PHARMACY MARKET

Aizon Launches GxP AI Bioreactor Application for the Pharma Industry

Aizon | February 02, 2021

Aizon launches its Bioreactor Application, the pharma industry's first predictive analysis and profound knowledge management application. The Aizon Bioreactor Application adds the bioreactor process to the "Smart Manufacturing" transformation that is accelerating across the Pharma and Biotech industry. Aizon is extraordinarily able to achieve GxP compliance and give an audit trail from the start of the process. The turnkey application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to identify and accurately anticipate deviations and results potentially leading to countless dollars in expense savings, diminished danger, and additional income potential gain.

Intended to work with both persistent and took care of batch bioreactors, the Aizon Bioreactor Application gives a profound understanding of the client's bioprocess manufacturing lifecycle. The application leverages specialized Edge AI and contextualization, which is a prerequisite to make the data actionable. Contextualized data is harnessed, analyzed, and visualized through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.

AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application. “It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyze complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimize bioreactor processes in commercial manufacturing.”

Aizon’s CEO, John Vitalie adds, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialization of their digital solutions. We see that this is key for pharma and biotech to realize the vision of smart manufacturing and accelerate their progress toward realizing the promise of the adaptive plant.”

About Aizon
Aizon is an enterprise software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within Pharma and other highly regulated industries. The Aizon AI platform and native GxP based applications seamlessly integrate unlimited sources of structured and unstructured data to deliver actionable, real-time insights across all manufacturing sites. Aizon brings deep domain expertise and works closely with Global System Integrators and technology partners to provide enterprise solutions to customers.

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PHARMA TECH

Advaxis and Ayala Pharmaceuticals Enter into Merger Agreement

Advaxis and Ayala Pharmaceuticals | October 20, 2022

Ayala Pharmaceuticals, Inc. a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers and Advaxis, Inc. a biotechnology company devoted to the discovery, development and commercialization of immunotherapies based on a technology which uses engineered Listeria monocytogenes, today announced that they have entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors and Advaxis’s candidate ADXS-504 in development for prostate cancer. Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, said, “Advaxis took a thorough approach in our quest to find the right partner with the right products. This merger is expected to enhance Advaxis’s portfolio of clinical assets, with Ayala’s proprietary gamma secretase inhibitors that are being developed as targeted therapies for rare and aggressive tumors. Ayala’s lead candidate, AL102, is currently being investigated in the Phase 2/3 RINGSIDE study in desmoid tumors, which we believe will accelerate the stage of product development for the combined company dramatically. We are particularly excited about very promising interim data from RINGSIDE, which showed that AL102 monotherapy had meaningful anti-tumor activity with tumor shrinkage in the majority of patients that appeared to be deepening over time. The combined management team has extensive commercial and R&D experience, and we believe we have the cash to advance the combined portfolio through key milestones in 2023, including longerterm data from Part A of RINGSIDE, clarity on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (ACC) and initial clinical and PSA data from the Phase 1 trial of ADXS-504 in prostate cancer. We believe that this transaction will also help drive our efforts to return to a Nasdaq listing and enhance our ability to access capital.” “We are pleased to announce the proposed merger with Advaxis, which is expected to provide our pipeline and AL102 with additional financial resources as well as additional infrastructure in the U.S. The two companies have a shared mission to develop innovative therapies to improve the lives of patients with cancer and I believe we have found a good partner to advance our pipeline and create value for our stakeholders.” Roni Mamluk, Ph.D., President and Chief Executive Officer of Ayala Consummation of the merger is subject to certain closing conditions, including, among other things, approval by the stockholders of Ayala. At the closing of the merger, Ayala will be delisted from The Nasdaq Global Market. The combined company’s common stock is expected to begin trading on the OTCQX at the effective time of the merger, subject to Advaxis’ planned efforts to have the stock of the combined company listed on Nasdaq, as to which no assurances can be made. About Ayala Pharmaceuticals, Inc. Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicting, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors, including adenoid cystic carcinoma and desmoid tumors. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 portion of a pivotal study for patients with desmoid tumors. AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC bearing Notch activating mutations. About Advaxis, Inc. Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These off-the-shelf immunotherapies are a significant advancement in immunotherapy as they integrate multiple functions into a single therapy by directing antigen presenting cells to stimulate T-cells and other components of the immune system, while reducing tumor protection in the tumor microenvironment, facilitating the elimination of tumors. The company has two programs in the clinic: ADXS-503 for late-stage lung cancer and ADXS-504 for early-stage prostate cancer.

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PHARMACY MARKET

Eyenovia's Novel Optejet® Dispenser Puts People's Eyes First

Eyenovia | September 06, 2022

Eyenovia, Inc. an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics, brings human-centric design to ophthalmology with its novel Optejet® dispenser. Traditional eye drops normally overdose the patient's eye with medication and preservatives. Eyenovia's easy-to-use, novel Optejet® dispenser administers precisely 8µL of medication to the eye, effectively treating the patient's condition while creating a more gentle dosing experience. "The unique delivery mechanism of the Optejet® will fundamentally change how we think about eye medication. Right now, traditional eye drops can result in significant dose-related side effects for the treatment of chronic illnesses like glaucoma. The Optejet® dispenser is designed for patients to experience easier administration and fewer side effects with similar efficacy." Michael Rowe, CEO of Eyenovia The Optejet® dispenser administers ophthalmic solutions horizontally using Eyenovia's proprietary Microdose Array Print (MAP™) technology. The system functions similar to an inkjet printer, delivering accurate microdoses through a precision spray. Traditional eye drops deliver four to five times larger volume than the human eye can actually hold, which causes eye drops to roll down the face and overdose the eye with preservatives. Poor delivery of eye drops is more than an inconvenience; it can prevent patients from using necessary medication because of the side effects. For example, with medication to help dilate the pupils for eye exams, up to 23% of patients experienced stinging and burning with the eye drops, causing patients to forgo eye exams. In Eyenovia studies, less than 1% of patients experienced stinging and burning. "Medications only work if patients take them, and with the Optejet, we have designed a way for patients to benefit from an easy-to-use, appropriate, lower dose spray that results in similar efficacy. We're excited for physicians and providers to be able to offer this revolutionary technology in the near future to patients who deserve a more positive experience," said Rowe. Eyenovia's first marketed invention is expected to be MydCombi™, a first-in-class drug-device combination microdose for in-office pupil dilation. This potentially will help save physician's chair time, eliminating the traditional three eyedrops used for a patient's eye exam. Other exciting innovations in the Eyenovia pipeline include MicroLine and MicroPine. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

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BUSINESS INSIGHTS

Anokion Announces $35 Million Equity Investment from Pfizer

Anokion | October 19, 2022

Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance announced that Pfizer has made a $35 million equity investment in Anokion through the Pfizer Breakthrough Growth Initiative. In conjunction with the investment, Michael Vincent, M.D., Ph.D., senior vice president and chief scientific officer, Inflammation & Immunology, Pfizer, has joined the company’s scientific advisory board, which will be announced later this year, and Allison Kean, M.D., executive director, Worldwide Business Development, Pfizer has joined Anokion’s board of directors as an observer. Separately, Anokion and Pfizer have entered into an agreement to leverage Pfizer’s development expertise and capabilities in support of the continued clinical development of KAN-101, Anokion’s lead candidate for the treatment of individuals with celiac disease. “We are excited about these agreements with Pfizer as they provide us with important resources and expertise to advance our KAN-101 clinical program and our earlier-stage pipeline. People living with autoimmune diseases like celiac disease need additional treatment options, and we are excited to work with Pfizer to potentially develop these utilizing our immune tolerance platform. We also look forward to leveraging Pfizer’s insights and capabilities in support of our Phase 2 clinical program in patients with celiac disease.” Deborah Geraghty, Ph.D., chief executive officer of Anokion “We believe Anokion has a unique opportunity to develop potential durable and disease-modifying treatment options for people with celiac disease and other immune-mediated disorders, and we look forward to supporting them in the continued development of KAN-101,” said Dr. Vincent. “The agreements announced today are yet another example of our commitment to collaborating with biotechs to accelerate compelling external science that could lead to true breakthroughs for patients.” Anokion intends to use a portion of the proceeds to fund its Phase 2 clinical program of KAN-101 for the treatment of individuals with celiac disease, a serious autoimmune disorder triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. Data from Anokion’s Phase 1 ACeD study (Assessment of KAN-101 in Celiac Disease) were presented at Digestive Disease Week (DDW) 2022, showing that treatment with KAN-101 was safe and tolerated, reduced T cell responses following gluten challenge, and demonstrated a dose-dependent inhibition of gluten-induced serum IL-2 (interleukin-2), a key disease biomarker that may correlate with the timing and severity of symptoms after gluten exposure in celiac disease. Based on favorable findings, Anokion is preparing to initiate patient dosing in a Phase 2 clinical trial in the second half of 2022, supported by Pfizer. About KAN-101 KAN-101 is an investigational therapy being evaluated as a treatment for individuals with celiac disease, a serious autoimmune disease triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. KAN-101 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of celiac disease. About Anokion Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease.

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