On February 17, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematological cancers, reported that it is hosting a Research and Development Day" via webcast on Thursday, February 24, 2022 at 8:00am Eastern Time to highlight the differentiating features of its patented DPX delivery platform (Press release, IMV, FEB 17, 2022, View Source [SID1234608229]).

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IMV’s DPX technology is a delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components. This versatile, immune-educating technology is being developed for application in a variety of therapeutic areas (e.g., oncology, infectious disease) where generation of a target-specific immune response is expected to mitigate disease.

The webcast will feature a presentation by Michael Kalos, Ph.D., Key Opinion Leader (KOL) and member of IMV’s board of directors, who will discuss the potential of IMV’s DPX delivery platform in addressing unmet medical needs in the current and future oncology landscape.

The IMV team will describe the DPX delivery platform technology and its differentiated immune-educating capabilities, highlighting key advantages demonstrated in both clinical and preclinical studies including its favorable safety profile. IMV management will also provide an update on the Company’s clinical programs and discuss key expected milestones in 2022. A live question and answer session will follow.

To register for the Research and Development Day, please click here(View Source).

Michael Kalos, Ph.D. is an internationally recognized expert in T cell therapy and immunotherapy and brings over 25 years of experience and expertise in cell therapy, oncology vaccines, and immune-oncology. Dr. Kalos has held executive and R&D leadership positions in biopharma at Arsenal Bio, Janssen, and Eli Lilly. Prior to his career in the biopharmaceutical sector, Dr. Kalos spent 10 years in academia, where he focused on the development of integrated translational biomarker programs to support the development of cell therapy and immunotherapy programs. The laboratory he founded and directed at the University

of Pennsylvania played a key role in the success of the clinical cell therapy program at Penn, including the development of the CTL019 program, which was licensed to Novartis and led to Kymriah, the first approved CART cell therapy product.

Dr. Kalos obtained his Ph.D. from the University of Minnesota and completed post-doctoral training in the laboratory of Phil Greenberg at the Fred Hutchinson Cancer Research Center. He has co-authored over 85 peer-reviewed manuscripts, including multiple highly cited articles in high-impact journals that have helped define the space of CAR- and TCR- based T cell therapy, as well as book chapters in the field of cancer immunotherapy. He also has over 26 issued patents in the fields of cell therapy, immunotherapy, and vaccines. Dr. Kalos now actively serves in an advisory capacity for a number of biopharmaceutical companies as well as international immunotherapy consortia and organizations.

On February 17, 2022 Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies designed to reprogram RNA processing and address the underlying drivers of disease, reported a strategic collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the discovery and development of small molecule therapeutics that modulate RNA processing using Remix’s REMaster drug discovery platform (Press release, Janssen Pharmaceutica, FEB 17, 2022, View Source [SID1234608228]). The agreement was facilitated by Johnson & Johnson Innovation.

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Under the terms of the agreement, Remix will receive an initial payment of $45 million in cash for upfront and research funding, and may also receive preclinical, clinical, commercial, and sales milestone payments and tiered royalties for any resulting products. In exchange, Janssen will have exclusive rights to three specific targets with applications in immunology and oncology. Remix will have the ability to opt into a portion of the costs of clinical development on one program in exchange for higher royalties. Under the agreement, Remix is eligible to receive total payments potentially exceeding $1 billion, subject to regulatory approvals and other conditions.

"We look forward to collaborating with this innovative team," said Peter Smith, Ph.D., Co- Founder and Chief Executive Officer of Remix Therapeutics. "Janssen is an ideal strategic partner for our REMaster platform. This collaboration further validates the therapeutic potential of our proprietary REMaster drug discovery platform and provides additional resources to translate our cutting-edge science into new medicines."

On February 17, 2022 Enveric Biosciences (NASDAQ: ENVB)("Enveric" or the "Company), a cutting-edge neuroscience company developing next-generation, psychedelic-inspired mental health medicines, reported that it is working with the University of Calgary’s Hotchkiss Brain Institute ("HBI"), a leading neurosciences center of excellence, at the Cumming School of Medicine in Calgary, Canada that is dedicated to advancing brain and mental health research and education, to establish a groundbreaking clinical trial of EVM-101 for the treatment of Cancer Related Distress ("CRD") (Press release, Enveric Biosciences, FEB 17, 2022, View Source [SID1234608227]).

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Approximately 50% of cancer patients report clinical levels of psychological distress having depressed mood, anxiety, demoralization, stress-induced clinical manifestations, and reduced quality of life1. Up to 40% of cancer patients meet the criteria for a mood disorder requiring treatment2. CRD is a significant unmet medical need with no current regulatory approval of pharmacotherapies and an urgent need to optimize the current standard of care for patients with cancer.3

A clinical trial, expected to launch later this year, of EVM-101, a first-generation psychedelic treatment, for CRD will be led by HBI researcher, Dr. Valerie Taylor, Head of the Department of Psychiatry, in Calgary, Canada.

"We are excited to collaborate with Enveric to study next-generation medicines that we hope will help people cope with the mental health challenges of a cancer diagnosis. This work will allow us to mobilize our combined resources to research options for cancer patients living with CRD," says Dr. Valerie Taylor.

The EVM-101 study will directly assess the core features of CRD that are most affected and amenable to improvement following a psilocybin-based treatment.

"With the rising rates of cancer and its associated psychological ailments that have been underestimated and underdiagnosed until recently, we are working hard to develop new treatments that help cancer patients suffering from CRD" said Dr. Bob Dagher, Enveric’s Chief Medical Officer. "Our collaboration with the research team at the University of Calgary’s Hotchkiss Brain Institute and IMPACT Clinical Trial Accelerator will help us to demonstrate the potential benefits of these novel treatments and get them to market as quickly as possible."

A regulatory submission to Health Canada is expected to soon be finalized. Patient enrollment in the clinical trial is expected to begin late in 2022 or early in 2023. The study design will employ proprietary psychiatry and psychotherapy-focused treatments for cancer patients with CRD. Patients will receive a single oral dose of EVM-101 in a supportive environment with psychotherapy to improve outcomes.

Enveric is committed to discovering and developing more effective treatments for cancer patients living with psychological distress and is currently working on three classes of new medicines: EVM-101, a first-generation oral psilocybin; EVM-201, a second-generation pro-drug; and EVM-301, a third-generation psychedelic-inspired and optimized new molecule.

References:

Mehnert, A., Hartung, T. J., Friedrich, M., Vehling, S., Brahler, E., Harter, M., et al. (2018). One in two cancer patients is significantly distressed: prevalence and indicators of distress. Psychooncology 27, 75-82. Doi: 10.1002/pon.4464
Holland et al. (2013). Distress Management. J Natl Compr Cancer Network 2013 Feb 1;11(2):190-209. doi: 10.6004/jnccn.2013.0027
Peters, L., Brederecke, J., Franzke, A., Zwaan, M., Zimmermann, T. (2020). Psychological Distress in a Sample of Inpatients with Mixed Cancer-A Cross-Sectional Study of Routine Clinical Data. Front Psychol. 2020 Nov 30; 11:591771. doi: 10.3389/fpsyg.2020.591771

On February 17, 2022 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter and full year ended December 31, 2021 and highlighted recent achievement of important milestones toward the Company’s key strategic initiatives (Press release, Coherus Biosciences, FEB 17, 2022, View Source [SID1234608226]):

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RECENT EXECUTION ON KEY STRATEGIC INITIATIVES
Building an innovative immuno-oncology company:

U.S. Food and Drug Administration ("FDA") granted toripalimab BLA priority review for nasopharyngeal carcinoma ("NPC") and assigned a target action date of April 30, 2022.
Toripalimab in combination with chemotherapy demonstrated a statistically significant overall survival benefit in prespecified interim analysis of Phase 3 clinical trial in patients with non-small cell lung cancer.
Initiated process to exercise option to license JS006, a TIGIT targeted antibody being evaluated in combination with toripalimab in an ongoing Phase 1/2 clinical trial.
Advancing internal immuno-oncology antibody into IND enabling studies.
Diversifying and growing the commercial product portfolio:

FDA approved YUSIMRY (adalimumab-aqvh), a Humira biosimilar, on December 17, 2021.
FDA accepted for review the BLA for CIMERLI (ranibizumab-ranq), a Lucentis biosimilar, and assigned a target action date in August 2022.
UDENYCA (pegfilgrastim-cbqv) on-body injector ("OBI") achieved both pharmacokinetic and pharmacodynamic bioequivalence in randomized clinical trial, enabling prior approval supplement filing with FDA in 2022; if approved, a UDENYCA OBI would compete directly with Neulasta Onpro which retains approximately 50% share of the overall pegfilgrastim market.
"We have made rapid progress transforming Coherus into an innovative immuno-oncology company supported by income from a diversified portfolio of FDA-approved products. In 2022, we expect to launch two new products, if approved, including our first immuno-oncology antibody, toripalimab, addressing an unmet need in nasopharyngeal carcinoma, as well as CIMERLI. We also plan to initiate a clinical trial in North America evaluating toripalimab in combination with JS006, a TIGIT-targeted antibody," said Denny Lanfear, CEO of Coherus. "Looking ahead to 2023, we project accelerating revenue growth with the planned launch of FDA-approved YUSIMRY into the $17 billion Humira market and the introduction of the UDENYCA on-body injector, if approved, a new presentation that would enable us to address the remaining $1.2 billion Neulasta Onpro segment of the pegfilgrastim market where there is currently no biosimilar competition."

Fourth Quarter and Full Year 2021 Financial Results

Net revenue, consisting of net sales of UDENYCA, was $73.4 million for the fourth quarter of 2021 compared to $110.4 million for the same period in 2020. Net revenue for 2021 was $326.6 million compared to $475.8 million for 2020. The declines for the fourth quarter and full year 2021 were primarily due to a decrease in the number of units of UDENYCA sold as well as a decline in net realized price due to increased competition and COVID-19 impacts.

Cost of goods sold ("COGS") was $12.1 million and $11.7 million during the three months ended December 31, 2021 and 2020, respectively, and $57.6 million and $37.7 million for the full years 2021 and 2020, respectively. Through the first quarter of 2021, Coherus sold inventory that was manufactured and expensed prior to the approval of UDENYCA in late 2018. This inventory was depleted in the first quarter of 2021, and since then COGS fully reflects per unit acquisition cost of UDENYCA. UDENYCA COGS also includes a mid single digit royalty on net sales payable through the first half of 2024.

Research and development ("R&D") expenses for the fourth quarter of 2021 were $50.8 million, compared to $44.6 million for the same period in 2020. The increase was mainly due to higher regulatory and development costs in support of the advancement of multiple pipeline product candidates. R&D expense for 2021 was $363.1 million compared to $142.8 million for 2020. The increase of $220.3 million was primarily due to the $136.0 million upfront license fee paid to Junshi Biosciences and also due to costs incurred in the development of YUSIMRY, toripalimab and additional presentations of UDENYCA.

Selling, general and administrative ("SG&A") expenses were $50.1 million for the fourth quarter of 2021, compared to $37.7 million for the same period in 2020. The increase was driven primarily by increased commercialization expense to support UDENYCA sales. For the full year 2021, SG&A expenses were $169.7 million, compared to $139.1 million for the prior year. The year-over-year increase is primarily due to costs incurred in support of UDENYCA commercial activities, as well as an increase in stock-based compensation expense.

Cash and cash equivalents were $417.2 million as of December 31, 2021, compared to $541.2 million as of December 31, 2020. During 2021, Coherus used $37.4 million in operating activities and $138.4 million in investing activities, including $136.0 million in an upfront payment to Junshi Biosciences. The Company received net cash proceeds of $51.9 million from financing activities related to the issuance of common stock to Junshi Biosciences, as well as proceeds from the exercise of stock options and from purchases under the employee stock purchase plan.

Net loss for the fourth quarter of 2021 was $45.7 million, or $(0.60) per share on a diluted basis, compared to net income of $9.7 million, or $0.12 per share on a diluted basis for the same period in 2020. Net loss for 2021 was $287.1 million, or $(3.81) per share on a diluted basis, compared to net income of $132.2 million, or $1.62 per share on a diluted basis for 2020.

Non-GAAP net loss for the fourth quarter of 2021 was $35.1 million, or $(0.46) per share on a diluted basis, compared to non-GAAP income of $18.6 million, or $0.23 per share on a diluted basis for the same period in 2020. Non-GAAP net loss for 2021 was $88.5 million, or $(1.17) per share on a diluted basis, compared to non-GAAP income of $176.7 million, or $2.16 per share on a diluted basis for 2020. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net income (loss) and a reconciliation to the most directly comparable GAAP measures.

2022 Guidance

Coherus projects combined R&D and SG&A expenses in 2022 to be in the range of $415 million to $450 million, excluding a potential $25 million milestone payable upon FDA approval of the toripalimab BLA for nasopharyngeal carcinoma and the $35 million fee to exercise the option for the license to JS006, which is expected to close in the first quarter of 2022. The projected increase compared to 2021 is driven primarily by costs the Company expects to incur with the anticipated launches of two new products, toripalimab and CIMERLI, as well as manufacturing and development costs for additional presentations of UDENYCA and for FDA-approved YUSIMRY, which Coherus is planning to launch in 2023.

This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information
When: Thursday, Feb. 17, 2022, starting at 5 p.m. ET
Dial-in: (844) 452-6826 (Toll-Free U.S. and Canada) or (765) 507-2587 (International)
Conference ID: 3677018

Webcast: View Source
Please dial-in 15 minutes early to ensure a timely connection to the call.
Fourth quarter and full year 2021 financial results are posted on the Coherus website at View Source

On February 17, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that following a pre-planned interim safety review of 81 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2 (Press release, Celsion, FEB 17, 2022, View Source [SID1234608224]). The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported.

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The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

The OVATION 2 Study is designed with an 80% confidence interval for an observed Progression Free Survival (PFS) Hazard Ratio of 0.75, which would mean an approximate 33% improvement in risk for cancer progression when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only). GEN-1 is an immunotherapy that produces safe and durable local levels of IL-12, a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

The Company also announced that more than 75% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from the first 39 patients who have undergone interval debulking surgery showed that the GEN-1 treatment arm is showing a 27% improvement in R0 surgical resection rate over the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed.

"Findings from our OVATION I and OVATION 2 studies show a consistent dose-dependent clinical response in both surgical outcome and tumor response, which is further supported by translational data of the tumor microenvironment," noted Nicholas Borys, M.D., Celsion’s executive vice president and chief medical officer. "We are encouraged by the current rate of patient recruitment and expect to complete enrollment by mid-2022. The primary endpoint for the study is progression-free survival (PFS) which we expect to report approximately 12 months after patient enrollment is completed."

In February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.

"We thank the DSMB members for their work and advice," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "FDA Fast Track and Orphan Drug Designations for GEN-1 in advanced ovarian cancer are important for our future commercialization efforts. In addition, under the Biologics Price Competition and Innovation Act of 2009, sponsors of new, licensed biological products like GEN-1 that are approved through a Biologics License Application receive 12 years of market exclusivity. The FDA cannot license any 351(k) application for a biosimilar or interchangeable product that relies on the previously approved product as a reference for biosimilarity during this 12-year period."

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, stage III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stages III and IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for regional approach to immune modulation.