On June 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that company management will present its corporate highlights at the Jefferies Healthcare Conference, June 8, 2022 with a presentation at 11:00 a.m. ET in New York, NY (Press release, Gamida Cell, JUN 1, 2022, View Source [SID1234615367]).

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Management will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.

A webcast of the event will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.

About Omidubicel

Omidubicel is an advanced cell therapy candidate under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for the second quarter of 2022. In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant.1 Unfortunately it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 Omidubicel has the opportunity, upon FDA approval to improve outcomes for patients based on transplanter feedback and increase access for patients to get to transplant. Omidubicel has the potential to treat approximately 2000 – 2500 patients each year in the U.S. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the E.U.5 and U.S. which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

On June 1, 2022 SOPHiA GENETICS (Nasdaq: SOPH), a leader in data-driven medicine, reported three abstracts accepted for poster presentation and one for online publication at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7 in Chicago (Press release, Sophia Genetics, JUN 1, 2022, View Source [SID1234615383]). SOPHiA GENETICS and GE Healthcare will also be hosting an Innovation Symposium on Monday, June 6th from 6:30 – 8:00 pm to present how the companies are working together to deliver on the promise of integrated cancer medicine by bringing global insights across multiple diagnostic modalities to clinical and biopharma customers.

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"These high-impact ASCO (Free ASCO Whitepaper) contributions from SOPHiA GENETICS and collaborators demonstrate how our multimodal technology and solutions help drive novel insights and enhance oncology discoveries," said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS. "By utilizing our data-driven medicine approach and by applying our AI and machine learning algorithms to real-world multimodal data sets, SOPHiA GENETICS has the potential to help inform treatment decisions at the individual patient level for cancer patients globally. I am really excited to attend ASCO (Free ASCO Whitepaper) to share how our mission to democratize data-driven medicine is helping transform cancer care."

An overview of the four accepted SOPHiA GENETICS abstracts at ASCO (Free ASCO Whitepaper) 2022 are included below. The full abstracts will be published in the Meeting Proceedings, an online supplement of the Journal of Clinical Oncology.

Individualized prediction of post-surgical pathologic T3a (pT3a) upstaging risk in localized renal tumors undergoing nephrectomy (UroCCR 15 study) (Abstract # 4547, Poster # 38)
Overview: UroCCR is a French national network of 37 multidisciplinary teams for kidney cancer management that collects longitudinal data on the routine clinical care of its patients. For the study, a retrospective cohort of 4,395 cases of clinical T1-T2 kidney tumors was analyzed. The study suggests that machine learning applied to pre-surgical multimodal data can predict the risk of pT3a upstaging of a localized kidney tumor and inform long-term outcomes at the individual patient level. The results have been validated on an external cohort of 1,759 patients with data from the clinical routine.
This abstract has been accepted for poster presentation in the "Genitourinary Cancer-Kidney and Bladder" session on June 4, 2022, 13:15-16:15 CDT.
Multimodal machine learning model prediction of complete pathological response to neoadjuvant chemotherapy in triple-negative breast cancer (Abstract # 601, Poster # 372)
Overview: Triple negative breast cancer (TNBC) is a biologically and clinically heterogenous disease, associated with poorer outcomes when compared with other subtypes of breast cancer. A retrospective cohort of 57 patients with early-stage TNBC treated with neoadjuvant chemotherapy was analyzed. The study suggests that machine learning applied to baseline multi-modal data can help predict pCR status after neoadjuvant chemotherapy for TNBC at the individual patient level, as well as stratify patients to inform long-term outcomes. Patients that would be predicted as non-pCR could benefit from concomitant treatment with immunotherapy, or dose intensification.
This abstract has been accepted for poster presentation in the "Breast Cancer-Local/Regional/Adjuvant" session on June 6, 2022, 08:00-11:00 CDT.
Multimodal prediction of response to neoadjuvant nivolumab and chemotherapy for surgically resectable stage IIIA non-small cell lung cancer (Abstract # 8542, Poster # 169)
Overview: The NADIM trial (NCT03081689), led by the Spanish Lung Cancer Group, assessed the antitumor activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC. This study is, to our knowledge, the first to offer a multimodal analysis of the response to neoadjuvant treatment for surgically resectable stage IIIANSCLC and is a proof of concept that a machine learning algorithm can be used to predict the pCR in this context. These preliminary results are being confirmed in the ongoing NADIM II trial (NCT03838159).
This abstract has been accepted for poster presentation in the "Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers" session on June 6, 2022, 08:00-11:00 CDT.
Multimodal machine learning model prediction of "individual" response to immunotherapy in 1L stage IV NSCLC (Abstract # e21151)
Overview: Immunotherapy (IO) is the standard of care in 1L stage IV non-small cell lung cancer (NSCLC) cases that are not eligible for targeted therapies. A retrospective 1-year cohort of 63 patients with advanced NSCLC, PD-L1 expression > 50%, and treated with 1L pembrolizumab monotherapy was analyzed. This proof-of-concept study suggests that machine learning applied to baseline multi-modal data can help predict response to IO at the individual patient level, as well as stratify patients to inform long-term outcomes. This algorithm is being improved and validated through a large real-world multicentric international observational study including more than 4000 patients (DEEP-Lung-IV study, NCT04994795).
This abstract has been accepted for online publication

On June 1, 2022 (the "Effective Date"), Akoya Biosciences, Inc. (the "Company") reported that entered into an Amendment No. 2 (the "Amendment") to Credit and Security Agreement, with the lenders party thereto and MidCap Financial Trust, as agent, in order to provide the Company an additional tranche of non-dilutive funding and allow the Company to draw the second tranche (Filing, 8-K, Akoya Biosciences, JUN 1, 2022, View Source [SID1234615484]). The Amendment provides that the second tranche of $10,000,000 will be drawn on June 1, 2022. Additionally, the Amendment provides the Company with a third tranche pursuant to which the Company may draw $10,000,000 any time after September 30, 2022 until September 30, 2023. The Amendment also delays the amortization start dates for the outstanding loan amounts from November 1, 2023 until April 1, 2025, at which point the Company will repay the principal amounts in seven equal monthly installments until the maturity date. Finally, the Amendment amended the interest rate payable on the term loan to apply an interest rate equal to the SOFR rate (with a floor of 1.61448%) plus 6.35%. Substantially all other terms and conditions, and covenants of the credit agreement remain unchanged. In connection with the Amendment, the Company agreed to pay the lenders a $75,000 commitment fee as well as a 0.25% fee upon the funding of each of the second tranche and third tranche amounts.

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On May 31, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported the acquisition of a targeted nanobody platform to its Discovery pipeline (Press release, Clarity Pharmaceuticals, MAY 31, 2022, View Source [SID1234615238]). The intellectual property, including a provisional patent and know-how, has been acquired from leading nanotechnology researcher Dr Kurt Gehlsen, who developed the technology for a maximum consideration of 400,000 options over Clarity Pharmaceuticals shares with a strike price of $1.40 together with cash consideration of up to US$250,000. Both the cash consideration and options are subject to certain provisions that relate to the achievement of development milestones for new products. In addition, Dr Gehlsen has joined the Company as a consultant to help drive the new nanobody program forward within Clarity.

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Nanobodies are attractive targeting molecules which can be engineered to bind to a wide range of cancers. The nanobody platform allows the development of high affinity products suitable for targeting receptors specific to cancer cells. By only targeting cancer cells and not healthy cells, this approach aims to kill cancer cells while limiting the side effects elsewhere in the body.

The nanobody platform adds exciting new opportunities to Clarity’s Targeted Copper Theranostics (TCTs) Discovery pipeline. Dr Gehlsen will work with Clarity’s R&D team to combine the platform with the Company’s proprietary SAR Technology and advance it from the lab, through preclinical studies and into clinical development.

Dr Gehlsen commented, "Clarity’s proprietary SAR Technology is ideally positioned to fully exploit the benefits of the nanobody platform. In combination with copper-64 for imaging and copper-67 for therapy, we are hoping to achieve high accuracy and high precision of the nanobody-based targeted radiopharmaceuticals for the diagnosis and treatment of a range of cancers. I look forward to working together with the Clarity team on progressing this technology through the preclinical studies and into clinical development".

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Clarity has always built its TCT products from the ground up, and the addition of targeted theranostic (diagnostic and therapeutic) nanobodies directed to novel cancer targets in combination with our proprietary SAR Technology is a logical step for our platform. The introduction of the nanobody platform solidifies Clarity as a pioneering developer of next-generation radiopharmaceuticals and will launch a new class of Targeted Copper Theranostics to our development pipeline, aiming to make the safest and most effective treatments to address unmet clinical needs in the large oncology market in a scalable and sustainable manner. We are excited to now have additional capability to develop further cutting-edge theranostics with Dr Gehlsen’s nanobody platform and streamline their development into clinical trials."

Dr Gehlsen’s academic experience is focused on cancer research and he held positions as an Associate Professor at the Sidney Kimmel Cancer Center, as an Associate Staff Scientist at the California Institute for Biological Research and as Founder, Vice President (VP) and Chief Operating Officer at the La Jolla Institute for Experimental Medicine. Dr Gehlsen has published over 140 manuscripts, book chapters and meeting abstracts and has over 100 patents and patent applications.

Previously, he was VP and Chief Scientific Officer (CSO) at Research Corporation Technologies, Inc. (RCT) Tucson, AZ., an investment and development company focused on early-stage technologies in the life sciences. He was Senior VP, Development and CSO at Maxim Pharmaceuticals, a public biopharmaceutical company that developed and launched Ceplene, the first immune counter-suppression therapeutic as a remission maintenance therapy for acute myeloid leukaemia. Dr Gehlsen was also Director of Research in the Experimental Medicine Division of Pharmacia, AB., Sweden, and La Jolla, CA, and was a Postdoctoral Fellow and Research Associate at the Sanford Prebys Burnham Institute.

This announcement has been authorised for release by the Executive Chairman.

On May 31, 2022 Fresenius reported that PEMEtrexed for injection, a drug used to treat adult patients with lung cancer and malignant pleural mesothelioma, is now available from Fresenius Kabi in the United States (Press release, Fresenius, MAY 31, 2022, View Source [SID1234615260]). This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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