Saturday, June 22, 2024

Takeda Receives Approval from European Commission for FRUZAQLA in Previously Treated Metastatic Colorectal Cancer

OSAKA, Japan & CAMBRIDGE, Mass. - Saturday, 22. June 2024 AETOSWire

Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial

− FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in the EU for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade

(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the U.S. Food and Drug Administration (FDA) for adults with mCRC who have been previously treated with oxaliplatin- and irinotecan-based regimens on November 8, 2023.1,2

“People living with metastatic colorectal cancer face numerous difficulties, stemming both from their illness and the adverse effects of therapies. Given the complex nature of the disease, introducing innovative treatments such as fruquintinib – an oral, chemotherapy-free targeted agent – is essential. I am looking forward to having a new choice for appropriate patients,” said Josep Tabernero, MD, PhD, director of Vall d´Hebron Institute of Oncology (VHIO).

The approval is based on results from the Phase 3 multi-regional FRESCO-2 trial. The trial investigated FRUZAQLA plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC. FRESCO-2 met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with FRUZAQLA, regardless of the prior types of therapies they received. FRUZAQLA demonstrated a manageable safety profile in FRESCO-2. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with FRUZAQLA plus BSC versus 21% of those treated with placebo plus BSC. Data from FRESCO-2 were published in The Lancet in June 2023.3

“Today's approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumors harbor actionable mutations,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “We look forward to offering patients a novel treatment option that has a manageable safety profile and can be effective regardless of the prior types of therapies they have received.”

About FRUZAQLA (fruquintinib)

FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. FRUZAQLA was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for potential use as part of combination therapy.

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA was approved by the U.S. Food and Drug Administration (FDA) in November 2023. A submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE®.

EUROPEAN UNION IMPORTANT SAFETY INFORMATION

Please consult the FRUZAQLA (fruquintinib) Summary of Product Characteristics (SmPC) before prescribing.

Guidance for use: FRUZAQLA should be initiated by a physician experienced in the administration of anticancer therapy. Patients should be given the package leaflet.

CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients.

SPECIAL POPULATIONS: Renal impairment: No dose adjustment is required for patients with mild, moderate, or severe renal impairment; Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. FRUZAQLA is not recommended for use in patients with severe hepatic impairment as FRUZAQLA has not been studied in this population; Elderly: No dose adjustment is required in patients aged 65 years or above; Paediatric population: There is no relevant use of FRUZAQLA in the paediatric population for the indication of metastatic colorectal cancer; Women of childbearing potential/Contraception in females: Women of childbearing potential should be advised to use highly effective contraception during treatment and for at least 2 weeks following the last dose of FRUZAQLA; Pregnancy: There are no clinical data available on the use of FRUZAQLA in pregnant women. Based on its mechanism of action, FRUZAQLA has the potential to cause foetal harm. Animal studies have shown reproductive toxicity, including foetal malformations. FRUZAQLA should not be used during pregnancy unless the clinical condition of the woman requires treatment with FRUZAQLA. If FRUZAQLA is used during pregnancy or if the patient becomes pregnant while on treatment, the patient must be informed of the potential hazard to the foetus; Breast-feeding: The safe use of FRUZAQLA during breast-feeding has not been established. It is not known whether FRUZAQLA or its metabolites are excreted in human milk. There are no animal data on the excretion of FRUZAQLA in animal milk. A risk to the breastfeeding newborns/infants cannot be excluded. Breastfeeding should be discontinued during treatment and for 2 weeks after the last dose; Fertility: There are no data on the effects of FRUZAQLA on human fertility. Results from animal studies indicate that FRUZAQLA may impair male and female fertility.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

    Hypertension: Hypertension, including hypertensive crisis, has been reported in patients treated with FRUZAQLA. Pre-existing hypertension should be monitored and adequately controlled in accordance with standard medical practices before starting FRUZAQLA treatment.

    Hypertension should be medically managed with antihypertensive medicinal products and adjustment of the FRUZAQLA dose, if necessary. FRUZAQLA should be permanently discontinued for hypertension that cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis.

    Haemorrhagic events: Haemorrhagic events have been reported in patients treated with FRUZAQLA, including gastrointestinal (GI) tract events. Serious and sometimes fatal bleeding events have been reported in patients after treatment with FRUZAQLA.

    Haematologic and coagulation profiles should be monitored in accordance with standard medical practices in patients at risk for bleeding, including those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding. In the event of severe bleeding requiring immediate medical intervention, FRUZAQLA should be permanently discontinued.

    Gastrointestinal perforation: GI perforation events, including fatal events, have been reported in patients treated with FRUZAQLA.

    Symptoms of GI perforation should be periodically monitored during treatment with FRUZAQLA.

    FRUZAQLA should be permanently discontinued in patients developing GI perforation.

    Proteinuria: Proteinuria events have occurred in patients treated with FRUZAQLA.

    Proteinuria should be monitored before initiation and during treatment with FRUZAQLA in accordance with standard medical practices. If urine dipstick proteinuria ≥ 2 g / 24 hours is detected, dose interruptions, adjustments, or discontinuation may be necessary. FRUZAQLA should be permanently discontinued in patients developing nephrotic syndrome.

    Palmar-plantar erythrodysaesthesia syndrome (PPES): PPES is the most frequently reported dermatological adverse reaction.

    If Grade ≥ 2 skin reactions are detected, dose interruptions, adjustments, or discontinuation may be necessary.

    Posterior reversible encephalopathy syndrome (PRES): PRES has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. PRES is a rare neurologic disorder that can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). In patients developing PRES, discontinuation of FRUZAQLA, along with control of hypertension and supportive medical management of other symptoms, are recommended.

    Impaired wound healing: Impaired wound healing has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies.

    Patients are recommended to withhold FRUZAQLA for at least 2 weeks prior to surgery. FRUZAQLA should not be resumed for at least 2 weeks after surgery, as clinically indicated when there is evidence of adequate wound healing.

    Arterial and venous thromboembolic events: It is recommended to avoid starting treatment with FRUZAQLA in patients with a history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or if they have a history of stroke and/or transient ischemic attack within the last 12 months. If arterial thrombosis is suspected, FRUZAQLA should be discontinued immediately.

INTERACTIONS

Effects of other medicinal products on the pharmacokinetics of FRUZAQLA

CYP3A inducers

Co-administration of FRUZAQLA with rifampicin (a strong CYP3A inducer) 600 mg once daily decreased FRUZAQLA AUCinf by 65% and decreased Cmax by 12%. The concomitant use of FRUZAQLA with strong and moderate CYP3A inducers should be avoided.

CYP3A inhibitors

Co-administration of FRUZAQLA with itraconazole (a strong CYP3A inhibitor) 200 mg twice daily did not result in clinically meaningful changes in the area under the concentration-time curve (AUC) and Cmax of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with CYP3A inhibitors.

Gastric acid lowering agents

Co-administration of FRUZAQLA with rabeprazole (a proton pump inhibitor) 40 mg once daily did not result in clinically meaningful changes in the AUC of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with gastric acid lowering agents.

Effect of FRUZAQLA on the pharmacokinetics of other medicinal products

Medicinal products that are substrates of P-glycoprotein (P-gp)

Co-administration of a single dose of dabigatran etexilate 150 mg (a P-gp substrate) with a single dose of FRUZAQLA 5 mg decreased AUC of dabigatran by 9%. No dose adjustment is recommended for P-gp substrates during concomitant use with FRUZAQLA.

Medicinal products that are substrates of breast cancer resistance protein (BCRP)

Co-administration of a single 10 mg dose of rosuvastatin (a BCRP substrate) with a single 5 mg dose of FRUZAQLA decreased AUC of rosuvastatin by 19%. No dose adjustment is recommended for BCRP substrates during concomitant use with FRUZAQLA.

UNDESIRABLE EFFECTS: The most commonly reported adverse reactions with FRUZAQLA are:

Very common

(frequency ≥1/10)
    

Thrombocytopenia, hypothyroidism, anorexia, hypertension, dysphonia, diarrhoea, stomatitis, aspartate aminotransferase increased, total bilirubin increased, alanine aminotransferase increased, palmar-plantar erythrodysaesthesia syndrome, musculoskeletal discomfort, arthralgia, proteinuria, asthenia, and fatigue

Common

(≥1/100 to <1/10)
    

Pneumonia, upper respiratory tract infection, bacterial infections, leukopenia, neutropenia, hypokalemia, epistaxis, throat pain, gastrointestinal haemorrhage, gastrointestinal perforation, pancreatic enzymes increased, oral pain, rash, and mucosal inflammation

About CRC

CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide and was associated with more than 1.9 million new cases and 900,000 deaths in 2022. In Europe, CRC was the second most common cancer in 2022, with approximately 538,000 new cases and 248,000 deaths.4 In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2024.5 In Japan, CRC was the most common cancer in 2022, with more than 145,000 new cases and 60,000 deaths.4 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.6,7,8,9,10

About the Phase 3 FRESCO-2 Trial

The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating FRUZAQLA plus BSC vs placebo plus BSC in patients with previously treated mCRC (NCT04322539). The study met all of its primary and key secondary endpoints, demonstrating that treatment with FRUZAQLA resulted in statistically significant and clinically meaningful improvement in OS and PFS. The safety profile of FRUZAQLA in FRESCO-2 was consistent with previously reported fruquintinib monotherapy studies. Results from the study were presented at ESMO in September 2022 and subsequently published in The Lancet in June 2023.11,3

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

References:

    Takeda Pharmaceuticals. (2024 April 26). Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer [Press Release]. Available here.

    Takeda Pharmaceuticals. (2023 November 8). Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer [Press Release]. Available here.

    Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9.

    Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 [online ahead of print]. doi: 10.3322/caac.21834

    American Cancer Society. Cancer Facts & Figures 2024. Atlanta, American Cancer Society; 2024.

    Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.

    D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.

    Venderbosch, et al. Mismatch repair status and braf mutation status in metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Res., 2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.

    Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 209;100(2), 266–273. doi:10.1038/sj.bjc.6604867.

    Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.

    Dasari NA, et al. LBA25 – FRESCO-2: A global phase 3 multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. Doi:10.1016/annonc/annonc1089.

 

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Contacts

Media Contacts:

Japanese Media
Jun Saito
jun.saito@takeda.com

U.S. and International Media
Emma Nash
emma.nash@takeda.com

Friday, June 21, 2024

ASTRA 1P Successfully Launched on SpaceX’s Falcon 9 Rocket

 Most powerful geostationary satellite to operate at 19.2 degrees East will deliver content from SES’s prime TV neighbourhood to 119 million households across Europe

(BUSINESS WIRE) -- SES announced today that the ASTRA 1P satellite was successfully launched by a SpaceX Falcon 9 rocket from Cape Canaveral Space Force Station in Florida, United States, at 5:35 pm local time.

The Ku-band satellite will augment and strengthen SES's prime TV neighbourhood at 19.2 degrees East while delivering content for public and private broadcasters, sports organisations and content owners to audiences across largest European TV markets. ASTRA 1P will also ensure the delivery of premium HD content directly to subscribers of HD+, SES’s high-definition satellite TV platform in Germany.

Built by Thales Alenia Space, ASTRA 1P is based on the 100% electric Spacebus NEO platform and features 80 transponders capable of delivering 500 HD TV channels. It is the most powerful satellite to operate at 19.2 degrees East, seamlessly replacing the current four satellites at the orbital location and continuing their mission of serving 119 million TV households.

“We are excited that ASTRA 1P will be joining our fleet of geostationary satellites, marking the next generation of satellites to operate at one of our most important orbital positions responsible for delivering content to hundreds of millions of viewers in Europe,” said Adel Al-Saleh, CEO of SES. “Ever since the launch of ASTRA 1A in 1988, our satellites have played a pivotal role in reliably delivering high-quality content to viewers. We are well-positioned to continue supporting our broadcast customers for many years to come with ASTRA 1P.”

To find out more about ASTRA 1P, visit our newsroom.

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About SES

SES has a bold vision to deliver amazing experiences everywhere on earth by distributing the highest quality video content and providing seamless data connectivity services around the world. As a leader in global content connectivity solutions, SES owns and operates the world’s only geosynchronous orbit and medium earth orbit (GEO-MEO) constellation of satellites with the unique combination of global coverage and high performance. By leveraging its vast and intelligent, cloud-enabled network, SES delivers high-quality connectivity solutions anywhere on land, at sea or in the air, and is a trusted partner to the world’s leading telecommunications companies, mobile network operators, governments, connectivity and cloud service providers, broadcasters, video platform operators and content owners. SES’s video network carries over 6,400 channels, reaching 363 million households, delivering managed media services for both linear and non-linear content. The company is headquartered in Luxembourg and listed on Paris and Luxembourg stock exchanges (Ticker: SESG). Further information is available at: www.ses.com.

 

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QpiAI Closes $6.5 Mill Pre-Series A Funding Led by Yournest and SIDBI Venture Capital to Enable Intelligence Modelling and Intelligence Compute Using Quantum Computers BANGALORE, India - Friday, 21. June 2024 AETOSWire Print

 BANGALORE, India - Friday, 21. June 2024 AETOSWire 


QpiAI closed first ever external investment with the pre-series A funding of $6.5 million led by Yournest and SVCL.

WFC, an angel group; Ramesh Radhakrishnan, a successful serial entrepreneur and venture capitalist; Ramaswamy Prabhakar, a Technologist and angel investor from Silicon Valley; Quick Heal Security founders Kailash Katkar and Sanjay Katkar and their family office; Lakshmeenarayanan, Former Chairman and CEO of Cognizant; Bhupinder Singh, former CPO of Bentley; Pratap Reddy, Silicon Valley serial entrepreneur and angel investor: Sahasra capital; and other angels also participated in the round.

With this funding, QpiAI will be implementing full stack 25 qubit Quantum computers that are scalable from 25 to 1000 physical superconducting qubits with the same infrastructure.

QpiAI will be aiming to increase revenues from software licensing of 7 software platforms: QpiAI-pro, QpiAI-explorer, QpiAI-opt, QpiAI-pharma, QpiAI-ML QpiAI-logistics and QpiAI-matter, which are based on Quantum computing and Generative AI technologies.

QpiAI is a revenue generating, enterprise focused technology startup and counts Fortune 500 companies globally as its customers in pharma, materials, chemical, cosmetics, automotive, financials and manufacturing.

Debraj Banerjee from SIDBI ventures will be joining the board of QpiAI as nominee of SIDBI venture capital.

Ramesh Radhakrishnan, the first external investor in QpiAI, joined the board as a nominee director of Qpi Technology, holding company of QpiAI

 


(BUSINESS WIRE) -- QpiAI, a leader in quantum computing and generative AI, announced its maiden external funding of $6.5 million to build Quantum computing and Generative AI products and platforms.


Dr Nagendra Nagaraja CEO and Founder of QpiAI quoted, “The pre-series A round of QpiAI will be remembered as a landmark funding round in Indian Deeptech. This round should allow us to lay a foundation of intelligence modelling and intelligence compute via Quantum computers and Generative AI. This funding will enable us to achieve breakthrough innovation in vertical integration of Generative AI and Quantum computing in enterprise and industrial applications. We will also be demonstrating 25 Qubit Quantum computers in our Bangalore HQ by Q4 CY2024/ Q1 CY 2025. With integration of HPC built out of our lab infra and integration all our 7 Quantum and Generative AI platforms we will have prototype of Quantum-HPC QpiAI datacenter, this can be scaled further to offer QCaaS (Quantum Compute as a Service). There is also good traction with our current customers to provide Quantum-HPC solutions with our software and compute infra. A very advanced Compute infra with Quantum capability that we will be deploying with this funding will allow us to innovate in Generative AI and Quantum software. QpiAI Quantum and AI stack, including hardware and software, will have tremendous impact on pharma, non-energy transition materials, chemicals, manufacturing, logistics and finance.”


Dr Nagendra further added, “There is also tremendous traction in the B2G segment with QpiAI thought leadership in Quantum and AI that has helped shape technology and infrastructure roadmaps. QpiAI is a Global company with its HQ in Bangalore, India and subsidiaries in US and Finland. As we work with Global enterprises and Governments including the US, Europe, Japan, the Middle East and Southeast Asia, we will be expanding our presence in these regions to create value to our customers and partners.”


Dr Manjunath R.V., Vice President for Quantum computers QpiAI, further added, “Building Scalable Quantum computers that can solve real world problems and bolster our industry verticals is a very key technology development. At QpiAI, we are very excited to have our own Quantum computers to further build Quantum and AI data centers. Our team is really happy to have multiple QPUs in our dilution refrigerator to make sure we achieve high quality quantum compute infrastructure. We can’t wait to see the next steps in our roadmap to advance Quantum computers scaling 25 qubits to 1000 qubits.”


Sachin Kumar, Lakshya Priyadarshi and Aswanth Krishnan, who leads software products and solutions on Generative AI and Quantum software, suggested, “In the last 4 years, we were able to commercialize our software platforms and achieve traction across large bluechip enterprise customers. With this funding and with all our 7 software products ready to scale, we envision scaling our software platforms globally. We anticipate a great time ahead for us. There is lot of customer interest to see QpiAI Quantum and AI software platform working on QpiAI Quantum-AI HPC datacenters to implement their next gen applications in pharma, materials, fintech, automotive and manufacturing.”


Sunil Goyal MD, Yournest who led the funding round, further added, "By investing in QpiAI, we're helping to propel India to the leading edge of quantum computing. This technology has the potential to revolutionize fields like materials science, drug discovery, automotive, and manufacturing. QpiAI's innovative approach makes them a key player in unlocking this potential, and we're thrilled to join Dr. Nagendra and the QpiAI team on this exciting journey."


Debraj Banerjee, President at SIDBI Venture capital and Board of Director of QpiAI who led the funding round from SIDBI ventures, further added, “SVCL is very excited to be part of this very important deeptech journey of national importance. Quantum computers will change the world when we commercialize it. The technology is of immense importance for national security and advance computation. Having a home-grown Quantum computer will be very important for our national institutes to further our progress in computation technologies. We are eagerly looking forward to a working 25 qubit machine from QpiAI by Q4 of CY24 /Q1 CY25.”


Ramesh Radhakrishnan, a very successful serial entrepreneur, a veteran VC and Board of Director at QpiAI, further added, “Quantum computers and AI are the future for all applied technologies in many different market segments including pharma, transport, cybersecurity, and financial among others. Integrating Application software with Quantum System software and hardware to make AI and Quantum computing work together is a fundamental innovation whose significance is going to be enormous. With centers in the US and Finland, QpiAI is well positioned to scale Quantum and AI technologies and address markets globally. I am very excited to be a part of this wonderful journey.”


About QpiAI


QpiAI (https://www.qpiai.tech) is a world leader in AI and Quantum computing. QpiAI is integrating Quantum computing and AI vertically to offer solutions to areas like manufacturing, industrial, transportation, finance, pharma and materials. It has various software platforms and products including QpiAI-pro, QpiAI-explorer, QpiAI-logistics, QpiAIopt, QpiAIML, QpiAI-pharma and QpiAI-Matter. With its innovation in commercial grade Quantum computing technology, QpiAI is providing impactful advances to generative AI and various industry verticals.


 


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QPS Announces New Global Clinical Research Operations Leadership

 (BUSINESS WIRE) -- QPS, a leading global contract research organization (CRO), is pleased to announce new clinical research operations leadership. This new clinical leadership will further align the existing global medical affairs, regulatory affairs, data services, and clinical operations units with the existing successful QPS Phase I clinics. The enhanced global capabilities will help QPS satisfy the need for agility, flexibility, and speed in the quickly evolving global drug development community.


“This addition of Mr. Derek Grimes to the QPS Global Leadership Team will enhance our ability to collaborate across business units to offer comprehensive custom-built clinical development programs to better address a future dominated by Biologics and Advanced Therapy programs and a demand for accelerated clinical trials,” said Benjamin Chien, Chairman, President and CEO of QPS.


Mr. Derek Grimes, QPS Executive Vice President and Global Head of Clinical Research is a distinguished executive with 26 years of leadership experience in healthcare and clinical research across both academic and private institutions. He has played a pivotal role in developing complex healthcare and clinical research organizations and has been the operational lead on several hundred clinical research programs for academic and industry-based organizations. Grimes’ extensive experience and contributions to the field have made him a respected leader in clinical research and healthcare management. Most recently, Grimes served as the Senior Vice President of Clinical Operations at Frontage Laboratories, where he led the operations for the Clinical Services Division.


“I am excited to join the team and look forward to getting started. There is huge potential in the QPS full-service global CRO offering and enhanced alignment of leadership across the units will benefit our clients tremendously,” says Grimes.


In 2022, QPS announced a full transformation to a globally structured organization leading to seamless delivery of preclinical, bioanalytical, and clinical trial services around the world. At the same time, the organization formalized its medical affairs and regulatory affairs departments and onboarded new senior leaders for those teams. This enhanced structure has benefited our global customers, as our teams now more closely collaborate across all global regions. The addition of Grimes to this organization will further solidify QPS’ ability to serve Biotech and Pharmaceutical clients around the world.


ABOUT QPS HOLDINGS, LLC


QPS is a global, full-service, GLP/GCP-compliant contract research organization (CRO) delivering the highest grade of discovery, bioanalysis, preclinical and clinical drug development services. Since 1995, QPS has grown from a small bioanalysis shop into a full-service CRO with 1,100+ employees in the US, Europe, and Asia. Today, QPS offers expanded pharmaceutical contract R&D services with special expertise in pharmacology, DMPK, toxicology, bioanalysis, translational medicine, clinical trials, and clinical research services. An award-winning leader focused on bioanalysis and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction, and turnkey laboratories and facilities. Through continual enhancements in capacities and resources, QPS stands tall in its commitment to delivering superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com or email info@qps.com.


 


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Contacts

QPS CONTACT:

Name: Gabrielle Pastore

Phone: 1-302-635-4290

Email: Gabrielle.Pastore@qps.com


 

Kolmar BNH Sharpens Global Competitiveness with Dual Functionality of HemoHIM

 SEOUL, South Korea - Friday, 21. June 2024



(BUSINESS WIRE) -- Kolmar BNH (KOSDAQ: 200130), a leading Original Development Manufacturing (ODM) company for health functional foods, strengthens its market position by acquiring certification for the additional functionality of HemoHIM, a renowned Korean health supplement.


The company secured approval from the Ministry of Food and Drug Safety for the fatigue-improving function of the HemoHIM extract complex of angelica gigas, etc., derived from angelica gigas and other components in 2023. This achievement was made six years after the launch of its HemoHIM Sustainable Technology Development Project. As a result, HemoHIM came to the market as a dual-functional health product designed to boost immune function and reduce fatigue.


HemoHIM, developed by Kolmar BNH in 2006, is the nation’s first individually-approved immune-boosting health supplement, formulated using indigenous natural ingredients like angelica gigas, cnidium officinale, and paeonia japonica. Distributed by Atomy, it's now a global success, exported to over 20 countries and generating over KRW 2 trillion in sales with exports exceeding $200 million. It has remained Korea's top-selling immune booster for over a decade.


Kolmar BNH validated the fatigue improvement function of HemoHIM through extensive clinical (human trials) and non-clinical trials (cell tests). In trials involving adults aged 30 to 59 experiencing fatigue, significant enhancements were observed in fatigue measures, including the Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI), following consumption of the HemoHIM extract complex of angelica gigas, etc. These findings were published in Phytomedicine Plus, an international journal dedicated to natural medicine, with patents registered in Korea and Russia.


Continuing its commitment to innovation following the launch of HemoHIM, Kolmar BNH allocates over 2% of its annual sales to R&D. This investment aims to enhance product functionality and fortify competitive advantage.


HemoHIM G, targeting the global market, is one of the results of such dedication to R&D. Launched in Taiwan last month, HemoHIM G is a new product for export that has made meticulous adjustments to its raw materials and ingredient proportions to comply with international food regulations. Its key ingredients such as Angelica sinensis, Ligusticum chuanxiong, and Paeonia lactiflora went through rigorous sourcing procedures and stringent quality control. The taste and aroma profiles were tailored to suit the preferences of global consumers. Furthermore, its safety has been certified in the prestigious academic journal “Toxicological Research”, accredited at the SCIE level.


Kolmar BNH official said, "Through relentless research and development efforts, Kolmar BNH has enhanced the competitiveness of HemoHIM. We are dedicated to promoting K-health functional food globally through ongoing innovations in HemoHIM."


 


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Contacts

Kolmar BNH

Jang Woo Lee

jay.lee@kolmar.co.kr

Mary Kay Inc. Presents New Findings on Skin Care Advances and the Use of Computational Tools in Identifying Skin Sensitivity

 DALLAS - Friday, 21. June 2024


(BUSINESS WIRE) -- Mary Kay Inc., a global leader in skin care innovation, recently revealed the results of two breakthrough research studies: first, an antioxidant treatment that can diminish the visible effects of pollution and aging on human skin; and second, a focus on the applications of computational tools to accurately predict the safety and potential reactions of human skin to various cosmetic ingredients. These findings were shared by Mary Kay scientists at the 2024 Society of Investigative Dermatology (SID) meeting in Dallas, Texas. The company was a silver-level sponsor of the event.


“Mary Kay scientists are at the forefront of skin care research, and we’re pleased to share our latest findings with the broader scientific community,” said Dr. Lucy Gildea, Chief Innovation Officer, Product & Science at Mary Kay. The ongoing partnership with the Society of Investigative Dermatology underscores Mary Kay’s dedication to advancing skincare science. By maintaining collaborative efforts, the company remains steadfast in its commitment to making significant breakthroughs in the field of dermatology, ultimately providing consumers with safer and more effective skincare solutions.


“Mary Kay's enduring commitment to research and development aligns perfectly with our goals at the Society for Investigative Dermatology," said Dr. Rebecca Minnillo, Chief Program, Communications and Development Officer at SID. "Our sustained partnership enables us to explore new frontiers in dermatological science, bringing us closer to breakthroughs that can transform skin care and treatment options.”


Mary Kay's research into the effects of air pollution on skin, conducted through multiple academic collaborations since 2016, revealed that an antioxidant blend of resveratrol, niacinamide, and oligopeptide-1 protects natural skin surface lipids from oxidative damage caused by particulate matter (PM) and UV radiation, both alone and combined. Additionally, this blend has been found to prevent free radical formation induced by blue light, demonstrating its potential in mitigating the detrimental effects of multiple environmental stressors on the skin.


Furthermore, Mary Kay is leveraging computational toxicology tools to enhance ingredient safety assessment of cosmetic and personal care ingredients. This innovative approach involves the use of advanced computational methods to predict the safety and potential toxicity of ingredients at an early stage, significantly reducing the need for extensive laboratory testing. Virtual screening allows for the early screening of compounds, ensuring only safe ingredients proceed in the development process. This method not only saves time and resources but also aligns with ethical and regulatory standards. By integrating these advanced tools, Mary Kay underscores its commitment to leveraging cutting-edge technology for product development, ensuring the highest standards of safety and efficacy for its consumers.


Mary Kay’s Dr. Gildea also hosted a compelling panel at SID, titled "Insights into the Effects of Pollution on Skin Health: Recent Discoveries & Emerging Perspectives,” comprising experts from varied fields of dermatology and molecular biology. Panelists included Dr. Thomas Haarmann-Stemmann, Group Leader at the Leibniz Research Institute for Environmental Medicine, who discussed the link between increased ambient temperature and skin aging. Dr. Elma Baron, Associate Professor of Dermatology at Case Western Reserve University, emphasized the significance of topical antioxidants in mitigating oxidative stress and improving skin health. Dr. Hong Sun, Assistant Professor at NYU Grossman School of Medicine, delved into molecular changes in skin cells exposed to environmental stressors, demonstrating the efficacy of antioxidant treatments in reversing gene expression changes associated with skin damage induced by UV and pollution exposure.


The sponsorship and findings presented at the 2024 SID meeting represent the latest efforts by Mary Kay to reinforce the brand’s long-standing commitment to advancing research and development in skin health and beauty. With over 1,600 patents for products, technologies, and packaging designs in its global portfolio, Mary Kay continues to lead the way in skincare innovation.


About Mary Kay

Then. Now. Always. One of the original glass ceiling breakers, Mary Kay Ash founded her dream beauty brand in Texas in 1963 with one goal: to enrich women’s lives. That dream has blossomed into a global company with millions of independent sales force members in more than 35 countries. For 60 years, the Mary Kay opportunity has empowered women to define their own futures through education, mentorship, advocacy, and innovation. Mary Kay is dedicated to investing in the science behind beauty and manufacturing cutting-edge skincare, color cosmetics, nutritional supplements, and fragrances. Mary Kay believes in preserving our planet for future generations, protecting women impacted by cancer and domestic abuse, and encouraging youth to follow their dreams. Learn more at marykayglobal.com, find us on Facebook, Instagram, and LinkedIn, or follow us on Twitter.


 


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Contacts

Mary Kay Inc. Corporate Communications

marykay.com/newsroom

972.687.5332 or media@mkcorp.com


 

C3i Center Inc is First CDMO in Canada to Receive Approval for a Drug Establishment License to Commercially Produce Cell Therapy Drug Products


 MONTREAL -

Company awarded commercial Drug Establishment License (DEL) for Canada following successful inspection of C3i’s contract development and manufacturing organization (CDMO) facility.

(BUSINESS WIRE)--C3i Center Inc (C3i) announced it has received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies, making C3i the first CDMO in Canada to achieve this milestone.


The approval follows an inspection by the cell and gene therapy experts from Health Canada. The DEL approval recognizes C3i as having industry-leading expertise, regulatory know-how, and strong quality standards.


“The C3i team worked hard to meet the requirements of a DEL and are proud that we received approval from Health Canada to commercially manufacture cell therapies.” – Louisa Petropoulos, CEO of C3i. “We are excited to be the first CDMO in Canada to reach this milestone, and there is more to come. Our goal is to manufacture cell and gene therapies for the global market. We expect to have the European Medicines Agency (EMA) conduct their inspection later this fall.”


C3i supports its clients in process development, scale-up and manufacturing for phase 1 to phase 3 clinical trials, as well as commercial cell and gene-modified cell therapies. C3i continues to expand its capabilities to include the production of viral vectors, exosomes, and other autologous and allogeneic cellular therapies.


About C3i Center Inc


C3i is a full-service, in-house CDMO with a vision to make life-saving cell and gene therapies available to everyone who needs them. C3i provides services to biotechnology companies, academic research groups, and pharmaceutical companies, supporting the advancement and commercialization of innovative technologies. C3i’s dedicated team is focused on providing clients with tailored services to meet their specific needs, expediting their innovative pipeline from development to commercial. C3i prides itself on delivering on-time, cost-efficient quality results. In-house services include phase-appropriate quality control testing, biomarker discovery, immune monitoring and diagnostic testing with College of American Pathologists (CAP)-accredited laboratories.


To learn more about who we are, visit www.c3icenter.com and for business inquiries, please contact our VP of Business Development, Sandra Donaldson, at sdonaldson@centrec3i.com.


 


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Contacts

 

sdonaldson@centrec3i.com