CD30-positive diffuse large B-cell lymphoma

MANNHEIM, Germany, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) has selected "acimtamig" for the nonproprietary name of the Company’s investigational drug for CD30-positive Lymphomas, previously known as AFM13. Following the WHO nomenclature scheme, the name recognizes the drug as a tumor targeting bispecific antibody. Acimtamig (AFM13) is currently being evaluated in combination with AlloNK® (formerly AB-101) natural killer (NK) cells in patients with relapsed or refractory (r/r) Hodgkin Lymphoma in LuminICE-203, a phase 2, open-label, multi-center study (NCT05883449); the study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients (PTCL). Acimtamig and AlloNK® therapy was recently granted fast track designation by the FDA, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. “Selection of the INN acimtamig by the WHO is an important milestone in the clinical development of AFM13 with initiation of the LuminICE-203 study underway,” said Dr. Adi Hoess, Chief Executive Officer at Affimed. “It adds to the momentum of the fast track designation awarded by the FDA earlier this year to the acimtamig and AlloNK® combination. We look forward to reporting the first data from the LuminICE-203 study in the first half of 2024 and to bringing this important therapy to patients with high unmet needs.” About Acimtamig (AFM13)Acimtamig is a first-in-class ICE® that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells. About Affimed N.V.Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Mannheim, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com. Forward-Looking StatementThis press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future. Investor Relations ContactAlexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102 Media ContactMary Beth Sandin Vice President, Marketing and CommunicationsE-Mail: m.sandin@affimed.com

This marks the first IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease Artiva also announced the formation of an advisory board to provide expertise in advancing innovative cell therapies for lupus and other autoimmune diseases SAN DIEGO--(BUSINESS WIRE)-- Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for AlloNK® (also known as AB-101), in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN). AlloNK is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved NK cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity (ADCC). This IND clearance marks the first for an allogeneic, off-the-shelf NK or CAR-T cell therapy in autoimmune disease. AlloNK is currently being investigated in two cancer clinical trials in combination with antibody or NK-engager biologics. Artiva presented data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the therapeutic potential and favorable safety pro AlloNK in combination with rituximab in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). “Seminal clinical data has been generated using autologous CAR-T cells suggesting that a deeper B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis. However, the use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line B-NHL patients in an ongoing Phase 1 study by enhancing the activity of rituximab. Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.” As Artiva broadens the applications of AlloNK into autoimmune disease, the company has assembled an advisory board of experts in SLE and LN: Kenneth Kalunian, M.D., is a clinician and Professor of Medicine at UC San Diego, where he directs the Lupus Research and Clinical Center of Excellence. Dr. Kalunian participates in multiple lupus clinical networks, including as a founding member of both the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) and the Lupus Clinical Investigators Network (LuCIN). Jill Buyon, M.D., is a clinician and Professor of Rheumatology and Director of the Division of Rheumatology at New York University (NYU) School of Medicine, and Director of the NYU Lupus Center. Dr. Buyon has published more than 200 papers in peer-reviewed science journals and has been an active member of the Accelerating Medicines Partnership. Maureen McMahon, M.D., is a clinician and Professor of Medicine / Rheumatology at UCLA and site director of the UCLA Lupus Clinical Trials Network. Her research and clinical work have focused on identifying new treatments for SLE. Brad Rovin, M.D., is a Professor of Medicine and Pathology and Director of the Division of Nephrology at The Ohio State University, Wexner Medical Center. Dr. Rovin studies the immunopathogenesis of glomerular and autoimmune diseases and is heavily involved in clinical trial development and design for investigator-initiated and industry-sponsored trials. “Although rituximab has been used off-label in the treatment of SLE, rituximab alone has been shown to give incomplete B-cell depletion. The addition of allogeneic NK cells as an ADCC-enhancing therapy could significantly enhance rituximab’s ability to drive deeper levels of B-cell depletion,” said Dr. Kalunian. “Furthermore, SLE patients may have lower levels of NK cells than healthy subjects, and these cells may be functionally impaired. An effective off-the-shelf cell therapy that can be administered and managed in the community setting could be well received by lupus patients and physicians.” About Systemic Lupus Erythematosus Systemic lupus erythematosus (SLE) is a chronic, potentially severe, autoimmune disease characterized by abnormal B-cell function and autoantibody production resulting in a range of clinical manifestations including end organ damage and an increased risk of death. SLE affects an estimated 160,000-320,000 patients in the U.S. Lupus nephritis (LN) is the most common end-organ manifestation of SLE, affecting approximately 40% of SLE patients, and more than 40% of patients with the most severe LN will develop end-stage renal disease requiring dialysis and transplant within 15 years. About AlloNK® AlloNK® (also known as AB-101) is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva is investigating AlloNK® in a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AlloNK alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL). Artiva is also investigating the safety and clinical activity of AlloNK in combination with rituximab in patients with lupus nephritis. In addition, Artiva is collaborating with Affimed N.V. in a Phase 2, open-label, multi-center, multi-cohort study (NCT05883449, LuminICE-203) testing a combination therapy, comprised of AlloNK and the innate cell engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Artiva selects cord blood units with the high affinity variant of the CD16 receptor and a KIR-B haplotype for enhanced product activity. Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other activating NK receptors, without the need for engineering. AlloNK is being administered in the outpatient setting over multiple doses and multiple cycles. About Artiva Biotherapeutics Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies that are safe and accessible to patients. Artiva has taken a Manufacturing-First approach to create a highly scaled process where one umbilical cord blood unit yields thousands of one-billion cell doses of AlloNK. Artiva’s pipeline includes AlloNK®, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme and with Affimed N.V. Artiva’s cell therapy manufacturing platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego. For more information, visit .

Objective response observed in 9/10 patients and complete response observed in 7/10 patientsNo patients proceeded to autologous stem cell transplant (ASCT) as of data cut-off Well tolerated safety profile - no Grade 3 or above CRS, no neurotoxicity SINGAPORE, June 16, 2023 (GLOBE NEWSWIRE) -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today presented encouraging safety and efficacy data from a combination study of its autologous CD30 CAR-T therapy (TT11) with Bristol Myers Squibb’s nivolumab at the 17th International Conference on Malignant Lymphoma taking place from June 13-17, 2023, at Lugano, Switzerland. TT11 is an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy that harvests the patient’s own T-cells and modifies them to target cancer cells expressing the CD30 protein, a well-validated lymphoma target. TT11 is currently being investigated in combination with Nivolumab in Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients after frontline therapy failure (NCT05352828). ACTION is a single arm multi-centre Phase 1b study. Study protocol involves patients being treated with 2 cycles of Nivolumab, followed by a single infusion of CD30.CAR-T preceded by lymphodepletion (LD) chemotherapy. An additional 2 cycles of Nivolumab are then given, followed by response assessment by PET/CT per Lugano 2014 criteria. Patients without progressive disease may undergo either autologous stem cell transplant (ASCT) or continue Nivolumab up to 6 additional cycles per physician and patient preference. A total of 15 patients were enrolled of which 13 were treated with Nivolumab + CD30 CAR-T therapy. 10 patients reached End of Treatment (Post-Nivo Cycle 4) and were evaluable for response. Of the 10 patients 9 responded to the treatment with complete disappearance of tumor observed by PET/CT in 7 patients and partial reduction in tumor size observed in 2 patients. One patient had stable disease. Of note, no patients proceeded to receive autologous stem cell transplant (ASCT) as of the data cut off. All 10 patients reaching EOT (Post-Nivo Cycle 4) proceeded to additional Nivo cycles. The therapy was well tolerated with no grade 3 or higher Cytokine Release Syndrome (CRS) and no neurotoxicity. Two patients experienced grade 1 CRS, which resolved without use of steroid or tocilizumab. CD30.CAR-T expansion and persistence was observed post infusion. CAR-T cells continued to persist until data cut-off for the results (day 77 post infusion) with peak expansion observed in peripheral blood at 8 days post infusion. “CD30 CAR-T therapy in combination with Nivolumab has demonstrated promising anti-tumor efficacy with a very good safety profile in r/r cHL patients after primary treatment,” said Sairah Ahmed, M.D., lead presentation author, and Associate Professor, The University of Texas MD Anderson Cancer Center. “The results are quite encouraging and warrant further development of this combination therapy among r/r cHL patients.” Circulating tumor ctDNA-MRD (minimum residual disease) was assessed with PhasED-Seq (Foresight Diagnostics) in 3 patients with complete responses at End of Treatment (EOT). All 3 patients (100%) had undetectable ctDNA-MRD demonstrating deep molecular response. Additional patient samples are currently under assessment. “We are very encouraged by the exciting results demonstrated by the ACTION study. These results offer the potential to re-define Hodgkin lymphoma treatment paradigm, offering a second line treatment alternative free of transplant and high dose chemotherapy to patients who fail frontline therapy,” said Thomas Willemsen, President and CEO, Tessa Therapeutics. He added, “The well tolerated safety profile is especially meaningful for older patients with poor tolerability and young adolescents with risk of long-term sequelae from current standard of care.” About Tessa TherapeuticsTessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumors. Tessa’s autologous CD30 CAR-T therapy TT11, is currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma as both a monotherapy (Phase 2) and combination therapy (Phase 1b). TT11 has been granted RMAT designation by the FDA and access to the PRIME scheme by European Medicine Agency. Tessa is also advancing an allogeneic “off-the-shelf” cell therapy platform targeting a broad range of cancers in which Epstein Barr Virus Specific T Cells (EBVSTs) are augmented with CD30-CAR. This platform is currently the subject of a Phase 1 clinical trial in CD30-positive lymphomas. Tessa has its global headquarters in Singapore, where the company has built a state-of-the-art, commercial cell therapy manufacturing facility. For more information on Tessa, visit www.tessacell.com. Cautionary Note on Forward Looking Statements This press release contains forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, to the fullest extent applicable) including, without limitation, with respect to various regulatory filings or clinical study developments of the Company. You can identify these statements by the fact that they use words such as “anticipate,” “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “may”, “assume” or similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the Company’s financial results, the ability to raise capital, dependence on strategic partnerships and licensees, the applicability of patents and proprietary technology, the timing for completion of the clinical trials of its product candidates, whether and when, if at all, the Company’s product candidates will receive marketing approval, and competition from other biopharmaceutical companies. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made, and disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company’s products are expressly for investigational use pursuant to a relevant investigational device exemption granted by the U.S. Food & Drug Administration, or equivalent competent body. Tessa Therapeutics Investor Contact Wilson W. Cheung Chief Financial Officer wcheung@tessacell.com Tessa Therapeutics Media Contact Tiberend Strategic Advisors, Inc. Bill Borden +1-732-910-1620 bborden@tiberend.com Dave Schemelia +1-609-468-9325 dschemelia@tiberend.com