METAP2

SHANGHAI, April 17, 2023 /PRNewswire/ -- Asieris Pharmaceuticals (688176.SH), a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary (GU) tumors and other related diseases, today released its 2022 annual report. While enhancing its product pipeline with steady progress in its global clinical trials, Asieris is building up its core marketing and sales team to implement its commercialization strategy that integrates solutions from diagnosis to treatment. Moreover, in 2022 the company increased its R&D investment, which includes expanding its Shanghai R&D Center, creating an innovation base and establishing a global clinical-development team in the US. Asieris is dedicated to becoming a global leader in diagnosis and treatment of GU tumors and other related diseases, by continuously focusing on the GU oncology field; strengthening its differentiated pipeline; developing a portfolio of competitive, integrated diagnosis-to-treatment solutions with potential blockbusters; and aggressively pursuing commercialization of these innovative products to soon deliver them to patients in need. Accelerate Global Clinical Development and Deepen Strategic Implementation to Treat GU Tumors Urological Disease Area In the field of urological diseases, APL-1202 (trade name: Vesique®) is a core product that Asieris has independently developed. Through the ANTICIPATE study – an international, multi-center Phase I/II clinical study that examines the combination of oral APL-1202 with tislelizumab, an anti-PD-1 antibody, as a neoadjuvant therapy for Muscle-Invasive Bladder Cancer (MIBC) – APL-1202 has progressed smoothly into the Phase II stage of the trial and completed its first patient enrollment in December 2022. The protocol of ANTICIPATE study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022. One year later, at ASCO's 2023 Annual Meeting in June, Asieris will further present the safety and efficacy data from its Phase I clinical trial. Meanwhile, APL-1202's ACCRUE trial – which examines oral APL-1202 in combination with intravesically-instilled chemotherapy for treating relapsed intermediate- and high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) – has been in close follow-up with patients. When the trial reaches its target event number, Asieris will immediately conduct the subsequent work, such as the database lock, unblinding, and statistical analysis. What's also steadily underway is the trial for APL-1202 monotherapy as a first-line treatment in naive, intermediate-risk NMIBC: it's in active patient recruitment in China. As a first-in-class, orally available and reversible MetAP2 inhibitor for anti-tumor treatment – and currently in the pivotal Phase III clinical trials to treat NMIBC – APL-1202 holds great promise to fill the existing gap in the marketplace for treating bladder cancer. Another core product that Asieris is developing for urological disease is APL-1706. Under the trade name Hexvix®, APL-1706's Phase III clinical trial in China completed its first patient procedure in November 2022; more patients are actively being enrolled. APL-1706 is actually the world's only approved imaging agent for bladder cancer diagnosis and surgical treatment. When combined with blue-light cystoscopy, APL-1706 has proven to effectively improve the detection rate of NMIBC – especially on carcinoma in situ. This results in more complete resection and reduced rates of tumor recurrence. Women's Health Disease Area In the field of women's health, Asieris' core product is APL-1702 (trade name: Cevira®), which is a drug-device combination photodynamic therapy product. In July 2022, its international, multi-center Phase III clinical trial completed enrollment. Asieris has been closely following up with patients in this trial. In June 2022, APL-1702's Phase III study protocol was also published in the peer-reviewed medical journal, BMJ Open. APL-1702 is mainly used for non-surgical treatment of cervical High-grade Squamous Intraepithelial Lesions (HSIL) caused by any HPV subtypes. APL-1702 could provide women with a new treatment option to alleviate the pain and risky side-effects commonly associated with surgical treatments. APL-1702 would be especially beneficial to women of childbearing age, because it aims to eliminate the adverse effects of surgical treatment on female reproductive functions. Other Diseases & Pre-Clinical Projects Asieris has also developed APL-1401, an oral drug to treat moderate to severe Ulcerative Colitis (UC) – for which there is currently no cure. In November 2022, the U.S. Food and Drug Administration (FDA) approved Asieris' Investigational New Drug (IND) application, for which Asieris is actively recruiting patients. As a dopamine β-hydroxylase (DBH) inhibitor, APL-1401 has a novel mode of action and is capable of raising dopamine (DA) and lowering norepinephrine (NE) concentrations – thereby normalizing intestinal immune homeostasis. Again, with no existing cure for UC, development of APL-1401 could provide UC patients a new treatment option. Asieris has also entered a collaboration agreement with ReviR Therapeutics, which aims to discover and develop innovative treatments for genitourinary (GU) tumors and other related serious diseases. Except that this arrangement enables Asieris to leverage ReviR's proprietary AI drug-discovery platform and RNA-targeting technologies. With its deep understanding of the GU disease field, Asieris continues to elevate its R&D capabilities and expand its product pipeline – all of it intended to offer patients more treatment options. Steady Implementation of Integrated Diagnosis-to-Treatment Commercialization Strategy, Centered Around Patients' Unmet Needs for Bladder Cancer Diagnosis & Treatment With years of deep cultivation in the field of managing GU diseases, Asieris is creating an advantageous product portfolio: ranging from bladder-cancer diagnosis, treatment and follow-up surveillance, to the spectrum of unmet patient needs within the disease-management cycle. This initially includes oral-treatment drug APL-1202, imaging agent APL-1706, and single-use flexible cystoscope APLD-2101. Administering the oral APL-1202 – combined with intravesically-instilled chemotherapy in relapsed intermediate- and high-risk NMIBC – could potentially lower the recurrence rate and help patients avoid or delay radical cystectomy, which would entirely remove their bladder. As a single-agent, first-line therapy for treating naive, intermediate-risk NMIBC, APL-1202 could possibly provide a new, safer option for patients and enable them to avoid painful intravesical treatment. The imaging agent APL-1706 can effectively improve the detection rate of NMIBC, especially for carcinoma in situ. This will result in more complete resection and reduce the rate of tumor recurrence. The single-use, flexible cystoscope APLD-2101 can provide multiple benefits: it significantly reduces a patient's discomfort and urethra damage caused by conventional rigid cystoscopes; avoids the risk of cross-contamination from repeat-use or incomplete sterilization; enhances operational convenience and simplicity; and even lowers the capital cost to hospitals and clinics. APLD-2101 now includes both an Uro-3500 (an electronic endoscope image processor) and an Uro-G (a disposable flexible cystoscope), after China's National Medical Products Administration (NMPA) accepted both of their registration applications – in July 2022 and February 2023, respectively. Asieris has taken several other steps to execute the commercialization strategy of its integrated diagnosis-to-treatment solutions: in April 2023, an Asieris subsidiary, Hainan Yahong Pharmaceutical Trading Co., Ltd., received a GSP Certificate from the Hainan Medical Products Administration; in August 2022, Asieris launched its Integrated Bladder Cancer Center (IBCC) in Hainan Province, China; it independently developed the "Miyihui" online, a doctor-service platform to integrate online disease management with offline, in-person clinical diagnosis and treatment services; and completed the core structure of its marketing and sales department, by hiring numerous managers to handle sales, marketing, commercial, market access, governmental affairs, medical affairs, and specific aspects of the integrated diagnosis-to-treatment strategy. Moving forward, as the company achieves product registration and go-to-market progress, it will recruit and supplement its marketing and sales team with those who are experienced in innovative drug and device products. Expanded the Company's R&D Capabilities, to Save Lives and Fulfill its Mission As part of its expansion and commercialization plans, Asieris continues to grow its R&D team and enhance its innovative capabilities. In 2022, the company expanded its R&D team from 104 to 176 personnel, an increase of nearly 70% more than the previous year. To further increase the in-depth R&D coverage – as well as strengthen its global competitiveness – the company expanded its R&D Center in Shanghai and broaden the scope of R&D across multiple core pipelines. Meanwhile, it established an innovation base in the Bay Area of California, which focuses on new targets and mechanistic research. The company is also building a clinical development team on the East Coast of the US, to accelerate its global R&D progress. Lastly, topping off all these achievements, in February 2023 the prestigious US magazine, Science, cited Asieris' role in saving a life. An American male patient was suffering from a rare "brain-eating" amoeba, when the University of California San Francisco (UCSF) reached out to Asieris for help. The amoeba, known as Balamuthia mandrillaris, is a very rare infectious pathogen of the central nervous system. Due to the lack of safe and effective treatments, the mortality rate of infected patients is reportedly as high as 90%. After screening thousands of compounds, a research team at UCSF and the Chan Zuckerberg Biohub discovered that nitroxoline was able to effectively fight Balamuthia. The UCSF team reached out to Asieris with an urgent request for assistance. Asieris immediately responded and shipped them APL-1202, its investigational drug for treating bladder cancer – which contains nitroxoline. APL-1202 went on to save this man's life. Such a meaningful contribution from Asieris also reflects the company's core values: to improve human health; bring greater dignity to the sick by developing impactful drugs; and fulfill its pledge to be a trusted partner in the healthcare industry. As Dr. Kevin Pan, the Founder, Chairman and CEO of Asieris Pharmaceuticals, summarizes it: "Over the past year, as we focus our efforts on meeting the unmet needs in diagnosing and treating GU tumors and other related diseases, we continue our stellar progress across product pipelines. While trying to expedite our global clinical development globally, we've steadily implemented our commercialization strategies and plans. Moving forward, we will continue to focus on the fields of our expertise; further expand and enrich our product pipeline; create a competitive portfolio that includes diagnostic and therapeutic products with cutting-edge technologies; and accelerate our development of these products to the market. Our mission is to not only benefit patients in China, but around the world." About Asieris Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally. View original content: SOURCE Asieris Company Codes: Shanghai:688176

SHANGHAI, Dec. 12, 2022 /PRNewswire/ -- Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the first patient enrolled in phase II clinical study of oral APL-1202 in combination with PD-1 inhibitor Tislelizumab as neoadjuvant therapy for muscular invasive bladder cancer (MIBC). This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients, to determine the recommended Phase 2 dose (RP2D), and to assess efficacy as neoadjuvant therapy for MIBC. The investigational new drug (IND) application was approved by the U.S. Food and Drug Administration (FDA) in June and the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in October 2021. The first patient was dosed in December of the same year. The trial completed the phase I dose-escalation trial and proceed to phase II in November 2022. APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in registration clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC. Tislelizumab is BeiGene's humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. The China National Medical Products Administration (NMPA) has approved Tislelizumab in nine indications and recently accepted a supplemental biologics application for tislelizumab in combination with chemotherapy as a first-line (1L) treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. Tislelizumab is the first investigational medicine from BeiGene's immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination.The global tislelizumab clinical development program includes more than 11,000 subjects enrolled to-date in 30 countries and regions. "APL-1202 in combination with Tislelizumab has shown a promising safety profile in the phase I stage of the clinical trial," commented Dr. John Zhuang, Chief Operation Officer at Asieris. "We will further explore the efficacy and safety of the combination in this phase II stage, and continue to make positive progress on the clinical development of the neoadjuvant therapy to address unmet medical needs and benefit more patients." About Asieris Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health and help people live more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs and adopts a forward-looking approach to product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally. SOURCE Asieris

With the American Society of Clinical Oncology (ASCO) Annual Meeting being held over the weekend, it was a hectic week for clinical trial news and updates. Here’s a look at just some of them. COVID-19-Related The National Institutes of Health (NIH) reported results from part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trial, specifically its ACTIVE-1 Immune Modulators clinical trial. The study found that both Bristol Myers Squibb’s Orencia (abatacept) and Johnson & Johnson's Remicade (infliximab) demonstrated a strong but not statistically significant improvement in time to recovery by the day of discharge from the hospital. This was the primary endpoint of the study. There were also substantial improvements in the trial’s key secondary endpoints of mortality and clinical status at 28 days. Non-COVID-19-Related Immutep presented new interim data from Part A of its Phase II TACTI-002 in first-line non-small cell lung cancer (NSCLC). The study is evaluating eftilagimod alpha in combination with Merck’s anti-PD-L1 checkpoint inhibitor Keytruda (pembrolizumab). Eftilagimod is a soluble LAG-3 protein. The drug combination demonstrated an improved overall response rate (ORR) of 37.3% in its intent to treat population and compared to 36.1% presented at last year’s ASCO meeting. Responses were seen in all PD-L1 subgroups with 32% ORR in patients with no or low PD-L1 levels, and the combination demonstrated an improved disease control rate of 73.3% compared to 66.7% at last year’s meeting. The company is also presenting an abstract for the design of its ongoing Phase IIb TACTI-003 trial at the meeting. That trial is evaluating the same drug combination as first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma. InxMed presented data from its Phase Ib trial of IN10018 in platinum-resistant recurrent ovarian cancer. The drug is an oral inhibitor of focal adhesion kinase. It was dosed with pegylated liposomal doxorubicin. Denali Therapeutics and Biogen initiated dosing on the Phase IIb LUMA trial of BIIB122 in early-stage Parkinson’s disease. BIIB122 is an investigational small molecule inhibitor of LRRK2 discovered and developed by Denali. Secarna Pharmaceuticals announced its partner Lipigon Pharmaceutical dosed the first patient in its Phase I trial of Lipisense. Lipisense is an antisense oligonucleotide for rare lipid-related diseases. PDS Biotechnology announced the expansion of its VERSATILE-002 trial of PDS0101 in combination with Merck’s Keytruda. PDS0101 is based on the company’s Versamune system and Infectimune T-cell activating technology platforms. Celltrion Healthcare presented post-hoc analysis of pivotal Phase III studies showing that the subcutaneous formulation of Remsima (infliximab) was associated with significantly greater clinical outcomes than IV formulation of the drug at week 30 in patients with rheumatoid arthritis. The drug is biosimilar to infliximab. Attgeno completed its Phase I trial of Supernitro for acute pulmonary hypertension. Supernitro is a potent substance that works by releasing NO in the pulmonary blood vessels. Attgeno also received the go-ahead in Sweden to initiate a Phase II trial of Supernitro for acute pulmonary hypertension after cardiac surgery. RhoVac AB reported that its RV001 (onilcamotide) failed to demonstrate its superiority over placebo in the Phase IIb BRaVac trial in prostate cancer and biochemical recurrence after curative therapy. RV001 stimulates the T-cells to spot and destroy cells that carry the RhoC protein. BioMarin Pharmaceutical announced updated results from its ongoing Phase I/II trial of valoctocogene roxaparvovec in severe hemophilia A. The drug is investigational gene therapy. Eureka Therapeutics and City of Hope treated the first patient with GPC3-positive advanced hepatocellular carcinoma (HCC) with ECT204, an experimental T cell therapy. The therapy targets ARTEMIS T cells. Horizon Therapeutics announced data from the Phase III trial of Uplizna in neuromyelitis optica spectrum disorder (NMOSD) patients with genetic variations. Uplizna is a highly specific CD19 B-cell depleting agent that targets an extended range of B cells. TScan Therapeutics received the go-ahead from the FDA to evaluate TSC-101 for hematologic malignancy patients undergoing allogeneic hematopoietic cell transplantation. TSC-101 targets the minor histocompatibility antigen HA-2. PolyPid completed enrollment in the Phase III SHIELD I study of D-PLEX100 for the prevention of surgical site infections in abdominal surgery. D-PLEX100 leverages Polymer-Lipid Encapsulation matrix (PLEX) technology with Active Pharmaceutical Ingredients for a prolonged and continuous release of the broad-spectrum antibiotic doxycycline. AffaMed Therapeutics dosed the first patient in its Phase I trial of AM712 for retinal diseases. The drug is a bispecific biologic molecule blocking both VEGF and Ang-2. BlueRock Therapeutics completed enrollment of its Phase I trial of pluripotent stem cell-derived dopaminergic neurons in Parkinson’s disease. The goal is to evaluate the safety, tolerability and preliminary efficacy of BRT-DA01. Antengene Corporation dosed the first patient in the Phase I STAMINA-001 trial of ATG-037 for patients with locally advanced or metastatic solid tumors. It is being tested alone and in combination with Merck’s Keytruda. ATG-037 is an oral small molecule CD73 inhibitor. Eledon Pharmaceuticals announced positive topline data from its Phase IIa trial of Tegoprubart for amyotrophic lateral sclerosis (ALS). The drug is a humanized monoclonal antibody that inhibits CD40 Ligand (CD40L). PAI Life Sciences dosed the first patient in a trial of SchistoShield, the company’s preventive vaccine against schistosomiasis. Schistosomiasis is caused by parasitic flatworms. Memo Therapeutics initiated a Phase I trial of MTX-005 against BK polyomavirus infection in renal transplant patients. The drug is a therapeutic antibody that neutralizes all strains of BKV at extremely low concentrations. Axsome Therapeutics published results from the pivotal Phase III GEMINI trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). It was published in The Journal of Clinical Psychiatry. The study demonstrated rapid, substantial and statistically significant improvement in depressive symptoms and induction of remission. The drug is an NMDA receptor antagonist, using a proprietary formulation and dose of dextromethorphan and bupropion. Sage Therapeutics and Biogen reported their Phase III SKYLARD study demonstrated promising results for women with severe postpartum depression. The trial evaluated zuranolone, an oral GAMA signaling pathway modulator. NeuroSense Therapeutics enrolled the first patient in its Phase IIB PARADIGM trial of PrimeC for amyotrophic lateral sclerosis (ALS). The drug is a novel, patented formulation of specific doses of two FDA-approved drugs, ciprofloxacin and celecoxib. ReAlta Life Sciences dosed the first patient in its Phase Ib inhaled lipopolysaccharide (LPS) challenge trial in support of RLS-0071 for severe asthma. RLS-0071 is a dual-action complement inhibitor and innate anti-inflammatory peptide in development for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases. NeoTX completed the first stage of a Simon 2 stage Phase IIa trial of naptumomab estafenatox (NAP) in combination with docetaxel in advanced non-small cell lung cancer (NSCLC) patients previously treated with chemotherapy and checkpoint inhibitors. NAP is a Tumor Targeted Superantigen (TTS) molecule; TTS binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating an expanding tumor specific immune cells that are redirected from the periphery to the tumor. Indivior enrolled the first patient in the Phase IIb trial of AEF0117 for moderate to severe cannabis use disorder. The drug is a first-in-class synthetic Signaling Specific Inhibitor. TauRx Pharmaceuticals announced unblinding of initial data from the completion of the randomized part of their Phase III LUCIDITY trial of HMTM for Alzheimer’s disease. Participants receiving the drug showed a substantially slower rate of decline. AbbVie presented full results from two studies from the Phase III SELECT-AXIS 2 program of Rinvoq (upadacitinib) in active non-radiographic axial spondylarthritis and patients with treatment-refractory active ankylosing spondylitis with an inadequate response to biologic disease-modifying antirheumatic drugs. Both studies hit the primary endpoints. AlgoTx received clearance from the FDA for a Phase II trial of ATX01 for chemotherapy-induced peripheral neuropathy. The trial will be in the pain of CIPN in adult cancer survivors. SynDevRx opened a Phase Ib/II trial of evexomostat in triple-negative breast cancer and baseline insulin resistance. The drug will be tested in combination with standard-of-care treatment Halaven (eribulin). Evexomostat binds irreversibly to MetAP2, triggering downstream improvements in the metabolic hormones insulin, leptin and adiponectin, regulation of key lipids, and inhibiting of the bFGF and VEGF-C. Dyve Biosciences presented data from the Phase II TARGETS study of DYV702 for pain associated with acute gout flares. DYV702 is a patented transdermal cream formulation of sodium bicarbonate. Trethera announced that the independent safety review committee unanimously recommends further trial advancement after reviewing favorable data from the Phase Ia dose escalation trial of TRE-515. The drug is a first-in-class deoxycytidine kinase inhibitor to treat solid tumors. Abivax published results from its Phase IIa trial of obefazimod for moderate to severe active rheumatoid arthritis. The drug has a novel mechanism of action based on the upregulation of a single, specific micro-RNA with anti-inflammatory properties called miR-124. Bristol Myers Squibb announced results from the primary analysis of the Phase II PILOT trial of Breyanzi (lisocabtagene maraleucel) in r/r large B-cell lymphoma after first-line therapy in patients who were not deemed candidates for high-dose chemotherapy and hematopoietic stem cell transplant. Breyanzi is a CAR-T therapy. Alterity Therapeutics initiated enrollment in its Phase II trial of ATH434 for Multiple System Atrophy. MSA is a rare neurodegenerative disease similar to Parkinson’s. ATH434 is engineered to decrease the toxic accumulation of alpha-synuclein and preserve nerve cells by restoring normal iron balance in the brain. Viracta Therapeutics announced that the Safety Monitoring Committee for its ongoing Phase Ib/II trial of Nana-val in patients with EBV+ solid tumors has approved advancing to the next dose level. Nana-val (nanatinostat and valganciclovir): nanatinostat is an oral histone deacetylase (HDAC) inhibitor being developed by Viracta. Valganciclovir is an antiviral agent. InVivo Therapeutics completed enrollment in the INSPIRE 2.0 Study for acute spinal cord injury patients. The trial is to evaluate the Neuro-Spinal Scaffold. MaaT Pharma announced the completion of its Phase Ib CIMON trial of MaaT033 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HRMS) having received intensive chemotherapy. The drug is a high-richness, high-diversity Microbiome Ecosystem Therapy (MET). VecctivBio dosed the first two patients in the Phase II STARGAZE trial of apraglutide in steroid-refractory gastrointestinal acute Graft-versus-Host Disease. The drug is a next-generation, long-acting GLP-2 analog. Vaxart reported positive preliminary data from its recently completed Phase Ib trial of its oral norovirus vaccine candidate in elderly adults. The data demonstrated a robust immune response across all doses. Braxia Scientific Corp. presented positive preliminary data from a Phase II trial of psilocybin-assisted therapy for treatment resistant depression. The data supported the feasibility of the company’s proprietary psilocybin-assisted therapy protocol with clinically meaningful improvements in depression severity. Cullinan Oncology presented updated data from its Phase I/IIa trial of CLN-081 in EGFR Exon 20 insertion mutation positive NSCLC. The drug is an orally available small molecule, next-generation, irreversible EGFR inhibitor. Biogen and Ionis Pharmaceuticals announced the Phase III VALOR trial results and an open-label extension (OLE) trial of tofersen for amyotrophic lateral sclerosis (ALS). Toferson is an antisense drug that binds to SOD1 messenger RNA (mRNA), helping it degrade by RNase-H, which decreases the synthesis of SOD1 protein production. Novo Nordisk announced results from two Phase IIIa trials of icodec, the company’s once-weekly insulin. It was non-inferior to Sanofi’s insulin glargine, Lantus. Acelyrin, Affibody and Inmagene Biopharmaceuticals reported positive Phase II data of izokibep in psoriatic arthritis. The drug appears to have better efficacy than current standard of care. Izokibep is an antibody mimetic, IL-17A inhibitor. Legend Biotech received clearance from the FDA for a Phase I trial of LB1908. The drug is an autologous CAR T-cell therapy targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with r/r gastric, esophageal or pancreatic cancers. Daiichi Sankyo presented data from a Phase I/II trial demonstrating patritumab deruxtecan demonstrated clinically meaningful and durable responses in two early-stage trials in previously treated patients with HER3 expressing metastatic breast cancer or advanced NSCLC without EGFR-activating mutations. The drug is a potential first-in-class HER3 directed antibody drug conjugate. Novocure and Zai Lab announced that their Phase II pilot study of Tumor Treating Fields (TTF) with standard-of-care as first-line treatment in gastric adenocarcinoma hit its primary endpoint of objective response rate with supportive signals across secondary endpoints. TTF is an investigational device for the treatment of gastric cancer, using electric fields that disrupt cancer cell division. OliX Pharmaceuticals completed patient enrollment in the Phase IIa trial of OLX101A. OLX101A is an investigational therapy for the treatment of hypertrophic scars. Incannex Healthcare announced positive data from the Phase II trial of IHL-42X for obstructive sleep apnea. The drug is a form of unique medical cannabis. Biogen and Bio-Thera Solutions presented positive Phase III data for BIIB800. The drug is a biosimilar candidate referencing Genentech’s Actemra/Roactemra (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. OncXerna Therapeutics presented new clinical data from an investigator-sponsored Phase II trial of bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients. Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor. Kazia presented positive final data from a Phase II trial of paxalisib in newly diagnosed GBM. The drug is a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway. PTC Therapeutics announced encouraging preliminary safety and efficacy data from its Phase Ib trial of unesbulin in advanced leiomyosarcoma (LMS) patients. The drug is an oral tubulin binding agent that arrests tumor cells in the G2/M phase, including cancer stem cells. The Janssen Pharmaceutical Companies of Johnson & Johnson announced primary data from the Phase III SHINE trial. It demonstrated that the combination of once-daily oral Umbruvica (ibrutinib) plus bendamustine-rituximab (BR) and rituximab maintenance significantly decreased the risk of disease progression or death by 25% in patients 65 years or older with newly diagnosed mantle cell lymphoma (MCL).