Monash Health

SAN FRANCISCO and SUZHOU, China, Sept. 17, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announced that clinical data of IBI354 (HER2 monoclonal antibody-camptothecin derivative conjugate) in advanced solid tumors was presented at the 2024 ESMO Congress (ClinicalTrials.gov, NCT05636215). The data presented is from a Phase 1/2 study aimed at evaluating the safety, tolerability, and preliminary efficacy of IBI354 in participants with advanced solid tumors. A total of 368 participants with advanced solid tumors were enrolled and received different doses of IBI354 monotherapy, including 178 with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other tumors. Among them, 42.7% of the participants had previously undergone five or more systemic treatment regimens. IBI354 monotherapy demonstrated excellent safety profile. The dosage was escalated to 18mg, with no DLT events observed. The most common treatment-related adverse events (TRAEs) were nausea, decreased white blood cell count and anemia. The incidence of interstitial lung disease (ILD) was only 1.6%, all of which were grade 1. Overall, 21.5% of patients experienced TRAEs ≥ grade 3, 2.4% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death. IBI354 monotherapy showed promising efficacy signals in multiple tumor types. In platinum-resistant ovarian cancer cohort (n=87, treated at 6~12mg/kg IBI354), the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%. In the 12mg/kg subgroup (n=40), the ORR reached 52.5% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%. As of the data cutoff date, the median follow-up time was 6.5 months, and both progression-free survival (PFS) and duration of response (DoR) had not yet matured. In HER2-positive breast cancer cohort (n= 59, treated at 6~15mg/kg IBI354), the ORR and DCR were 67.8% and 88.1%, respectively. In HER2-low breast cancer cohort (n=67, treated at 6~15mg/kg IBI354), the ORR and DCR were 41.8% and 82.1%, respectively. In the 12mg/kg subgroup (n=26), the ORR and DCR were 61.5% and 88.5%, respectively. In HER2-positive gastrointestinal malignancies cohort (n=35, treated at 6~15mg/kg IBI354), the ORR and the DCR were 57.1% and 91.4%, respectively. 26 participants were diagnosed with colorectal cancer, of which 14 achieved an objective response ( 1 subject with HER2 IHC2+ FISH+ achieved a confirmed objective response), resulting in an ORR and DCR of 53.8% and 92.3%, respectively. As of press date, another participant with HER2 low expression (IHC2+ FISH-) colorectal cancer achieved a confirmed objective response. Professor Qi Zhou, Chief Physician at the Gynecologic Oncology Center of Chongqing University Affiliated Cancer Hospital and the Principal Investigator of the gynecologic oncology cohort study, stated, "Approximately 70% of ovarian cancer patients experience relapse within 3 years following surgery and platinum-based adjuvant therapy, eventually developing platinum resistance after multiple recurrences[1]. These patients have limited effective treatment options. Current evidence indicates that non-platinum single-agent chemotherapy or the addition of anti-angiogenic therapy results in an ORR of just 4-13.2% and a median OS of merely 10.9-14 months[2]-[3][4][5][6]. As a fully-validated target, HER2-targeted therapy has proven effective in breast and gastric cancers. IBI354, an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown good anti-tumor activity in platinum-resistant ovarian cancer with HER2 expression of 1+. In our Phase 1 study, the ORR was 67.5%, DCR was 88.9%, and median rate is 39.0% at the 12mg/kg Q3W dose level, while maintaining a favorable safety profile. Extending the PFS and OS remains a critical clinical challenge in platinum-resistant recurrent ovarian cancer. The development of antibody-drug conjugates for the treatment of resistant recurrent cancers has become a hot spot, and promising results have been observed. The clinical efficacy of antibody-drug conjugates targeting HER2 low expression warrants further clinical research and exploration, which could benefit more patients with platinum-resistant ovarian cancer." Doctor Daphne Day from the Medical Oncology Department at Monash Health in Melbourne, Australia, stated: "Breast cancer is the second most commonly diagnosed cancer globally, the most common cancer in women, and a cause of cancer-related deaths. HER2 amplification or overexpression has been proven to play a significant role in the occurrence and progression of breast cancer, underscoring the importance of HER2-directed therapy. IBI354, as an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown promising preliminary results, with meaningful objective response and disease control rates in HER2-positive and -low breast cancer. Additionally, IBI354 has demonstrated excellent clinical safety and tolerability. Existing clinical data suggest that IBI354 has substantial development potential in the breast cancer population." Professor Lin Shen from Peking University Cancer Hospital, stated, "Colorectal cancer (CRC) has become the second most common malignant tumor in China, and its incidence and mortality rates are still rising annually[7]. The HER2-targeted therapy plays an important role in the later-line treatment of CRC. Preliminary results suggest that IBI354, an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown positive efficacy in HER2-positive gastrointestinal malignancies. Notably, IBI354 has also demonstrated antitumor effects in HER2-low CRC populations, where HER2-targeted therapies are relatively less effective. IBI354 has exhibited good clinical safety and tolerability in later-line CRC patients, supporting further exploration and development in this population." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "With the rapid advancements in ADC drugs for oncology treatment, Innovent is strategically positioning itself in the ADC field. At this year's ESMO conference, we are showcasing, for the first time, the safety and efficacy data of IBI354 across various advanced solid tumors, fully demonstrating Innovent's platform capabilities in ADC drug development. We will continue to invest in research and development of ADC innovative molecules, with the aim of providing patients more and better treatment options." About IBI354 (Anti-HER2 Antibody-Camptothecin Derivative Conjugate) IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent's proprietary novel topoisomerase inhibitor NT3 platform. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Innovent Biologics is conducting clinical research in China, the United States, and Australia to assess the efficacy and safety of IBI354 for treating various advanced malignancies. Additionally, multiple new ADC molecules from Innovent's NT3 platform are under clinical development and have shown promising safety and efficacy signals. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The Australian government will pilot a network for sharing information on cyber threats in the healthcare sector. It has recently set aside A$6.4 million ($4.2 million) to launch an Information Sharing and Analysis Centre (ISAC) for the Australian healthcare system. WHY IT MATTERS In Australia, the ISAC has long been operating in the banking and finance sector. The government said its establishment in other high-risk sectors such as healthcare has been "long overdue." Applications for the government's grant to develop the ISAC in the sector are open until July 23. THE LARGER CONTEXT Australian healthcare continues to be a major target of cybercriminals. Based on latest data from the Office of the Australian Information Commissioner, there were 104 notifications of data breaches involving health service providers in the second half of 2023. Just before Christmas day last year, St Vincent's Health , one of the country's largest not-for-profit health and aged care providers, reported that hackers deleted some still unidentified data from its system. This year also saw one of the biggest ransomware attacks in Australian healthcare. In May, e-prescription delivery service MediSecure was hit by a cyberattack that led to information relating to prescriptions and personal information of healthcare providers from its systems up until November 2023 being allegedly exposed to the dark web . Meanwhile, Monash Health was also named as one of those whose data were affected in the ransomware attack that hit ZircoDATA in February. In 2022, the Australian government passed a law amending the Security of Critical Infrastructure Act 2018 to extend its protection to the healthcare and medical sector, among other changes. The amendment meant that hospitals and other entities within the sector would be required to undertake enhanced cybersecurity obligations, including taking preparedness exercises and vulnerability assessments and creating a cybersecurity incident response plan. Early this year, the Australian Cyber and Infrastructure Security Centre released an advisory for critical infrastructure sectors, proposing the obligation to create and maintain a Critical Infrastructure Risk Management Program. ON THE RECORD "The last two years [have] been the beginning of a big, overdue national journey to lift up cybersecurity across the country to better protect our citizens. Healthcare faces a vulnerability trifecta. Cybercriminals know that every Australian depends on these essential services – and that they cannot afford to be offline over extended periods. Healthcare providers tend to hold highly sensitive data, and they often struggle with building and funding strong cyber protections. That’s why healthcare providers are one of the most common, and most damaging, targets of cyber attack. This is a pattern we see all over the world," Home Affairs and Cyber Security Minister Clare O’Neil commented in a media release.

Ozempic and GLP-1 drugs like it became household names due to their potent weight loss benefits, and are now proving useful in a slew of other chronic conditions.Women are noticing other benefits, too, including some that may be flying under pharmaceutical companies radars. Reports have emerged of unexpected pregnancies among women on GLP-1 treatment, and researchers have mused of possible effects on fertility or on hormonal disorders as well.Melanie Cree, a pediatric endocrinologist at Children's Hospital Colorado, is one physician looking into this question. Working with her colleagues, she conducted a randomized trial testing semaglutide, the ingredient in Novo Nordisks Rybelsus and Wegovy, in women and adolescents with polycystic ovary syndrome, or PCOS.Cree said this research provides evidence of what these medications can do for PCOS, reproductive measures and periods specifically. While results from Crees first trial arent yet published, they were encouraging enough to spur Cree to launch another, larger trial testing the link between weight loss, metabolic changes and reproductive function in people with PCOS.PCOS is a set of symptoms caused by a hormonal imbalance, usually overproduction of testosterone, that disrupts ovulation. The condition leads to cysts developing in the ovaries, which in turn changes an individuals menstrual cycle and may result in infertility. People with PCOS can also develop insulin resistance, increasing the risk of Type 2 diabetes and other cardiometabolic issues. The disorder is typically diagnosed during adolescence.There is no standard treatment for PCOS, and diagnosis can often be time-consuming and difficult. The World Health Organization estimates 70% of affected women remaining undiagnosed globally.[Researchers] haven't pinpointed the reason or background etiology for the condition, said Pardis Hosseinzadeh, an assistant professor of gynecology and obstetrics at Johns Hopkins School of Medicine. So obviously, when that's not fully discovered yet it gets hard to treat PCOS, because it affects many different systems in the body.Depending on symptoms, doctors may recommend different medications or other interventions, such as weight management or birth control that helps with ovulation, mood changes and hormonal acne.Studies like mine and my colleagues are very important because there are currently no FDA-approved medications for PCOS, Cree said.Weight loss can improve symptoms of PCOS and is therefore usually an objective of treatment. Often, metformin, a diabetes medication, is prescribed, but other lifestyle interventions or even bariatric surgery may also be used.One of the primary reasons I started looking at GLP-1s is because there is this tight association between weight, PCOS hormones and PCOS periods, Cree said.Endocrinologists and doctors helping women with PCOS are well aware of the difference weight loss can make in menstrual cycles and hormone regulation. Last year, the American Society for Reproductive Medicine, or ASRM, updated its guidelines for treating PCOS, which had been the same since 2018. The new guidelines now note the potential for GLP-1 drugs like semaglutide to help control weight.Chau Thien Tay, an endocrinologist at Monash Health who contributed to the new guidelines, told BioPharma Dive that weight loss therapies were considered in the previous framework. The inclusion of GLP-1s this time around simply reflects a shift in the therapeutic landscape guided by recent advancements and clinical evidence, she wrote.With her new study, Cree aims to study whether PCOS symptoms are eased with weight loss, regardless of method, or whether GLP-1 drugs specifically can help with hormonal disorders.The 10-month trial, which aims to recruit 80 girls and women between 12 and 35 years old, will test the effects of injected semaglutide on ovulation. It will also assess whether age or metabolic and hormonal changes could predict the response to GLP-1 treatment.By going across that reproductive lifespan, [the study] can help us determine and move towards personalized medicine for individuals by understanding if there is a difference in the response between teenagers and adults, Cree said.Based on the previous, smaller study using oral semaglutide over a shorter time span, Cree believes the injectable version will help regulate ovulation.A lot of the patients who have PCOS, or who struggle with PCOS or other issues like insulin resistance and obesity, may have irregular cycles from not having regular ovulation, said Hosseinzadeh. It's been very well known to [healthcare providers] that weight loss of up to 5% of body weight in patients with PCOS can help regulate their cycles by resuming regular ovulation.GLP-1 drugs hoped-for effect in PCOS could be related to their purported impact on fertility, which researchers are now looking at more closely following widespread reports on social media.While theres thought to be a link between weight loss and fertility or pregnancy outcomes, the strength of the association is still unclear.Some doctors theorize that unexpected pregnancy in people taking GLP-1s may be due to the drugs impact on the effectiveness of oral birth control, as it slows down the digestive process.Wegovy, which contains semaglutide and is labeled for obesity, comes with a warning to discontinue use two months prior to planning to become pregnant. ASRMs PCOS guidelines also advise contraception for women taking GLP-1s due to limited safety data during pregnancy.A spokesperson for Novo Nordisk said in an email that, based on animal studies, Wegovy may present risks to the fetus during pregnancy. The company has established a pregnancy registry for Wegovy to collect safety information.The spokesperson added that Novo has not conducted studies to assess the efficacy and safety of our FDA-approved GLP-1 medicines in patients with PCOS, and have no immediate plans to do so.A spokesperson for Eli Lilly said the company has not studied the impact of tirzepatide on fertility in humans. (Tirzepatide is the drug ingredient in Zepbound, the medicine Lilly sells for obesity.) Lilly encourages pregnant people exposed to Zepbound to contact the company. The spokesperson did not answer BioPharma Dives questions on PCOS.The companies positions arent atypical. Pregnant women are often excluded from clinical testing due to the risk of potential harm to the fetus. And the dramatic weight loss that GLP-1 treatment can induce may not be healthy during pregnancy.I think its still not prime time to say that [weight loss drugs] could be used for other indications or are fully safe to be used right before trying for pregnancy, or for patients who are trying for pregnancy, Hosseinzadeh said. So we still need some more data. But we also don't have any data to say that they're harmful.Such information is important, as GLP-1 drugs are proving particularly attractive to women. While obesity rates between men and women are similar, prescriptions for weight loss medicines like Ozempic skew heavily toward women, according to recent U.S. data cited by Reuters. Earlier data from pharmacy benefit manager Prime Therapeutics found a similar imbalance. Clinical trials testing Wegovy and Zepbound for obesity enrolled more women than men, too.It may be that the GLP-1s can help [PCOS] patients in the long term, Hosseinzadeh said We tend to get really focused on the effects on fertility and reproduction during the reproductive years, but we're looking at the middle part of the spectrum. This is a condition that affects a woman throughout her life. '