SpringWorks Therapeutics Enters into Research Collaboration with Leading Cancer Institute to Further Evaluate Nirogacestat as a BCMA Potentiator in Multiple Myeloma

On August 30, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into a sponsored research collaboration with Dana-Farber Cancer Institute (Dana-Farber) (Press release, SpringWorks Therapeutics, AUG 30, 2021, View Source [SID1234591665]). The collaboration is designed to further investigate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor (GSI), with anti-B-cell maturation antigen (BCMA) agents in a variety of preclinical multiple myeloma models. Constantine Mitsiades, M.D., Ph.D., Assistant Professor of Medicine at Dana-Farber and Harvard Medical School, will serve as the Principal Investigator for the research, which will utilize preclinical in vivo models from the Mitsiades Lab to simulate the multiple myeloma tumor microenvironment. In addition, the research will also deploy functional genomics approaches to explore determinants of response and mechanisms of resistance to GSI + BCMA combination therapy.

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners to evaluate nirogacestat in combination with BCMA therapies across modalities.

"SpringWorks has demonstrated its commitment to understanding the science and advancing the clinical exploration of GSI + BCMA combination therapies," said Dr. Mitsiades. "I am pleased to collaborate with them towards the goal of improving clinical outcomes for patients with multiple myeloma while simultaneously enabling the advancement of the underlying science."

"We are delighted to be collaborating with the Mitsiades Lab at Dana-Farber to expand our understanding of nirogacestat’s mechanism of action when combined with BCMA therapies," said Badreddin Edris, Ph.D., Chief Operating Officer of SpringWorks. "Dr. Mitsiades and his colleagues have been at the forefront of developing cutting-edge translational models of multiple myeloma and we believe that this collaboration has the potential to yield novel insights that can help us to further refine our approach to improving outcomes for these patients."

Under the terms of the sponsored research agreement, SpringWorks will be responsible for funding the work and will retain an option to exclusively license any new intellectual property emerging from the research collaboration.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA therapies using a variety of preclinical multiple myeloma models.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

FDA Grants Lantern Pharma Additional Orphan Drug Designation for Drug Candidate LP-184 in Glioblastoma Multiforme & Malignant Gliomas

On August 30, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation (ODD) for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas (Press release, Lantern Pharma, AUG 30, 2021, View Source [SID1234591495]). This news follows the recent announcement of the FDA granting LP-184 ODD for the treatment of pancreatic cancer.

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LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including glioblastoma and pancreatic cancer.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. Analyses driven by RADR, Lantern’s proprietary machine learning-based artificial intelligence platform, have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair components as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy. According to market analysts at GlobalData, the global GBM market is expected to reach $1.8 billion USD in therapy sales and is growing at a CAGR of 12.8%.

"GBM represents an important, underserved clinical opportunity, with a significant unmet medical need," stated Panna Sharma, President & CEO of Lantern Pharma. "This second Orphan Drug Designation from the FDA for the LP-184 program marks another major milestone and is further validation of the power of our data-driven approach to oncology drug development, aimed at more targeted and effective oncology therapies."

"We recently reported positive preclinical data that demonstrated LP-184 inhibits tumor growth by greater than 106% and improved survival in animal models of GBM," continued Mr. Sharma. "This new data that we reported, in collaboration with the Kennedy Krieger Institute and Johns Hopkins, on the efficacy of LP-184 in GBM cell lines, in-vivo animal models, and in patient-derived neurospheres, validated in-silico predictions generated by our RADR A.I. platform. We believe LP-184’s ability to cross the blood-brain barrier, together with its anti-tumor efficacy and sensitivity correlations with relevant biomarkers, highlight LP-184’s potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs to address the unmet needs in GBM and other aggressive central nervous system tumors."

"With our extended and expanded agreement with the Kennedy Krieger Institute and Johns Hopkins, we look forward to further advancing the potential of LP-184 as a new, potent treatment option for GBM, especially in areas of unmet clinical need, including MGMT-unmethylated, temozolomide (TMZ)-resistant GBMs, and also EGFR-aberrant or recurrent GBMs, all of which are often associated with poor prognosis and outcome for patients."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

BeiGene Signs a Clinical Trial Agreement with ImmixBio to Evaluate IMX-110 + Tislelizumab in Solid Tumors

On August 30, 2021 ImmixBio reported to assess the safety, tolerability, and efficacy of IMX-110 in combination with tislelizumab in a P-I/IIa trial in patients with advanced solid tumors (Press release, Immix Biopharma, AUG 30, 2021, View Source [SID1234588074])

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The novel approach of combining ImmixBio’s tissue specific therapeutics (TSTx) with immunotherapies could expand the population of cancer patients experiencing extended remissions
The pre-clinical studies showed IMX-110 turns "cold" tumors "hot," and IMX-110 + murine anti-PD-1 demonstrated extended survival in a genetic mouse model of pancreatic cancer vs multi-drug combinations in the literature showed substantial rationale to combine IMX-110 and tislelizumab

CHIMERIC APPOINTS JENNIFER CHOW AS CEO & MD

On August 30, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company, reported the appointment of current Chief Operating Officer, Jennifer Chow, as Chief Executive Officer and Managing Director (Press release, Chimeric Therapeutics, AUG 30, 2021, View Source [SID1234587227]).

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Ms Chow has been Chief Operating Officer of Chimeric since November 2020. Prior to joining Chimeric, Ms Chow was Head of Global Marketing, Analytics and Commercial Operations at leading global CAR T company Kite Pharmaceuticals (acquired by Gilead Sciences in 2017 for US$12 billion). Ms Chow was responsible for assessing and prioritizing research and external assets for development, ensuring optimal clinical development of the Kite pipeline for global commercialisation.

Ms Chow has more than 20 years of commercial strategy and marketing experience focused on cellular therapy, hematology and oncology. She was previously Global Cell Therapy Commercial Lead at Celgene Corporation and was responsible for designing and developing the global CAR T commercial strategy and operating model. Ms Chow was also formerly at Roche, Nycomed/Takeda and Schering Canada.

"We are delighted to announce the appointment of Jennifer as MD & CEO. During her time with Chimeric thus far as COO, Jennifer has demonstrated outstanding dedication and leadership while importantly proving to be exceedingly knowledgeable in the field of cell therapy," said Paul Hopper, Executive Chairman, Chimeric Therapeutics.

"The team we’ve been able to assemble at Chimeric brings deep scientific & commercial cell therapy expertise to the business and gives us great confidence moving forward under Jenn’s leadership."

For the purpose of ASX Listing Rule 3.16.4, a summary of the material terms of Ms Chow’s employment agreement is set out in appendix 1.

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.

Heat Biologics to Provide Corporate Update

On August 30, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported CEO Jeff Wolf will host a conference call on Thursday, September 2nd at 11:00 A.M. Eastern Time to provide an update on the Company’s activities (Press release, Heat Biologics, AUG 30, 2021, View Source [SID1234587028]).

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The conference call may be accessed by dialing 844-602-0380 for U.S. callers or +1 862-298-0970 for international callers. A webcast of the call may be accessed at View Source or on the Company’s website at View Source

An audio replay of the call will be available through September 16, 2021, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 42602.