemvaleukin and pembrolizumab monotherapy arms, in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The primary endpoint of ARTISTRY-7 is progression-free survival as assessed by the investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Additional endpoints include objective response rate, overall survival, disease control rate, duration of response, time to response, cancer antigen-125 response, pharmacokinetics (PK)/ pharmacodynamics (PD) and safety. The study is expected to enroll approximately 376 patients. Patients will be randomized to one of four treatment arms to receive nemvaleukin and pembrolizumab combination therapy, pembrolizumab monotherapy, nemvaleukin monotherapy, or investigator’s choice chemotherapy.

More information can be found at www.clinicaltrials.gov (NCT05092360, GOG-3063, ENGOT-ov68)

About Nemvaleukin Alfa (nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

On October 26, 2021 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported the expansion of an existing research agreement, led by Menashe Bar-Eli, Ph.D., Professor, Department of Cancer Biology, at The University of Texas MD Anderson Cancer Center, and will evaluate the potential efficacy of the combination of NT219, a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3, and immuno-oncology drugs, such as anti-CTLA4 or anti-PD1/PDL1 antibodies (Press release, Purple Biotech, OCT 26, 2021, View Source [SID1234591959]).

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"Previously completed preclinical studies have shown that NT219 is able to overcome resistance to certain treatment approaches, with results demonstrating sensitization of various tumor types to the approved therapies," said Hadas Reuveni, Ph.D., VP Research and Development of Purple Biotech. "This new research leverages preclinical data depicting the interface of the lymphoid and myeloid systems within the biology, as well as a target in human cancer. It provides an opportunity to address the alterations of metabolism of both the tumor and the responsive human immune system, altering a "cold" tumor unresponsive to immune oncology approaches into a responsive "hot" one. This collaboration will also provide an opportunity to assess potential synergies mitigating anti-apoptotic mechanisms associated with TGFbeta and the canonical WNT pathway."

"Our prior preclinical studies with NT219 demonstrated its effect on the STAT3 and IRS pathways and the encouraging clinical data presented at ASCO (Free ASCO Whitepaper) 2021 supports the further evaluation of potentially combining NT219 with immunotherapy agents," said Dr. Reuveni. "We look forward to understanding the potential impact of such combinations through this expanded research collaboration. Based on the profile of NT219 and the data generated to date, we believe there are multiple potential benefits that can be derived by combining NT219 with certain immuno-oncology drugs."

"We are thrilled to expand this collaboration, and we believe that combining NT219 with immune-oncology backbone therapies is an important path forward for our NT219 clinical program," said Isaac Israel, Chief Executive Officer of Purple Biotech. "The collaboration is an important step in the translational work that could support the advancement of this potential treatment into the clinic. We recently presented promising initial clinical data for NT219 as a monotherapy treatment for advanced solid tumors and look forward to the availability of additional top-line data from the first part of this ongoing Phase 1/2 clinical trial."

Previous research conducted by Dr. Bar-Eli demonstrated that treatment of mice-bearing melanoma with early generation compounds of NT219 inhibited tumor growth and metastasis by blocking STAT3 and IGF1R/IRS signaling. The inhibition of downstream pro-angiogenic and pro-invasion factors in-vivo, such as VEGF, MMP-2 and IL-8, was shown, as well as the suppression of macrophage recruitment to the tumor microenvironment.

On October 26, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that it will be hosting a virtual R&D Day event detailing the company’s proprietary NAM-enabled natural killer (NK) cell therapy pipeline today, Tuesday, October 26, at 8:00 a.m. ET (Press release, Gamida Cell, OCT 26, 2021, View Source [SID1234591977]). During the event, the company will highlight Gamida Cell’s new programs leveraging next-generation, NAM-enabled, genetically modified NK cells in development for solid tumors and hematological cancers, as well as provide an update on the clinical development of GDA-201, its lead cryopreserved, off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas, including an update on the status of its Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).

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Update Regarding IND Application for GDA-201:

The company recently submitted an IND application to FDA for a Phase 1/2 trial with a cryopreserved formulation of GDA-201 in patients with diffuse large B cell lymphoma and follicular lymphoma and was notified that the IND application has been placed on Clinical Hold prior to the initiation of patient dosing. The FDA has requested modifications in donor eligibility procedures and sterility assay qualification. Gamida Cell is in active communication with the FDA with the objective to promptly address these requests to potentially enable the requirements for IND acceptance and study initiation. The initiation of the planned Phase 1/2 trial of GDA-201 may be delayed beyond the end of 2021, pending the outcome of FDA interactions.

"While we work to resolve outstanding issues with our IND, we are pleased to be able to share updates regarding our NAM-enabled NK cell programs," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "We believe that the issues raised by FDA are addressable and can hopefully be resolved in an expeditious manner. In the meantime, we are pleased to elaborate on the power of NAM combined with the genomic tools that we have harnessed to enable us to create potentially transformative immuno-oncological therapies that may move beyond what is currently possible with existing approaches. These advances in our NK cell pipeline will help to further our mission to bring cancer patients potentially curative cell therapies."

Update Regarding NK Cell Therapy Programs:

During today’s virtual event, Gamida Cell management and partners will provide an overview of the company’s NK cell programs, including:

Objective to improve treatment of both hematological cancers and solid tumors in which genetic modifications to allogeneic NK cells may overcome immunosuppressive microenvironments.
Review of Gamida Cell’s proprietary NAM expansion process, which enhances the potency, function and persistence of NK cells while improving homing to and retention in lymphoid tissues.
Descriptions of Gamida Cell’s genetically modified NK cell immunotherapy programs (GDA-301, GDA-401, GDA-501 and GDA-601), which utilize CAR- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid-tumors.
Discuss a research collaboration with the Dana-Farber Cancer Institute studying the in vitro natural killer (NK) cell killing activity of GDA-601, Gamida Cell’s nicotinamide (NAM)-enabled genetically modified NK cell therapy in multiple myeloma. GDA-601 is a CD38 CRISPR knockout combined with a CD38 CAR NK cell construct that has demonstrated promising preclinical results, including reduced fratricide and increased cytotoxicity against a multiple myeloma cell line.
Phase 1 data on the safety and efficacy of GDA-201, a NAM-enabled, unmodified allogeneic NK cell therapy that has produced positive clinical results in the treatment of diffuse large B cell lymphoma and follicular lymphoma, both of which have significant unmet need.
"This is an exciting time for Gamida Cell as we have expanded R&D activities to augment our NK cell pipeline," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "During today’s event, we will share our plans to advance the clinical development of GDA-201 based on highly encouraging clinical data in patients with lymphoma that have arisen from a physician sponsored study. We also plan to illustrate how our proprietary NAM expansion process, combined with our advanced genetic modifications, differentiate our NK cell programs as may meaningfully help patients with solid tumors and hematologic malignancies."

A replay of the webcast will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.