Latest news with #IchnosGlenmarkInnovation
Time of India
4 days ago
- Business
- Time of India
Glenmark's blood cancer drug ISB 2001 shows promising results in trial
Ichnos Glenmark Innovation, a clinical stage biotechnology company focused on oncology, has announced promising results for an innovative drug used for the treatment of relapsed or refractory multiple myeloma (RRMM), a rare form of blood cancer that affects plasma cells in bone marrow. Coded ISB 2001, the drug demonstrated an overall response rate (ORR) of 79% in a Phase 1 global study based on finding from patients who were administered a recommended dose. Patients who had exhausted other advanced treatments, such as CAR-T cell therapy and bi-specific antibodies, also showed encouraging results when given the drug. IGI is an alliance between the New York-based scientific research group Ichnos Sciences and Indian drug maker Glenmark. Senior haematologists say that the drug could potentially be an important candidate in the treatment of patients - who exhaust other therapy options due - to its unique mechanism of engaging the body's T cells (that are a vital part of the immune system) along with the attacking two sites on the tumour cell. Dr Shyam Rathi, consultant, clinical hematology, PD Hinduja Hospital & Medical Research Centre in Mumbai, said: 'It can definitely be a game changer in treatment of multiple myeloma which keeps relapsing thus exhausting treatment options quickly. This new drug looks very attractive because it targets two different sites on the cancer cell and it engages the body's own T-cells.' 'We have existing bi-specific antibodies where the target is only one antigen and they develop resistance very fast. However, ISB 2001 targets the two sites on the cancer cell and we expect some better results. It looks exciting in the future.' In lay terms, ISB 2001 binds to three sites on the cancer tumour. First, the ISB 2001 activates the CD-3 T-lymphocytes, which are the cells that have the natural attacking power against tumour cells. Next, it binds to two additional sites. The first is BCMA (a protein found on myeloma cells), which is the target for bi-specific antibodies but there is also CD38, which is the binding site of the widely prescribed drug called daratumumab, branded as Darzalex by Johnson & Johnson. Glenmark, which is pinning a lot of hopes on the new drug, is in advanced talks with multiple global Big Pharma companies for a licensing deal, Chairman and Managing Director Glenn Saldanha told analysts over an earnings call recently. 'The discussions are progressing really well, and we anticipate a positive outcome very quickly,' said Saldhana. He said a deal for ISB 2001 will 'really be transformational for Glenmark' and 'will overshadow anything else that we are doing in the near term.' 'You should see some visibility around a licensing deal pretty quickly.' Last year Ichnos and Glenmark entered into a partnership for discovery of cutting-edge therapies, specifically to treat blood related cancers and malignancies like multiple myeloma. The global market for multiple myeloma treatment is seeing a surge. The business for such drugs is expected to rise to $33 billion by 2030, up from $23.5 billion in 2023,according to Bloomberg Intelligence estimates. Hang Quach, professor of haematology at the University of Melbourne noted that the data presented on ISB 2001 highlighted the 'remarkable anti-myeloma activity of this first-in-class trispecific antibody-T cell engager in heavily pre-treated RRMM patients' including those who have exhausted other approved therapies. According to Quach, ISB 2001 has the potential 'to redefine the treatment landscape for multiple myeloma, offering new hope for patients with limited therapeutic options.' The drug demonstrated a favourable safety profile throughout the dose-escalation phase, with no dose-limiting toxicities (DLTs) reported.
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Business Standard
4 days ago
- Health
- Business Standard
Glenmark's cancer drug shows strong results in early trial for Myeloma
Glenmark Pharmaceuticals' arm, Ichnos Glenmark Innovation (IGI), shared encouraging early results from a new cancer drug being tested on patients with a difficult form of blood cancer—relapsed or refractory multiple myeloma (RRMM). The results were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The drug, called ISB 2001, is the first of its kind to target three markers (BCMA, CD38, and CD3) in a single treatment and has shown strong response rates in patients who have already undergone multiple prior therapies. In the dose-escalation stage of the trial, 35 patients were treated, most of whom had received a median of six prior therapies. Among 33 patients who received active doses (50 micrograms and above), the overall response rate (ORR) was 79 per cent, and 30 per cent achieved a complete or near-complete response. Safety data showed that cytokine release syndrome (CRS) occurred in 69 per cent of patients, mostly at Grade 1 severity. Four patients experienced Grade 2 CRS, and no cases of severe CRS or dose-limiting toxicities were reported. One patient experienced a mild neurological side effect, and infection rates remained low. The trial is continuing with a dose-expansion phase to determine the recommended Phase 2 dose and the optimal dosing schedule. According to Professor Hang Quach of the University of Melbourne and St Vincent's Hospital, ISB 2001 showed activity in patients who had previously received multiple treatment types, including T-cell redirecting and BCMA-targeted therapies. Lida Pacaud, Chief Medical Officer at IGI, said the current focus is on identifying the appropriate dose and expanding the trial to a broader patient population.
Mint
4 days ago
- Business
- Mint
Glenmark-Ichnos cancer drug shows 74% response in phase-1 trial
Mumbai: Ichnos Glenmark Innovation (IGI), a joint venture between Glenmark Pharmaceuticals and Ichnos Sciences, on Monday shared promising results from an ongoing phase-1 trial of ISB 2001, a novel drug targeting relapsed or refractory multiple myeloma. The data, presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), showed an overall response rate (ORR) of 74% in heavily pre-treated patients. Refractory multiple myeloma refers to cases where the cancer does not respond or stops responding to treatment. Multiple myeloma is a rare, incurable blood cancer affecting plasma cells. While several therapies have been approved in recent years, most patients eventually relapse or become resistant, leaving limited treatment options. ISB 2001 is being developed by IGI to address this unmet need, particularly in patients who have previously received T-cell–based therapies such as CAR T-cells or bispecific antibodies. It is a first-in-class tri-specific antibody designed to simultaneously target BCMA, CD38, and CD3—three proteins associated with multiple myeloma. The drug aims to overcome resistance mechanisms seen with earlier-generation immunotherapies, while minimizing off-tumour toxicity. The phase-1 trial, known as TRIgnite-1, is evaluating the drug's safety and efficacy in patients who have exhausted standard treatment options. The latest data, from the full dose-escalation phase, covered 35 patients with a median of six prior lines of therapy. The overall response rate was 74%. 'The high response rates and low safety concerns demonstrated in the dose-escalation portion of the TRIgnite-1 study, conducted in a heavily pre-treated population across multiple types of therapies, reinforce the promise of ISB 2001 as a potential new treatment for patients,' said Lida Pacaud, M.D., chief medical officer at IGI. 'As we advance to the second part of the TRIgnite-1 study, our focus is now on defining the recommended dosing schedule and evaluating ISB 2001 in a larger population of heavily pre-treated RRMM patients, where we hope to observe similarly impressive treatment responses and tolerability,' Pacaud said. Among patients receiving higher, active dose levels (≥50 µg/kg), the ORR rose to 79%, with 30% achieving complete or stringent complete responses. Patients who had not previously received T-cell–based treatments saw an ORR of 84%. Even among those with prior exposure to CAR T or CD38-targeted therapies, response rates remained strong, ranging from 71% to 73%. The safety profile of ISB 2001 was favourable, with no dose-limiting toxicities reported. The most common side effect was cytokine release syndrome (CRS), seen in 69% of patients—mostly mild (Grade 1), with only four cases classified as moderate (Grade 2). There were no severe neurological adverse events. The market for multiple myeloma is projected to grow to about $33 billion by 2030, according to estimates by Bloomberg Intelligence. The trial has now entered its dose-expansion phase, which will determine the recommended Phase 2 dose and optimal dosing schedule. ISB 2001 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in 2023 and recently received Fast Track status, underscoring the agency's recognition of its potential.
Economic Times
06-05-2025
- Business
- Economic Times
Glenmark Pharma shares in focus after FDA grants fast track status to cancer drug
Glenmark Pharmaceuticals shares will be in focus on Tuesday after the company announced that its innovation arm, Ichnos Glenmark Innovation (IGI), has received 'fast track' designation from the US Food and Drug Administration (FDA) for its investigational therapy ISB 2001. ADVERTISEMENT The designation applies to adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ISB 2001 is a tri-specific antibody therapeutic designed to target BCMA and CD38 on myeloma cells, as well as CD3 on T cells, enabling a targeted immune response against cancer. The therapy is currently being evaluated in a Phase 1 dose expansion clinical study. Ichnos Glenmark Innovation recently completed the dose escalation portion of its Phase 1 clinical trial in patients with heavily pre-treated multiple results from the study, presented during an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated a high overall response rate (ORR), durable responses, and a favorable safety results from the dose escalation portion will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025. ADVERTISEMENT The FDA's fast track designation is intended to facilitate the development and accelerate the review of drugs that treat serious conditions and address unmet medical needs, with the goal of making important new treatments available to patients sooner.A drug granted fast track status may be eligible for more frequent meetings and communications with the FDA, as well as rolling review of any marketing application. ADVERTISEMENT It may also qualify for priority review if certain criteria are met. Notably, ISB 2001 was previously granted 'orphan drug' designation by the FDA in July 2023. Also Read:8 Nifty Microcap stocks that can jump 100-230% in the next 12 months ADVERTISEMENT According to Trendlyne data, the average target price for the stock is Rs 1,691, indicating an upside of 20% from current levels. The consensus recommendation from 12 analysts is a 'Buy'. Also Read: 5 timeless Warren Buffett quotes every investor should know ADVERTISEMENT On Monday, Glenmark Pharma shares closed 2.2% higher at Rs 1,405.7 on the BSE, while the benchmark Sensex rose 0.37%. The stock has declined 13% year-to-date but has surged 155% over the past two years. Its current market capitalisation stands at Rs 39,670 crore. Also Read: SBI, LIC among 10 large-cap stocks that are below industry PE levels can rally up to 32% (Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times) (You can now subscribe to our ETMarkets WhatsApp channel)
Time of India
06-05-2025
- Business
- Time of India
Glenmark Pharma shares in focus after FDA grants fast track status to cancer drug
Glenmark Pharmaceuticals shares will be in focus on Tuesday after the company announced that its innovation arm, Ichnos Glenmark Innovation (IGI), has received 'fast track' designation from the US Food and Drug Administration (FDA) for its investigational therapy ISB 2001. The designation applies to adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ISB 2001 is a tri-specific antibody therapeutic designed to target BCMA and CD38 on myeloma cells, as well as CD3 on T cells, enabling a targeted immune response against cancer. The therapy is currently being evaluated in a Phase 1 dose expansion clinical study. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track default , selected Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Ichnos Glenmark Innovation recently completed the dose escalation portion of its Phase 1 clinical trial in patients with heavily pre-treated multiple myeloma. Initial results from the study, presented during an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated a high overall response rate (ORR), durable responses, and a favorable safety profile. Live Events Complete results from the dose escalation portion will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025. The FDA's fast track designation is intended to facilitate the development and accelerate the review of drugs that treat serious conditions and address unmet medical needs, with the goal of making important new treatments available to patients sooner. A drug granted fast track status may be eligible for more frequent meetings and communications with the FDA, as well as rolling review of any marketing application. It may also qualify for priority review if certain criteria are met. Notably, ISB 2001 was previously granted 'orphan drug' designation by the FDA in July 2023. Also Read: 8 Nifty Microcap stocks that can jump 100-230% in the next 12 months Glenmark Pharma: Price Target According to Trendlyne data, the average target price for the stock is Rs 1,691, indicating an upside of 20% from current levels. The consensus recommendation from 12 analysts is a 'Buy'. Also Read: 5 timeless Warren Buffett quotes every investor should know Glenmark Pharma: Share price performance On Monday, Glenmark Pharma shares closed 2.2% higher at Rs 1,405.7 on the BSE, while the benchmark Sensex rose 0.37%. The stock has declined 13% year-to-date but has surged 155% over the past two years. Its current market capitalisation stands at Rs 39,670 crore. Also Read: SBI, LIC among 10 large-cap stocks that are below industry PE levels can rally up to 32% ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
