On April 25, 2022 Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that positive new data were presented at the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings in Salt Lake City, Utah (Press release, Orca Bio, APR 25, 2022, View Source [SID1234612929]).

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The new data on Orca Bio’s lead investigational high-precision cell therapy, Orca-T, include updated results from 137 patients with hematologic malignancies, which continued to show an increase in overall survival rates and a reduction of acute and chronic graft versus host disease (GvHD) compared to standard of care; positive outcomes in a subset of patients with myelofibrosis who received Orca-T; and new analyses demonstrating Orca Bio’s manufacturing platform is reliable, robust and scalable.

"These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD. This could be a compelling option for patients battling serious hematological malignancies who currently face devastating transplant-related risks," said Everett Meyer, M.D., Ph.D., primary investigator. "These results, combined with the reliable and centralized Orca-T manufacturing, could potentially transform treatment options for patients and physicians."

Orca Bio presented pooled data from 137 patients in the single-center Phase 2 and multi-center Phase 1b trials of Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS), with at least 100 days of follow-up and a median of 341 days. For comparison purposes, an independent CIBMTR-based control arm was identified, consisting of similar patients with hematologic malignancies who received a standard of care allogeneic hematopoietic stem cell transplant ("alloHSCT") over a similar timeframe. Results demonstrated that:

Rates of moderate-to-severe chronic GvHD were low among Orca-T recipients, occurring in only 5% of patients at one year compared to 38% who received a standard alloHSCT.
GvHD-free, relapse-free survival (GRFS) was 71% at one year for Orca-T patients compared to 21% in the CIBMTR-based control arm.
The overall survival for patients who received Orca-T was 90% at one year compared to 68% in the CIBMTR-based control arm.
Additionally, Orca Bio presented findings from a manufacturing reliability analysis of 100 Orca-T products in the Phase 1b trial. All investigational cell therapies were manufactured at Orca Bio’s cGMP facility in Sacramento, CA, and transplant centers and donor sites were located across the U.S. All products were successfully delivered and infused to patients within 72 hours or less.

"We produce a unique batch of drug for each patient who receives an Orca-T product, and this drug is made up of fresh, living cells that need to be infused on an extremely rapid timeline," said Nate Fernhoff, Ph.D., co-founder and chief scientific officer at Orca Bio. "Reliable and scalable manufacturing have been integral to the development of our therapies since day one. These results not only show that Orca-T continues to reduce GvHD and improve survival rates over time, but that we have maintained the ability to reliably manufacture, deliver and infuse all patients in a timely manner regardless of donor and patient location. This is an important indication of our ability to potentially deliver this therapy urgently and seamlessly to patients in need."

In a separate poster, Orca Bio presented updated data on the treatment impact of Orca-T in 12 patients with myelofibrosis compared to nine patients who received a standard of care alloHSCT. Orca-T recipients had lower incidence of acute and chronic GvHD (33% with Orca-T versus 100% with alloHSCT) and the data suggest Orca-T was well-tolerated. Treatment with Orca-T resulted in engraftment with regression of marrow fibrosis, indicating potential efficacy for the treatment of myelofibrosis.

Based on the favorable results of the Phase 1b and 2 clinical trials, a randomized registrational Phase 3 trial evaluating Orca-T against standard of care alloHSCT, named Precision-T, is now open. More details will be announced in the coming weeks.

Links to the abstracts follow:

Title: Orca-T Demonstrates Encouraging Overall Survival, Gvhd Reduction, and Tolerability in Patients with Hematologic Malignancies
Poster Number: 412

Title: Outcomes for Myelofibrosis Patients Following Myeloablative Allogeneic Stem Cell Transplantation Using the Orca-T Graft from HLA-Matched Related and Unrelated Donors
Poster Number: 413

Title: Manufacture and Distribution of High-Precision Orca-T Is Reliable, Robust, and Scalable
Poster Number: 415

About Orca-T
Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

On April 25, 2022 Shuwen Biotech, an integrated in vitro diagnostic company with focuses on women’s health, reported that it has obtained a CE mark for its quantitative qPCR kit for measuring ERBB2 gene expression in breast cancer tissue (CercaTestTM ERBB2 Assay) (Press release, Shuwen Biotech, APR 25, 2022, View Source [SID1234613090]).

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Immunohistochemistry (IHC) analysis of HER2 protein expression and fluorescent in situ hybridization (FISH) have been used to characterize HER2 status in breast cancer to guide anti-HER2 therapies. However, studies have shown that current standard qualitative HER2 IHC assay is insufficient especially in the low range (0 and 1+) of HER2 expression. In particular, a recent study showed the use of HER2 IHC assays as a companion diagnostic test for the new drug trastuzumab deruxtecan may result in misassignment of patients for treatment.1 In view of the direct link between gene amplification, RNA transcription, and protein expression, experts have suggested measures of messenger RNA as potentially a more reproducible quantitative assay.2

CercaTestTM ERBB2 Assay is a quantitative real-time PCR assay for accurate measurement of ERBB2 gene expression in breast cancer tissue slices. Contiguous quantitative PCR cycle numbers may be generated from different FFPE tissue samples with the same IHC scores (such as HER2 0 or 1+), allowing delineation of different ERBB2 mRNA expression levels in full spectrum. The assay is run on commonly available PCR platforms, thus obviating the need for pathology readings and scorings and avoiding human subjectivity and errors.

"With CercaTestTM ERBB2 Assay and MammaTyper, we have shown that qPCR analysis of ERBB2 mRNA in our assays exhibits high inter- and intra-laboratory reproducibility and good concordance with HER2 IHC scores by experienced pathologists, even in HER2 low expression samples.3, 4 Coupled with our RNXtract Nucleic Acid Extraction Kit and RNXtract Automated Purification System, CercaTestTM ERBB2 Assay provides simple, fast, reproducible and accurate assessment of ERBB2 mRNA levels in tissue samples including HER2-low breast cancer samples. We believe our CercaTestTM ERBB2 Assay and MammaTyper potentially offer superior companion diagnostics for anti-HER2 therapies especially the newer generation of anti-Her2 ADC drugs," commented Barclay Li, Chief Scientific Officer of Shuwen Biotech. Both CercaTestTM ERBB2 Assay and MammaTyper are commercially available worldwide through Cerca Biotech GmbH, a European subsidiary of Shuwen Biotech.

1. Fernandez et al., Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue,
JAMA Oncol. 2022 Apr 1; 8(4):1-4. doi: 10.1001/jamaoncol.2021.7239.
2. Allison et al., ERBB2-Low Breast Cancer-Is It a Fact or Fiction, and Do We Have the Right Assay? JAMA Oncol. 2022 Apr 1; 8(4):610-611. doi: 10.1001/jamaoncol.2021.7082.
3. Wirtz et al., Biological Subtyping of Early Breast Cancer: A Study Comparing RT-qPCR with Immunohistochemistry. Breast Cancer Res Treat. 2016 May 24; 157:437–446. Doi: 10.1007/s10549-016-3835-7
4. Varga et al., An International Reproducibility Study Validating Quantitative Determination of ERBB2, ESR1, PGR, and MKI67 mRNA in Breast Cancer Using MammaTyper, Breast Cancer Res. 2017 May 11; 19(1):55. doi: 10.1186/s13058-017-0848-z.

On April 25, 2022 Astellas Pharma US, Inc. ("Astellas") reported that it is accepting applications for the sixth annual Astellas Oncology C3 Prize (Changing Cancer Care), a global challenge that funds and advances the best non-treatment ideas to improve cancer care for patients, caregivers and the broader oncology community (Press release, Astellas, APR 25, 2022, View Source [SID1234612897]). The C3 Prize awards a total of $100,000 in grants and additional resources to advance ideas that address everyday challenges facing people impacted by cancer.

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"The C3 Prize is focused on advancing innovations in cancer care beyond medicine to make every day better for those impacted by cancer," said Anthony Yanni, M.D., Senior Vice President and Global Head of Patient Centricity, Astellas. "Through the C3 Prize, we aim to fuel innovations that address patient and caregiver challenges and foster connections and empowerment throughout the cancer journey. In particular this year, solutions that address some of today’s most pressing issues, such as mental health, caregiver support and health disparities and equity, are encouraged."

Sparking Innovation to Make an Impact for the Cancer Community
Innovation through the lens of patients and caregivers fuels the C3 Prize. Many previous C3 Prize innovators have a personal connection to cancer, which aligns with Astellas’ philosophy that understanding the patient journey is critical to driving meaningful advancements in cancer care.

"As soon as I learned about the C3 Prize, it was clear to me that the Oncopadi app was exactly the kind of innovation Astellas was seeking to support," said Dr. Omolola Salako, 2020 C3 Prize Grand Prize winner, Founder and CEO, Oncopadi and 2022 C3 Prize Judge. "The funds and resources we received have enabled our team to close the cancer gap, strengthen the cancer care system and create new paths to improving the patient experience. The C3 Prize has fueled my personal mission and cemented the legacy of my sister, whose cancer journey motivated me to become an oncologist and launch Oncopadi."

Astellas Oncology will award one Grand Prize winner $100,000 USD in grants, and name two Innovation Prize winners. All winners will be provided with access to tools and resources to help them develop and advance their idea, including a yearlong complimentary membership to MATTER, a global healthcare startup incubator, community nexus and corporate innovation accelerator. The Grand Prize Winner will also receive hands-on support, expertise and resources from Slalom, a global consulting firm focused on strategy, technology and business transformation.

The C3 Prize finalists will participate in a virtual pitch event with an expert panel of volunteer judges, who are experts in cancer care and advocacy, healthcare innovation, and business strategy and consultation.

Details About the C3 Prize Application Process
The C3 Prize is open to applicants through June 3, 2022. Astellas will select three finalists who will participate in a virtual pitch event with the panel of judges to determine the Grand Prize winner and two Innovation Prize winners. Winners will be publicly announced in July 2022.

All eligible entries will be evaluated on the following criteria: potential to make a positive impact on people affected by cancer, originality/differentiation from existing solutions, scalability and financial viability of idea, and the effect of the C3 Prize to help further the idea. The C3 Prize is not just for complex solutions – ideas can be in the form of support tools, educational efforts, technology solutions and beyond. Past winners include people who have lived with cancer, caregivers, healthcare providers, patient advocates, entrepreneurs and more.

On April 25, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported the Company’s participation in Bloom Burton & Co.’s Healthcare Investor Conference 2022 (Press release, Theratechnologies, APR 25, 2022, View Source [SID1234612913]).

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Theratechnologies Presentation Details:

Date: Tuesday, May 3, 2022
Presentation Time: 1:30PM ET
Location: Metro Toronto Convention Centre, Track B

The conference which features 66 of Canada’s premier publicly-traded and venture-backed private companies together with the most promising pre-venture companies in the healthcare industry. Investors have the opportunity to obtain corporate updates from presenting companies and participate in Bloom Burton’s 1-on-1 meeting system with company management. Only registered attendees can participate in the event. Register HERE to attend the event.

On April 25, 2022 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB,OTCQB:BVAXF) ("BioVaxys" or "Company"), reported that it has entered into an agreement with the Deaconess Research Institute ("DRI") to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at Deaconess Health System ("Deaconess") (Press release, BioVaxys Technology, APR 25, 2022, View Source [SID1234612931]). DRI, based in Evansville, Indiana, is the clinical studies arm of Deaconess, a premier regional provider of health care services in the United States. Access to ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918, the Company’s autologous haptenized tumor cell vaccine for late-stage ovarian cancer.

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The standard of care for late-stage ovarian cancer often involves surgically debulking of the tumor mass. The debulked tumor cells will be used to test and validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction. Following shipment to BioElpida s.a. ("BioElpida"), the Company’s bioproduction partner in Lyon, France, the tumor cells will then be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production, a requirement for the planned Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA"). BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing to launch a Phase I clinical study for BVX-0918 later this year.

BioElpida developed various tests and validation procedures needed to support GMP manufacturing, such as sterility testing for transport, hapten fixation, and cryopreservation solutions, as well as antibody generation, bioburden screening of the haptens, and endotoxin assays; access to debulked tumor means that BioElpida will begin the final stages of the vaccine production protocol and GMP validation. BioVaxys and BioElpida have also designed and fabricated a specialized shipping package which would cryopreserve the tumor sample while in transit from any hospital site to the BioElpida site.

BioVaxys President & Chief Operating Officer Kenneth Kovan says, "Having complied with the regulatory oversight involved in obtaining waste tumor samples, BioVaxys is now able to provide BioElpida with the materials required for finalizing the vaccine production protocol and performing process validation in the lead up to our planned CTA submission to the European regulator."

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.