On December 6, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that it will host a virtual research and development day on Wednesday, December 15, 2021 at 12pm Eastern Time (Press release, Y-mAbs Therapeutics, DEC 6, 2021, View Source [SID1234596559]).

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The Y-mAbs research and development day will feature presentations from oncology key opinion leaders ("KOLs") Javier E. Oesterheld, M.D. (Atrium Health) and Jaume Mora, M.D., Ph.D. (SJD Barcelona Children’s Hospital).

Dr. Oesterheld will present on the current treatment landscape in the U.S. with DANYELZA (naxitamab-gqgk); and Dr. Mora will present dosing experience with naxitamab for patients with pediatric high-risk neuroblastoma and other solid tumors from compassionate use.

An update on Y-mAbs Therapeutics’ broad and advanced product pipeline, including the SADA technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK) MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).

A question and answer session will follow the formal presentations. To register for the event, please click here.

Featured KOLs:

Jaume Mora, M.D., Ph.D. is the scientific director of Oncology and Hematology at SJD Barcelona Children’s Hospital, as well as the director of its Developmental Tumours Laboratory. He is a member of several national and international scientific societies, including the International Pediatric Oncology Society, which awarded him the Schweisguth Prize, and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which in 2000 honored him with the young investigator award (YIA), as well as the Career Development Award (CDA). In 2011, Dr. Mora was the recipient of the annual BBVA Foundation Award and in 2006 he was awarded first prize of the Spanish Association Against Cancer (AECC) award for the study of child cancer.

Javier E. Oesterheld, M.D., is board certified in pediatric hematology-oncology and is helping to lead the ongoing pursuit of better treatments for childhood cancer. In 2017, he was named the first Jeff Gordon Children’s Foundation Endowment Chair – Levine Children’s Cancer and Blood Disorders Program, a role that supports his mission to improve lives and outcomes of pediatric cancer patients. He’s also the principal investigator for Carolinas Kids Cancer Research Coalition, in conjunction with the developmental therapeutics program at Levine Children’s Hospital. Additionally, Dr. Oesterheld is the study chair and/or site principal investigator for multiple clinical research studies into acute leukemia, refractory pediatric acute lymphoblastic leukemia, relapsed and refractory Neuroblastoma, and relapsed sarcomas. His research has been published in top journals and has led to numerous lecture invitations.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 6, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, and CEPI, the Coalition for Epidemic Preparedness Innovations, reported the expansion of their agreement in order to support the development of a self-amplifying mRNA (SAM) vaccine designed to tackle the Omicron COVID-19 variant (Press release, Gritstone Oncology, DEC 6, 2021, View Source [SID1234596537]). CEPI will provide up to $5 million in additional funding to conduct a Phase 1 clinical trial of Gritstone’s Omicron vaccine candidate in South Africa, where a CEPI-funded clinical trial of Gritstone’s Beta variant COVID-19 vaccine is due to begin shortly. The SARS-CoV-2 T cell epitopes (TCEs) administered within Gritstone’s SAM COVID-19 vaccines are minimally impacted by mutations found within the Omicron variant, reinforcing the platform’s potential to address both Omicron and future variants of concern.

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CEPI is already funding up to $20.6 million to support preclinical studies, manufacturing process optimization, and a Phase 1 trial of Gritstone’s Beta variant vaccine candidate (containing beta-Spike plus additional TCEs), which will be initiated by South Africa’s University of the Witwatersrand in the coming weeks. The funding announced today will expand the Phase 1 trial to include additional arms to evaluate an Omicron-specific version of the vaccine (which contains omicron-Spike plus TCEs). Gritstone has commenced manufacturing its SAM vaccine to specifically target the Omicron variant, and the Omicron arms of the Phase 1 trial are expected to begin in Q2 2022, subject to regulatory approval.

The recently described Omicron variant, first identified in South Africa on November 9, 2021, was designated a variant of concern by the World Health Organization (WHO) on November 26, 2021. Early evidence suggests that Omicron carries an increased risk of re-infection, and sequence analysis has revealed many mutations in Spike, which may reduce clinical effectiveness of existing vaccines and/or therapeutic antibodies.

Enabling equitable access
CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone have agreed that this Omicron vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if it is proven to be safe and effective. The COVAX Facility aims to deliver equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.

Dr Richard Hatchett, CEO of CEPI, said: "While key questions are yet to be answered about Omicron, its transmissibility, and its potential ability to evade our current vaccines, the stakes are too high to delay developing Omicron-specific vaccine candidates. Given the uncertainties, we must accelerate crucial R&D so vaccines are available to tackle Omicron as soon as possible – just in case we need them. There is no time to lose, so I’m pleased that within 10 days of Omicron being declared a Variant of Concern by the WHO, CEPI is expanding its partnership with Gritstone to support a new Omicron vaccine candidate which can be made globally accessibly through COVAX."

"Our vaccine platforms are built on the premise that a best-in-class vaccine against a virus will drive strong neutralizing antibodies directed to surface antigens such as Spike, and strong cytotoxic T cell responses against other conserved viral antigens to eliminate virally infected cells. This broad immune response would, in principle, provide superior protection against a virus that is mutating its surface protein. Omicron is an example of a novel SARS-CoV-2 variant that may escape clinical protection conferred by vaccines that only afford narrow, Spike-specific immunity," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. "Our SAM technology provides an innovative platform likely capable of delivering on the attractive concept of broad, durable immunity. We are thrilled to be quickly expanding our relationship with CEPI in our shared goal of finding new vaccine solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks."

Self-amplifying mRNA vaccines
As with the mRNA-based COVID-19 vaccines that are now in global use, self-amplifying mRNA vaccines use the body’s own machinery to make antigenic protein itself rather than injecting the antigen directly into the body.

However, in self-amplifying mRNA vaccines, viral RNA is adapted in a way that allows only the genetic sequence for a specific antigen to be expressed, while keeping the part of the RNA that allows it to produce multiple copies of itself—the self-amplification machinery.

The benefit of this approach is that the dose of RNA can be reduced while maintaining the potency of the vaccine. Gritstone’s vaccine candidate may also elicit T-cell immune responses against non-Spike gene fragments, which are slower to mutate than the genes associated with the SARS-CoV-2 Spike protein and could potentially provide broad protection against other SARS-CoV-2 strains.

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 Recursion (NASDAQ: RXRX), a clinical-stage biotechnology company decoding biology to radically improve lives by industrializing drug discovery, development and beyond through disruptive innovation, reported expansion of the company’s existing strategic collaboration in fibrosis with Bayer AG (Press release, Recursion Pharmaceuticals, DEC 6, 2021, View Source [SID1234596535]). The expanded collaboration will include Recursion’s powerful inferential search capabilities based on its growing maps of human cellular biology, giving Bayer the ability to further accelerate the work already underway in expanding the universe of novel fibrotic hypotheses. Recursion and Bayer may now work on more than a dozen programs in total of relevance to fibrotic disease. All projects will remain subject to the previously agreed upon economics, where each potential program could generate more than $100 million in commercial milestone payments plus royalties on future sales.

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Inferential search enables Recursion to materially expand the depth and breadth of the drug discovery space in a more efficient fashion – reducing time and costs to better operationalize the process. In the expanded collaboration, the company will leverage the Recursion Map, a collection of actionable scientific insights derived from the application of machine learning solutions on massive relatable datasets, to explore hundreds of billions of biological relationships that span whole-genome genetic perturbations, hundreds of soluble factors, and hundreds of thousands of pharmacological perturbations. Inferred relationships of interest will be validated in Recursion’s wet-labs and digital vivariums to rapidly advance therapeutic hypotheses and generate data which is fed back into Recursion’s Operating System to improve future predictions.

"Our collaborations are centered around the goal of delivering better drugs to patients faster than we could on our own," said Recursion Co-Founder & CEO Chris Gibson, PhD. "At Recursion, we believe inferential search is the future of drug discovery and have made key advances in this space. We have a deep respect for and trust in our colleagues at Bayer and are looking forward to including these new tools in our collaboration and potentially expanding the number of programs we go after together – all for the benefit of patients."

"The speed and scale of progress made in a short period of time on a number of fibrotic disease models with our collaborators at Recursion has been impressive," said Philip Larsen, Senior Vice President and Global Head of Research and Early Development at Bayer. "Fibrotic diseases are an important cause of morbidity and mortality worldwide. We look forward to the continued collaboration and adding inferential search to further accelerate our mission to deliver transformative therapies for patients with fibrotic diseases of the lung, kidney, heart and more."

Recursion first deployed inferential search internally in July 2020 within the oncology space. In early 2021, Recursion transitioned nearly all new internal discovery efforts to use inferential search. Based on progress achieved to date, Recursion has demonstrated that a program can advance from inference to in vivo validation in less than six months. Through the collaboration expansion, Recursion will bring this powerful new technology to Bayer in order to accelerate and expand the ongoing work the teams have undertaken together in fibrosis.

On 6 December 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, DEC 6, 2021, View Source [SID1234596534]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022.

Since the announcement 29 November 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 29,908,560 B shares of DKK 0.20 as treasury shares, corresponding to 1.3% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 20 billion during a 12- month period beginning 3 February 2021. As of 3 December 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 31,155,009 B shares at an average share price of DKK 563.25 per B share equal to a transaction value of DKK 17,547,995,580.