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- 2026-05-05 06:45:33
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- Tarlatamab designated as an orphan drug for SCLC
- by Eo, Yun-Ho Jan 15, 2024 05:36am
- Amgen’s drug candidate ‘Tarlatamab,’ intended for treating small cell lung cancer (SCLC), has received orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) announced this decision through its first orphan drug designation posting of the New Year. The approved indication is for treating adult patients with progressive SCLC whose cancer had progressed after previous second-line treatments. The research team led by Professor Ahn Myung Ju, from the Division of Hematology-oncology in the Department of Medicine at Samsung Medical Center, has confirmed Tarlatamab as a potential treatment for second-line treatment in SCLC. Their research article was published in the New England Journal of Medicine (NEJM). The research team demonstrated the treatment potential of bispecific T-cell engagers like Tarlatamab. Tarlatamab is a novel bispecific T-cell engager drug that recognizes antigens present on both cancer cells and immune cells. Even when cancer cells manage to evade immune cells, Tarlatamab can engage immune T-cells, directing them to closely target cancer cells and initiate an attack. Professor Ahn’s research team conducted this research with the goal of identifying a novel therapeutic strategy that could maximize the effects of Tarlatamab while ensuring the safety of patients. They conducted a study enrolling 220 patients who had not responded to the first-line treatment for SCLC, from 56 institutions across 17 countries and randomly assigned to clinical groups for evaluation. According to the U.S. Food and Drug Administration (FDA), the research team administered two different doses of Tarlatamab, 10mg and 100mg, to patients and assessed various prognosis such as treatment reactions and drug-related side effects. As a result, the optimal dosage for the drug was determined to be 10mg of Tarlatamab administered every 2 weeks, which led to clinical improvements in prognosis and a reduction in side effects. According to the research group, patients who received 10 mg showed an objective response rate of 40%, which was higher than the 32% response rate observed in those who received a 100 mg dose. The median progression-free survival in the 10-mg group was 4.9 months, higher than the 3.9 months in the 100-mg group. The overall survival, measured at nine months following the treatments, was 68% for the 10-mg group and 66% for the 100-mg group. The 10-mg dose demonstrated a higher treatment effect with fewer side effects. Since Tarlatamab is a T-cell activating therapy, the most common side effect is ‘cytokine release syndrome.’ In the 10-mg group, 51% of the patients experienced cytokine release syndrome, whereas, in the 100-mg group, 61% did. “SCLC, classified into limited and extended stages, is characterized by its rapid progression without clear incremental stages. For most patients, metastasis to other lungs or organs presents treatment challenges. Currently, treatment options remain limited. Consequently, I hope that ongoing research will contribute to alleviating the suffering of patients,” Professor Ahn said.
- Company
- Boryung partners with Baxter for 2 anesthesia drugs in Korea
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Boryung announced on the 10th that it signed a sales agreement with Baxter Korea to sell inhalation anesthesia ‘Suprane Solution (desflurane)’ and blood substitute ‘Plasma Lyte 148 Inj’ in the domestic market. Suprane, developed by Baxter, is a premier inhalation anesthesia for inducing or maintaining anesthesia during surgery. It offers rapid and accurate control of the depth of anesthesia and has the lowest solubility among inhaled anesthetic, enabling fast and predictable patient recovery after anesthesia. Plasma Lyte 148 Inj is an original fluid solution developed by Baxter. It is a physiologically balanced blood substitute with sodium, magnesium, and potassium levels similar to human plasma. Plasma Lyte 148 Inj is used to replenish and adjust extracellular fluid in cases of decreased circulating blood volume and interstitial fluid and to adjust metabolic acidosis. Plasma Lyte 148 Inj, a fluid therapy that can improve therapeutic outcomes for critically ill patients, has demonstrated its effectiveness in decreasing the mortality rate in patients with SIRS when compared to the Normal Saline group. It has also been shown to reduce risk factors associated with post-operative complications in open surgeries. An additional advantage is that Plasma Lyte 148 Inj is calcium-free, allowing its administration before and after a blood transfusion, as well as during a transfusion. Inhalation anesthesia Suprane (left) and blood substitute Plasma Lyte 148 Inj 1000 mL(right). The recent contract will broaden Boryung’s portfolio of anesthesia-related drugs and enhance its business capabilities. Boryung has been actively involved in sales marketing efforts for its anti-vomiting drug ‘Naseron (ramosetron)’ and drug designed to reverse neuromuscular blockade, ‘Breathon (sugammadex).’ Naseron ranks the first in the market among ramosetron-based products, while Breathon is the second-leading product in the sugammadex-based market. With its anesthesia task force and academic sales marketing expertise, Boryung will concentrate its efforts on expanding the market share of these two products. "Suprane and Plasma Lyte 148 Inj are important drugs for ensuring the safety and quality management of surgical patients undergoing anesthesia," Jung Woong-je, RX Division Leader at Boryung, commented. "Based on these two products, our focus will center around strengthening our market presence within the field of anesthesiology."
- Company
- Generic companies partially win Trajenta patent challenges
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Generic companies have won the dispute over unregistered use patents of Trajenta (linagliptin). Although the unregistered formulation patent remains, this patent is reportedly relatively easy to avoid or invalidate. As such, the industry expects there is a higher possibility that generic versions of Trajenta will be released earlier after the drug’s substance patent expires in June. According to the pharmaceutical industry on the 11th, the Intellectual Property Trial and Appeal Board ruled that the validity of claims in the invalidation trials against the three Trajenta use patents by Genuone Science and others against Boehringer Ingelheim were established. Genuone Sciences had filed trials against Boehringer Ingelheim to invalidate 3 Trajenta’s use patents (10-1558938, 10-1655754, 10-1806786) in October 2020. Kukje Pharm, GC Biopharma, Mother’s Pharmaceutical, and Boryung had also joined in the trial with Genuone Sciences at the time. After about a year and three months, the first instance court, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies. All three patents expire in May 2027. If the patent challengers had lost in the first instance court, the release of a generic version of Trajenta would have been pushed back to after 2027. However, with the win, Trajenta generics will likely be available sooner, after the expiry of Trajenta’s substance patent in June this year. The first substance patent for Trajenta expired in August last year, and the second substance patent will expire in June this year. In July last year, Genuone Science and the other companies also succeeded in avoiding the unlisted formulation patent through a trial to confirm the passive scope of patent rights. It is estimated that 7 unlisted formulation patents and 1 unlisted use patent remain for Trajenta. However, industry insiders believe that the remaining patents are generally easy to avoid or invalidate or were registered later and do not have a significant impact on the early launch of Trajenta generics. Moreover, in the case of the 3 use patents, which are key to the launch of generic versions of Trajenta, the IPTAB clearly stated the grounds for their invalidation, such as lack of description and inventiveness, the generic company has a high chance of winning later trials even if the original company appeals. On the reason for invalidating Trajenta’s use patents, IPTAB pointed to “The experimental data related to linagliptin dosage is not disclosed in the patent specification, and linagliptin dosage or combination therapy with other diabetes drugs can be easily be invented from prior art." In other words, the trial court invalidated Trajenta’s patents on two grounds: lack of description and inventiveness. In effect, all 3 use patents directly related to Trajenta’s indication were invalidated, increasing the likelihood of early generic launch after the expiration of Trajenta's substance patent. Jong Hyuk Park, a patent attorney who participated in the patent trial, said, "This decision is significant in that it the court judge on the patentability of additional unlisted use patents that were later registered through divisional patent applications when the indications are already preannounced. Since it was determined that the patents were invalid in terms of both lack of description and inventiveness, it is unlikely that the decision will be reversed on appeal."
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- New colorectal cancer drug Braftovi will receive reimb
- by Jan 12, 2024 07:05am
- Ono Pharmaceutical Korea held a press conference celebrating reimbursement listing of Braftovi (ingredient: encorafenib), a targeted drug for the treatment of metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. All eyes are on Braftovi, a new targeted drug for metastatic colorectal cancer emerging after a 15-year gap, for its potential to address unmet demands for treatment options. Experts have assessed that, based on proven efficacy, Braftovi is likely to be highly utilized. On the 11th, Ono Pharmaceutical Korea held a press conference celebrating the reimbursement listing of Braftovi (ingredient: encorafenib), a targeted drug for the treatment of metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. Braftovi is a targeted drug, emerged 15 years after Merck’s Erbitux (cetuximab), for the treatment of colorectal cancer. In Phase 3 BEACON CRC studies, Braftovi has demonstrated efficacy and a safety profile in patients with BRAF V600E mutation who have developed tolerance to previous therapies. Based on clinical results, patients who received the combination therapy of Braftovi and cetuximab demonstrated a median overall survival (OS) of 9.3 months, a significant extension compared to the 5.9 months observed in those treated with the combination therapy of irinotecan and cetuximab. The mortality risk decreased by 39%. The therapy’s benefits were consistently observed, regardless of the patient’s systemic therapy outcomes, the number of previous therapies, tumor metastasis range and location. The group that received the combination therapy of Braftovi and cetuximab has shown 10 times higher overall response rate (ORR) compared to the comparative thearpy group (19.5% in Braftovi combination therapy group vs. 1.8% in comparative therapy group). With a three-fold increase in Progression free survival (PFS), the risk of disease progression and death was reduced by 56%. Moreover, the group that received the combination therapy of Braftovi and cetuximab has shown an overall satisfactory safety profile, with a lower rate of severe adverse drug reactions compared to the comparative therapy group. "In the treatment of metastatic colorectal cancer, conventional therapies such as FOLFIRI and FOLFOX, in addition to Erbitux, have been used. However, there were concerns about drug toxicity and side effects. The combination therapy of Braftovi and Erbitux has shown longer treatment duration and a lower treatment discontinuation rate," Cha Yongjun, Professor in the Hematology-Oncology Department at the National Cancer Center, stated. Braftovi may have a role in treating BRAF V600E, which is associated with poor prognosis The BRAF V600E mutation occurs in approximately 4.7% of patients with metastatic colorectal cancer in Korea. Patients carrying this mutation tend to have worse prognosis, such as larger tumor size and peritoneal metastasis, compared to those who do not have the BRAF V600E mutation. In metastatic colorectal cancer patients with BRAF V600E mutation, the OS was 11.4 months, which was less than half of the 43 months for BRAF V600E-negative. The guidelines of the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) have identified the BRAF V600E mutation as a factor associated with poor prognosis in metastatic colorectal cancer, and they recommend BRAF mutation testing for all diagnosed patients. In clinical practices, it is recommended for all metastatic colorectal cancer patients to undergo RAS mutation testing and BRAF mutation testing. As a result, the analysis suggests that Braftovi may have broad clinical utility. “Currently, the available treatment options for colorectal cancer are limited. The therapeutic outcomes for second-line treatments following unsuccessful first-line treatment have been minimal. Nine out of ten patients have failed to proceed to third-line treatments. There is a critical need for new therapeutic options,” Kim Seung Tae, Professor of the Division of Hematology-Oncology at the Samsung Medical Center, commented. Professor Kim analyzed that “BRAF V600E mutated metastatic colorectal cancer is associated with poor prognosis and a significantly high rate of peritoneal metastasis. While the first-line standard treatment typically includes anti-EGFR therapy such as Erbitux, it has been reported that BRAF V600E mutation is less responsive to chemotherapy. Therefore, Braftovi could potentially become a first-line treatment option.”
- Company
- Nexviazyme prescriptions are available at general hospitals
- by Eo, Yun-Ho Jan 12, 2024 07:05am
- Sanofi-Aventis Korea’s Nexviazyme (Avalglucosidase Alfa) Prescriptions for Pompe disease treatment ‘Nexviazyme’ will be available at general hospitals. According to the industry, Sanofi-Aventis Korea’s Nexviazyme (Avalglucosidase Alfa) has recently passed the Drug Committee (DC) of tertiary general hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul Asan Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, and other hospitals where Pompe disease treatment is possible. Nexviazyme, developed based on Sanofi’s enzyme replacement therapy ‘Myozyme (avalglucosidase alfa)’ with improvements in usage and dosage, has become the first biobetter to receive preferential drug pricing by the government. In 2016, the government made an announcement regarding preferential drug pricing system, including both biosimilars that demonstrated healthcare enhancements in Korea and biobetters that demonstrated improvements from previously approved biomedicines. According to the announcement, recognizing the challenges in developing biobetters compared to incrementally modified drugs (IMD, synthetic drugs), the pricing of biobetters was set at 100-120% of the pricing of their drug targets (original biological drugs). Utilizing glycoengineering techniques, Nexviazyme has increased the amount of M6P, an important factor in the drug's intracellular uptake, by approximately 15-fold compared to Myozyme. The higher amount of M6P leads to increased drug uptake and improved GAA activity, effectively reducing damage to muscle cells through efficient glycogen breakdown. Moreover, the increased surface M6P enhances immunogenicity, providing safety benefits Pompe disease is a hereditary neuromuscular disorder caused by a deficiency in the enzyme acid alpha-glucosidase (GAA), which is responsible for breaking down glycogen in the muscles. The condition is progressive and can affect individuals of all ages. Left untreated, it can lead to irreversible muscle damage, respiratory and motor function impairment, and even premature death. In the COMET and MINI-COMET studies, enrolling Pompe disease patients, treatment with Nexviazyme demonstrated a 2.43% improvement in forced vital capacity (FVC) compared to Myozyme, with the benefit persisting consistently for up to 97 weeks. In 6 minute-walk test, compared to Myozome, participants administered with Nexviazyme showed a mean distance increase of 30m (4.71%) and demonstrated improvements in the trial’s secondary objectives, including gross motor function, health-related quality of life, and others.
- Company
- FDA approves BLA for Dong-A ST’s Stelara biosimilar
- by Chon, Seung-Hyun Jan 11, 2024 05:45am
- Dong-A ST announced on the 5th that Accord Biopharma, a subsidiary of Intas Pharmaceuticals, has completed Biologics License Application (BLA) for Stelara biosimilar ‘DMB-3115’ to the U.S. Food and Drug Administration (FDA). The BLA, originally submitted in October 2023, has now been approved by the FDA. FDA accepts BLA for DMB-3115 of Dong-A ST. Dong-A ST and Meiji Seika Pharma will be responsible for R&D of DMB-3115 and exclusively distribute the product to Instas, Accord Biopharma, and Accord Healthcare. The BLA submission was based on the results from quality equivalence testing between Stelara and DMB-3115 conducted in both the United States and Europe. The global Phase 3 clinical trials enrolled patients with moderate to severe chronic plaque psoriasis, and the result demonstrated therapeutic equivalence between DMB-3115 and Stelara. There were no clinically significant differences in safety. Stelara, developed by Janssen, is a treatment for various inflammatory diseases, including plaque psoriasis, ulcerative colitis, Crohn’s disease, and ulcerative colitis. Stelara is a blockbuster biomedicine and has recorded global sales of $17.77 billion (approx. 22 trillion won). DMB-3115 has been under joint development by Dong-A Socio Holdings and Meiji Seika Pharma since 2013. In July 2020, to facilitate more efficient global progress, the development and commercialization rights for DMB-3115 were transferred to Dong-A ST. In July 2021, Dong-A ST finalized a technology transfer agreement with the multinational pharmaceutical company, Instas Pharmaceuticals. Instas acquired exclusive rights for the approval and sales of DMB-3115 in global markets, except for several Asian countries such as Korea and Japan. Instas plans to commercialize DMB-3115 globally via its subsidiaries, Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada. Meanwhile, Dong-A ST and Meiji Seika Pharma will be responsible for R&D of DMB-3115 and exclusively distribute the product to Instas, Accord Biopharma, and Accord Healthcare. In July 2023, Accord Healthcare, a subsidiary of Instas, completed submission of BLA for DMB-3115 to the European Medicine Agency. “Based on the proven therapeutic equivalence and safety between DMB-3115 and Stelara, we have successfully submitted the BLA in the United States following our success in Europe,” explained Park Jaehong, R&D President at Dong-A ST. “To fast-track the entry of DMB-115 into global markets, including Europe and the United States, we are fully committed to efficiently completing the remaining procedure in close collaboration with Instas.”
- Company
- Dong-A ST signs MOU with Israel’s Eleven Therapeutics
- by Son, Hyung-Min Jan 11, 2024 05:45am
- On the 9th, Dong-A ST announced that it had signed a memorandum of understanding (MOU) with Israel-based Eleven Therapeutics to develop an RNA-based gene therapy at the JP Morgan Healthcare Conference in San Francisco, USA. The two companies will conduct joint research to discover targeted RNA therapies for fibrotic diseases using Eleven Therapeutics' platform technology, TERA. The TERA platform leverages massively parallel processes to map the chemical space and reveal the structure-activity relationship (SAR) of RNA molecules using artificial intelligence (AI)/ machine learning (ML) and is being used to discover optimal xRNA drugs. Dong-A ST has selected gene therapy as one of its major areas of focus for its future and has been continuing efforts to expand its R&D capabilities from synthetic drugs - its previous forte - to gene therapy. Founded in 2020, Eleven Therapeutics is an Israeli biotech company that develops xRNA therapies by combining combinatorial chemistry and synthetic biology technologies with artificial intelligence and machine learning. The company received a USD 9 million investment from the Bill and Melinda Gates Foundation as support for the development of its RNA design platform and announced a research partnership with Novo Nordisk to develop RNA therapeutics for cardiovascular diseases using its DELiveri platform technology last summer. In addition to Israel, Eleven Therapeutics has laboratories and offices in Cambridge, UK, and Boston, USA, and has been actively continuing research activities in all three countries. Yaniv Erlich, CEO and co-founder of Eleven Therapeutics said, "We are delighted to be working with DONG-A ST on our journey to address the unmet medical needs in fibrotic diseases. Based on our newly forged partnership, we will work to apply xRNA therapies to various disease areas." Jae Hong Park, President of Research and Development at Dong-A ST, said, "By collaborating with Eleven Therapeutics, we have come one step closer to developing innovative RNA therapies. We will strive to transform into a gene and cell therapy specialty company."
- Company
- 5th JAK inhibitor Jyseleca lands in general hospitals in KOR
- by Eo, Yun-Ho Jan 11, 2024 05:45am
- Another JAK inhibitor can now be prescribed at general hospitals in Korea. According to industry sources, Gilead's Jyseleca (filgotinib) has passed the drug committee (DC) review of major national hospitals and medical institutions like Seoul Asan Medical Center and Hanyang University Hospital. After the drug was approved for reimbursement in November last year, its company is now starting to compete for prescriptions in earnest. Jyseleca was first approved with reimbursement as a treatment for rheumatoid arthritis and moderate-to-severe active ulcerative colitis. Patients eligible for reimbursement are those with either of the conditions and do not respond adequately to or are intolerant to existing treatment, and include those who show inadequate response or are intolerant to TNF-α inhibitors among patients aged 65 years and older. Jyseleca received a conditional reimbursement decision for the rheumatoid arthritis and ulcerative colitis indications from HIRA’s Drug Reimbursement Evaluation Committee in July last year. At the time, DREC judged that reimbursement was adequate if the company accepted a price below than the evaluated amount. Eisai Korea then accepted a price less than 90% of the weighted average price of alternative drugs, and omitted insurance price ceiling negotiations with the National Health Insurance Service and quickly received reimbursement in Korea. JAK inhibitors currently available in Korea include ‘Xeljanz (tofacitinib),’ ‘Olumiant (baricitinib),’ and 'Rinvoq (upadacitinib).’ How well Jyseleca will be able to exert its influence amid these drugs remains to be seen. Meanwhile, Jyseleca (filgotinib) is an adenosine triphosphate (ATP) a competitive and reversible inhibitor that selectively inhibits JAK1. JAK1 is a substance that transmits inflammatory cytokine signals and is considered a major treatment target for rheumatoid arthritis. Some of the recent treatments that were released inhibit JAK2 or JAK3, depending on their mechanism of action, but there is some opinion that both mechanisms are involved in immune cell proliferation and homeostasis regulation, and may cause adverse reactions. The drug's efficacy was demonstrated through Phase III trials, including FINCH1, FINCH2, and FINCH3. In the FINCH1 study, Jyseleca 200mg improved arthritis symptoms by more than 20% at 12 weeks when administered to patients with moderate-to-severe active RA (rheumatoid arthritis) despite continued methotrexate (MTX) treatment.
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- K-pharma advances in new Alzheimer’s drug discovery
- by Jan 09, 2024 05:50am
- New drugs for treating Alzheimer’s disease developed by Korean pharmaceutical companies have entered the late phase of clinical trials, and industry watchers are closely monitoring their potential for commercialization. Aribio has recently submitted an Investigational New Drug (IND) application for its oral treatment candidate AR1001 for Alzheimer’s disease, to eight European countries. Aribio is about to enter the late phase of clinical trials in Europe, following its success in initiating Phase 3 clinical trials in Korea and United States. Additionally, each of the new Alzheimer’s disease drug candidates developed by GemVex, CHA Biotech, and NKMAX has entered Phase 2 clinical trials. The Korean pharmaceutical companies including Aribio (candidate product: AR1001), GemVex (candidate product: GV1001), CHA Biotech (candidate product: CB-AC-02), NKMAX (candidate product: SNK01), Shaperon (candidate product: Nucerin), and Neurorive (candidate product: NR-0701), and others are advancing in new Alzheimer’s drug developments. Aribio entered Phase 3 clinical trials in the United Sates…GemVex has concluded Phase 2 clinical trials in Korea and is preparing for global clinical trials. According to the industry on the 6th, Aribio submitted a European IND application on the 26th of last month for the approval of a global Phase 3 clinical trials called ‘Polaris-AD’ for AR1001. The European clinical trials will enroll 400 patients with early Alzheimer’s disease from eight European countries, including the U.K., France, Germany, Spain, Italy, Denmark, Netherlands, the Czech Republic, and Slovakia. AR1001 utilizes multimodal mechanisms to target the underlying causes of Alzheimer’s disease, such as PDE5 and toxic proteins. In 2022, Phase 3 clinical trials were initiated in the United States, and these trials are recruiting patients and administering the drug at 60 major clinical sites across the United States. Samjin Pharmaceutical holds exclusive sales rights for AR1001 in Korea. Samjin Pharmaceutical and Aribio have signed a joint development of Phase 3 trials in Korea, as well as the exclusive sales rights for the domestic market. Both companies are currently conducting Phase 3 trials in Korea. In Phase 2 clinical trials, AR1001 demonstrated therapeutic effects in patients with elevated levels of blood pTau-181, a significant factor associated with Alzheimer’s disease. Additionally, the AR1001 10mg cohort demonstrated a decrease in cognitive decline compared to the placebo group, while the AR1001 30mg cohort demonstrated enhancements in cognitive abilities related to pattern recognition. GemVex is currently developing GV1001, a candidate multimodal treatment for Alzheimer’s disease. GV1001 has successfully concluded the Korean Phase 2 clinical trials and is preparing for global Phase 2 clinical trials. GV1001 binds to the Gonadotropin-releasing hormone receptor (GnRHR) expressed in microglia and astrocytes, effectively suppressing neuroinflammation. By binding to GnRHR, present on these two cell types, GV1001 functions as a cytokine that modulates brain immune responses. GemVex will conduct simultaneous clinical trials in seven European countries using the Phase 2 clinical trials IND application submitted to the FDA. The clinical trials will evaluate the therapeutic effects and safety of the drug with 185 moderate to severe patients administered with doses of 0.56 mg and 1.12 mg over 52 weeks. CHA Biotech is conducting Phase 1/2a clinical trials for its new drug candidate CB-AC-02. CB-AC-02 is a stem cell therapy utilizing placenta-derived mesenchymal stem cells and is under development using mass culture and cryopreservation techniques. NKMAX is currently developing the cell therapy SNK01 through its subsidiary NKGen Biotech. The company has successfully completed the drug administration to patients enrolling in the Phase 1/2a clinical trials. SNK01 is designed to recognize and eliminate reactive T cells and damaged neurons, thereby reducing neuroinflammation and improving the overall brain immune system. In the Phase 1 clinical trials conducted in Mexico, NKGen Biotech’s SNK01 demonstrated the therapeutic effects in patients with moderate to severe Alzheimer’s disease. Three out of ten patients who were administered SNK01 showed improved symptoms in the AD Composite Score (ADCOMS), while six patients showed no change without further deterioration. Furthermore, the FDA has granted permission to continue the Phase 1/2a clinical trials without requiring preclinical trials, based on the results obtained from the Mexico Phase 1 clinical trials. Neurorive and Shaperon, completing pre-clinical trials, aim to enter a late phase of clinical trials. Shaperon is developing NuCerin for treating patients with moderate to severe Alzheimer’s disease. NuCerin is designed to inhibit microglia and TNF-α production and under development to alleviate neuroinflammation. NuCerin is currently in the Korean Phase 1 clinical trials. Nucerin demonstrated no Dose Limiting Toxicities (DLT) up to the third level of dosage during the trial, following a dose escalation design. Additionally, Shaperon signed a technology transfer contract with Kukjeon Pharmaceutical in March 2021. Neurorive is currently conducting Korean Phase 1 clinical trials for their candidate product NR-0701. NR-0701 utilizes acetylcholinesterase and phosphodiesterase (PDE) inhibitors, which are the active ingredients found in medications like Donepezil, used for Alzheimer’s disease, and Viagra, respectively. Through this mechanism, Neurorive aims to achieve effects that are comparable to increased therapeutic effects of Alzheimer's disease drug Donepezil while simultaneously reducing the toxicity associated with Viagra-class drugs, maximizing neurotransmission capacity.
- Company
- GC Biopharma says its ‘Shingrix vaccine shows effect in P2T
- by Lee, Seok-Jun Jan 09, 2024 05:49am
- GC Biopharma (CEO Eun-cheol Heo) today announced positive Phase 2 results for its shingles vaccine, CRV-101 (ingredient name amezosvatein),’ which is being developed by its U.S. partner Curevo Vaccine. The data represent top-line results from a head-to-head comparison of GSK's market-leading shingles vaccine, Shingrix, and CRV-101, which meets all primary endpoints and demonstrated non-inferiority and superior tolerability to GSK’s shingles vaccine Shingrix. To evaluate the immunogenicity and safety of CRV-101, Curevo Vaccine inoculated 876 healthy adults aged 50 years and older with two different vaccines, at 2-month intervals, as the second booster shot. The results showed that CRV-101 met its primary endpoint, demonstrating non-inferiority to Shingrix through humoral immune responses. The Vaccine Response Rate (VRR) for CRV-101 was 100%, compared to 97.9% for Shingrix. The Phase 2 results provided a basis for dose selection, which Curevo plans to build upon to initiate a Phase 3 study later this year. CRV-101 is a premium herpes zoster vaccine developed by genetic recombination with an immune-boosting adjuvant. It is designed to induce an optimal immune response with a low risk of side effects. According to the global market research firm Evaluate Pharma, the global market for shingles vaccines is expected to reach $5.85 billion by 2028, including the U.S. market.
