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- 2026-05-04 18:09:04
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- Dupixent, 1st biologic approved for pruritic rash indication
- by Son, Hyung-Min Mar 05, 2024 05:49am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center. As Dupixent is approved to treat prurigo nodularis (nodular itchy rash), the drug emerged as the only available treatment option among biologic agents. Previously, there were limited treatment options for treating prurigo nodularis, a condition that causes extreme itchiness. Sanofi hosted a press conference at Novotel Ambassador Seoul Gangnam on the 28th to commemorate the company’s expansion of Dupixent indications to treat prurigo nodularis. Dupixent is a biological agent designed to target interleukin (IL)-4 and IL-13 signaling pathway, biomarkers of type 2 inflammation, and regulates the symptoms. The drug has shown effects in inflammatory diseases such as atopic dermatitis and eosinophilic esophagitis. Moreover, Dupixent secured an expanded indication for prurigo nodularis. Last December, Dupixent was approved in Korea for treating moderate to severe prurigo nodularis in patients aged 18 years and older who had inadequate responses to or were not recommended for a topical treatment. Prurigo nodularis is a chronic dermatitis associated with type 2 inflammation. It is known to significantly impact a patient’s quality of life more than any other inflammatory skin disease due to extreme itchiness. High-dosage topical steroids are commonly prescribed for the treatment, but their long-term use can pose safety risks. These risks include dermal atrophy, infection, blurry vision, and vision deterioration. The introduction of Dupixent, which has confirmed efficacy and safety, may improve patient’s quality of life. This approval was based on the PRIME and PRIM2 Phase 3 clinical studies. The studies included 311 patients aged 18 and older with prurigo nodularis. The primary endpoint was the proportion of patients who achieved scores of 4 points or greater reduction in the Worst-Itch Numeric Rating Scale (WI-NRS) at 12 weeks and 24 weeks. In PRIME clinical results, the patients who received Dupixent showed nodule reduction at 12 weeks and 24 weeks. At 24 weeks, 48% of patients with Dupixent showed an improvement in their condition measured by a WI-NRS score of 4 points and a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S). Therefore, the improvement by Dupixent treatment was significantly greater than the 18% observed in the placebo group. Furthermore, the PRIME2 clinical study also demonstrated that 45% of patients who received Dupixent showed an improvement by a WI-NRS score of 4 points or more and a score of 0 or 1 point in the IGA PN-S, a significantly higher proportion of patients with improvements compared to the 16% in the placebo group. Throughout the first 24 weeks, Dupixent displayed a consistent safety profile that is similar to what is known from other indications. “Prurigo nodularis is often associated with type 2 inflammatory diseases such as atopic dermatitis and asthma. Almost half of the patients with prurigo nodularis also have atopic disease. Dupixent is the only biologic agent available for targeting this disease,” Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center, said. “Over 60% of patients suffer from sleep-related deterioration due to chronic itch, which is often linked to psychological disorders such as depression or anxiety,” Ahn added. “The previous treatment options for prurigo nodularis were limited. Therefore, the introduction of biologic agent that is effective and has fewer side effects can improve the quality of life of the patients,” Ahn emphasized.
- Company
- Kolon Life Science appeals to the Supreme Court for Invossa
- by Nho, Byung Chul Mar 05, 2024 05:49am
- On the 28th, Kolon Life Sciences decided to appeal to the Supreme Court against the manufacturing and sales license revocation ruling that had been made for its knee osteoarthritis cell gene therapy Invossa-K Inj (“Invossa”). In its appeal to the court, Kolon Life Sciences explained, "While we respect the court's decision, we will strive to restore the scientific achievements and value of Invossa, the world's first gene therapy for osteoarthritis, by correcting the misunderstandings that arose regarding the product’s legal principles and safety at the appellate court.” In 2019, Kolon Life Sciences filed an administrative suit to seek the court’s ruling on the illegality and injustice of the MFDS’s decision to revoke Invossa’s marketing authorization but lost both the first and second trials. Kolon Life Sciences acknowledged that there was an error in indicating the origin of the cells for the 2nd liquid, which was the main substance at the time of the application and approval of Invossa. However, since all non-clinical and clinical trials were conducted with the same cells in all stages before its authorization, the company believes the safety and efficacy of Invossa have been verified by the MFDS, and based on which the company plans to continue its vigorous defense in the final appeals following the first and second appeals. Kolon Life Sciences emphasized that the outcome of the administrative proceedings is completely unrelated to the Phase III clinical trial being conducted by Kolon TissueGene in the U.S. and that it decided to proceed with the final trial to correct the misinformation related to Invossa and restore its scientific value. Accordingly, regardless of the outcome of the administrative proceedings, Kolon TissueGene's Phase III clinical trial on TG-C (formerly known as Invossa) in the U.S. is proceeding according to plan. The company is enrolling and dosing 1,020 patients in the U.S., with the last 150 patients enrolled as of January 2024. In addition, TG-C was approved by the U.S. Food and Drug Administration (FDA) in December 2023 to expand its indication to Degenerative Disc Disease (DDD), in addition to being evaluated in Phase II clinical trials for knee osteoarthritis. In October 2023, Kolon Life Sciences was acquitted on appeal in the second trial of a criminal case against company executives who were charged with obstruction of justice against the Ministry of Food and Drug Safety (MFDS), resolving allegations that the company engaged in intentional manipulation and concealment. Long-term follow-up of patients from 2019 to the present has also shown no direct causal relationship between tumor development and treatment with Invossa.
- Company
- Hugel receives FDA approval for its botulinum toxin Letybo
- by Nho, Byung Chul Mar 05, 2024 05:48am
- On the 4th, Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration (FDA) on February 29th for 50 units and 100 units of its botulinum toxin Letybo (Korean brand name: Botulax). The FDA approval of Letybo represents a strong affirmation of Hugel's product quality and credibility, as it has met the rigorous standards of one of the world's leading regulatory authorities. It also further underscores the company’s global leadership position. With the approval, Hugel has become the first and only Korean company and one of the top 3 players globally that have obtained market approvals in the 3 major global aesthetic markets—the United States, China, and Europe. To date, it has received marketing approvals in a total of 63 countries and has continued to expand its global coverage. The United States is the world's largest medical aesthetic market, accounting for over 50% of the total market. According to data from global research firms Decision Resource Group and the Boston Consulting Group, the market is expected to continue to grow, by nearly twofold from KRW 3.25 trillion in 2023 to KRW 46.36 trillion by 2031. Hugel is currently in the process of finalizing its market penetration strategy, aiming to commercially launch the product by the middle of this year. The launch of Letybo in Canada last year laid a solid foundation for the company’s entry into the North American market, setting the stage for accelerated penetration into the U.S. market. A Hugel official said, “As a leading global medical aesthetic company, we are delighted to be able to release Letybo in the United States, the world's largest and yet still fast-growing market. We will build on our unparalleled performance and leadership in Korea, as well as our comprehensive academic programs, to add value and differentiate ourselves in the industry."
- Company
- New multiple myeloma Ab ‘Elrexfio’ expects to enter KOR
- by Eo, Yun-Ho Mar 05, 2024 05:48am
- Pfizer Korea ‘Elrexfio,’ a new bispecific antibody to treat multiple myeloma, is expected to become commercially available soon. Pfizer Korea has applied for approval of Elrexfio (elranatamab) last year, and it is currently under review by the Ministry of Food and Drug Safety (MFDS), according to industry sources. Elrexfio is expected to be commercially available in the first half of this year. Last August, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Elrexfio. Elrexfio indication is now approved for patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Elrexfio binds bispecific B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells and activates T cells by engaging the cells, resulting in myeloma cell death. It is a BCMA-directed agent that can be administered subcutaneously, with once-weekly dosing and biweekly long-term dosing after 24 weeks of initial treatment. The phase 2 MagnetisMM-3 clinical study demonstrated efficacy of Elrexfio. In the clinical study, Elrexfio showed significant responses as the first BCMA-targeted treatment for patients with relapsed or refractory multiple myeloma who had received many prior therapies. The overall response rate (ORR) of 97 patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy before Elrexfio administration was 58%, and approximately 82% of the patients maintained the response for at least nine months. The median first response time was 1.2 months. Furthermore, the FDA has granted ‘Breakthrough Therapy Designation’ and ‘Orphan Drug Designation’ to Elrexfio. It has received conditional approval from the European Medicines Agency (EMA) and is currently under review for approval in South Korea and Japan.
- Company
- Intensifying competition in ulcerative colitis drug market
- by Son, Hyung-Min Mar 04, 2024 05:53am
- New drug development for conquering ulcerative colitis drives competition among global pharmaceutical companies. Competition in the market will likely intensify due to the efficacy shown by new drugs, including JAK inhibitors Rinvoq and Xeljanz, anti-integrin drugs, and S1P receptor modulators, in clinical trials, in addition to biological medicine Omvoh, a recently approved drug. While TNF-alpha inhibitors such as Humira and Remicade currently dominate the market for ulcerative colitis, the market landscape is forecasted to change. Omvoh, Eli Lily’s interleukin (IL)-23 inhibitor, has been approved in Korea, the industry said on the 27th. Omvoh can treat patients with ulcerative colitis who have previously had failed response to corticosteroids or immunomodulators. Omvoh selectively binds to the p19 subunit of IL-23 and offers a targeted treatment mechanism for the disease. The efficacy of Omvoh was confirmed in Phase 3 LUCENT-1 and 2 clinical trials that included patients with moderately active ulcerative colitis. The clinical trials enrolled patients who had inadequate response to corticosteroids, immunomodulators, or one or more biological medicines. The patients were randomized to receive Omvoh or placebo, starting with a 12-week intravenous administration followed by a 40-week maintenance therapy through subcutaneous injection. The clinical results have shown that the Omvoh group demonstrated a clinical remission rate of 24.2% compared to 13.3% in the placebo group. The Omvoh group achieved 27.1% in histologic-endoscopic mucosal improvement (HEMI), a significant improvement compared to 13.9% in the placebo group. Based on the results after evaluating 544 patients who underwent a 40-week maintenance therapy, 49.9% of patients in the Omvoh group achieved clinical remission, compared to 25.1% of the placebo group, demonstrating Omvoh’s efficacy. Regarding the safety of Omvoh, the most common adverse reactions associated with Omvoh were respiratory infections (7.9%), headaches (3.3%), and rash (1.1%). Omvoh will likely compete with Janssen’s Stelara, an IL-12 and IL-23 inhibitor. Stelara is indicated for Crohn’s disease, besides ulcerative colitis. Eli Lily, the company responsible for developing Omvoh, is currently evaluating Omvoh for Crohn’s disease in clinical trials. Skyrizi, an interleukin-23(IL-23) inhibitor.In addition to Omvoh, the company is also working on securing indications of interleukin inhibitors for treating ulcerative colitis. Abbvie is also developing Skyrizi, an interleukin-23(IL-23) inhibitor like Omvoh, for the treatment of ulcerative colitis. Skyrizi received approval in Korea only for Crohn’s disease. Both the INSPIRE study, which evaluated the effectiveness of induction therapy at 12 weeks, and the Phase 3 COMMAND clinical study, which evaluated maintenance therapy at 52 weeks, demonstrated Skyrizi’s effectiveness compared to the placebo group. Janssen is developing Tremfya, an IL-23 inhibitor, for the treatment of ulcerative colitis. In the Phase 2 clinical study, Tremfya’s clinical response was achieved in 80% of Tremfya-treated patients. Janssen is conducting a multinational Phase 3 clinical study in patients with active ulcerative colitis. S1P receptor modulators have also proven effective, in addition to JAK inhibitors and anti-integrin drugs In addition to interleukin inhibitors, JAK inhibitors, and anti-integrin drugs have secured indications for ulcerative colitis. JAK inhibitors work by blocking the activity of JAK, a kinase that regulates immunity and inflammation. This mechanism of action is effective in reducing inflammation. JAK inhibitors are used to treat autoimmune diseases such as ulcerative colitis, rheumatoid arthritis, atopic dermatitis, and inflammatory bowel disease. Eisai’s Jyseleca, Pfizer’s Xeljanz, and Abbvie’s Rinvoq. Among the JAK inhibitors that have received approval in Korea, the medicines that have secured indications for ulcerative colitis are Abbvie’s Rinvoq, Eisai’s Jyseleca, and Pfizer’s Xeljanz. These drugs are undergoing clinical trials to evaluate their effectiveness as maintenance therapy for ulcerative colitis. Takeda’s Kynteles, an anti-integrin drug, has secured an indication for ulcerative colitis. Kynteles inhibits the migration of lymphocytes, which causes inflammation, into the gastrointestinal tract. Recently, the sphingosine-1-phosphate (S1P) receptor modulator has entered the market. Pfizer’s Velsipity recently received approval in Europe after securing approval in the United States last year. Inhibition of the S1P receptor can reduce the leakage of lymphocytes circulating in the lymph nodes, thereby diminishing inflammatory responses. Velsipity demonstrated efficacy in patients with ulcerative colitis who have previously had a failed response or intolerance to one or more treatments. Velsipity has shown effectiveness in patients who have had an inadequate response to at least one or more biologic or Janus kinase JAK inhibitor therapy compared to the placebo. It has been shown that there are improvements in endoscopic outcomes, alleviation of symptoms, and a restoration of the intestinal barrier. Velsipity aims to compete with BMS’s similar S1P receptor modulator, Zeposia. Zeposia, which received approval in Korea last year, secured reimbursement this year and launched in the market. It has landed in general hospitals, where prescriptions are being actively written.
- Company
- Generics of ‘Opsumit’ face tough competition in KOR
- by Kim, Jin-Gu Mar 04, 2024 05:52am
- The product photos of Opsumit (left) and Masiten (right). In the market for the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan, the period of priority of sale given to the first generic drugs is set to expire on the first of next month. While Janssen’s ‘Opsumit’ competes with Samjin Pharm’s ‘Masiten’ in the market, Daewoong Pharmaceutical’s newly launched ‘Macimit’ is expected to join the competition. As the generic’s market share is insignificant at below 1%, Daewoong’s introduction into the market draws the pharmaceutical industry’s attention related to potential market expansion in the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan. The sales of Opsumit 13%↓ in a year due to drug pricing decreases following the generic launch. The market size for the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan totaled 15.2 billion won last year, according to a pharmaceutical market research company IQVIA on the 29th. This figure represents a 13% decrease from 17.4 billion won in 2022. The market has gradually expanded, with 11.9 billion won in 2019, 16.3 billion won in 202, 16.0 billion won in 2021, and 17.4 billion won in 2022. However, the sales decreased by over 10% last year. The decrease in sales is likely due to the drug pricing decrease of the original medicine following the generic launch. Samjin Pharm filed a claim for passive trials to confirm the scope of a right involving the active ingredient patent of Opsumit against Janssen in May 2022. Samjin Pharm won the first trial in April of the following year. Last May, Samjin Pharm launched Masiten Tab after receiving the trial results. During the same period, the price of Opsumit, Janssen’s original medicine, decreased by 30%. The Ministry of Health and Welfare (MOHW) issued a decrease in Opsumit price following the reimbursement listing of the drugs with the same active ingredient. Janssen has appealed to the patent court in response to the first trial judgement. However, the company did not file a suspension of execution related to the drug pricing reduction. While accepting the government’s measure of drug pricing reduction, Janssen has decided to continue with the patent dispute with Samjin Pharm to protect the patent right. The quarterly sales of the treatments Opsumit, the original drug for treating pulmonary arterial hypertension (PAH) with the active ingredient macitentan, and its generic, Masiten. The quarterly sales of Opsumit steadily recorded 4.0 to 4.6 billion won until the second quarter of last year, then rapidly dropped to around 3 billion won after the third quarter. The decrease is due to a reduction in drug pricing that took effect after the third quarter of last year, following the generic launch in May of last year. Masiten had a market share of 0.5% in Q4 last year. Will Daewoong’s introduction lead to an expansion of the generics market? Samjin received a right for priority of sale after successfully challenging the Opsumit patent. Daewoong also challenged the same patent for Opsumit, but Samjin was a step ahead in obtaining the approval for its generic version. Therefore, Samjin obtained the priority of sale for the Opsumit generic alone. The priority of sale was granted from April 21st of last year until March 1st of this year. Although Samjin sold the generic without competition, Masiten’s impact on the market is insignificant. Last year, Masiten generated cumulative sales of merely over 20 million won. After the priority of sale ends, another generic is expected to enter the market on the 1st of next month. Daewoong Pharmaceutical obtained approval for their Macimit, as a generic version of Opsumit, in May of last year. It is anticipated that Daewoong Pharmaceutical will launch the product after next month. Daewoong’s introduction draws the pharmaceutical industry’s attention regarding the potential market expansion of generics containing the active ingredient macitentan. In the market of the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan, Masiten had a market share of 0.5% in the fourth quarter of last year.
- Company
- Bayer releases 2 new CVD drugs with reimb in KOR
- by Eo, Yun-Ho Mar 04, 2024 05:52am
- Bayer Korea, which has been slow to launch new drugs, is making a comeback, recently succeeding in reimbursing two of its cardiovascular drugs in Korea. According to industry sources, Bayer Korea launched its heart failure drug ‘Verquvo (vericiguat)’ with reimbursement on September 1 last year and its kidney disease drug ‘Kerendia (finerenone)’ on February 1 this year. The addition of the two drugs is expected to revitalize Bayer's cardiovascular division, which did not have a prominent pipeline since the launch of its novel oral anticoagulant (NOAC) ‘Xarelto (rivaroxaban).’ Verquvo, the first sGC stimulator for heart failure Verquvo was approved in December 2021 as a combination therapy in Korea as a treatment to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient intravenous (iv) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Conventional heart failure treatments work by blocking the harmful effects of the natural neurohormonal system that is activated by myocardial and vascular dysfunction. In contrast, Verquvo is a soluble sGC stimulator that has a novel mechanism of action to improve myocardial and vascular function by catalyzing the synthesis of intracellular cyclic guanosine monophosphate (cGMP), which regulates cardiac contractility, vascular tone, and cardiac remodeling. It is the first-in-class sGC stimulator approved for the treatment of chronic heart failure. The Phase III VICTORIA trial, which became the basis for Verquvo’s approval, was shown to reduce the risk of hospitalization in patients with heart failure. A total of 5,050 patients were enrolled in the study, including 1,132 Asian patients. Study results showed that at a median of 10.8 months of follow-up, the risk of death from cardiovascular disease or first hospitalization due to heart failure was about 10% lower in the Verquvo group than that of the placebo group, and the trial met its primary efficacy endpoint with an annual absolute risk reduction of 4.2%. Kerendia, the first kidney failure drug introduced in 20 years Kerendia was approved in Korea in May 2022 by the KFDA for the treatment of adult patients with chronic kidney disease (CKD) and Type 2 diabetes to reduce the risk of end-stage kidney disease (ESKD) and a sustained decline in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. Until now, only treatments that target hemodynamic changes and metabolic abnormalities, 2 of the 3 causes that worsen chronic kidney disease in type 2 diabetes, had existed, but the introduction of Kerendia made available a treatment that inhibits inflammation and fibrosis in the kidneys. Kerendia’s reimbursement approval was based on the reduction in kidney disease progression, cardiovascular benefit, and safety that was demonstrated through the Phase III trials FIDELIO-DKD and FIGARO-DKD. In the FIDELIO-DKD study, Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo.
- Company
- Hanmi Pharm ‘confirms the effect of SERM+Vitamin D combo’
- by Son, Hyung-Min Feb 29, 2024 06:03am
- Hanmi Pharmaceutical announced on the 27th that the results of big data-based research on 'SERM+Vitamin D combination drugs', including its own ‘RaboneD’, were published in the SCI-level international journal, 'Osteoporosis International'. RaboneD is an osteoporosis treatment developed by Hanmi Pharmaceutical that combines vitamin D with the SERM class raloxifene. The study compared the efficacy of selective estrogen receptor modulator (SERM) + vitamin D combination and SERM alone in 2,885 patients diagnosed with osteoporosis using insurance claims data from the National Health Insurance Service from 2017 to 2019. Sang-Min Kim, Professor of Orthopedic Surgery at Korea University College of Medicine Guro Hospital, Seong-Eun Byun, Professor of Orthopaedic Surgery, CHA Bundang Medical Center, and Hanmi Pharm’s data science team participated in the study. Study results showed that the SERM+Vitamin D combination significantly lowered the risk of osteoporotic fractures by approximately 23% compared with SERM alone, and the combination reduced the risk of hip fracture by approximately 75% compared with SERM alone. This is the first real-world, data-driven study to analyze the fracture reduction effect of a SERM+vitamin D combination compared with SERM alone. The results showed that the SERM+Vitamin D combination was effective in reducing the risk of hip fracture as well as osteoporotic fractures compared to SERM alone. Professor Sang-Min Kim, said, "We found that the risk of osteoporotic fracture was significantly lower in the SERM+Vitamin D administered group compared with the monotherapy group in women with osteoporosis aged 50 years and older in Korea. The results suggest that the SERM+Vitamin D combination may be a viable option for postmenopausal women with a relatively low fracture risk.” Professor Seong-Eun Byun, said, “SERM class osteoporosis treatments not only improve bone density and lipid profiles, but also act like antiestrogen in the uterus and breast, so there is less concern about the risk of endometrial and breast cancer. As Vitamin D is an important factor that controls the whole body calcium homeostasis and is known to be necessary for bone health, several guidelines recommend adequate intake of vitamin D for patients with osteoporosis." An Hanmi Pharmaceutical official said, "As a typical chronic disease, the number of osteoporotic fractures has been continuously increasing with Korea’s entry into a super-aged society. Therefore, we expect the results of this study to broaden the treatment options for doctors and patients.”
- Company
- Roche Korea appoints Ezat Azem as new CEO
- by Eo, Yun-Ho Feb 29, 2024 06:03am
- Roche Korea is welcoming its new CEO, who will take up the position after a two-month vacancy. According to an interview, Roche Korea recently appointed Ezat Azem as new CEO. Before his appointment in Korea, Ezat Azem was a General Manager in Roche’s Greece subsidiary. Ezat Azem joined Roche’s Israel subsidiary in 1997 and worked in the marketing business unit. Later, he headed the subsidiaries in Slovenia and Greece. Ezat Azem has a background in medical training, having graduated from The Hebrew University of Jerusalem Medical School. Later, he completed an executive MBA from Tel Aviv University. Meanwhile, former Roche Korea CEO Nic Horridge retired in 2023 and has been appointed head of the Australian subsidiary. Nic Horridge was appointed as the head of Roche Korea in October 2018 and led the corporation for approximately five years. While he was in office, Nic Horridge’s significant achievements included the expansion of the anticancer immunotherapy ‘Tecentriq (atezolizumab)’ to include first-line treatment of lung cancer. Additionally, he facilitated new listings of ‘Evrysdi (risdiplam)‘ for spinal muscular atrophy, ‘Vabysmo (faricimab)’ for eye diseases, and ‘Rozlytrek (entrectinib),’ a tumor-agnostic drug.
- Company
- K-Bio’s potential rises in targeted anticancer therapy
- by Son, Hyung-Min Feb 29, 2024 06:03am
- The achievements made by the pharmaceutical and bio-industry companies in Korea in developing targeted antitumor therapies are being introduced at academic conferences overseas. iLeadBMS and PharosiBio have announced positive preclinical study results, and have received the green light to enter main clinical trials. The ESMO Targeted Anticancer Therapies Congress 2024 was held in Paris, France, for 3 days from February 26. The European Society for Medical Oncology, one of the world's three major oncology societies, organizes the congress every year to showcase promising new targets and candidates. On the 26th, iLeadBMS, a drug developer subsidiary of Ildong Pharmaceutical, presented clinical trial results on its IL2106, a molecular glue (targeted protein degradation, TPD), through a poster presentation. Founded in December 2020, iLeadBMS is a bioventure that develops new drugs in the field of small molecules. Ildong Pharmaceutical became the company’s largest shareholder in July 2021. The TPD molecule being developed by iLeadBMS has a mechanism of action that degrades proteins that cause cancer and eliminates the target itself. Targeted anticancer drugs inhibit tumor growth by acting on the target protein, but TPDs offer an advantage as they target the cause of the disease. Although no TPD product has been commercialized yet, pharmaceutical companies that have seen the promise of the technology have been continuously joining in on the challenge. In addition to Ildong Pharmaceutical, Novo Nordisk and Daewoong Pharmaceutical have entered the development stage. iLeadBMS targets CDK12, a protein that regulates the expression of genes related to cancer. The CDK12 protein is known to be expressed in several solid tumors, including breast and gastric cancers. In a preclinical trial, IL2106 potently inhibited cells expressing triple-negative breast cancer and HER2-negative gastric cancer through targeted protein degradation. IL6-110 was particularly successful in significantly reducing cyclin K levels in HCC70 cells that cause triple-negative breast cancer. In a study conducted on mouse models, IL2106 demonstrated a favorable pharmacodynamic (PK) profile using a single oral dose. The team concluded, "These findings can serve as evidence that molecular glues could serve as a novel CDK12/13 inhibitor.” On the 26th, PharosiBio also announced through a poster presentation that it had confirmed the efficacy of its colorectal cancer drug candidate, PHI-501, in a preclinical trial. PHI-501 is a bispecific antibody that targets pan-RAF and DDR1 (Discoidin Domain Receptor 1). By targeting the two biomarkers, PharosiBio expects its candidate to show efficacy in inhibiting cancer cell growth and metastasis. The preclinical trial was conducted on the mouse in vivo model to confirm PHI-501’s mechanism of action as monotherapy, on whether it can overcome resistance to BRAF inhibitors while showing antitumor effects. Results showed that PHI-501 suppressed tumor growth in a colon cancer xenograft model with BRAF or KRAS mutations. More specifically, PHI-501 showed 96% tumor suppression in the BRAF xenograft model and 83.3% tumor suppression in the KRAS xenograft model. PHI-501 also suppressed tumor growth by 76.1% in a model that showed resistance to the recently approved colorectal cancer drug Vitrakvi by Ono Pharmaceutical. Based on the positive results found in preclinical trial results, PharosiBio plans to initiate clinical trials to confirm the efficacy of PHI-501.
