Latest news with #Imugene
Yahoo
2 days ago
- Business
- Yahoo
Imugene Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL
Since the February update, an additional 5 patients have been dosed, resulting in 2 Complete Responses (CR) and 3 Partial Responses (PR) 75% Overall Response rate (ORR): 6 total CR and 3 PR in Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer First patient remains cancer free at 15 months and ongoing with additional patients having durable responses at 2, 5, and 11 months+ and durability data continuing to mature Patients in the trial have previously failed at least 3 lines of therapy with many patients failing 4-6 lines of therapy, including autologous CAR-T, reinforcing the potential of azer-cel in this high-unmet-need population Based on these positive results, Imugene expects to meet with the US FDA in Q4 2025 regarding a pivotal / registrational study for azer-cel Trial now open to enrol into CAR T naïve niche indications in other lymphomas Additional update expected in coming months SYDNEY, July 14, 2025 /PRNewswire/ -- Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, is pleased to announce exciting new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappearance of all signs of cancer in response to treatment. Since then, two additional patients have also achieved a Complete Response, and three patients have achieved Partial Response (cancer reduction by at least 50%) bringing the best overall response rate to 75% and the CR rate to 55%. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2). Evaluable patients Treatment N Overall Response Rate (ORR) Complete Response (CR) At Day 60 Best Durability (Time of response) DLBCL Lymphodepletion (LD)1 +azer-cel +Interleukin-2 (IL-2) 12 9/12 (75%) 6/11 (55%) >450 days on going For approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response. Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand). Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal / registrational trial for azer-cel. Leslie Chong, Managing Director and CEO of Imugene, said: "We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA. Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel." Dr John Byon, Chief Medical Officer of Imugene, said: "DLBCL remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment. We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists." The FDA Fast Track Designation for DLBCL received for azer-cel is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of the designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria. Imugene continues to actively enrol patients into the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response. About the Phase 1b azer-cel trial The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated. About diffuse large B cell lymphoma (DLBCL) DLBCL is an aggressive and fast-growing type of non-Hodgkin's lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse. [1]Science Direct Volume 60, Issue 5, November 2023 About primary central nervous system lymphoma (PCNSL) PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients. About other types of B Cell Lymphoma Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments. About Interleukin 2 (IL-2) IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells. For more information please contact: Leslie ChongManaging Director and Chief Executive Officerinfo@ General Investor Enquiriesshareholderenquiries@ Media EnquiriesMatt Wrightmatt@ Connect with us on LinkedIn @Imugene LimitedFollow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body's immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T's for solid tumours and B-cell vaccine candidates. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies that are currently marketed globally. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Together with leading specialists and medical professionals, we believe Imugene's immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited. View original content to download multimedia: SOURCE Imugene Ltd Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
News.com.au
2 days ago
- Business
- News.com.au
Health Check: Imugene goes to the well after reporting more blood cancer ‘cures'
Imugene reports two more 'complete responders' in its cell therapy trial Clever Culture Systems shares surge 17% on deal with Big Pharma Novo Nordisk Compumedics shares vault 24% after full-year update Imugene (ASX:IMU) will forge ahead with a planned pivotal US trial for its blood cancer therapy Azer-cel, having recorded more 'complete responses' in its phase 1b study. There's also the matter of cash, with Imugene shares this morning entering trading halt amidst a capital raising reportedly targeting $35 million. The trial is testing the company's CD-19 Car-T therapy on patients with relapsed diffuse large B-cell lymphoma. This is an especially aggressive blood cancer and these patients have failed multiple therapies. The company reports that of five further patients evaluated, two showed a 'complete response'. A complete response is the disappearance of all cancer signs – a.k.a. a cure. A further five showed a 'partial response' – at least a 50% cancer cell reduction. This takes the total number of complete responses to six and partial responses to three, out of 12 patients. The effect has endured for at least 60 days, with the first patient treated remaining cancer free at the 15-month mark. 'Allo 'allo, we're on to something If approved, Azer-cel would be the first off-the-shelf Car-T therapy using donor cells rather than the patients' own material. This is the allogeneic (allo), as opposed to autologous, method. Car-T therapies involve taking T-cells out of blood and tricking them up with agents that bolster their cancer-busting abilities. They are then re-introduced into the bloodstream. The re-engineered cells pursue a target, in this case the CD-19 protein expressed by blood cancers. Next stop: FDA The ongoing study is being carried out at 13 US sites and the first of five planned local sites. The company in February treated the first Australian participant, at Sydney's Royal Prince Alfred Hospital. The subjects were dosed with Azercel, combined alongside chemotherapy and the immunity agent interleukin 2. Imugene plans to meet with the US Food & Drug Administration (FDA) in the December quarter, to discuss a pivotal registration study. As of the end of March, Imugene held cash of $36 million. Drug development is hideously expensive and the last raising is never the final one, and what better time to go to the well than after positive clinical results? Imugene raised $53 million in 2023 and $80 million in 2020 and this year entered into a $20 million convertible note issue. Imugene shares have lost 68% year to date, adjusting for a share consolidation that reduced its 7.46 billion shares on issue to a more respectable 219 million. Clever Culture bulks up with fat-busting drug maker Clever Culture Systems (ASX:CC5) has signed up Big Pharma Novo Nordisk for one of its automated agar plate reading devices to monitor ultra-clean drug making facilities. The maker of the weight loss and diabetes drugs Ozempic and Wegovy, Novo Nordisk will acquire and appraise one of Clever Culture's AI-enabled device APAS Independence units, in view of a full global rollout across its facilities. The AI-enabled APAS Independence devices automatically read the hundreds of agar plates required to ensure that pathogens don't enter aseptic facilities. The units can manage 200 plates per hour, freeing up microbiologists to focus on the minority of plates that read positive. To date Clever Culture has focused on 90 millimetre 'settle' plates that are left open, to absorb any nasties in the room. A tweaked APAS also will read 55mm 'contact' plates, which are dabbed on surfaces, such as a gown or gloved fingertips. Nova Nordisk will assess both settle and contact plate modules. Courting Big Pharma Clever Culture CEO Brent Barnes says the 'milestone' deal aligns with the company's focus on the big drug makers, most of which have centres to appraise new products. To date Clever Culture also sold the devices to Astrazeneca, Bristol Myers Squibb and Thermo Fisher Pharma Services, while a fifth drug maker recently completed a 'successful evaluation'. The five drug makers on the books represent a sales opportunity of between 60 to 80 units. At last count the company had 13 APAS devices in the field, with foundation client Astrazeneca accounting for nine of them. The company cites a 'pipeline' of 40 customers, representing upfront revenue of about $75 million and $15 million of recurring revenue. The APAS unit sells for US$350,000, but Clever Culture then derives ongoing income from an annual software licence of US$30,000 (rising to US$50,000 with the contact plate modality). There's also an annual hardware maintenance fee of $US15,000-25,000. The FDA approved APAS Independence in May 2019 and European regulators followed suit in September 2021. There's no snoozing at Compumedics Sleep and neurological testing house Compumedics (ASX:CMP) has reported record revenue of $51 million for the year to June 2025, up 4%. What's more, the company has returned to profitability, with underlying earnings of $3 million. Compumedics also reports record sales orders of $63.4 million, up 22%. The key driving force was the growth of the US sleep diagnostics arm, up 39% to $53 million. The company also affirmed current year guidance of revenue of at least $70 million and underlying earnings of around $9 million. 'This result reflects the step-change underway at Compumedics,' founder and executive chairman Dr David Burton says. "We are building a more predictable, higher-margin business model and seeing consistent revenue growth, expanding margins and meaningful traction in the US." Proteomics ain't horsing around In time for the spring racing season, Proteomics International Laboratories (ASX:PIQ) says its oxidative stress test Oxidx can detect muscle damage in thoroughbreds. As published in the peer-reviewed journal Veterinary Medicine and Science, the 'groundbreaking' results show Oxidx can identify and assess recovery from exercise-induced damage. The study was based on 34 nags. The company says up to 85% of thoroughbreds sustain at least one injury during their racing seasons, potentially because of undetected muscle injuries. 'Oxidative stress has been implicated in many disease and injury states, with levels often reflective of a person or animal's health condition.' Via its 66% owned OxiDx Pty Ltd, Proteomics plans to launch Oxidx locally in the current half. Proteomics has a commercialised diabetic kidney disease diagnosis and plans to launch an endometriosis assay locally in the current quarter. No pay, no worries says Pacific Edge Pacific Edge (ASX:PEB) reports resilient demand for its bladder cancer diagnostic in the US, despite authorities withdrawing reimbursement coverage. The Kiwi-based company said US June quarter test volumes declined 12% to 5717, relative to the March quarter. Asia Pacific volumes – including those derived here – rose 8.8% to 1183. The company attributed the decline mainly to customers moving to its Cxbladder Triage product, from the discontinued Cxbladder Detect. Cxbladder Triage tests accounted for 77% of total US assays, up from 22% in the March quarter. Pacific Edge also said it had held positive discussions with Novitas, its US Medicare gatekeeper, about reinstating coverage. This was 'based on evidence not considered in the review that led to the non-coverage decision.'
News.com.au
19-05-2025
- Business
- News.com.au
Health Check: Biotechs obey the Three Commandments of life sciences
Anatara has taken a different tack post-trial results, while Chimeric is raising funds and Imugene proposes a share consolidation Heramed falls victim to US healthcare funding cuts D-Day looms for Mayne Pharma holders – or will there be a twist? Biotechs are heeding the Three Commandments of Life Sciences, as evidenced by ASX announcements over the last few days. Why have only three emerged from the Mount? Inspired by Donald Trump's famed negotiating skills and the supermarkets' shrinkflation practices, we managed to whittle them down from ten – and got adultery removed for good measure. Anatara cuts the pineapple in other ways Commandment One: when a clinical trial faileth, do not throweth in the towel prematurely. In the case of Anatara Lifesciences (ASX:ANR), the company dipped out with a phase II trial testing its drug candidate – Garp – on irritable bowel syndrome (IBS) patients. Garp, as in Gastrointestinal ReProgramming, contains a form of bromelain, an enzyme found in pineapple stems of all things. Enlisting 78 volunteers, the study failed to meet the primary endpoint of a meaningful improvement in IBS symptoms, compared to placebo. This was despite a 40% 'sustained and consistent' improvement, as measured by the IBS symptom scoring system. The gist is that while there was an 'apparent trend of pain and distension relief', the more subjective measures did not show a clear pattern of improvement and this affected the overall score. For example, questions included "how dissatisfied are you with your bowel functioning the past 10 days?" The answers 'appeared to confound the result, presumably because the underlying disease is still present with a level of symptomatology'. Anatara is continuing its anti-obesity pre-clinical studies, which are expected to take about six months to complete. The other lesson here is that in devising primary endpoints, one should be-eth bloody careful to picketh the right ones. Chimeric seizes the day Commandment Two: Don't wasteth a successful trial result: go-eth to the well. True to that lore, Chimeric Therapeutics (ASX:CHM) on Friday requested a trading halt 'pending an announcement in relation to a capital raising'. The shares are frozen until tomorrow, or possibly today if the news come through. On Thursday Chimeric shares soared 60%, or two-thirds of the cents after the company said two out of three evaluable patients in its phase IIb trial had achieved a complete response. A complete response means remission or – in layman's terms – a cure. The third patient had 'achieved stable disease, whereby the cancer is neither increasing nor decreasing in extent or severity'. The study tested Chimeric's natural killer (NK) cells, agents in the blood stream with heightened cancer busting powers. Chimeric's candidate, CHM-0201 was administered alongside standard-of-care chemotherapy patients to the for acute myeloid leukemia. The three patients are the first to be targeted of 20 subjects, with 12 enrolled as of December. The first patient was dosed in June last year. The three patients were ineligible for transplantation and had not been previously treated. Honey – we shrunk the share base Commandment Three: when one's share price plummeteth, one should seeketh to consolidate one's shares. Imugene (ASX:IMU) proposes a share consolidation to reduce its circa 7.46 billion shares on issue by a factor of 34, subject to investor approval at an EGM. Imugene shares have fallen more than 70% over the last two years – and lost close to 10% this morning. In theory, the shares would be worth 68 cents a share post-consolidation. Apart from the 'vibe' of a company no longer being in 'penny dreadful' territory, share consolidations don't change anything fundamentally. Heramed loses US hospital partner HeraMED (ASX:HMD) has fallen victim to Trumpian public healthcare funding cuts, with hospital partner Broward Health ceasing use of the company's digital foetal monitoring tool Heracare. Heramed says Broward believed that Heracare worked quite well, including reducing pre-term births significantly. But the First, Second and Third Commandment of US healthcare is that economic imperatives come before clinical ones. As a Medicaid 'safety net' hospital, Broward took up Heracare courtesy of a state grant. As of April 1 this year, federal allotments to the states to fund such services have been reduced by US$8 billion annually. Heramed has appointed a US healthcare commercialisation firm, Aspire Health Innovations, to further its US growth. The company also is in commercial discussions with potential partners 'in other markets with stable healthcare policy environments.' Vitura pots another one Medical cannabis intermediary Vitura Health (ASX:VIT) has added another chain of clinics to its range of outlets, albeit indirectly. Vitura's 50% joint venture Flora has acquired the digital platform Heyday Medical, 'one of Australia's most respected medicinal cannabis clinics'. Established in 2020, the chain claims to have services more than more than 5000 patients. The deal involves Flora paying $350,000 in cash, plus a 15% stake in Flora post-deal, the value of which has not been quantified. Vitura owns the Canview marketplace, Doctors on Demand telehealth business, CDA Clinics (medical cannabis telehealth) and a the clinic chain Candor Medical. Last November Flora acquired the Releaf Group, which operates telehealth and physical clinics. Mayne and Island shares have a rest Mayne Pharma (ASX:MYX) shares are in trading halt until Wednesday, pending news of a 'material announcement' pertaining to US dermatological group Cosette's $7.40 a share cash takeover offer. Last Thursday, Mayne issued an independent report opining the offer was 'fair and reasonable', with an assessed value of $6.61 to $7.50 per share. Barring any surprise, Mayne holders will meet on June 18 to approve the scheme of arrangement. Meanwhile, Island Pharmaceuticals (ASX:ILA) shares are on trading halt pending a capital raising. The developer of both a treatment and prophylactic for dengue fever, Island had cash of $4.8 million as of the end of March.
