On February 16, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various products for the immuneoncology space, is pleased to reported the establishment of an agreement with Cato SMS, to advise on the submission of its clinical application to Health Canada in order to initiate a Phase I trial using AccuTOXTM against breast cancer (Press release, Defence Therapeutics, FEB 16, 2022, View Source [SID1234626247]).

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CATO SMS is a consulting firm with more than 30 years of global experience to guide clinical development of biopharma pipelines. With offices across North America, Europe, and the Middle East, CATO SMS has experience conducting trial designs in more than 25 countries. Their specialists deliver innovative regulatory consulting solutions to guide complex challenges with a proven center of excellence in oncology.

"We are very pleased to work with Cato SMS on our AccuTOXTM program. This step is central to Defence as it ensures the achievement of important milestones for our clinical program. Cato SMS will be designing the clinical protocol, pre-CTA meeting package, CTA Compilation and Submission as well as regulatory affairs for our AccuTOXTM Phase I trial" says Mr. Plouffe, the CEO of Defence.

The AccuTOXTM program consists of using a lead variant of the AccumTM molecule to trigger cell death in cancer cells. When combined with the immune-checkpoint inhibitor CTLA-4, this lead AccumTM triggered potent anti-tumoral response in several cancer models including, T-cell lymphoma, melanoma, colon and breast cancer. As such, Defence plans to use AccuTOXTM in its Phase I to treat breast cancer patients in Q4 of 2022.

According to Fortune Business InsightsTM, the Global Breast Cancer Therapeutics Market to exhibit 13.1% CAGR and hit USD 55.27 Billion till 2027.

On February 16, 2022 Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies that target signal regulatory proteins (SIRP), reported a $84 million Series B financing co-led by Westlake Village BioPartners and OrbiMed (Press release, Electra Therapeutics, FEB 16, 2022, View Source [SID1234610665]). Other participating investors include Redmile Group, Cormorant Asset Management, Cowen Healthcare Investments, RA Capital, and New Leaf Venture Partners. Electra was previously funded by its parent company, Star Therapeutics.

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Electra is building a pipeline of novel therapies targeting SIRP, a family of cell surface receptors on various immune cell types. The company is taking a first-in-class approach to engage SIRP beyond the current drug development efforts in cancer, by targeting specific SIRP proteins to deplete targeted pathological immune cells. ELA026, the company’s lead product candidate, exhibits this novel mechanism of action and is currently in Phase 1 clinical studies, including a trial in secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening inflammatory disease. ELA026 is also advancing in other immunological diseases. In addition, the company’s pipeline includes preclinical programs in immunology and immuno-oncology.

"We are thrilled to introduce Electra and share our novel approach to targeting SIRP," said Adam Rosenthal, PhD, CEO and Co-founder of Electra. "Our team has made rapid progress advancing our lead product candidate, ELA026, from an idea to the clinic in less than 3 years, and we are excited by each of our three pipeline programs targeting numerous diseases with significant unmet need."

Proceeds from the financing will be used to continue advancing ELA026 in clinical trials for sHLH and other immunological diseases. The funding will also support advancement of an additional preclinical pipeline program targeting SIRP in immunology, as well as Electra’s immuno-oncology platform that leverages SIRP to promote targeted depletion of tumor cells.

"It is inspiring to see the rapid progress and success of Electra’s pioneering work in targeting SIRP to develop therapies for immunological diseases. ELA026 represents a novel mechanism for targeting diseases driven by aberrant myeloid and T cell activity, and has enormous potential to address life-threatening diseases like sHLH, as well as other severe inflammatory diseases," said Beth Seidenberg, MD, Founding Managing Director at Westlake Village BioPartners.

Electra’s Board of Directors consists of Beth Seidenberg, MD, Founding Managing Director at Westlake Village BioPartners; Carl Gordon, PhD, CFA, Managing Partner at OrbiMed; Nancy Stagliano, PhD, Executive Board Chair, and Adam Rosenthal, PhD, CEO and Co-founder of Electra. Electra’s Board observers are Amrit Nagpal, Managing Director at Redmile Group and Vijay Lathi, Managing Director at New Leaf Venture Partners.

"We are impressed by the bold vision of the Electra team which has deep insights into drug discovery and development, and we are pleased to support Electra as they translate their approach with SIRP to patients in need of innovative treatment options," said Carl Gordon, PhD, CFA, Managing Partner at OrbiMed.

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a life-threatening hyperinflammatory condition for which there is no approved treatment. sHLH can be triggered by cancer, immunotherapy, infection, or an autoimmune disease. Once triggered, sHLH requires immediate intervention. Without treatment, it can rapidly progress from symptoms such as persistent fever, hepatomegaly and/or splenomegaly, and cytopenias, to multi-organ failure and death. Even with the current use of off-label treatments that have toxicity challenges and limited efficacy, sHLH remains fatal in approximately 60% of adults within 3.5 years.

On February 16, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, reported that it will report fourth quarter and full year 2021 financial results on Monday, February 28, 2022, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 16, 2022, View Source [SID1234608185]).

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Dynavax will host a conference call and live audio webcast on Monday, February 28, 2022 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4678925. A replay of the webcast will be available for 30 days following the live event.

On February 16, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported the availability of FusionPlex Dx and LiquidPlex Dx in Europe, part of its industry-leading Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products (Press release, Invitae, FEB 16, 2022, View Source [SID1234608168]). Invitae is delivering essential high quality innovation for precision oncology in the fight against cancer.

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With this announcement, Invitae provides the highest quality CE-IVD products to enable European pathologists and oncologists to efficiently provide vital information, in a timely manner, to guide cancer therapy for patients.

"This is a major step toward our mission to bring comprehensive genetic information into mainstream medicine," said Vishal Sikri, President of Oncology at Invitae. "Our best in class FusionPlex and LiquidPlex tests will enable more patients access to the right cancer therapies at the right time, which is especially critical in Europe where the majority of molecular testing is performed locally in decentralized hospital settings."

In line with ESMO (Free ESMO Whitepaper) guidelines for non-small cell lung cancer (NSCLC), Invitae’s FusionPlex Dx and LiquidPlex Dx allow comprehensive genomic profiling (CGP) and companion diagnostic (CDx) use for solid tumor neoplasms including NSCLC in tissue biopsy and where tissue is a limiting factor. The panels are intended to be used on Illumina’s Next Generation Sequencing (NGS) platforms for IVD testing.

"Increasing patient access to content on our instrument fleet through partnerships such as those with Invitae speaks to our mission to improve human health by unlocking the power of the genome," said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. "We congratulate Invitae on its first CE-IVD cancer testing kits, a significant milestone."

FusionPlex Dx identifies structural variants including fusions in RNA derived from formalin-fixed, paraffin-embedded tumor specimens. FusionPlex Dx covers multiple actionable variants in a 41-gene panel to provide CGP for patients with solid malignant neoplasms. FusionPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping alterations, anaplastic lymphoma kinase (ALK) fusions, ros proto-oncogene 1, receptor tyrosine kinase (ROS1) fusions, ret proto-oncogene (RET) fusions, neurotrophic receptor tyrosine kinase 1-3 (NTRK1, NTRK2, NTRK3) fusions, and for whom treatment with a targeted therapy may be beneficial.

LiquidPlex Dx identifies substitutions and insertion-deletion mutations in cell-free circulating tumor DNA (ctDNA) isolated from plasma derived from whole blood of cancer patients (liquid biopsy). LiquidPlex Dx interrogates 29 genes to provide CGP for patients with solid malignant neoplasms. LiquidPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with METex14 skipping alterations, and for whom treatment with a targeted therapy may be beneficial.

"With Invitae’s simplified workflow and reporting solutions, both tests will enable any facility with sequencing technology, combined with our solutions, to accurately profile solid tumors using tissue or blood samples for therapy selection," said Sikri. "Precision medicine has increasingly delivered better outcomes for many cancer patients over the last several years. Molecular pathology has never been more important as the fight against cancer shifts towards precision oncology and targeted therapies based on genomic testing. Yet globally, access to the exponentially increasing therapy options is not guaranteed."

On February 16, 2022) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported preliminary and unaudited revenues for the fourth quarter and full-year 2021 and provided an update on key highlights for 2022 (Press release, CASI Pharmaceuticals, FEB 16, 2022, View Source [SID1234608186]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented "In March 2021, we in licensed CB-5339, a first-in-class VCP/p97 inhibitor for the greater China market. In June 2021, we dosed our first patient in our CID-103 program, a fully human IgG1 anti-CD38 monoclonal antibody’s Phase 1 study; and in December 2021, we received CTA approval from CDE for BI-1206, a first-in-class novel anti-FcγRIIB antibody. Thanks to the efforts of the global CASI team, we have been able to successfully advance our pipeline initiatives during 2021 and position ourselves for continued progress during 2022."

"With EVOMELA as our primary commercial product, we have built a commercial group of more than 100 hematology sales and medical marketing specialists in China. We believe that we have significantly increased the value of our commercial franchise and that our commercial franchise brings us closer to the key opinion leaders in the Chinese hematology-oncology space. We believe that the value of our commercial franchise is also is a key reason many global innovators choose to partner with us due to our access to the market and local clinical development resources. In 2021, our commercial franchise has thoroughly prepared for the anticipated China NDA filing of CD19 CAR-T program, which we currently expect to be in late 2022 or early 2023" Dr. He commented.

Dr. He continued, "Our achievements in 2021 form a great foundation from which we plan to build upon throughout 2022 and beyond. We continue preparations for the commercialization of CNCT-19. During 2022, we anticipate that EVOMELA will continue to be the core of our commercial operation, while we further progress our other pipeline assets. During 2022, we anticipate the start of the BI-1206 phase I trial in China; CB-5339 is expected to receive CTA approval from NMPA during 2022; and CID-103’s Phase I study will continue. We are excited by our momentum and will continue to execute on several key milestones across our broad portfolio in the quarters ahead."

Preliminary and Unaudited Fourth Quarter and Unaudited Full-Year 2021 Revenues, Cash Position, and 2022 EVOMELA (melphalan for injection) Revenue Guidance

·The Company anticipates that it will report EVOMELA revenue of approximately $9.12 million for the fourth quarter ended December 31, 2021, and approximately $30 million for the full-year ended December 31, 2021, exceeding the projected $27 million guidance, and representing a 100% percent increase over the 2020 revenue of $15 million.

·The Company is targeting full-year 2022 revenue guidance of more than 30% growth over 2021 for EVOMELA.

·CASI expects to report approximately $38.7 million of cash and cash equivalents as of December 31, 2021.

·The Company’s fourth quarter and full-year 2021 revenues are preliminary and are subject to the completion of the Company’s 2021 audit. Complete fourth quarter and full-year 2021 financial results will be reported in March 2022.

Key Highlights for 2021

CASI continues to advance pipeline products through clinical trial stages in China and globally.

·Our partner, Juventas Cell Therapy Ltd ("Juventas"), continues the development of CNCT19, an autologous CD19 CAR-T investigative product for which CASI has co-commercial and profit-sharing rights. CNCT19 is being developed as a potential treatment for patients with hematological malignancies which express CD19 including, B-cell acute lymphoblastic leukemia ("B-ALL") and B-cell non-Hodgkin lymphoma ("B-NHL"). The Phase 1 studies in B-ALL and B-NHL in China have been completed by Juventas. The Phase 2 B-ALL and B-NHL registration studies are both currently enrolling.

·Along with our partner, BioInvent, we continue to progress the development and regulatory framework for BI-1206 in China. The National Medical Products Administration (NMPA) granted BI-1206 Clinical Trial Application (CTA) approval in December 2021. EC approval from a leading investigational site was granted in January 2022. BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors.

·CB-5339 CTA application for the Multiple Myeloma indication is in preparation after receiving pre-IND feedback from NMPA in January 2022. Cleave Therapeutics is responsible for the ex-China development of CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, and is evaluating the molecule, in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

·CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI maintains exclusive global rights and is developing CID-103 for the treatment of patients with multiple myeloma. The Phase 1 dose escalation and expansion study of CID-103 in patients with previously treated relapsed or refractory multiple myeloma is ongoing in France and the UK.