On December 14, 2020 Novocure (NASDAQ:NVCR) reported that the Swiss Federal Office of Public Health (BAG) has added Optune in combination with temozolomide to the List of Remedies and Equipment (MiGeL) for the treatment of patients with newly diagnosed glioblastoma (GBM), effective April 1, 2021 (Press release, NovoCure, DEC 14, 2020, View Source [SID1234572818]). The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland.

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"We are extremely pleased that Switzerland has established national reimbursement for Optune," said Thomas Hefti, Vice President Europe and Emerging Markets (EMEA). "Access to our therapy continues to grow throughout the world, demonstrating health insurers’ increasing recognition of Optune."

"National reimbursement of Optune for newly diagnosed GBM patients in Switzerland represents an incredible effort by our team to expand access to our therapy as well as an increased understanding of the benefits of our therapy among health insurers," said Pritesh Shah, Novocure’s Chief Commercial Officer. "We are proud of this accomplishment and will continue working diligently to expand access to GBM patients who may benefit."

About Optune
Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells with specific membrane properties. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.

For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Important Safety Information
Contraindications
Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Use of Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune for GBM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions
Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.

The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment.

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

On December 14, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 21, 2020 (Press release, Immunic, DEC 14, 2020, View Source [SID1234572838]).

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The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is re-ranked annually. All securities in the index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements, among other criteria.

The NASDAQ Biotechnology Index forms the basis for a number of Exchange Traded Funds (ETFs), including the iShares NASDAQ Biotechnology ETF (Nasdaq: IBB). More information about the Index can be found at View Source

On December 14, 2020 Modulus Discovery Inc. ("Modulus"), a pre-clinical stage technology-driven drug discovery company reported that it was invited to present at the 39th Annual J.P. Morgan Healthcare Conference in January 2021 (Press release, Modulus Discovery, DEC 14, 2020, View Source [SID1234574447]). The J.P. Morgan Healthcare Conference, which attracts over 500 companies and 12,000 investors, is going virtual for 2021, and the webcast will be made available online following the live event.

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S. Roy Kimura, co-founder and CEO, will present on January 12, 2021 at 8:40 AM EST and will give a brief introduction to the company’s cutting edge simulation-based drug discovery platform and its maturing portfolio of small-molecule drug discovery projects in chronic inflammation, oncology, and infectious diseases including COVID and related RNA viruses. Following the event, the company will be available for meetings with interested parties to further describe its unique discovery platform and capabilities and lead programs currently in pre-clinical studies.

Comment from S. Roy Kimura, CEO, Modulus Discovery, Inc.
"We are delighted to be given this opportunity to introduce our company’s technology platform, small-molecule discovery capabilities, and unique portfolio of R&D programs. Our lead programs targeting chronic inflammation / autoimmune diseases and oncology are currently approaching the IND stage, and we would be happy to provide information about them to interested parties for potential clinical partnerships."

On December 14, 2020 Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, reported that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery (Press release, Avelas Biosciences, DEC 14, 2020, View Source [SID1234572803]). Pegloprastide is designed to deliver a fluorescent marker to cancer cells to aid surgeons in identifying positive margins in real time during surgery. Positive margins can be a sign that cancer may be left behind, requiring a second surgery.

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"We now have clarity on the development path to make fluorescence image-guided surgery the new standard of care for breast cancer lumpectomies," said Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas. "Pegloprastide has the potential to greatly reduce the number of repeat surgeries, potentially improving outcomes for hundreds of thousands of women and saving thousands of lives."

The presence of positive margins is a significant challenge in breast-conserving surgery. Positive surgical margins occur when post-operative pathology indicates cancer cells are present at or very close to the edge of removed tissue, indicating that there may be residual cancer left behind after an operation. It is estimated that each year in the United States more than 260,000 women undergo a lumpectomy, of which one-third (more than 80,000) are repeat surgeries with the goal of achieving negative margins.1 Beyond that, of the estimated 90,000 women who choose a mastectomy, many choose it for fear of incomplete initial lumpectomy or due to an initial attempt at a lumpectomy that resulted in positive margins.1

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is under investigation to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. A Breakthrough Therapy designation provides more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.

Previously reported positive top-line data from the company’s completed Phase 2/3 study, which evaluated the safety and efficacy of pegloprastide in women with primary, nonrecurrent breast cancer undergoing surgery, met its primary endpoint of detecting cancer in margin specimens in real time (p<0.001). The data showed use of pegloprastide during surgery correctly identified cancer in up to 75% of patients who would have otherwise been candidates for a repeat (re-excision) surgery. Observed re-excision rate in the study was 6% in patients whose surgeries included pegloprastide. Current re-excision rates are estimated at 20-40% among all patients receiving an initial lumpectomy. 2-7

About Pegloprastide (AVB-620) and QUEST SPECTRUM Fluorescent Imaging Device

Pegloprastide (AVB-620) is based on the science of activatable cell-penetrating peptides and is the only fluorescence-based clinical cancer detection product that uses the ratio of two fluorophores within the same molecule (ratiometric imaging) to provide more accurate and actionable information. Pegloprastide’s ratiometric readout attenuates common artifacts of fluorescent imaging, including differences in drug concentration and distance of the camera from the tissue area of interest. Pegloprastide is used during surgery with a specialized fluorescent imaging device manufactured for Avelas by Quest Medical Imaging, based on its QUEST SPECTRUM platformtechnology. QUEST SPECTRUM device has a wide field of view and provides a rapid assessment of tissue. Beyond breast cancer, Avelas has plans to explore the use of pegloprastide during surgery for other types of cancer, including ovarian, colorectal, head and neck, melanoma, and sarcoma.

About Quest

Quest Photonic Devices is a group of companies that is developing high-end multispectral imaging cameras and light sources for medical and industrial use. Through its subsidiary companies, Quest Medical Imaging B.V. and Quest Medical Imaging Inc., Quest focuses specifically on the medical market of fluorescence image-guided surgery and is committed to improving patient care and surgical outcomes.

On December 14, 2020 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, reported that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020 (Press release, Gamida Cell, DEC 14, 2020, View Source [SID1234572819]).

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During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites. The company believes the clinical comparability requirement will be met if the time to neutrophil engraftment in patients from the company’s ongoing expanded access program (EAP) using omidubicel produced at Gamida Cell’s planned commercial manufacturing sites is consistent with the results achieved in the Phase 3 clinical trial. Based on the feedback received at the meeting with FDA, Gamida Cell intends to submit a full BLA for omidubicel in the second half of 2021 in lieu of the company’s previous plan to initiate a rolling BLA submission by the end of 2020. The revised plan could support a potential commercial launch of omidubicel in the United States as early as mid-2022.

"Although we are disappointed by the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel achieved pre-specified primary and secondary endpoints. Commercial manufacturing readiness activities are underway, and we believe we will be able to complete all the requirements discussed with FDA," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "With this clarity, we look forward to proceeding towards a full BLA submission in the second half of 2021. We continue to prepare for the commercialization of omidubicel on the revised timeline, as we continue to provide omidubicel to patients in need through our expanded access program."

The planned BLA submission for omidubicel is supported by a Phase 3 study which met its primary and secondary endpoints. The international, multi-center, randomized Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. Omidubicel is the first bone marrow transplant cell therapy product to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S. and EU.

As previously announced, given the encouraging Phase 1 data presented at the 2020 ASH (Free ASH Whitepaper) meeting, the company also plans to submit an IND for GDA-201, its expanded natural killer cell investigational therapy, in 2021.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the U.S. Food and Drug Administration or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. 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 of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy has not been established by the U.S. Food and Drug Administration or any other health authority.