CD138

LOS ANGELES, Aug. 6, 2024 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi) announces a $1M investment commitment by the Myeloma Investment Fund (MIF) in a $30M Series B financing round prior to the planned start of a first-in-human Phase 1 study of our lead program, QXL138AM, in patients with locally advanced unresectable and/or metastatic solid tumors and multiple myeloma. QXL138AM is a Masked Immunocytokine (MIC) comprised of a masked interferon alpha (IFNa) fused to an antibody that targets the CD138 protein on the surface of the tumor cells. Once QXL138AM binds to the tumor cell, proteases on the cell surface cleave the mask off of the IFNa allowing it to bind its receptor. Activation of the IFNa receptor complex induces direct killing of tumor cells in addition to activating innate and adaptive anti-tumor immunity. Preclinical data has demonstrated significant anti-tumor efficacy across more than 10 tumor types including multiple myeloma where complete regression at doses as low as 0.1 mg/kg have been observed. Nammi has secured Orphan Drug Designation in multiple myeloma from the FDA on the strength of this data. "While the multiple myeloma field has greatly benefitted from development of bispecific and cell therapies, there unfortunately remains a significant need for novel therapeutics such as QXL138AM.", said David Stover, Ph.D., President and CEO of Nammi. "We are very excited to partner with MIF and the Multiple Myeloma Research Foundation (MMRF) and leverage their expertise to accelerate the development of QXL138AM. Together, we will work to realize the potential of this therapy to improve the lives of patients with multiple myeloma." With this investment by MIF, Nammi anticipates the $30M Series B financing round will be fully subscribed upon its closing when the first patient has been treated with QXL138AM. "Nammi's innovative technology and its application in multiple myeloma is an important step for the myeloma patient community," said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation. "Advancing new therapeutic options for patients is the most critical task-at-hand, so we are thrilled to support Nammi's Phase-1 trial to learn the potential of this exciting new immunotherapy approach." About Nammi Therapeutics, Inc. Nammi Therapeutics, Inc. is an immuno-oncology company based in Los Angeles that is developing platforms and products that selectively activate anti-tumor immunity within the tumor microenvironment while minimizing systemic activation. By reducing systemic activation of the immune system, Nammi expects to improve safety and enhance the ability to combine multiple immune modulators. In addition to the MIC platform, Nammi has also developed a nanoparticle platform to deliver Immune Modulating Prodrugs (IMPs) using their Nammisome technology. Multiple Nammisome clinical candidates have also been selected for development. For more information visit or email [email protected] About the Myeloma Investment Fund (MIF) The Myeloma Investment Fund is a venture philanthropy fund that invests in promising companies, clinical assets, and technologies in oncology to drive the development of new therapies for multiple myeloma. The MIF collaborates closely with portfolio companies to help them advance multiple myeloma research. This evergreen fund is supported entirely by philanthropy; all profits will be reinvested back into research for more effective treatments until there is a cure for every patient. For more information, visit About the Multiple Myeloma Research Foundation (MMRF) The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. We drive the development and delivery of next-generation therapies, leverage data to identify optimal and more personalized treatment approaches and empower myeloma patients and the broader community with information and resources to extend their lives. Central to our mission is our commitment to advancing health equity so that all myeloma patients can benefit from the scientific and clinical advances we pursue. Since our inception, the MMRF has committed over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market, which have tripled the life expectancy of myeloma patients. To learn more, visit For MMRF or MIF media inquiries, please contact: Anna Otis, Manager, Brand Marketing, [email protected] SOURCE Nammi Therapeutics, Inc.

SAN DIEGO, July 23, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO), today announced the publication of the first multi-site study in multiple myeloma (MM) comparing optical genome mapping (OGM) to traditional cytogenetic methods for the detection of structural variants (SVs). Multiple myeloma is a type of blood cancer originating in the plasma cell, known as a plasma cell neoplasm (PCN), and though sensitive and accurate identification of genetic abnormalities in MM samples is critical for patient risk stratification, predication of response to therapy options, and understanding of pathogenesis, many genome analysis methodologies, including fluorescence in situ hybridization (FISH) and chromosomal microarray (CMA), are limited in their ability to detect complex gene rearrangements in PCN samples. Additionally, karyotype (KT) fails for PCNs at a higher rate than for leukemias because plasma cells are fragile and grow poorly in culture, leaving additional unmet need. Because OGM doesn’t require culture, it may be well suited to fill this gap. In this study, conducted by researchers at University of Texas MD Anderson Cancer Center and The Johns Hopkins Hospital, researchers concurrently analyzed 45 PCN samples using KT, FISH, OGM, and next-generation sequencing (NGS). OGM uniquely identified complex genomic rearrangements that are associated with cancer proliferation and progression, resulting in a change in prognostication beyond that indicated by traditional cytogenetic analysis in 18% of cases. In at least five cases (11%), OGM’s unique findings provided precise information to predict response to target therapies like BCMA monoclonal antibody, CAR-T, or GPRC5D targeted therapies, which may have therapeutic implications. The study results highlight OGM’s ability to provide researchers with a highly sensitive, accurate genome-wide analysis that can lead to a more comprehensive understanding of genetic subtypes in PCN when compared with FISH and KT. Key findings: Compared to FISH, OGM achieved 100% sensitivity, specificity, and accuracy in cases after CD138 selection and 96.6% sensitivity, 100% specificity, and 98.3% accuracy in unselected casesOGM detected gains of chromosome 1q in several samples, a known high-risk factor in MMOGM revealed 18 hyperdiploidy, 4 hypodiploidy, and 9 IGH or MYC rearrangements undetected by FISHIn 18% of cases (8 out of 45), OGM identified chromoanagenesis that was undetected by FISHIn 18% of cases (8 out of 45), OGM changed the prognostication beyond that indicated by standard cytogenetics/FISH analysisOGM detected 366 novel structural variants and copy number variants that are potentially relevant to the formation and development of MM “Though many research studies demonstrate OGM’s utility in leukemias and other blood cancers, we were pleased to see robust findings from the first multi-site study of OGM in multiple myeloma, which is a blood cancer that is more difficult for researchers to assess. OGM has the potential to identify pathogenically relevant variants missed by other methods that further our understanding of MM, which we believe may lead to greater adoption of the workflow in labs focused on cancer research,” commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The publication can be viewed here. About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services. For more information, visit www.bionano.com or www.bionanolaboratories.com. Forward-Looking Statements of Bionano This press release contains forward-looking statements contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “ability,” “believe,” “can,” “may,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances and the negatives thereof) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of OGM to detect SVs missed by other cytogenetic methods, including KT, FISH, and CMA; the ability and utility of OGM to provide highly sensitive, accurate genome-wide analysis, that can lead to a more comprehensive understanding of genetic subtypes in PCN when compared with FISH and KT; the ability and utility of OGM to detect SVs relevant to multiple myeloma; the ability of OGM to provide results that are concordant traditional methods, including FISH and KT; the ability of OGM to detect SVs that are relevant to prognostication; and other statements that are not historical facts. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and future bank failures, the ongoing conflicts between Ukraine and Russia and Israel and Hamas, and related sanctions, and any global pandemics, inflation, or supply disruptions, on our business and the global economy; challenges inherent in developing, manufacturing and commercializing products; our ability to further deploy new products and applications and expand the markets for our technology platforms; the failure of OGM to detect SVs missed by other cytogenetic methods, including KT, FISH, and CMA; the failure of OGM to provide highly sensitive, accurate genome-wide analysis, that can lead to a more comprehensive understanding of genetic subtypes in PCN when compared with FISH and KT; the failure of OGM to detect SVs relevant to multiple myeloma; the failure of OGM to provide results that are concordant traditional methods, including FISH and KT; the failure of OGM to detect SVs that are relevant to prognostication; future study results that contradict or do not support the study results described in this press release; our expectations and beliefs regarding future growth of the business and the markets in which we operate; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of institutions to obtain funding to support adoption or continued use of our technologies; and including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We are under no duty to update any of these forward-looking statements after the date they are made to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date the statements are made. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this press release. CONTACTS Company Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com

SHANGHAI and ROSELAND, N.J., June 5, 2024 /PRNewswire/ -- Oricell Therapeutics, a pioneering clinical-stage biopharmaceutical company, has presented the two-year long-term follow-up results of OriCAR-017, an open-label Phase I study evaluating GPRC5D-targeted CAR-T therapy in patients with relapsed/refractory multiple myeloma (RRMM), in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Efficacy & Durability of OriCAR-017 in RRMM Patients The updated data demonstrates that OriCAR-017 elicits deep and durable responses in RRMM patients as well as a favorable safety profile, including those refractory to anti-CD38 therapies, PIs, IMIDs, and those who have failed BCMA targeting CAR-T treatment. The long-term efficacy and safety follow-up results support OriCAR-017 as a promising therapeutic approach for RRMM. Currently, Oricell is smoothly advancing the clinical development of OriCAR-017 in both China (NCT06182696) and the United States (NCT06271252). As of January 16, 2024, all ten patients responded well to OriCAR-017, with the last patient having completed a 24-month follow-up. The overall response rate (ORR) was 100.0%, with a stringent complete response rate (sCR) of 80.0% and a very good partial response rate (VGPR) of 20.0%. All patients achieved 100% minimal residual disease negativity (MRD) at day 28, which was further confirmed as 100% negative at the 3-months follow-up. The median duration of response (mDoR) was 10.43 months (95% CI, 5.00-17.00), the median progression-free survival (mPFS) was 11.37 months (95% CI, 5.93-18.00), and the median overall survival (mOS) had not yet been reached (7 patients were still under survival follow-up, 1 patient died due to disease progression, and 2 patients died from COVID-19). In the high-dose group, where 67% of patients were previously treated with BCMA CAR-T, the mDoR was 17.23 months (95% CI, 7.33-NR), and the mPFS was 19.10 months (95% CI, 8.30-NR). Currently, a BCMA CAR-T-treated patient is still in remission (>24 months). Safety Profile of OriCAR-017 in the Treatment of RRMM The therapy was well-tolerated, with 9 out of 10 patients (90%) experiencing Grade 1 cytokine release syndrome (CRS) and only 1 patient (10%) experiencing Grade 2 CRS. No Grade 3 or higher CRS was observed. The median time to CRS onset was 2 days (range 1-9 days), with a median duration of 6 days (range 3-9 days). No immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicities (DLTs) were observed. There were no serious adverse events (SAEs) or treatment-related deaths, cerebellar disorders, or delayed infections reported. Pharmacokinetics (PK) of OriCAR-017 in RRMM Patients There were no pharmacokinetic differences between dose levels, with a Cmax of 7354.7 copies/μL and an AUC0-28 of 68587 copies•day/μg. At high doses, CAR-T cells were still detectable at 9 months, and after 21 months of follow-up, one patient had CAR-T cell expansion above the lower limit of quantitation (LLOQ). Patients with Tlast ≥ 9 months had a longer PFS compared to those with Tlast < 9 months. G5 Expression in Response to OriCAR-017 Treatment in RRMM No correlation was observed between antigen expression and therapeutic efficacy. Baseline data from all patients showed positive GPRC5D expression in bone marrow CD138+ plasma cells (MMPC), while 50% of relapsed patients showed downregulated expression detected by flow cytometry. OriCAR-017 Demonstrates Significant Potential in Severely Progressed RRMM Patients It's worth noting that the study included patients with complex and advanced disease characteristics. Among the ten R/R MM patients, 40% had extramedullary disease (EMD), 50% had undergone one or more BCMA-directed CAR-T treatments, 70% had high-risk cytogenetics, 70% were classified as ECOG 2 score status, and 80% were at International Staging System (ISS) stages II & III. OriCAR-017 demonstrates its potential as a safe and efficacious treatment option for RRMM patients, marking a substantial progress in the fight against multiple myeloma and offering hope to those facing demanding health conditions. Details for the presentation as below: Oral Presentation #7511 Title: OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Session Type:Rapid Oral Abstract Session Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia Link: About OriCAR-017 OriCAR-017, a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D, is a groundbreaking innovation in the treatment of relapsed/refractory multiple myeloma (RRMM). Leveraging Oricell Therapeutics' cutting-edge proprietary technology platforms, OriCAR-017 exhibits clearly differentiated binding avidity, persistence, anti-tumor efficacy and safety profile. OriCAR-017 received IND approval from FDA in Jan 2024 after its approval by NMPA in 2023. Impressive clinical results from the POLARIS study continue to be released. Currently, Oricell has assembled a skilled team to operate in both the U.S. and China, collaboratively accelerating pipeline development globally. SOURCE OriCell Therapeutics Co., Ltd.