On June 16, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, and the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU) reported an agreement to initiate a collaborative Phase 2 clinical study evaluating sotigalimab, Apexigen’s monoclonal antibody targeting CD40, in combination therapy for patients with recurrent BRCA wild type ovarian cancer. Sotigalimab, Apexigen’s lead immuno-oncology therapeutic candidate, is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability (Press release, Apexigen, JUN 16, 2021, View Source [SID1234590990]).

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"We are excited to collaborate with the NSGO-CTU and ENGOT, premier organizations with tremendous experience conducting gynaecological oncology clinical trials," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. "The poor survival in advanced ovarian cancer is due both to late diagnosis as well as a lack of effective second-line therapy. Robust preclinical and early clinical data underscore the utility of next-generation immune-modulating therapies, such as sotigalimab. We believe combining sotigalimab treatment with chemotherapy or chemotherapy plus radiation shows promise in offering new therapeutic options for patients with recurrent BRCA wild type ovarian cancer. We’re fortunate to have the opportunity to explore these combinations with the NSGO-CTU and ENGOT as we continue to address the greatest outstanding challenges in oncology."

"Our purpose at the NSGO-CTU and ENGOT is to improve management options in gynaecological cancer indications by conducting and coordinating clinical trial efforts across countries," added Mansoor Raza Mirza, M.D., Medical Director of the NSGO-CTU and Chair of ENGOT. "The evaluation of sotigalimab, a novel and promising agent, in this Phase 2 randomized study is an important next step to improve the standard of care for patients with ovarian cancer. We look forward to working with Apexigen to reach our mutual goal."

About Sotigalimab (APX005M)
Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. Sotigalimab targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of sotigalimab to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. Sotigalimab is currently in Phase 2 clinical development for the treatment of cancers such as esophageal and gastroesophageal junction cancers, melanoma, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for sotigalimab can be found at www.clinicaltrials.gov.

On June 16, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that G1’s Chief Executive Officer Jack Bailey will participate in the 2021 Raymond James Human Health Innovation Conference. The fireside chat will take place on June 22nd at 9:20 AM EDT (Press release, G1 Therapeutics, JUN 16, 2021, View Source [SID1234587573]). This meeting is being held virtually, and a live webcast will be accessible on the Events & Presentations page of View Source

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On June 16, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported the acquisition of the remaining 22 percent of shares outstanding in its Founded Entity, Alivio Therapeutics ("Alivio") (Press release, PureTech Health, JUN 16, 2021, View Source [SID1234584766]). Alivio’s therapeutic candidates, in development for inflammatory disorders including inflammatory bowel disease (IBD), will be integrated into the Company’s Wholly Owned Pipeline.

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The acquisition aligns with PureTech’s strategy to advance a Wholly Owned Pipeline designed to harness key immunological, fibrotic and lymphatic system mechanisms to treat serious diseases with significant unmet needs. The programs and the underlying AlivioTM technology platform are expected to be funded by PureTech as well as through partnerships and grants. The integration of this program is in line with the budget for PureTech, which extends into the first quarter of 2025, as previously guided.

"PureTech founded Alivio alongside leading scientists Jeffrey Karp, Ph.D., Professor of Medicine at Brigham and Women’s Hospital and Robert Langer, Sc.D., David H. Koch Institute Professor at MIT to pioneer a novel strategy to more effectively treat inflammatory disorders through highly targeted immunomodulation at the site of disease. This promising approach fits well within our Wholly Owned Pipeline and we will be able to leverage our strength in immunology and related technologies as we progress therapeutic candidates to potentially treat inflammatory diseases," said Daphne Zohar, Founder and Chief Executive Officer of PureTech. "We’re pleased to add the Alivio programs to our pipeline and proud to advance a platform that we hope will bring new therapeutic options to millions of people with chronic and life-limiting autoimmune and inflammatory diseases."

The Wholly Owned Pipeline will include the addition of LYT-500, an orally-administered therapeutic candidate in development for the treatment of IBD. Utilizing the Alivio technology platform, LYT-500 consists of two active agents intended to selectively act at the inflamed tissues while reducing their impact on the normal tissue. LYT-500 contains a unique combination of IL-22 and an anti-inflammatory drug, which is designed to address the two key underlying causes of IBD pathogenesis and progression, namely mucosal barrier disruption and inflammation.

Existing biologic therapies indicated for IBD must be provided through multiple injections over time and are associated with several limitations including loss of efficacy over time and increased risk for opportunistic infections. Using the Alivio technology platform, a biologic agent and small molecule drug can be combined into a single oral dosage form that offers the potential for enhancing the treatment of inflamed tissues to maximize efficacy, while reducing systemic exposure to minimize toxicity. Unlike other therapies in development for IBD, LYT-500 has the potential to provide an oral drug therapy that targets multiple mechanisms of disease pathogenesis, while reducing the potential for systemic side effects.

The integration also includes the addition of therapeutic candidate, LYT-503/IMB-150, to the Company’s pipeline, which is being developed in collaboration with Imbrium Therapeutics as a potential non-opioid treatment for interstitial cystitis or bladder pain syndrome (IC/BPS). An IND filing for LYT-503/IMB-150 is expected in 2021. PureTech will also continue to evaluate existing and additional anti-inflammatory programs leveraging the Alivio platform technology.

PureTech’s Wholly Owned Pipeline also includes three clinical-stage programs: LYT-100, a selectively deuterated form of pirfenidone that has demonstrated anti‑inflammatory and anti-fibrotic activity and is being advanced for idiopathic pulmonary fibrosis and potentially other PF-ILDs, where registration-enabling studies are being planned and is currently being evaluated in a Phase 2 trial to treat respiratory complications and related sequelae of Long COVID as well as a Phase 2a proof-of-concept study in patients with breast cancer-related, upper limb secondary lymphedema; and LYT-200, a monoclonal antibody targeting immuno-suppressive galactin-9, which is in a Phase 1 trial for metastatic solid tumors. PureTech’s Wholly Owned Pipeline also includes LYT-300 an oral version of allopregnanolone (a natural neurosteroid), developed using PureTech’s proprietary Glyph platform, and several other discovery platforms leveraging the company’s expertise in lymphatic targeting.

The consideration for the acquisition of the minority interests in Alivio consist of a closing cash payment and potential future cash payments upon successful achievement of certain milestones. The transaction is a small transaction for the purposes of Annex 1 of Listing Rule 11 and smaller than a class 2 transaction for the purposes of Listing Rule 10.

On June 16, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will present at the Raymond James Human Health Innovation Conference, taking place virtually from June 21 – 23, 2021(Press release, Mustang Bio, JUN 16, 2021, View Source [SID1234584089]). The company will present on Wednesday, June 23, 2021, at 8:00 a.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s presentation will be available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting.

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On June 16, 2021 Kytopen, a transformative biotechnology company offering non-viral delivery that links the discovery, development and manufacturing of engineered cell therapies, reported it was awarded a SBIR Fast Track grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH) (Press release, US NIH, JUN 16, 2021, View Source [SID1234584087]). Kytopen is eligible for up to $2M over the course of the 3-year award as project milestones are successfully completed within the Phase I and Phase II portions of the grant.
Natural killer (NK) cells represent a high impact population for cell therapy, but due to limitations in current methodologies for gene delivery, NK cells remain a largely untapped resource. This SBIR grant will be used to demonstrate that non-viral delivery via Kytopen’s Flowfect platform can alleviate this limitation on NK cell gene editing at both research and manufacturing scale, which is needed for pre-clinical and clinical studies. Due to the major potential impact NK cells represent in a clinical setting, non-viral Cas Ribonucleoprotein (RNP) gene knockout will allow for novel therapeutic applications in infectious disease, autoimmune disorders, and immuno-oncology.
Paulo Garcia, Kytopen’s CEO and Co-Founder will serve as the Principal Investigator (PI) on the grant. Dr. Garcia explains that "engineered NK cells have tremendous therapeutic promise including the potential to treat solid tumors in an allogeneic modality. The Flowfect platform will facilitate high-throughput target discovery while providing a clear path towards clinical manufacturing of next-generation cell products."
NK cells are a subset of innate immune cells that can respond to threat without antibody priming. This quick response to stimuli makes them an ideal immunotherapy candidate. Yet, genetic modification in NK cells has proven to be difficult using conventional viral and non-viral transfection methodologies. Alternative delivery methods are necessary in order to make genetic modifications at reproducible and efficient rates, while maintaining high cell viability and functionality.
The awarded study leverages continuous fluid flow coupled with low energy electric fields for transfection via a proprietary Flowfect platform (Figure 1). This platform represents a novel approach to non-viral delivery in historically "hard-to-transfect" human cells. The current research proposes to engineer non-activated NK cells with Cas RNPs for gene editing using the Flowfect platform. To achieve this goal, Kytopen has outlined a two-phase research strategy which focuses on stability and functionality of edited NK cells both in vitro and in vivo.
NIH sponsored grant programs are an integral source of capital for early-stage U.S. small businesses that are creating innovative technologies to improve human health. These programs help small businesses break into the federal research and development arena, create life-saving technologies, and stimulate economic growth. Kytopen is honored to be a recipient of this competitive award from the NIH/NIAID and looks forward to unlocking biological capabilities of engineered NK cells for improving patients’ lives during the performance of this project.

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About the Flowfect Technology
Kytopen’s proprietary Flowfect platform eliminates the complexity of gene editing and integrates discovery, development and manufacturing in one flexible and scalable non-viral delivery solution. The Flowfect technology utilizes electro-mechanical energy to disrupt the cell membrane and introduce genetic material (such as RNA, DNA, or CRISPR/Cas RNP) to a wide variety of hard-to-transfect primary cells. During the Flowfect process, a solution containing cells and genetic payload suspended in a proprietary buffer flows continuously through a channel while the solution is exposed to a low energy electric field. Due to the continuous flow and low electrical energy required, cells engineered using Flowfect exhibit high viability while also exhibiting high transfection efficiency post-processing. The Flowfect technology utilizes relatively high flow rates enabling cell engineering in minutes for discovery and optimization (e.g. 96 well plate in <10 minutes) and direct scale up to manufacturing volumes of >10mL, engineering over 2 billion cells per minute in a single channel.