On April 6, 2022 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported that two important milestones on advancing the speed and scale of its spatial phenotyping solutions, will be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting in New Orleans, April 8 to 13 (Press release, Akoya Biosciences, APR 6, 2022, View Source [SID1234611514]). First, the company will showcase the industry’s first 100-plex dataset for deep spatial phenotyping at single cell resolution, across an entire tissue sample. Second, they will preview a new universal chemistry to enable accelerated validation of biomarkers discovered using deep spatial phenotyping.

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Powered by the high-speed imaging capabilities of PhenoCycler-Fusion, the company will showcase how a panel of 100+ markers mapped across whole slides, at single-cell resolution, can give us unprecedented insights into tumor-immune biology. In addition to the speed of imaging, the system has a proprietary file compression algorithm that can reduce file sizes from terabytes to gigabytes. This powerful combination makes it easier for cancer researchers to scale up their spatial discovery efforts with larger panels.

Complementing the 100-plex dataset, and first unveiled at Spatial Day in December 2021, the company will also preview its new universal chemistry for rapid biomarker validation. Because the 100-plex panel and universal chemistry workflows are grounded in the same barcoded antibodies, customers can discover novel biomarkers using PhenoCycler-Fusion and leverage the same chemistry to validate the resulting biomarkers on the Fusion, as a standalone system, at a capacity of 100+ samples per week. Providing cohesion and consistency of imaging methods, chemistry and data analysis will accelerate the translation of spatial discoveries into actionable biomarker signatures.

These novel datasets and customer case studies will be presented during Akoya’s Exhibitor Spotlight Theater, titled ‘Comprehensive Spatial Phenotyping: Mapping the Tumor Microenvironment at Scale’ on April 12 at 3 PM (CST).

Speakers include:

Sizun Jiang, PhD, Principal Investigator, Beth Israel Deaconess Medical Center
Bernard Fox, PhD, Harder Family Endowed Chair in Cancer Research, Earle A. Chiles Research Institute, Providence Cancer Center
Oliver Braubach, PhD, Head of Applications, Akoya Biosciences
"We are excited to demonstrate the rapid advancement of our spatial phenotyping solutions. The speed enabled by our platforms is a catalyst not just for biomarker discovery but also accelerates the pace of development of our internal R&D teams," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "We are looking forward to sharing these latest innovations at AACR (Free AACR Whitepaper) and at the AGBT Annual Meeting in June, we will be showcasing our advancements in multiomics and spatial transcriptomics."

To view the full list of 23 abstracts and posters and to register for the Exhibitor Spotlight Theater, please visit akoyabio.com/aacr2022.

On April 6, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 8:45 a.m. ET (Press release, Bicycle Therapeutics, APR 6, 2022, View Source [SID1234611513]).

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A live webcast of the fireside chat will be accessible in the Investors and Media section of Bicycle’s Website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the fireside chat date.

On April 6, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric, will participate in three upcoming investor conferences (Press release, Enveric Biosciences, APR 6, 2022, View Source [SID1234611512]):

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Benzinga Psychedelics Capital Conference
Date: Tuesday, April 19th at 11:10 a.m. ET
Location: Fontainebleau Miami Beach in Miami, FL
To attend, please register here.

Sequire Cannabis & Psychedelic Conference
Date: Wednesday, April 20th at 1:00 p.m. ET
Location: Virtual
To attend, please register here.

KCSA Psychedelics Investor Conference
Date: Wednesday, April 27th at 11:00 a.m. ET
Location: Virtual
To attend, please register here.

For more information about the conferences, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate representative, or send an email to KCSA Strategic Communications at [email protected].

On April 06, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that an Investigational New Drug ("IND") application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been approved by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, APR 6, 2022, View Source [SID1234611511]).

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SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"), submitted the IND, for a small Phase I clinical trial investigating safety, earlier this year. 3D Medicines expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China. The approval of the IND by the NMPA triggered a $1 million milestone payment to SELLAS, which the Company expects to receive in the second quarter of 2022. 3D Medicines’ current clinical development plan provides for initiation of a Phase II clinical trial following receipt of satisfactory safety data from the Phase I study; the initiation of the Phase II study will also trigger a milestone payment to SELLAS. Total remaining potential milestone payments to SELLAS under the license agreement between the two companies could total $191.5 million, not including future royalties.

"We are pleased that the 3D Medicines’ IND application filed earlier this year is now approved by China’s NMPA which allows 3D Medicines to move forward with their planned Phase 1 clinical trial. This marks the beginning of development of GPS in China which is an important milestone for SELLAS," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS.

About 3D189
3D189, also known as SELLAS’ lead product candidate, GPS, is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein which is present and over-expressed in an array of hematological malignancies and solid tumors. When administered to a patient as a monotherapy or in combination with standard treatments, GPS’ induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells. The immunotherapy has the potential to be a highly effective approach to prolonging survival by delaying or preventing recurrence in patients in complete remission or with minimal residual disease.

3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.

On April 6, 2022 Shenzhen Pregene Biopharma, a clinical-stage biopharmaceutical company engaged in discovering, developing, manufacturing and commercializes innovative medicines and CellPoint, a cell therapy company developing CAR-T therapeutics for use at the point-of-care (POC), reported an exclusive license agreement for the development and commercialization of PRG-1801, Pregene’s single domain antibody-based anti-BCMA chimeric antigen receptor T cell (CAR-T) program, for the treatment of hematological indications in Europe and the United States (Press release, PreGene, APR 6, 2022, View Source [SID1234611510]).

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PRG-1801 is a single domain antibody anti-BCMA CAR-T cell therapy in development for the treatment of relapsed/refractory multiple myeloma that has demonstrated strong signs of efficacy and an excellent safety profile in its initial investigator-initiated trial and Phase I/II clinical trials.

Under the terms of the collaboration, Pregene will receive over €20 million of upfront and near-term consideration, and is eligible to receive additional development, commercial milestone and royalty payments. CellPoint will be responsible for the development and commercialization of the anti-BCMA CAR-T therapy in Europe and the US. As part of this partnership, Pregene will also provide translational and lentivirus manufacturing services to be reimbursed by Cellpoint.

"We are excited to partner with Cellpoint to develop CAR-T cell therapies via a POC platform," said Jishuai Zhang, Chief Technology Officer and Co-founder of Pregene. "The potential of our single domain antibody fully human BCMA CAR-T to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR-T product candidate. We expect the POC modality to enable faster treatment for broader patients using our differentiated CAR-T therapy, and we look forward to working with the team at CellPoint as they seek to develop and commercialize PRG-1801."

Tol Trimborn, Chief Executive Officer of CellPoint, said: "We are very pleased to add Pregene’s novel anti-BCMA CAR-T therapy to our CAR-T portfolio and look forward to develop it using our decentralised, POC manufacturing model. This is our second clinical stage program and we have demonstrated we can provide cell therapy to cancer patients in only 6 days vein-to-vein, from apheresis to infusion. We are excited to work closely alongside Pregene to bring this to patients with a convenient, readily available treatment alternative."

About PRG-1801 (anti-BCMA CAR-T)

PRG-1801 is an anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in an investigator initiated trial and Phase I/II clinical trials. In addition to multiple myeloma, Pregene is investigating PRG-1801 in patients with autoimmune diseases. In May of 2021, Pregene and Dr. Reddy’s Laboratories announced a license agreement whereby Dr Reddy’s acquired the exclusive rights in India for PRG-1801.

Clinical trials of PRG-1801 include:

Phase I trial to evaluate the safety and tolerance of patients with relapsed/ refractory multiple myeloma after anti-BCMA CAR-T infusion, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of anti-BCMA CAR-T for relapsed/refractory multiple myeloma. Available clinical data showed overall response rate (ORR) of 100%. A Phase II clinical trial is now ongoing.
Investigator-initiated trial in China to evaluate the safety and efficacy of PRG-1801 (NCT03661554). Among 34 patients treated, 30 (88.2%) patients achieved best objective response and 19 (55.8%) patients achieved complete response. No neurotoxicity was observed among treated patients. Grade 3 CRS occurred in only one patient (2.9%), and all the other patients had lower grade or no CRS.