On April 25, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its first quarter 2022 financial results and operational highlights before open of U.S. markets on Thursday, May 5, 2022 (Press release, Autolus, APR 25, 2022, View Source [SID1234612915]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm BST to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 3245616. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 3245616.

On April 25, 2022 BrickBio, the leader in RNA facilitated site- specific protein assembly, reported an invited poster at the annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Conference highlighting some of the results from its multi-year effort to develop the most efficacious therapeutic sites, inaccessible to other technologies, that the company incorporated into its Site Select Panel (Press release, BrickBio, APR 25, 2022, View Source [SID1234612934]). The panel uses the company’s powerful RNA engine to incorporate unnatural amino acids (UAAs) to produce 50 different homogenously conjugated antibodies in a matter of a few weeks.

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BrickBio has commercialized their flagship protein conjugation platform which leverages engineered RNA to introduce site-specific chemistries into any protein, enabling many applications through the same novel mechanism – such as homogenously conjugating two or more molecules to generate best-in-class therapeutics. Combined with the largest sets of compatible chemistries, BrickBio can incorporate and optimize any moiety ranging from oligonucleotides, LNAs, to complex hydrophobic payloads.

The pipeline candidate depicted in the poster (#3940), Next Generation Site-Specific ADCs targeting Breast and Gastric Cancer, highlighted the advantage of the powerful BrickADC platform towards breast & gastric cancer with improved efficacy, better safety, and overall lower dosages developed using the previously revealed Site-Select Panel. Identification of these optimal sites, which are inaccessible with other conjugation technologies, are currently being transferred between next-generation antibody scaffolds, such as bispecifics, nanobodies, or other fragments in BrickBio’s undisclosed internal and partnered pipeline.

BrickBio’s undisclosed pioneering efforts towards Protein Origami Therapeutics and Synthetic Virology were also highlighted, which leverage the same core technology that drive BrickADCs. Protein Origami enables the spatial orientation of multiple proteins into a multimeric complex, resulting in synergistic modalities that have yet to be explored due to the inability to generate such structures prior to BrickBio. In addition, the Synthetic Virology platform revolves around the retargeting of capsids via protein conjugation to engineer tropisms, improve safety, increase infectivity, and eliminate immunogenicity. BrickBio has produced stellar data in-vivo demonstrating conserved tropism, no immunogenicity, and 2X infectivity with improved AAV half-life.

BrickBio is continuing its partnership efforts from AACR (Free AACR Whitepaper) 2022 by meeting with potential collaborators for work on BrickADCs, Protein Origami Therapeutics, and modified AAV capsids.

"The BrickBio platform and processes have unleashed the full potential of the unnatural amino acid technology, enabling new therapeutic modalities, all linked by the same conjugation chemistries," said James Italia, VP of Commercial Development at BrickBio, "Specifically, the BrickADC platform highlights the unprecedented precision in our discovery engine. Our industry partners are adjusting their R&D directions since realizing they can engineer novel best-in-class therapeutics with BrickBio which they could not generate before." James concluded.

"BrickBio’s platform has the most diverse toolbox of engineered RNA and complementary chemistries, that have shown an immediate impact in producing improved, next generation, antibody drug conjugates, such as bispecific multi-site antibodies that have the ability to increase the drug to antibody ratio (DAR) while decreasing hydrophobicity," stated John Boyce, President, CEO, and Co-Founder of BrickBio, as well as Co-Founder of Tiger Gene, L.L.C. "The ability to modify therapeutic proteins extends beyond antibodies and protein-protein conjugates, but also to viral vectors such as modified AAVs with re-programmed tropism. These reprogrammed AAVs are being designed to provide a safe, tissue specific delivery vehicle that may re-ignite a number of gene therapy programs that have been stalled. BrickBio has delivered a near term solution to improve patient treatment through next generation ADCs, and is well positioned to usher in new era of gene therapy delivery vehicles," Boyce concluded.

On April 25, 2022 Cerus Corporation (Nasdaq: CERS) reported that it has signed a five-year contract with the American Red Cross for the INTERCEPT Blood System for Platelets (Press release, Cerus, APR 25, 2022, View Source [SID1234612900]).

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Under the terms of this contract, Cerus will continue to supply the Red Cross the INTERCEPT Blood System used to produce pathogen reduced platelets, in support of the Red Cross goal to transition toward a full pathogen reduced platelet supply for its hospital customers across the U.S.

"The Red Cross is a global leader in transfusion medicine, with a track record of establishing blood safety protocols that have provided a blueprint for many blood centers globally. Cerus is proud of our long history of collaborating with the Red Cross, as they have played a critical role in the deployment of the INTERCEPT Blood System to safeguard the U.S. blood supply," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "Thanks to their leadership and commitment to blood safety, the Red Cross is now the largest producer of INTERCEPT treated blood components in the world. Our partnership has made thousands of INTERCEPT treated platelets available for patients across the country each day, and we are excited to extend this relationship and continue advancing the INTERCEPT Blood System."

Supplying about 40 percent of the nation’s blood supply, the Red Cross is the largest provider of blood products in the United States, collecting more than 4.6 million blood donations and 1 million platelet donations for its approximately 2,500 hospital and transfusion center customers in 2021.1

"The safety and sustainability of the blood supply is of paramount importance for us, as well as for the hospitals, physicians and patients who we serve," said Chris Hrouda, president, Biomedical Services at American Red Cross. "INTERCEPT treated platelets meet the FDA’s bacterial safety requirements and also protect patients against a broad spectrum of transfusion-transmitted infections caused by known and unknown pathogens. The Red Cross remains committed to finding proactive ways to ensure the safety and availability of the blood supply."

On April 25, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead gene therapy obecabatagene autoleucel (obe-cel), a CD19-directed autologous chimeric antigen receptor (CAR) T therapy that is being investigated in the ongoing FELIX Phase 2 study of adult relapsed / refractory B-Acute Lymphocytic Leukemia (ALL) (Press release, Autolus, APR 25, 2022, View Source [SID1234612917]).

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The FDA grants RMAT designation to drug candidates in recognition of the therapy’s potential to address significant unmet medical needs in patients with serious or life-threatening conditions. RMAT designation provides important benefits in the drug development process, designed to facilitate and expedite development and regulatory review.

"RMAT designation is an important regulatory milestone for obe-cel and highlights its potential to address the unmet medical need for adult patients with relapsed and refractory B-ALL," said Dr. Christian Itin, Chief Executive Officer of Autolus. "RMAT designation from FDA, PRIME designation from EMA and ILAP designation from MHRA facilitate regulatory interactions with key health authorities and supports our drive to bring this innovative therapy to patients as quickly as possible."

obe-cel has previously been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

On April 25, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that the European Hematology Association (EHA) (Free EHA Whitepaper) has accepted an abstract with initial clinical data from Caribou’s ongoing ANTLER Phase 1 trial of CB-010 for the EHA (Free EHA Whitepaper) 2022 Hybrid Congress, being held in Vienna, Austria, June 9-12, 2022 (Press release, Caribou Biosciences, APR 25, 2022, View Source [SID1234612937]).

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Information on EHA (Free EHA Whitepaper)’s timelines for release of abstracts and data presentations is available on the EHA (Free EHA Whitepaper) website.

About CB-010

CB-010 is the lead product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 trial. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to boost the persistence of antitumor activity. CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knock out. Additional information on the ANTLER trial can be found at View Source using identifier NCT04637763.

About Caribou’s Novel Next-Generation CRISPR Platform

CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Type II and Type V CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems occasionally edit unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed chRDNAs (pronounced "chardonnays"), RNA-DNA hybrid guides that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.