Therapeutic DeliveryVol. 13, No. 1 Industry NewsFree AccessIndustry news update covering September 2021Elaine HarrisElaine Harris *Author for correspondence: E-mail Address: Elaine.Harris@TuDublin.iehttps://orcid.org/0000-0003-1538-9947School of Chemical & Pharmaceutical Science, Technological University Dublin, IrelandSearch for more papers by this authorPublished Online:7 Dec 2021https://doi.org/10.4155/tde-2021-0078AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Company newsWindgap Medical have successful investment funding roundWindgap Medical, Inc. (MA, USA) announced on 7 September that it has successfully completed initial closing of over $17 million of series B-1 equity financing round of investment. A second close targeting a further $15 million of investment is due to complete by the end of the year.Windgap is developing and commercializing proprietary wet/dry autoinjector platforms, ANDI®. It is claimed that this novel delivery platform is capable of facilitating a more stable, table-resistant delivery option for existing and novel therapeutics. The first ANDI product will be epinephrine for use in the treatment of anaphylaxis with a commercial partner the Danish-based company, ALK-ABELLÓ [1].IME Medical Electrospinning announces name change to VIVOLTAIME Medical Electrospinning (Leiden, The Netherlands) announced on 7 September that it was changing its name to VIVOLTA. The company had initially started as a spin out from the Technical University Eindhoven, and its focus has now evolved from high-tech equipment builder to a MedTech company.Vivolta’s proprietary electrospinning technologies allow for the production of nanofibers that can act as a drug delivery platform for controlled and localized delivery of active therapeutics through resorbable nanofiber-based implants. At an early stage of development, the company believes that this technology is particularly suitable for the local delivery of pain medication [2].Locate bio closes £10 million funding roundIt was announced on 3 September by Nottingham-based company Locate Bio (Nottingham, UK) that it had closed its £10 million funding round. Locate Bio is developing three orthobiologic platform technologies addressing the repair and regeneration of both bone and cartilage. One of their platforms, CognitOss, is an antibiotic loaded tissue scaffold used for the treatment of osteomyelitis. The antibiotic has dual release properties, initially to clear the infection and then an extended-release profile to prevent reoccurrence.Announcing the closing of the funding round, Locate Bio’s CEO John von Benecke stated:“This investment round is truly transformational for Locate Bio and I would like to thank Mercia for their continued support and collaboration and to welcome BGF. We are developing a suite of promising next-generation orthobiologics products that have the potential to disrupt the market and bring significant benefits to patients with debilitating conditions. Following our spin out from The University of Nottingham’s internationally recognized School of Pharmacy, we bring the strength of controlled drug delivery, to the principally medical device field of orthopedics. We have continued to make good progress in our strategy of building a world leading, diversified orthobiologics business, which has resulted in this oversubscribed funding round. This financing will allow us to further develop our exciting portfolio of differentiated products as we embark on our next phase of growth” [3].Nanoform receives funding to solve challenges for global healthNanoform (Helsinki, Finland) – the Helsinki-based company particle engineering company – announced on 29 September that it had received funding from the Bill and Melinda Gates Foundation for proof of concept studies for its CESS® platform technology. The Controlled Expansion of Supercritical Solutions (CESS) process was initially developed in 2012 at the University of Helsinki and the spin out company Nanoform was established in 2015. The patented technology allows for creation of API nanoparticles directly from solution with controlled particle size, shape and polymorphism.Announcing the award of the funding the COO of Nanoform, Christian Jones, commented: “Our goal is to improve the lives of over 1 billion patients. We are delighted to receive this funding from the Gates Foundation to evaluate how our proprietary CESS platform can help more novel therapies reach patients who need them. Too many medicines suffer from poor solubility and bioavailability and never make it to market, not to mention the challenge many patients have in accessing medicines globally. By applying Nanoform’s innovative technologies and multidisciplinary expertise we strive to unlock many new therapies for patients going forward” [4].Drug delivery company Acino acquired by ADQIt was announced on 16 September that the Swiss-based pharmaceutical manufacturer, Acino (Zurich, Switzerland), was acquired by the UAE holding company ADQ (Abu Dhabi, UAE). Acino has an existing platform of proprietary drug delivery technologies and specializes in modified release oral and oral dispersible dosage forms. Acino has an interest in many emerging markets including the Middle East, Africa and Latin America.By acquiring Acino, ADQ intends to develop an integrated pharma platform with capabilities in areas such as formulation development, in-licensing, manufacturing and commercialization. This acquisition represents ADQs largest single investment in the pharmaceutical/healthcare sector to date [5].Collaborations & agreementsImpel NeuroPharma partners with Phil Inc. for novel treatment for migraineThe San Francisco based company Phil, Inc. (CA, USA) announced on 29 September a partnership with Impel NeuroPharma, Inc. (WA, USA) to offer patient support and distribution services for Impel’s proprietary nasal spray Trudhesa™ (dihydroergotamine mesylate). Trudhesa is indicated (in adults) for the acute treatment of migraine with or without aura and employs the Precision Olfactory Delivery (POD®) Technology to facilitate rapid delivery of the active via upper nasal delivery.Trudhesa is the company’s lead product and its pipeline also includes therapeutics targeting the CNS via this delivery option; INP105 (olanzapine) and levodopa/carbidopa [6].Bio-Thera & Intract to collaborate on oral antibody medicine programBio-Thera Solutions, Ltd (Guangzhou, China) and Intract Pharma (London, UK) announced a global collaboration and licensing agreement on 27 September. Under the terms of the agreement Bio-Thera will gain access to Intract’s Soteria® and Phloral® colonic-targeting drug delivery technologies to develop novel oral monoclonal antibody therapeutics. Soteria is Intract’s proprietary technology that facilitates the formulation of monoclonal antibodies, as tablet or capsule. In addition to the gastro protective properties of the capsule or tablet, a dual action enhancer in the core then protects the active therapeutic from enzymatic degradation and also enhances its colonic delivery.Intract has granted Bio-Thera a worldwide license to its oral biologics drug delivery platform for an undisclosed monoclonal antibody product and Bio-Thera will have the option to expand the collaboration for additional therapeutics and indications. Under the terms of this agreement Intract will lead the preclinical phase of the collaboration [7].Vect-Horus & MDimune establish a CNS drug delivery collaborationSouth Korean biotech company MDimune (Seoul, Republic of Korea) and Vect-Horus (Marseille, France) – a spin out company from Aix Marseille University – disclosed on 7 September that they had agreed terms of a collaboration to facilitate drug delivery strategies to enhance transport across the blood–brain barrier transport. The collaborative research agreement will allow MDimjune’s cell-derived vesicles technology, BioDrone® to be combined with Vect-Horus’ proprietary vector technologies, VECTrans®, to target the delivery of CNS drugs across the blood–brain barrier.Announcing the collaboration, Seung Wook Oh, Chief Scientific Officer of MDimune, stated “we are thrilled to launch this collaboration with Vect-Horus. Joining two innovative technologies will not only facilitate the entry of our CDVs into the brain, but also help overcome the most critical barrier in the CNS drug development” [8].Approvals & regulatory updatesJanssen announces approval for long acting Schizophrenia treatmentIt was announced on 1 September by the Janssen Pharmaceutical Companies of Johnson & Johnson (NJ, USA) that the US FDA had approved its long-acting therapeutic for the treatment of schizophrenia in adults, Invega Hafyera™. This approval adds to the company’s portfolio of extended-release injectable products for the treatment of schizophrenia including Risperdal Consta®, Invega Sustenna® and Invega Trinza®.Discussing the results of Phase III trials results and subsequent approval of Invega Hafyera, Gustavo Alva, M.D., Medical Director at ATP Clinical Research (CA, USA) and 6-month paliperidone palmitate clinical trial investigator said; “For too long, we have accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes. The Phase III trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence” [9].RenovoRx receives new 510(k) clearance for RenovoCath® delivery system for targeted treatment of solid tumorsThe Californian-based company RenovoRx (CA, USA) announced on 7 September that it had received a 510(k) clearance from the FDA for its RenovoCath Delivery System. This proprietary delivery system forms the device component of RenovoGem™, a novel drug/device combination used in RenovoRx’s Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform. This platform consists of a dual-balloon infusion catheter and has been designed for arterial delivery of chemotherapeutic agents direct to tumors.In announcing the clearance Shaun Bagai, Chief Executive Officer at RenovoRx, stated “Our novel RenovoTAMP therapy platform isolates the region of disease enabling delivery of the optimal dose of targeted chemotherapy to the tumor location. We believe this new design cleared through the FDA 510(k) process will further improve RenovoTAMP’s targeted delivery. Our focus is maximizing patient survival while minimizing side effects for cancer patients” [10].Clinical trialsOramed's Phase II oral insulin nonalcoholic steatohepatitis trial reaches over 50% enrolmentThe New-York based oral drug delivery company, Oramed (NY, USA), announced on 15 September that it had completed over 50% of the enrolment for the Phase II clinical trial for its oral insulin capsule ORMD-0801 for the treatment of nonalcoholic steatohepatitis (NASH). Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.ORMD-0801 employs Oramed’s proprietary a novel protein oral delivery (POD™) technology and, if the trials are successfully completed, it could become the first commercially launched oral capsule for the delivery of insulin in the treatment of diabetes. Additionally, Oramed is developing an oral glucagon-like peptide-1 analog capsule, ORMD-0901, which is at an earlier stage of clinical development [11].TriSalus commences clinical trial for treatment of uveal melanoma liver metastasesIt was announced by TriSalus Life Sciences (CO, USA), on 7 September that it had enrolled its first patient for the PERIO-01 clinical trial investigating treatment of uveal melanoma liver metastases. The trail will involve the delivery of SD-101, a Toll-like receptor 9 agonist via the proprietary pressure-enable drug delivery approach, which allows for administration of the therapeutic intravascularly directly into visceral organ solid tumors. It is claimed that proprietary pressure-enable drug delivery technology allows for the creation of a high-pressure gradient that improves delivery and penetration of therapy into tumors.Discussing the initiation of the trial, Mary Szela, President and CEO of TriSalus, stated; “Tumor-directed delivery of therapeutics is an exciting opportunity to help improve outcomes across a wider range of procedures by overcoming intratumoral pressure that can prevent drugs from adequately penetrating the tumor. The new TriNav Infusion System utilizes SmartValve™, a first-in-kind, proprietary technology that has been shown to modulate pressure and flow with the goal for improved therapeutic delivery and deeper penetration into the tumor while helping to protect healthy tissue” [12,13].It was announced on 2 September by R3 Vascular Inc. (CA, USA) that they had initiated their first-in-human study on their novel bioresorbable, sirolimus-eluting scaffold (Magnitude BRS) for the treatment of critical limb ischemia due to occlusive below-the-knee arterial disease.The platform technology is one which employs both an innovative scaffold design and bioresorbable polymer technology, and the company claims that this leads to biomechanical performance that is comparable with that offered by metallic stents.The investigational device that is to be studied in this trial is intended to restore blood flow to the limb affected by CLI and provide symptomatic relief to the patient, as well as to reduce the risk of limb amputation [14].Early stage developmentChlorambucil-Iron oxide nanoparticles employed as a drug delivery system for leukemia cancer cellsA paper was published on 8 September in the International Journal of Neuromedicine entitled ‘Chlorambucil-iron oxide nanoparticles as a drug delivery system for leukemia cancer cells’. The paper, authored by Hussein-AlAli et al., described the preparation of iron-oxide nanoparticles (IONPs) that were loaded with chlorambucil via an ionic gelation method. A release study of the drug loaded nanoparticle composite indicated a pseudo second order release profile for the IONPs studied. The authors reported that the IC50 of the IONPs against WEHI cancer cells (leukemia cell lines) was indicative of possible therapeutic application while maintaining good biocompatibility with 3T3 normal cell lines [15].AFYX presents pre-clinical work on mucoadhesive patch for the delivery of antibodiesAFYX Therapeutics (Copenhagen, Denmark) presented data on 7 September that described preclinical studies it carried out in collaboration with the University of Sheffield (Sheffield, UK) delivering antibody fragments directly to inflamed tissue in mucosal diseases using the company’s Rivelin® patch technology. The study indicated that anti-TNF-α antibody fragments could be delivered to the oral mucosa.These preclinical studies compliment work ongoing with the company’s lead candidate – Rivelin clobetasol for the treatment of oral lichen planus – which is in Phase II clinical trials. The company’s proprietary oral mucosal delivery platform is based on an electrospinning manufacturing process, which produces a highly porous micro/nanomaterial to act as the scaffold for the mucoadhesive patch [16].Self-assembling drug delivery system for local anestheticsAn article in Nature Biomedical Engineering published on 13 September entitled ‘Delivery of local anesthetics by a self-assembled supramolecular system mimicking their interactions with a sodium channel’ describes the design of a synthetic receptor for a particular family of anesthetic drugs that can act as both a delivery and release system. This class of drugs, site-1 sodium channel blockers, are highly potent and have a narrow therapeutic window that can be modified by developing a controlled release delivery vehicle. The researchers modified two sodium channel peptides with hydrophobic domains so that they assembled into nanofibers. These self-assembled nanofibers form with the two peptides positioned together, mimicking the way they are positioned on the sodium channel, thus providing a delivery vehicle for the anesthetic drugs that improves their bioavailability and modifies their release.The authors anticipate that this novel encapsulation method may find applicability as a broader platform for the development of systems that rely on receptor–drug interactions [17].Nanoform technology delivers successful results for Herantis cerebral dopamine neurotrophic factor drug candidateNanoform Finland Plc (Helsinki, Finland) announced on 9 September that it had completed a successful proof-of-concept study in collaboration with Herantis Pharma Plc (Espoo, Finland). The study focused on applying Nanoform’s proprietary nanoforming process to Herantis’ recombinant cerebral dopamine neurotrophic factor (rhCDNF) drug candidate. The study was designed to assess Nanoform’s platform technology to enhance the delivery of Herantis’ candidate for the treatment of Parkinson’s disease, rhCDNF, via an intranasal delivery route.The company has reported that the rhCDNF protein remains stable during the formulation process and that initial testing revealed that it retained its structure, function and efficacy. It is now proposed that the project move to the next stage – termed a proof-of-process study – with the stated aims of further refining the size and shape of the rhCDNF nanoparticles and to optimize the formulation and evaluate biodistribution following intranasal delivery [18].Verve Therapeutics announce positive preclinical data for their novel delivery technologyVerve Therapeutics (MA, USA) announced positive in vivo data on 23 September concerning its proprietary lipid nanoparticle delivery platform (LNP). This technology relies on the use of a novel ligand which targets the amino acid sugar N-acetylgalactosamine (GalNAc) to facilitate delivery of base editors to the liver in mouse models of homozygous familial hypercholesterolemia. This model can be used to test therapeutics for the treatment of one type of atherosclerotic cardiovascular disease. The approach Verve is taking is to formulate the lipid nanoparticles to encapsulate both the mRNA that encodes for a gene or base editor and a guide RNA which is capable of targeting the gene of interest expressed in the liver. Following the successful completion of the lead optimization stage, the company intends to initiate IND-enabling studies in 2022.Speaking at the announcement of these positive early-stage results, Andrew Bellinger, MD, PhD, chief scientific officer of Verve said: ‘Our goal at Verve is to transform the future treatment of cardiovascular disease by creating single-course gene editing treatments, with lead programs that leverage base editors to turn off disease-driving genes in the liver. In some patient populations, such as homozygous familial hypercholesterolemia, using LNPs for delivery of base editors is not possible, requiring the need for an alternative delivery approach to treat these patients. To address this, we have designed and developed a proprietary GalNAc-LNP to enable efficient and potent liver editing regardless of LDLR expression. We are very excited to share findings leveraging this delivery approach, which may allow us to reach patients who lack LDLR and may be applicable in other populations where liver-targeted delivery is advantageous’ [19].PatentsICBII announce 7th patent on their blood–brain barrier permeable technologyThe notice of allowance for a 7th patent on their blood–brain barrier permeable technology was disclosed by Innovative California Biosciences International, Inc. (CA, USA) on 22 September. The company claims that this patent will further strengthen its SMART* Molecules technology platform. SMART* is the acronym the company has chosen for trans–blood brain barrier delivery platform and stands for ‘Specific Molecular Architecture for Recognition and Therapy’.Announcing the issuance of the patent, Ram Bhatt, Founder and Chief Scientist of ICBII said: ‘With efficient brain uptake, SMART molecules have cleared up to 66% of aggregated amyloid-beta and alpha-synuclein with once weekly, low dose injections over 8–12 weeks in animal models of Alzheimer’s and Parkinson’s diseases, respectively. This provides ICBII scientists with the necessary tools to potentially cure otherwise incurable brain disorders and improve debilitation of patients afflicted by diseases such as Alzheimer’s, Parkinson’s, multiple system atrophy and glioblastoma.”The company claims their SMART molecule platform design enables a tailored approach for new therapies for a broad range of complex diseases that includes diseases of the CNS, the treatment of various cancers and age-related macular degeneration [20].Starpharma announce granting of a new patent for their therapeutic delivery platformOn 15 September the pharmaceutical company Starpharma (Melbourne, Australia) announced the issuance of new composition of matter patent by the United States Patent and Trademark Office (USPTO).US11,118,016 entitled ‘Therapeutic dendrimer’ discloses novel dendrimers comprising of ‘a core unit, five generations of building units which are lysine residues or analogues; thereof, first terminal groups comprising a cabazitazel residue covalently attached to a diglycolyl linker group and second terminal groups comprising a PEG group.’Disclosing the granting of this new patent Starpharma CEO, Dr Jackie Fairley, commented: ‘The grant of this new US patent illustrates the unique and compelling benefits of Starpharma’s DEP® drug delivery technology and DEP cabazitaxel.’Starpharma’s proprietary DEP drug delivery platform utilizes nanoparticulate technology to produce formulations with increased bioavailability and lower toxicity. Their lead candidate is DEP cabazitaxel, proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana®) and it is currently in Phase II clinical trials for a number of solid tumour cancer types [21].SummarySeptember 2021 saw a number of companies with a therapeutic delivery focus announce positive funding news including Windgap, Nanoform and Locate Bio. This month also saw approvals for a number of enhanced delivery therapeutics including Janssen’s, Invega Hafyera and RenovoRx’s RenovoCath. Collaborations announced this month included Impel NeuroPharma with Phil Inc. and Vect-Horus and MDimune.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.