On November 22, 2021 Novocure (NASDAQ: NVCR) reported that the final patient has been enrolled in the phase 3 pivotal LUNAR trial evaluating the efficacy of Tumor Treating Fields (TTFields) together with immune checkpoint inhibitors or docetaxel for treatment of patients with advanced stage 4, non-small cell lung cancer (NSCLC) following progression while on or after platinum-based therapy (Press release, NovoCure, NOV 22, 2021, View Source [SID1234595923]). Non-small cell lung cancer impacts nearly 200,000 patients every year in the U.S., and lung cancer is the leading cause of cancer-related death globally.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"LUNAR marks Novocure’s second phase 3 pivotal study to complete enrollment this quarter and is our first of several late-stage clinical trials expected to deliver final data over the next two years," said William Doyle, Novocure’s Executive Chairman. "LUNAR will provide the first randomized dataset to evaluate increased survival when Tumor Treating Fields is used together with immunotherapy, versus immunotherapy alone. I am proud of our employees and am grateful to our principal investigators and patients for their courage and dedication to advancing clinical studies."

LUNAR is a phase 3 pivotal trial testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. TTFields therapy is intended principally for use in combination with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes. Patients will be followed for 12 months with final data expected year-end 2022.

About Lung Cancer

Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have recently been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On November 22, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the nine months ended September 30, 2021 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 22, 2021, View Source [SID1234595942]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Adamis made significant advancements over the past year," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "We resubmitted our NDA for ZIMHI to the FDA. We initiated and began enrolling patients in a Phase 2/3 clinical trial to evaluate the use of Tempol for the treatment of COVID-19. Under our new commercial partner, we have seen significant sales growth for SYMJEPI. Most significantly, in October we received an early approval for ZIMHI for the treatment of opioid overdose and commercial introduction is expected during the first quarter of 2022."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI

On October 18, 2021, Adamis announced that the U.S. FDA had approved the Company’s ZIMHI TM (naloxone HCL Injection, USP) 5 mg/0.5 mL product.

ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.

According to the preliminary data from the CDC, overdose deaths in the U.S. exceeded 100,000 for the twelve months ending April 2021.

The Company’s U.S. commercial partner, US WorldMeds is preparing to commercially launch ZIMHI in the first quarter of 2022.
SYMJEPI

In October 2020, US WorldMeds completed the transition of control of the commercial operations of SYMJEPI from Sandoz, Inc.

The U.S. market for epinephrine exceeded $1.7 billion in annual sales for the 12-month period ending September 30, 2021, according to Symphony Health market data.

Despite the marketing challenges posed by the pandemic and related lockdowns, Symphony Health data indicates SYMJEPI unit sales increased approximately 98% for nine months ending September 30, 2021, versus the first nine months of 2020.
TEMPOL

Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity.

Recently, the National Institutes of Health (NIH) highlighted Tempol as a potential home treatment for COVID-19.

In September, the first patient was enrolled into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 and the Company is expanding the number of clinical study sites, including several potential sites outside the U.S.

Adamis licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus infection, influenza and COVID-19.

In addition to the work in COVID, the Company is exploring additional indications for the use of Tempol including, but not limited to the treatment of methamphetamine use disorder.
US COMPOUNDING

In July 2021, the Company sold assets relating to its US Compounding human compounding pharmacy business. Under the terms of the sale, the Company expects to receive monthly payments over a 12-month period in an amount equal to one to two times the amount collected for sales of products to certain identified customers included in the sale.

By the end of October, USC had ceased manufacturing both human and veterinary pharmaceutical products and the employment of all USC employees has ended.

The Company is now engaged in a process of selling or otherwise disposing of the remaining assets of the business.
Financial Results

The business conducted through our USC subsidiary is treated as a discontinued operation as of September 30, 2021. Accordingly, for this period the major current assets, other assets, current liabilities, and noncurrent liabilities have been reported as components of total assets and liabilities separate from those balances of the continuing company operations. At the same time, the results of all discontinued operations have been reported as components of net loss separate from the net loss of continuing operations. Additionally, the financial statements of the comparable prior periods were reflected in conformity with the current period’s presentation as discontinued operations.

Reflecting these discontinued operations accounting principles, revenues for the nine months ended September 30, 2021 and 2020 were approximately $3.4 million and $2.1 million, respectively. The increase in revenue was primarily attributable to US WorldMeds’ marketing initiatives for SYMJEPI.

Selling, general and administrative expenses for the nine months ending September 30, 2021 and 2020 were approximately $13.2 million and $9.6 million, respectively. The increase was primarily attributable to an increase in legal fees.

Research and development expenses were approximately $9.1 million and $6.6 million for the nine months ending September 30, 2021 and 2020, respectively. The increase was primarily due to development related to ZIMHI and Tempol.

Cash and equivalents as of September 30, 2021 was approximately $28.7 million. Based on the operating capital that Adamis provided to USC over the last four quarters, we estimate the shutdown of the USC business may reduce those cash expenditures by approximately $1.2 million per quarter starting in the fourth quarter of 2021, excluding expenses associated with the winding down of USC’s business. Additionally, over the next four quarters, the Company estimates to receive additional cash amounts relating to the sale of certain USC assets.

Conference Call

Adamis will host a conference call and live webcast today, November 22, 2021, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the nine months ending September 30, 2021, as well as provide an update on business developments and activities.

A live audio webcast of the conference call will also be available via this link – View Source;tp_key=857fdc0361. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source

On November 22, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will host an inaugural Spatial Day on December 15, 2021 at 12 p.m. ET. The program will feature Akoya speakers and experts at the forefront of this new field who will discuss how spatial biology is uniquely positioned to address challenges in discovery, translational and clinical research, where the field is headed, and Akoya’s vision for the future (Press release, Akoya Biosciences, NOV 22, 2021, View Source [SID1234595888]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Akoya is a pioneer in the rapidly emerging field of spatial phenotyping, a transformational new application that is giving unprecedented context to cell-cell interactions within tissue biology. Understanding spatial biomarker signatures within the framework of spatial phenotyping has the potential to unlock an explosion of new applications in medicine and research, such as the ability to segment patient populations based on immune interactions, development of spatial diagnostic assays, drug discovery, and design or identification of personalized therapeutic interventions. Biomarkers that predict response or resistance to drugs, based on understanding specific types and subtypes of immune cells and the ability to map their spatial distribution, are among the most advanced opportunities with spatial phenotyping.

The agenda and speakers are as follows:

Welcome & Introduction, Brian McKelligon, CEO, Akoya
Revolutionizing Our Understanding of Disease Biology, Kai Kessenbrock, PhD, Principal Investigator, Human Cell Atlas Initiative, University of California, Irvine, CA, and Robert Schreiber, PhD, Professor of Pathology, Washington University, St. Louis, MO
Q&A Roundtable, hosted by Niro Ramachandran, PhD, CBO, Akoya
Changing the Standard of Care Using Spatial Biomarkers, Carl Barrett, PhD, VP, Translational Medicine, AstraZeneca plc, and Kurt Schalper, MD, PhD, Professor of Pathology and Oncology, Yale University, New Haven, CT
Q&A Roundtable, hosted by Pascal Bamford, PhD, SVP, R&D, Akoya
The Future Direction of Akoya, Niro Ramachandran, PhD, CBO, Akoya
Closing remarks, Brian McKelligon, CEO, Akoya
Audience Q&A

On November 22, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Regeneron has extended the research term of its collaboration with the Company to discover and develop gene therapies for hearing loss (Press release, Decibel Therapeutics, NOV 22, 2021, View Source [SID1234595908]). The research term will be extended to November 15, 2023, and Regeneron will pay Decibel an extension fee of $10 million in Q4 of 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the collaboration launched in 2017, Decibel is developing three gene therapy programs targeting congenital, monogenic hearing loss with Regeneron. Decibel plans to initiate in 2022 a Phase 1/2 clinical trial of DB-OTO, the Company’s lead gene therapy product candidate, designed to provide hearing to individuals born with profound hearing loss due to mutation of the otoferlin gene. Decibel is also advancing AAV.103 and AAV.104, gene therapy programs targeting other monogenic forms of hearing loss, with Regeneron. AAV.103 aims to restore hearing in individuals with mutations in the GJB2 gene, and AAV.104 aims to restore hearing in individuals with mutations in the STRC gene.

"Decibel and Regeneron scientists have worked closely to advance our gene therapy pipeline for the treatment of congenital, monogenic hearing loss, bringing our lead program, DB-OTO, within sight of the clinic. We are pleased that Regeneron has elected to extend the research term, which extends our access to Regeneron’s world-leading genomic and genetic technologies, and therapeutic discovery and development expertise," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "This collaboration, which plays to each party’s strengths, is an important part of our ability to accelerate the discovery and development of innovative genetic therapies for patients in need."

"The inner ear is a highly promising frontier for gene therapy, and we believe that the programs being developed in collaboration with Decibel could lead to novel medicines that help people with congenital, monogenic hearing loss," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer, Regeneron. "We’re pleased to extend this successful collaboration, which is an important component of Regeneron’s growing genetics medicine portfolio. Regeneron and Decibel will continue to work together to combine novel gene therapy technologies with deep biologic expertise, so as to bring life-changing medicines to those suffering with hearing loss."

Through the collaboration, Regeneron provides Decibel with broad access to its proprietary suite of technologies to support Decibel’s goal of discovering new medicines for congenital, monogenic hearing loss. Regeneron also directly participates in and provides financial support for Decibel’s research and development efforts under the collaboration through milestone payments and reimbursement intended to fund approximately half of the costs of the collaboration programs. Decibel retains worldwide development and commercialization rights to the product candidates being developed in the collaboration and will pay Regeneron tiered royalties based on net sales.

On November 22, 2021 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported that Claudine Prowse, Ph.D., chief financial officer, will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference, being held November 29, 2021 to December 2, 2021 (Press release, Gennao Bio, NOV 22, 2021, View Source [SID1234595924]). A pre-recorded webcast of the presentation will be available beginning at 10:00 AM ET on November 22, 2021, on the company’s website, www.gennao.com, and will be archived for 30 days.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!