On April 25, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported that Dr. Cheng Liu, President and CEO, to participate in person at the PEGS Boston Conference and Expo at Hynes Convention Center on May 2-6, 2022 (Press release, Eureka Therapeutics, APR 25, 2022, View Source [SID1234612926]).

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Dr. Liu will be participating in two engagements. He will be hosting a roundtable discussion on the challenges and opportunities of targeting intracellular antigens and presenting Eureka’s approach of using TCR-mimic antibodies to target intracellular antigens, both in the Oncology Stream – Antibodies for Cancer Therapy Track.

On April 25, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report first quarter financial results on Thursday, April 28, 2022, at 8:30 a.m. ET (Press release, GlycoMimetics, APR 25, 2022, View Source [SID1234612894]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The dial-in number for the conference call is (844) 413-7154 for domestic participants or (216) 562-0466 for international participants, with participant code 1068226. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers are able to connect.

A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1068226.

On April 26, 2022 Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported that the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company’s Investigational New Drug (IND) application to begin its pivotal Phase 2b/3 study of mocravimod (named MO-TRANS) (Press release, Priothera, APR 25, 2022, View Source [SID1234612910]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Priothera will initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult Acute Myeloid Leukemia (AML) patients undergoing allogenic hematopoietic stem cell transplant (HSCT). The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Allogenic stem cell transplantation is the only potentially curative approach for AML patients, however current treatment options are still associated with a high number of side effects, and high mortality rates.

Florent Gros, Co-Founder and CEO of Priothera, commented "The FDA IND clearance to initiate the MO-TRANS study assessing mocravimod in AML patients undergoing allogeneic HSCT is another major milestone for Priothera. We are on track to initiate this pivotal Phase 2b/3 clinical trial and are looking forward to working alongside a large team of enthusiastic investigators across the US, Europe and Asia, who share our goal of bringing mocravimod to patients as an adjunctive and maintenance treatment for AML and potentially other hematologic malignancies."

About Mocravimod
Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogenic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogenic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

On April 25, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported that updated infection data on omidubicel in comparison to umbilical cord blood transplantation (UCB), was shared in an oral presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022 (Press release, Gamida Cell, APR 25, 2022, View Source [SID1234612927]).

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The presentation, which received a TCT Best Abstract Award, titled "Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation," was presented by Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA. The data from a sub-study of the Phase 3 randomized trial of omidubicel showed early and enhanced recovery of variety of immune cells, including circulatory dendritic cell subtypes, NK cells and CD4+ T cells within the first 28 days and sustained B-cell recovery from Day 28 onwards, and such immune recovery was associated with lower rates of severe infection. The data from an additional analyses of CD4+ subsets, T-cell receptor repertoire diversity and recent thymic emigrants support the long-term durability and functionality of the omidubicel graft.

"These data provide mechanistic support for the reduced infection rates seen with omidubicel-treated patients in the Phase 3 study, and clear demonstration of the benefits of omidubicel over standard cord blood transplantation, which can be associated with immune and hematopoietic recovery challenges that are devastating to patients," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "As we advance omidubicel through the FDA review process, these data demonstrate that the therapy has the potential to change the outlook for patients suffering from blood cancer, who all too often struggle with post-transplant recovery complications."

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.

In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022. All poster presentations are publicly available at www.ASTCT.org.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.

Omidubicel 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 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 are able to enhance, 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. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.

On 25 April 2022 Epitopea, a transatlantic cancer immunotherapeutics company and global leader in exploiting a new class of untapped tumour-specific antigens (TSAs), reported a $13.6M (£10.3M) seed investment from a transatlantic syndicate of top-tier life sciences investors, including Advent Life Sciences, CTI Life Sciences, Cambridge Innovation Capital (CIC) and Fonds de solidarité FTQ (Press release, Epitopea, APR 25, 2022, View Source [SID1234632198]). The seed round was also supported by Novateur Ventures and the Harrington Discovery Institute/University Health Holdings. The funding will leverage Epitopea’s ground-breaking CryptigenTM approach to create transformational immunotherapies that target broad cancer patient populations in both solid and haematological cancers.

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The company’s proprietary technology provides an innovative approach to identifying shared, aberrantly expressed tumour specific antigens, known as CryptigensTM, that it has exclusively licensed from the Université de Montréal (UdeM). The licensing deal was catalysed by IRICoR, a Canadian Centre of Excellence in Commercialization and Research, which supported and incubated the development of the technology. CryptigenTM TSAs are uniquely and broadly presented across cancer types, providing tumour-specific targets for immunotherapies that are predicted to kill malignant cells while sparing non-cancerous cells, potentially delivering significant therapeutic benefit across broad patient populations with minimal side effects.

The seed round funding will be used to build the company’s executive team, advance further research on this new class of antigens, and catalyse their translation into novel cancer immunotherapeutics, including therapeutic vaccines, cell therapies, and TCR-based biologics.

Dr Jon Moore, CEO, Epitopea and Operating Partner at Advent Life Sciences, said

"The outstanding work of Epitopea’s co-founders, Université de Montréal scientists Drs. Claude Perreault, and Pierre Thibault, has opened a tremendous and potentially transformative opportunity for future cancer patients. With this significant seed financing by a syndicate of world-class investors from Canada and the UK, we can start translating these discoveries into novel therapeutics. We will be guided by science, deploying the best modalities available to help cancer patients achieve durable benefits."

Dr Laurence Rulleau, Partner, CTI Life Sciences, said

"CTI is delighted to co-lead the seed round of Epitopea, which is the first investment from our third fund, CTI LSF III. We are convinced that Epitopea has the potential to fundamentally change the paradigm of how cancer patients can be treated with therapeutics vaccines and other immunotherapies to significantly improve their quality of life. Epitopea will explore a variety of early and longer-term value creation strategies including partnerships with third parties as well as developing its own therapeutic modalities based on its CryptigenTM TSAs."