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Celsius Holdings, Inc. Reports Record First Quarter 2022 Financial Results

On May 10, 2022 Celsius Holdings, Inc., (Nasdaq: CELH), maker of the leading global fitness drink, CELSIUS reported preliminary financial results for the first quarter ended March 31, 2022 (Press release, Celsius Therapeutics, MAY 10, 2022, View Source [SID1234614146]). Management will host a conference call today at 4:30 p.m. Eastern Time to discuss the results with the investment community.

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A PDF containing our first quarter 2022 results and full financial tables is available at:
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To participate in the conference call, please call one of the following telephone numbers at least 10 minutes before the start of the call:

Webcast: View Source

An audio replay of the call will be available on the Company’s website at:
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Arcellx Announces Dosing of First Patient in its Phase 1 Clinical Trial Evaluating ACLX-001, the First Therapeutic in the Dosable and Controllable ARC-SparX Platform, for the treatment of Patients with Relapsed or Refractory Multiple Myeloma

On May 10, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that the first patient has been dosed in its open-label, multicenter ACLX-001 Phase 1 clinical trial (NCT04155749) to evaluate the company’s novel ARC-SparX program in patients with relapsed or refractory multiple myeloma (r/r MM) (Press release, Arcellx, MAY 10, 2022, View Source [SID1234614145]). ARC-SparX is a universal cell therapy platform comprised of SparX (soluble protein antigen-receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and are engineered to activate only when engaged with a SparX protein bound to a myeloma cell. Both the ARC-T cells and SparX proteins utilize the company’s proprietary novel synthetic binding scaffold called the D-Domain.

"Our ARC-SparX platform, powered by our proprietary D-Domain technology, has the potential to yield transformative therapies that can unleash the full potential of CAR-Ts to treat challenging conditions, including solid tumors. By addressing antigen heterogeneity and dose limiting toxicities, ARC-SparX could help many patients and address significant unmet clinical needs," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "ACLX-001 is intended to demonstrate the advantages for our ARC-SparX platform technology and may potentially enable rapid development of future ARC-SparX programs in our portfolio. We look forward to enrolling additional patients in this study and evaluating the clinical outcomes."

"We are excited to be participating in this clinical trial to evaluate ACLX-001 in patients with relapsed or refractory multiple myeloma," said Binod Dhakal, M.D., M.S., associate professor of medicine, Division of Hematology/Oncology, Medical College of Wisconsin, and clinical investigator on both Phase 1 trials of CART-ddBCMA and ACLX-001. "ARC-SparX provides physicians with the ability to control the dose and frequency of SparX administration. This may allow the physician to better manage toxicities associated with traditional CAR-T therapies, potentially increasing patient access to this treatment option."

Initial data from the ACLX-001 Phase 1 study is expected in 2023. For more information about the clinical trial program, visit ClinicalTrials.gov (NCT04155749).

About the ARC-SparX Platform Technology
The ARC-SparX platform is designed to allow for controllability and adaptability to potentially reduce toxicities that are often associated with serious dose-limiting adverse events and to overcome tumor heterogeneity. It is a modular therapy which utilizes a universal ARC-T cell combined with an off-the-shelf SparX protein to separate the tumor-recognition and tumor-killing functions. SparX (soluble protein antigen-receptor X-linkers) proteins utilize our D-Domain technology engineered to recognize antigens on the surface of diseased cells and flags those cells for detection by the ARC-T cells. ARC-T cells express a D-Domain-based CAR engineered to specifically recognize a unique TAG in the SparX protein. ARC-T cells are dosed separately and only activated to kill the target cell when they encounter a SparX protein bound to the target antigen and thus are controlled through SparX dose modulation. Arcellx has developed a collection of SparX proteins that bind different antigens on the surface of diseased cells. Multiple SparX proteins with different antigen specificity can be administered to potentially address antigen heterogeneity or antigen escape that contribute to relapsed and refractory disease.

About the Phase 1 Study Evaluating ACLX-001 for Patients with Relapsed or Refractory Multiple Myeloma (NCT04155749)
The Phase 1 study evaluating ACLX-001 in adults with relapsed or refractory multiple myeloma (r/r MM) is a first-in-human, open-label, multicenter, dose escalation clinical trial designed to evaluate ARC-SparX, in which a matrix escalation of either ARC-T cells or SparX-001 or both may be escalated based on clinical correlative data, including pharmacokinetics of SparX-001 and ARC-T expansion. The primary objective of this study is to evaluate the safety and tolerability of ARC-SparX. A secondary objective is to identify a dosing strategy associated with ARC-T cell expansion kinetics that results in the best mix of efficacy, as determined by International Myeloma Working Group response criteria, and safety profile.

Eiger BioPharmaceuticals and AnGes Announce Exclusive Partnership for Regulatory Approval and Commercialization of Zokinvy® (lonafarnib) in Japan

On May 10, 2022 Eiger Biopharmaceuticals Inc. ("Eiger",Nasdaq: EIGR) and AnGes Inc. ("AnGes", TYO: 4563) reported that the companies entered into an agreement for the regulatory approval, marketing, and distribution of Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford progeria syndrome (HGPS or progeria) and processing-deficient progeroid laminopathies (PL) in Japan (Press release, Eiger Biopharmaceuticals, MAY 10, 2022, View Source [SID1234614144]).

Under the terms of the agreement, AnGes is responsible for obtaining and maintaining regulatory approval for Zokinvy in Japan and will be the exclusive partner for distribution and commercialization. Eiger will receive upfront and milestone payments up to $1.5M as well as earn revenue from the sale of Zokinvy to AnGes.

"We are thrilled to build a new partnership with Eiger for Zokinvy in Japan. We are committed to obtaining regulatory approval in an expeditious manner to deliver Zokinvy to the HGPS and PL patients in Japan," said Ei Yamada, President and CEO, AnGes. "In parallel with the regulatory approval process, we will persistently advance our preparations to initiate the diagnostic test for HGPS as part of developing the genetic disease diagnosis testing of new-born babies at AnGes Clinical Research Laboratories (ACRL) established last year."

"We are pleased to enter into this partnership with AnGes to seek regulatory approval and commercialization of Zokinvy in Japan to help patients suffering from progeria and progeroid laminopathies," said David Cory, President and CEO, Eiger. "This collaboration is representative of Eiger’s strategic approach to fully leverage our innovative therapies to enhance shareholder value and support underserved patients around the world."

About progeria and progeroid laminopathies

Progeria, also known as Hutchinson-Gilford progeria syndrome, and progeroid laminopathies are separate and distinct ultra-rare, fatal, genetic premature aging diseases that accelerate mortality in young patients. It is estimated that there are 400 children worldwide with progeria and 200 children with progeroid laminopathies.

Progeria is caused by a point mutation in the LMNA gene, yielding the farnesylated aberrant protein, progerin. Progeroid laminopathies are genetic conditions of accelerated aging caused by a constellation of mutations in the LMNA and/or ZMPSTE24 genes yielding farnesylated proteins that are distinct from progerin. While non–progerin producing, these genetic mutations result in disease manifestations with phenotypes that have overlap with, but are distinct from, progeria.

Without Zokinvy therapy, children with progeria commonly die of the same heart disease that affects millions of normally aging adults (arteriosclerosis), by an average age of 14.5 years. Disease manifestations include severe failure to thrive, scleroderma–like skin, global lipodystrophy, alopecia, joint contractures, skeletal dysplasia, global accelerated atherosclerosis with cardiovascular decline, and debilitating strokes.

About Zokinvy (lonafarnib)

Zokinvy was approved in the U.S. in November 2020 to reduce the risk of death with HGPS (progeria), and to treat processing-deficient progeroid laminopathies. It is indicated for adults and children over 12 months of age.

Zokinvy blocks the accumulation of defective, farnesylated proteins which form tight associations with the nuclear envelope, leading to cellular instability and premature aging in children and young adults with progeria and processing-deficient progeroid laminopathies.

Zokinvy is a first-in-class disease-modifying agent that has demonstrated a statistically significant survival benefit in children and young adults with progeria. In patients with progeria, Zokinvy reduced the incidence of mortality by 60% (p=0.0064) and increased average survival time by at least 2.5 years. The most commonly reported adverse reactions were gastrointestinal (vomiting, diarrhea, nausea), and most were mild or moderate (Grade 1 or 2) in severity. Many progeria patients have received continuous Zokinvy therapy for more than 10 years.

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Merck will not receive any milestone payments for the development of lonafarnib for the treatment of progeria and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.

For more information including prescribing information for Zokinvy in the U.S. please go to www.zokinvy.com. Please click here for the full U.S. important safety information. Eiger has filed a marketing authorization application with the European Medicines Agency and expects a CHMP opinion in Q2 2022. Zokinvy is not approved for any indication in Japan.

RhoVac AB announces Database Lock in its clinical phase IIb trial of onilcamotide

On May 10, 2022 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on May 10th, 2022, that its phase IIb study in prostate cancer, BRaVac, has reached "Database Lock" (Press release, RhoVac, MAY 10, 2022, View Source [SID1234614143]). This means that all data from the trial is now finally reported, cleaned and "locked" in the data base. The next step will be analysis to produce the results. As previously stated, RhoVac anticipates having its primary results no later than at the beginning of June.

RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after local curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. Patient recruitment was conducted in six European countries (Finland, Sweden, Denmark, the United Kingdom, Belgium and Germany) and in the United States. Recruitment ended in September 2021, when 180 patients had been included. The objective of the study is to show that onilcamotide can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted and no unexpected adverse reactions have been identified, confirming the anticipated safety of the drug. Now, the study has reached "Database Lock" with only a few weeks to go until the primary results are known. All results, including subgroup analyses, will be available in the summer.

CEO, Anders Månsson, comments: "BRaVac started at the end of 2019, and much of the study has been run in pandemic conditions, which it has taken extraordinary efforts to overcome. We are happy to conclude that we have overcome all obstacles, that our intermediary safety reviews have all been positive, and now, after database lock, we await with excitement and anticipation what the primary results will bring in terms of efficacy."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 10-05-2022 20:50 CET.

Teva Publishes 2021 ESG Progress Report, Showcasing Further Integration of ESG Into Business, Robust Targets and Strengthened ESG Governance Structure

On May 10, 2022 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a leading global pharmaceutical company providing medicines to nearly 200 million people daily, reported that published its 2021 ESG Progress Report (Press release, Teva, MAY 10, 2022, View Source [SID1234614141]). The report details how Teva further integrated ESG into its business strategy—implementing a strengthened ESG governance structure and setting 13 ambitious targets related to access to medicines, ethics, environment and responsible supply chain, some of which are now linked to the company’s financing strategy and executive compensation.

"As one of the world’s largest manufacturers of generic medicines, ESG is integral to the long-term strategy of our company and is part of everything we do," said Kåre Schultz, President & CEO of Teva. "Our ESG Progress Report details our actions in 2021, which include issuing a $5 billion sustainability-linked bond, tying our financing strategy to access to medicines and environmental targets. We are in a unique position to help create a healthier future, bringing our essential medicines within reach for more people and reinforcing business integrity through our compliance and ethics policies and trainings."

This year’s ESG Progress Report offers a comprehensive view of ESG at Teva, with new disclosures related to scope 3 emissions, pay equity and the company’s responsible supply chain, and continues to align with leading reporting standards—the Global Reporting Initiative (GRI), Sustainability Accounting Standards Board (SASB) and Task Force on Climate-Related Financial Disclosures (TCFD).

The ESG Progress Report shares Teva’s progress, including:

Integrating ESG further into the business with a $5 billion sustainability-linked bond (SLB): Upon issuance, Teva’s SLB was the largest in the world, the first in the pharmaceutical industry linked to both social and environmental targets and the first from a generic medicines company. The SLB holds Teva accountable to reducing scope 1 and 2 GHG emissions by 25% and increasing access to essential medicines for patients in low- and middle-income countries (LMICs) by 150% by the end of 2025.
Making medicines available and accessible to those who need them: Teva has launched four access to medicines programs to-date, 50% of its 2025 target, including an expanded partnership with Direct Relief and Global HOPE to provide critical treatments for children with cancer and blood disorders across sub-Saharan Africa and new programs in France, Israel and Ghana. Last year, the company also had 585 marketing authorizations approved in LMICs and donated more than $487 million worth of medicines.
Minimizing environmental impact across Teva’s business and value chain: Since 2019, Teva has reduced its scope 1 and 2 GHG emissions by 13%, more than half of its 2025 target. Since 2020, the company also reduced its scope 3 GHG emissions by 5% (20% of 2030 target), increased its total proportion of energy from renewable sources by 4% (to 33%) and improved energy efficiency by 6%. In this same timeframe, it achieved an 8% reduction in both waste from operations and water withdrawal in areas projected to be in water stress.
Fostering an inclusive workplace: Last year, the representation of women in executive and senior management positions at Teva increased by 1.8%. The company also trained nearly 90% of employees on how to foster an inclusive culture.
Promoting ethics and operating with integrity: Teva trained more than 20,000 employees (99.6% of those assigned) on ethics. The company published three new position statements outlining its stance on patient safety, responsible supply chain and risk management. Teva was also ranked in the top 1% in the EcoVadis sustainable procurement assessment as a result of its efforts to make more responsible decisions regarding supply chain partners.
Teva’s ESG performance continues to improve across key rating indices—including S&P Global, ISS ESG, EcoVadis and FTSE4Good—which listed Teva among the top 10-20% of companies in its industry in 2021.