On June 7, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical stage company developing novel hydroxyl dendrimer therapeutics, reported a poster presentation of preclinical data demonstrating its hydroxyl dendrimer-based therapeutics reduce toxicity in targeted delivery to plexiform neurofibroma, a slow growing tumor associated with neurofibromatosis type 1 (NF1), at the 2022 Neurofibromatosis (NF) Conference hosted by the Children’s Tumor Foundation and taking place at Loews Philadelphia Hotel in Philadelphia, PA, June 18 – 21, 2022 (Press release, Ashvattha Therapeutics, JUN 7, 2022, View Source [SID1234615694]).

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Poster presentation details can be found below:

Title: Hydroxyl Dendrimer Therapeutics Reduce Toxicity in Targeted Delivery to Plexiform Neurofibroma
Presenter: Emma C. Mazurek
Date: Sunday, June 19, 2022
Time: 5:40 – 7:40 p.m. ET
Location: Loews Philadelphia Hotel, Millennium Hall, Second Floor

On June 7, 2022 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported the appointment of industry veteran Andrew S. Sandler, M.D., as its Chief Medical Officer (Press release, Alpine Immune Sciences, JUN 7, 2022, View Source [SID1234615693]). Dr. Sandler joins Alpine from Kiadis Pharma, a Sanofi Company, where he was Chief Medical Officer. Dr. Sandler’s anticipated start date is August 17, 2022.

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"We are very excited and fortunate to have Andy join the Alpine team. His appointment comes at a time where we are quickly advancing our three development programs across multiple oncology and autoimmune disease indications," said Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Andy is a highly experienced Chief Medical Officer with extensive clinical development expertise, and has a passion for developing novel therapies for patients with life-threatening and debilitating diseases."

"I am thrilled to join the Alpine team and continue to advance the clinical strategy and development of the company’s extremely promising pipeline, including acazicolcept, davoceticept, and ALPN-303," said Dr. Sandler. "I look forward to integrating with the development teams to continue to advance these exciting therapies that were built from Alpine’s directed evolution platform and have the potential to improve the lives of many patients."

Dr. Sandler brings over 25 years of industry and clinical practice experience. Prior to his role at Kiadis Pharma/Sanofi, Dr. Sandler was Senior Vice President of Medical Affairs at Medivation (Pfizer). Before that, Dr. Sandler held various roles including Chief Medical Officer, Executive Vice President, Research and Development, Seattle Site Head, and Senior Vice President, Clinical and Medical Affairs at Dendreon Pharmaceuticals. Earlier in his career, Dr. Sandler was Chief Medical Officer at Spectrum Pharmaceuticals and Vice President and Head of Global Medical Affairs for Oncology at Bayer Healthcare Pharmaceuticals. Dr. Sandler also previously held various positions at Berlex Oncology/Schering AG and Seattle Genetics, Inc.

Dr. Sandler holds a B.S. degree in Neuroscience from the University of Rochester. He obtained his M.D. degree and completed his residency in Internal Medicine at Mount Sinai Medical Center, followed by a fellowship in Hematology/Oncology at the University of California, San Francisco. Dr. Sandler also holds a Certificate in Epidemiology and Biostatistics.

On June 7, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a focus on immuno-oncology, reported it has entered into a sponsored research agreement (SRA) with Principal Investigator James W. Welsh, M.D. of The University of Texas MD Anderson Cancer Center (Press release, Kiromic, JUN 7, 2022, View Source [SID1234615692]).

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Under the two-year SRA, in vivo preclinical data will be generated from Kiromic’s Gamma Delta T cell (GDT) allogeneic therapies. This SRA is intended to evaluate efficacy and patient safety outcomes to support three new investigational drug (IND) applications to the U.S. Food and Drug Administration (FDA).

"We believe that the SRA will enable us to generate key in vivo data efficiently and swiftly that will demonstrate the synergistic advantages of our Gamma Delta T cell therapies in combination with existing anticancer treatment modalities. These submissions will expand the total number of our product candidate therapies to five. The first of these three new IND submissions – the Deltacel – is expected to be submitted during the second half of the year," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Importantly, we expect to begin the activation of the Deltacel clinical trial by the end of this year. We believe utilizing non-genetically engineered Gamma Delta T cells as our first-in-human study is ideal to establish the tolerability and safety of our proprietary allogeneic cell therapy platform."

In addition to Deltacel/KB-GDT – Kiromic’s non-engineered Gamma Delta T cells that are expanded, enriched and activated through a proprietary method – the second IND is expected to focus on Procel/KB-PD1, a genetically engineered product candidate targeting PD-L1+ tumors. The third IND is expected to focus on Isocel/KB-ISO, a genetically engineered product candidate targeting mesothelin isoform 2+ tumors. This isoform of mesothelin is a tumor-specific target identified by Kiromic’s proprietary DIAMOND AI bioinformatics platform.

The SRA and the anticipated filing of the three IND applications described above will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials as follows:

Deltacel in combination with a standard antitumor modality
Procel in combination with a standard antitumor modality
Isocel in combination with a standard antitumor modality
Procel as monotherapy
Isocel as monotherapy

On June 7, 2022 R-Biopharm AG, a leading German biotechnology company operating on a global scale, reported the acquisition of AusDiagnostics (Press release, R-Biopharm, JUN 7, 2022, View Source [SID1234615691]). R-Biopharm is expanding its product portfolio with the addition of the Australian specialist and manufacturer of molecular biology multiplex diagnostics, extraction reagents, and laboratory automation equipment. The company is thereby unlocking new market segments in clinical diagnostics and continuing on its path of steady internationalization. "The existing and future molecular biology multiplex analysis platforms for syndrome testing from system supplier AusDiagnostics broadens our molecular biology expertise and perfectly complements our present clinical diagnostics portfolio," states Christian Dreher, CEO of R-Biopharm. "The acquisition strengthens our position as a reliable partner for system solutions and offers our customers additional options for diagnostics."

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Upon its establishment in 2006, the Australian company introduced its patented Multiplex Tandem PCR (MT-PCR) on the market. The current technology allows the simultaneous detection of up to 24 pathogens or resistance genes from a single sample, thus shortening the lengthy test procedure in human and animal diagnostics as well as environmental, agricultural, and food analysis. The analysis platform is used in laboratories and hospitals throughout the world for detecting a broad range of diseases.

AusDiagnostics CEO Scott Gilroy said that the transaction marked an exciting new chapter for the company: "Both AusDiagnostics and R-Biopharm AG share the same commitment to innovation in the biotechnology space. This acquisition strengthens AusDiagnostics and will accelerate our global presence. We’ve experienced tremendous, industry-leading growth over the past two years, which has been underpinned by our broad suite of innovative products, talented team, and incredible, loyal customers. Joining the R-Biopharm group will allow us to further build on this and continue to deliver exceptional products and service for our Australian and international customers."

AusDiagnostics currently has 92 employees with offices in New Zealand, the USA, and Great Britain. Its production facilities in Australia and Great Britain supply a steadily growing network of more than 25 distributors and partners around the world – from which R-Biopharm expects further synergy effects for production as well as international service and support in its clinical diagnostics line.

On June 7, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, and MigVax, an Israeli biopharmaceutical company developing an oral subunit vaccine against COVID-19, reported that they have signed a development agreement to leverage Catalent’s proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine (Press release, Catalent, JUN 7, 2022, https://www.catalent.com/catalent-news/catalent-and-migvax-sign-agreement-to-develop-an-orally-disintegrating-freeze-dried-tablet-vaccine-against-covid-19/ [SID1234615689]).

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MigVax’s lead oral vaccine program, MigVax-101, has shown positive results in preclinical tests, and in November 2021. As an oral formulation, MigVax-101 could offer significant potential advantages in low-and middle-income countries over today’s first-generation injected vaccines, including ease of administration, transport and storage, the potential to tackle future variants, and applicability to a broader population. In addition, MigVax’s oral approach may allow for mucosal protection, a benefit that may prove important in preventing infection.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, and is recognized as one of the world’s best-performing ODTs, offering multiple advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience. Utilizing the Zydis ODT technology, Catalent’s innovative Zydis Bio facilitates the oral delivery of macromolecules. Under the terms of the agreement, Catalent will undertake a feasibility study to formulate MigVax-101 into a Zydis Bio ODT dose form and evaluate its preclinical performance and stability properties. Work will be carried out at Catalent’s Zydis facility in Swindon, U.K.

"We are excited to collaborate with Catalent to simplify the transportation, storage and administration of our MigVax oral Covid-19 vaccine," commented Mr. Ran Amir, MigVax’s CEO. "Once our vaccine can be transported using the Zydis Bio technology, in unrefrigerated vehicles and stored in standard warehouses, it will be much easier and cost-effective for countries everywhere to roll out mass-vaccination programs. We believe this is a major step forward that will help society cope with the viruses in our midst as we continue returning to the ‘new normal’."

"Zydis Bio technology offers numerous potential benefits to this program, and has previously been used to successfully deliver antigens to the oral mucosae," commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. He added, "In addition, the ease of administration and the potential for removal of the need for cold chain storage and transport means that the oral vaccine would have significantly fewer restrictions in terms of global distribution, compared with current cold chain injectable vaccines."

Catalent’s 250,000-square-foot site in Swindon, U.K., houses the company’s Zydis development and manufacturing operation, which produces over one billion ODTs annually.