Acetazolamide/Dronabinol

MELBOURNE, Australia, July 27, 2022 /PRNewswire/ -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), ('Incannex' or the 'Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 June 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration ('FDA') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals. Cannabinoid IHL-42X: positive phase 2a clinical trial results in patients with obstructive sleep apnoea In June 2022, Incannex announced positive results from full analysis of its phase 2 clinical trial on the effect of IHL-42X to treat patients with obstructive sleep apnoea ('OSA'). IHL-42X is a proprietary cannabinoid combination drug comprised of tetrahydrocannabinol ('THC') and acetazolamide. The clinical trial assessed IHL-42X at reducing the apnoea hypopnea index ('AHI') in patients with OSA. Data was also collected for other aspects of sleep quality, THC clearance (relevant to vehicle operation) and safety. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, participants attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety. The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital. Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses. Low dose IHL-42X reduced AHI in trial participants by an average of 50.7%, compared to baseline, with 25% of participants experiencing a reduction in AHI of greater that 80%. Oxygen desaturation index was reduced by an average of 59.7%, relative to baseline, which improved patient sleep quality and reduced cardiovascular stress. In low dose IHL-42X samples, THC blood concentrations were well below the limits for impaired driving the morning after dose administration. Importantly, IHL-42X was well tolerated with low dose IHL-42X observed to have a lower number of total treatment emergent adverse events than placebo. The Company considers the trial results to be a major success and step forward to provide confidence for further assessment in pivotal studies necessary for drug registration. During the quarter, Incannex sought advice from FDA on the Company's long term clinical trial development plan. Following liaison with FDA, the next steps for the development of IHL-42X includes the finalisation of clinical trial designs and arrangement of operational imperatives necessary to open an investigational new drug application ('IND') with FDA. Cannabinoid IHL-216A: neuroprotective cannabinoid combination drug inhaled post-concussion or traumatic brain injury ('TBI') IHL-216A combines cannabidiol ('CBD') with a volatile anaesthetic agent (isoflurane) and has been developed by Incannex to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits. During the quarter, Incannex announced that IHL-216A was observed to have a strong neuroprotective effect in a widely known model of sports concussion. The pre-clinical study compared IHL-216A to its component drugs, CBD and isoflurane, in a rodent model of sports concussion that was developed in collaboration with the US National Football League (NFL) to accurately represent the type of brain injury that occurs in sports related concussion. The study compared six groups of twenty-four rodents. Animals were tested in a Y-maze activity, which measures spatial memory by determining the animal's ability to discriminate between a novel (new) and familiar arm. After 24 hours, injured animals treated with IHL-216A were found to have no difference in a discrimination index compared to sham ('uninjured') animals (mean difference= 0.0598, p=0.5855). In contrast, and after 24 hours, the discrimination index was significantly reduced for injured animals treated with either the vehicle for the active pharmaceutical ingredient or isoflurane alone, compared to uninjured animals (mean diff=0.2704, p=0.0498 and mean diff=0.3095, p=0.0245 respectively). The group treated with CBD alone demonstrated intermediate performance after 24 hours. These findings indicate that the defect in spatial memory observed at 1 day post injury is restored in animals treated with IHL-216A. The findings from this study further support the protective effect of IHL-216A in concussion and traumatic brain injury and expands upon the initial animal study conducted by Incannex in 2020, the results of which were released on the 15th of December 2020 in the announcement titled, "Positive results from IHL-216A TBI/concussion study". The Incannex scientific team is targeting a pre-IND meeting with FDA in Q3 2022 to discuss the Company's intention to conduct an expedited clinical trial program required for a new drug application and marketing approval. IHL-216A drug formulation development required for in-human studies is also nearing a conclusion following an extensive research and development process commenced in June 2021. Due to the product's potential therapeutic utility in contact sports, IHL-216A is designed to satisfy World Antidoping Authority (WADA) and Australian Anti-Doping Authority's (ASADA) specifications for use by athletes at risk of TBI and Chronic Traumatic Encephalopathy, otherwise known as CTE. Cannabinoid IHL-675A: multi-use drug candidate with observed to outperform CBD in multiple preclinical models of inflammation During the quarter, Incannex continued preparatory activities for its phase 1 clinical trial to assess IHL-675A soft gel capsules. The aims of the study are to demonstrate that there are no, or minimal, additional side effects associated with the combination of CBD and hydroxychloroquine ('HCQ') compared to each drug alone and that the uptake and metabolism (pharmacokinetics) of the two drugs do not materially interfere with one another. FDA pre-IND guidance was sought and received following six distinct in vitro and in vivo studies using established disease models relevant to inflammatory disorders. In each of these models, IHL-675A outperformed CBD in supressing inflammation, indicating a wide scope of applications to potentially disrupt the CBD market. Subsequent to the end of the June quarter, Incannex received approval from the Human Research Ethics Committee (HREC) to commence a phase 1 clinical trial investigating IHL-675A in humans for the first time. Extensive formulation development work to manufacture IHL-675A gel capsules has been completed and the first batch of product has been manufactured for the trial. Subject to clinical success, the results of the phase 1 clinical trial will form part of three FDA IND applications for each of the initial three indications the Company is pursuing for IHL-675A. Patient recruitment is anticipated to begin in August 2022. Psychedelic therapies: psilocybin and psychotherapy for generalised anxiety disorder ("Psi-GAD") During the June 2022 quarter, the Psi-GAD phase 2a clinical trial led by Dr Paul Liknaitzky at Monash University ('Monash') continued at pace. The aim of the trial is to assess participants with severe generalised anxiety disorder following the administration of psilocybin and specialised psychotherapy sessions. Importantly, the trial protocol and development plan incorporate a range of treatment innovations currently unseen in the field of psychedelic therapy and has been discussed with FDA officials in a pre-IND meeting undertaken in the December quarter of 2021. Primary outcomes from the trial are safety, efficacy and tolerability, and secondary outcomes are assessments of quality of life, functional impairment, and comorbidities. A preliminary analysis of patient data will be conducted by an independent data safety monitoring board after 30 patients have completed primary endpoint assessment. This preliminary analysis will allow the trial investigators to inform the second part of the trial (n=42) and/or the follow-up pivotal phase 2b clinical trial that Incannex is actively planning. 22 participants are enrolled in the trial and the remaining 8 participants are anticipated to be enrolled during the current quarter. Principal investigator of the trial, Dr Paul Liknaitzky said; "Operationally, the trial is proceeding as smoothly as we could have hoped from the outset. We're currently undertaking three dosage sessions per week, which is the fastest pace of operation for any psychedelic trial in the world". Psychedelic therapies: virtual reality ('VR') exposure response therapy ('ERP') and psychedelics During the March 2022 quarter, Incannex executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment in combination with a psychedelic drug treatment. The VR therapy has been established by BrainPark, a state-of-the-art clinical research platform at the Monash Turner Institute for Brain and Mental Health. Incannex intends to combine the VR ERP therapy tool with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders. The associated research and development will be led by Dr Paul Liknaitzky at Monash, a highly reputable, globally recognised, and innovative university that ranked #40 in the world in the US News and World Report 2022. Incannex and Monash are in advanced stages of discussion in relation to a research agreement for the clinical trials required to develop the new treatment form. The initial clinical trial will assess optimal dose, safety, and tolerability of the treatment method. Corporate Activity: Acquisition of APIRx Pharmaceuticals USA, LLC In May 2022, Incannex announced that it completed a binding share sale and purchase agreement to acquire 100% of the issued share capital in APIRx Pharmaceuticals USA, LLC ('APIRx'). The stakeholders in APIRx ('Sellers') will be issued a total of 218,169,506 new shares at a value of A$0.573 per share to satisfy the purchase of APIRx, which represents the price agreed at the signing of the binding terms sheet announced on March 24, 2022. Approval to issue the shares to the APIRX sellers in consideration for the acquisition of APIRx was sought and approved at a meeting of shareholders on June 9, 2022. 99.27% of voting shareholders approved the issue of shares to the sellers. Legal transfer of the APIRx group of companies to Incannex is currently being facilitated so that the group of companies sit within a wholly owned subsidiary of Incannex. Thereafter, development plans associated with assets from the APIRx acquisition may be appropriately initiated and formalised by Incannex. The acquisition of APIRx presents Incannex with both long and short-term opportunities for significant value growth. APIRx has twenty-two (22) active clinical and pre-clinical research and development projects underpinned by an intellectual property portfolio that includes 19 granted patents and 23 pending patents. It holds a diverse portfolio of promising therapeutic candidates targeted at treating an extensive range of conditions including pain disorders, addiction disorders, mental illnesses, gastrointestinal diseases, gum disease, skin conditions and ophthalmic conditions. The initial priority drug candidates from for Incannex are: Medchew Dronabinol for chemotherapy induced nausea and vomiting Medchew Rx for pain and spasticity in multiple sclerosis CanQuit and CanQuitO – patented chewing gums that combine nicotine and cannabinoids and cannabinoids and opioid antagonists for smoking cessation and opioid addiction respectively CheWell – patented high-bioavailability CBD chewable tablet or chewing gum for the over-the-counter market. Corporate Activity During the quarter, Incannex completed a short-dated option program to raise a total of A$23.6M at an exercise price of A$0.35 per share. The options expired on April 22, 2022, and a total of 67.3M new shares were issued. For every two (2) new shares that were issued as a result of the program, one (1) piggy-back option was granted to participants. Piggy-back options have an exercise price of A$1.00 (equivalent to approx. US$17.25 per ADR on NASDAQ), expiring April 28, 2023. A total of 33.7M piggy-back options were issued. At June 30, 2022, Incannex recorded A$37.5M in cash at bank. A$1.83M was recorded as cash outflows associated with research and development activities. Notably, Incannex is eligible to receive an annual cash rebate equivalent to approximately 43.5% of all monies spent on research and development in Australia. Incannex shares trade in Australia on the ASX under stock code "IHL". Incannex American Depository Shares (ADSs) also trade on the NASDAQ under code "IXHL". Each IXHL ADS represents 25 ordinary shares of the Company. Item 6.1 of Appendix 4C (below) represents amounts paid to directors and related parties. About Incannex Healthcare Limited Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Website: Investors: [email protected] Forward-looking statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release. Contact Information Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 [email protected] US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 [email protected] Compliance statement This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. This statement gives a true and fair view of the matters disclosed. Date: ...............27 July 2022................................................ Authorised by: ...............By the Board................................................ (Name of body or officer authorising release – see note 4) Notes SOURCE Incannex Healthcare Limited

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).