On 6 December 2021 Immunocore Holdings Plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported the initial Phase 1 data of IMC-C103C, a bispecific T cell engager targeting MAGE-A4, in selected advanced solid tumors (Press release, Immunocore, DEC 6, 2021, View Source [SID1234596499]).

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IMC-C103C was developed using the company’s innovative ImmTAC technology platform and is being developed in partnership with Genentech, a member of the Roche Group. The trial (IMC-C103C-101) includes a Phase 1 dose escalation to evaluate safety, maximum tolerated dose / expansion dose, and preliminary clinical activity. The initial Phase 1 data from this study is the subject of a presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress.

The presentation includes data from 44 patients enrolled across 10 dose-escalation cohorts. Indications with high MAGE-A4 prevalence (eg. serous ovarian, synovial sarcoma) enrolled all-comers with retrospective MAGE-A4 testing by immunohistochemistry (IHC) while other indications required prospective confirmation of tumor MAGE-A4 expression by IHC.

IMC-C103C demonstrated a manageable safety profile. The most common any-grade, treatment-related adverse events were consistent with cytokine release syndrome, were dose dependent and rapidly resolved. The most common related grade 3 or grade 4 adverse event was neutropenia, typically at doses ≥ 90 micrograms. Neutropenia was reversible, with treatment interruption or G-CSF, and was not dose-limiting. None of the treatment-related AEs led to discontinuation or death.

IMC-C103C dose escalation began at 0.5 micrograms, the minimum anticipated biological effect level (MABEL), and includes 10 cohorts to date. Pharmacodynamic biomarkers of T cell activation were first observed at 15 micrograms and became consistent and robust at doses ≥ 90 micrograms. IMC-C103C treatment results in a substantial increase in T cell infiltration in tumor biopsies relative to baseline.

The most frequently enrolled patients had platinum relapsed/refractory ovarian cancer, who were enrolled regardless of their tumor MAGE-A4 protein expression. Most of these patients had low or no MAGE-A4 protein expression in their tumors as measured by IHC (median H score = 8). One ovarian cancer patient, with a very low MAGE protein expression, treated at a dose of < 90 micrograms, had a durable confirmed partial response (PR) with 8.3 months duration. An additional ovarian cancer patient at a dose of ≥ 90 micrograms, also with very low MAGE-A4 protein expression, has a confirmed partial response ongoing at 4.4+ months. One of the three non-ovarian cancer patients (head and neck squamous cell carcinoma) at a dose of ≥ 90 micrograms has a confirmed PR that is ongoing.

"IMC-C103C is our second T cell engager to demonstrate durable clinical activity, now in multiple solid tumors," stated Bahija Jallal, Chief Executive Officer. "We are highly encouraged to see these responses in ovarian and head and neck cancer. The durable PRs in ovarian cancer occur in heavily pre-treated patients even with low MAGE-A4 protein tumor expression. We have initiated an expansion arm in ovarian carcinoma, while we continue signal searching and determining the optimal dose in multiple solid tumors."

Earlier this month, Immunocore initiated an expansion arm in high grade serous ovarian carcinoma at 140 micrograms. IMC-C103C-101 will continue to explore the optimal dose and evaluate clinical activity in multiple solid tumors. The company plans to present additional data from this program in 2022. IMC-C103C is part of a co-development / co-promotion collaboration with Genentech under which Immunocore shares program costs and profits equally.

Conference Call Information
Immunocore will host a live webcast and conference call today beginning at 8:00 am E.T. to discuss the results with Dr. Diwakar Davar, an assistant professor of medicine and a medical oncologist and hematologist at the University of Pittsburgh Medical Center (UPMC). A live webcast of the conference call will be available under "Events" in the Investor Relations section of Immunocore Holdings’ website at www.immunocore.com. The presentation from today’s call and the archived webcast will be available on Immunocore’s website after the conference call concludes and will be available for 30 days following the call.

On December 6, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported it will review interim data results presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from the PBCAR0191 CD19 allogeneic CAR T program and provide other CAR T program updates during a company-hosted webcast and conference call on Saturday, December 11, 2021 at 7:30 PM ET (Press release, Precision Biosciences, DEC 6, 2021, View Source [SID1234596516]).

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Precision previously announced that abstracts accepted by ASH (Free ASH Whitepaper) are now available at www.hematology.org, and the following two abstracts will be presented during oral presentation sessions:

Oral Presentation: #626. Allogeneic CAR-T PBCAR0191 with Intensified Lymphodepletion is Highly Active in Subjects with Relapsed/Refractory B-cell Malignancies (Abstract #302)
Presenting Author: Bijal Shah, M.D., Moffitt Cancer Center
Date/Time/Location: Saturday, December 11, 2021 at 4:15 PM ET in the Georgia World Congress Center, B401-B402

Oral Presentation: #704. Preliminary Safety and Efficacy of PBCAR0191, an Allogeneic ‘Off-the-Shelf’ CD19-Directed CAR-T for Patients with Relapsed/Refractory (R/R) CD19+ B-ALL (Abstract #650)
Presenting Author: Nitin Jain, M.D., The University of Texas MD Anderson Cancer Center
Date/Time/Location: Monday, December 13, 2021 at 10:45 AM ET in the Georgia World Congress Center, Sidney Marcus Auditorium

Company-Hosted Webcast and Conference Call Information
Precision will host a conference call and webcast on Saturday, December 11, 2021 at 7:30 PM ET to discuss interim data results for PBCAR0191 presented at the ASH (Free ASH Whitepaper) annual meeting, as well as additional updates regarding its allogeneic CAR T pipeline. This event is not an official program of the ASH (Free ASH Whitepaper) annual meeting. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 1178837. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source

On December 6, 2021 Scilex Holding Company ("Scilex"), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), and Vickers Vantage Corp. I, a Cayman Islands corporation (NASDAQ: VCKA) ("SPAC"), reported the signing of a letter of intent for a proposed business combination (Press release, Sorrento Therapeutics, DEC 6, 2021, View Source [SID1234596536]).

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Scilex is dedicated to the development and commercialization of non-opioid pain management products for treatment of acute and chronic pain. Scilex’s commercial product ZTLIDO (lidocaine topical system) 1.8%, a non-opioid prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, shows continued sales growth of 35% year over year despite the continued impact of the COVID-19 pandemic. SP-102 (SEMDEXA) is the first non-opioid novel injectable corticosteroid gel formulation product in Phase 3 development for the treatment of lumbar radicular pain, containing no preservatives, surfactants, solvents, or particulates. If approved by the FDA, SP-102 (SEMDEXA) will be available in a pre-filled syringe formulation and will be administered as an epidural injection for the treatment of sciatica. Based on preclinical and clinical studies to date, SP-102 (SEMDEXA) extends the residency time at the site of injection and has not demonstrated the safety concerns that led the FDA to warn against using other injectable steroid formulations by the epidural route of administration.

By 2022, the overall estimated number of epidural steroid injection (ESI) procedures in the U.S. is expected to be 12.1 million across all Medicare and private coverage patients, with lumbar radiculopathy/sciatica procedures comprising approximately 88% of all ESIs administered, according to a proprietary study by Syneos Health Consulting. Despite widespread utilization of ESIs, concerns persist in the market about particulate and solution steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. Opioid prescriptions account for about 40% of the chronic back pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternate pain therapies without the medical and societal challenges.2,5 As a result, a significant unmet medical need exists within the market for a novel, non-particulate ESI formulation that demonstrates safety and effectiveness in controlled clinical trial evaluations.7

In the U.S., more than 30 million people suffer from low back and radicular pain. This population is expected to grow as the overall population ages.1,2 Many patients experience moderate to severe pain with intolerance of and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs).3,4 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.2 Opioid prescriptions account for about 40% of the chronic back pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternate pain therapies without the medical and societal challenges.2,5

Henry Ji, Chairman and Chief Executive Officer of Sorrento Therapeutics, Inc. and Executive Chairperson of Scilex said, "If completed, this transaction could propel us into the next phase of growth, and we are excited to work towards partnering with a world-class group of investors at Vickers who recognize the opportunity for much needed change in the treatment of millions of patients suffering from acute and chronic pain worldwide."

Jaisim Shah, President and Chief Executive Officer of Scilex, stated, "I am excited to lead Scilex as we continue to work to deliver best-in-class non-opioid therapies for patients in acute and chronic pain. We are moving rapidly toward potential commercialization of our late-stage non-opioid pain programs while continuing to grow our early pipeline to address this high unmet need area with the ongoing opioid crisis of today and in the future. We believe this proposed business combination could set Scilex on its path to becoming a highly resourceful leader in delivering best-in-class therapies for non-opioid pain management."

"Scilex’s leaders have done an exceptional job of building the company to date. We were particularly interested in partnering Vickers Vantage with a company with novel best-in-class approaches and treatments in high unmet need areas, a deep pipeline and an exceptional management team. We believe Scilex embodies such a platform and company, with its focus on addressing high unmet need with non-opioid therapies in this time of the worsening opioid crisis. We believe that a proposed merger of Scilex and Vickers Vantage Corp I could build near and long-term value for shareholders," said Jeffrey Chi, Chairman and Chief Executive Officer of Vickers Vantage Corp I.

Terms of Letter of Intent

Completion of the proposed transaction is subject to the negotiation of a definitive merger agreement (the "Merger Agreement"), approval by the SPAC’s and Scilex’s boards of directors, satisfaction of the conditions negotiated in the proposed Merger Agreement and approval of the proposed transaction by the SPAC’s shareholders. Accordingly, there can be no assurance that a Merger Agreement will be entered into or that the proposed transaction will be consummated. Further, readers are cautioned that those portions of the letter of intent that describe the proposed transaction, including the consideration to be issued therein, are subject to change.

The letter of intent contemplates the combined company (the "Combined Company") changing its name to Scilex Holding Company and being led by Scilex’s current management team. The letter of intent provides for gross proceeds of up to $140 million, dependent on the level of SPAC shareholders that exercise redemption rights. Assuming execution of the proposed Merger Agreement and consummation of the proposed transaction, the Combined Company expects to capitalize on the commercialization of ZTlido (lidocaine topical system) 1.8%, a best-in-class prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia; SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, or SP-103, a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of acute low back pain; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia in multiple Phase 1 programs to be initiated in 2021.

Assuming the SPAC and Scilex enter into the proposed Merger Agreement, the parties will look to seek approval from the SPAC’s shareholders in the first half of 2022.

Contingent upon execution of the Merger Agreement, the SPAC would file a registration statement on Form S-4 with the SEC, which would include a proxy statement/prospectus, and each party would file other documents regarding the proposed transaction with the SEC.

On December 6, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported the appointment of Bob Dagher, MD, as Chief Medical Officer, effective immediately (Press release, Enveric Biosciences, DEC 6, 2021, View Source [SID1234596465]).

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Dr. Dagher brings over 20 years of experience working in clinical development in the pharmaceutical industry for both small and large pharmaceutical companies and as a board-certified physician from the American Board of neurology and psychiatry. He has an extensive therapeutic background concentrated in the neuroscience space which includes a focus on psychotic, affective and anxiety disorders, as well as neuroimmunology, neurodegeneration and movement disorders. Furthermore, Dr. Dagher has supported and driven successful drug development programs from preclinical stages through Phase 4 clinical trials.

"Dr. Dagher joins our team at a crucial time where we are continuing to build momentum and drive development of our key psychedelic molecules for the mind and cannabinoids for the body," said Dr. Joseph Tucker, Chief Executive Officer, Enveric Biosciences. "Dr. Dagher brings extensive experience working in the pharmaceutical industry with a focus and passion for drug development for neurological and mental health indications. His experience is expected to be very valuable as he will lead Enveric alongside our clinical team in continuing to advance our pipeline. Dr. Dagher’s addition to Enveric is key addition as we continue our focus on building a world-class management team."

"As a trailblazing Company working to discover and develop the next-generation treatments through the use of both psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, Enveric has major potential to make a real difference for mental health and cancer patients in need," said Dr. Dagher. "As Chief Medical Officer, I look forward to working with the leadership and clinical teams to harness the power of these groundbreaking technologies to truly help bring solutions to various indications ranging from cancer-related distress to a whole host of other mental health disorders."

Prior to joining Enveric, Dr. Dagher served as the Chief Medical Officer at WCG MedAvante-ProPhase where he led the clinical science organization to help forge and develop compelling scientific solutions to match industry challenges. Before joining WCG, Dr. Dagher served as the Chief Medical Officer at Cadent Therapeutics, where he led and advanced the company’s pipeline of small molecules, coupled with the implementation of precision biomarkers, for the development of innovative programs in rare diseases and common indications targeting movement and cognitive disorders. Following his early experience treating patients in academic and private practice settings, Dr. Dagher started his career in the pharmaceutical industry at GlaxoSmithKline, followed by Sanofi/Genzyme working on neurology, psychiatry, and urology indications.

Robert Wilkins, MD, stepped down from his role of Chief Medical Officer on November 29th, 2021. David Johnson, Executive Chairman, stated, "I want to thank Robert for his commitment to Enveric over the past two years. His contributions to our team have been significant and meaningful. His leadership has helped guide our transformation into the biotechnology company we are today. We relied on Robert’s expertise having worked with several biomedical startups in the past and have valued his deep knowledge in the pharmaceutical space. His guidance and insights have helped shape Enveric’s leadership team. We are grateful for the significant contributions he has made to Enveric and wish him the best of luck on his future endeavors."

On December 6, 2021 ITI reported that it will be attending the 2nd International Symposium on Merkel Cell Carcinoma (Press release, Immunomic Therapeutics, DEC 6, 2021, View Source [SID1234596484]).

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The focus of this symposium is to explore emerging data that may allow improvements in clinical guidelines, develop innovative approaches, and to understand the basic biology that drives this disease. We will include updates from the most recent clinical guidelines as well as emerging data highlighting MCC biology. This meeting will be partly in lecture format with talks from leaders in the field as well junior faculty and trainees. We will also include focused panel discussions and poster presentations to optimize real time feedback and collaboration. The educational purpose of this symposium is to disseminate emerging data and to advance MCC research by stimulating collaborative meeting.