On April 10, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the results of the Phase I study for IBI322 (anti-CD47 /PD-L1 bispecific antibody) in patients with advanced solid tumors were presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Poster No. CT513) (Press release, Innovent Biologics, APR 10, 2022, View Source [SID1234611859]).

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This is a first-in-human, phase Ia/Ib dose escalation/expansion study of IBI322 monotherapy in patients with advanced solid tumors who failed standard of care treatment. 58 subjects were enrolled in the study, 16 of which (27.6%) had previously received PD-1/L1 treatment. The highlights for the study results were as follows:

20 patients with various advanced solid tumors at active doses of IBI310 ≥10 mg/kg group were evaluable per RECISTv1.1, 4 achieved PR, with investigator assessed ORR 20%.
Among 9 patients with NSCLC treated at active doses of IBI310 ≥10 mg/kg group, 3 achieved PR, with investigator assessed ORR 33.3% and the DCR 88.9%.
IBI322 was well tolerated and showed a favorable safety profile. Treatment related adverse events (TRAEs) occurred in 74.1% (43/58) patients, most frequent TRAEs including anemia, platelet count decreased, pyrexia. The majority of the TRAEs were in grade 1-2. No treatment related death occurred as the cut-off date.
Phase Ia dose expansion study with IBI322 monotherapy has kept updating with longer follow-up after the cut-off date. Preliminary response and disease control have been observed in specific indications (such as SCLC). More clinical data will be mature and presented in the future.

Furthermore, given that IBI322 has demonstrated promising efficacy signals and favorable safety and tolerability profile, phase Ib trial has been conducted to further explore the safety and efficacy of IBI322 in multiple indications.

Professor Jie Wang, principal investigator of the study, Chief of Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, stated: "Immune checkpoint inhibitors (ICI) have shown promising efficacy in various tumor types, but many clinical challenges still remain. With the increasing prescription of ICI in first-line setting, many patients developed into ICI resistance or has poor response rate in clinical practice. Therefore, it is of great clinical significance to develop next generation bi-specific immune checkpoint inhibitors. CD47 is one of the most promising targets in immunotherapy. With innovate bispecific antibody development technology, IBI322 showed favorable safety and preliminary efficacy signals in subjects who had failed previous standard treatment, which increased our confidence in the subsequent expansion cohort study."

Dr. Hui Zhou, Vice President of Innovent, stated: "IBI322 is a bispecific antibody that specifically targeting recombinant anti-differentiation cluster 47 (CD47) and anti-programmed death ligand 1 (PD-L1).IBI322 is independently developed by Innovent Biologics and the company owns global proprietary rights. We are very excited to observe preliminary efficacy and manageable safety profile in patients with advanced malignancy who failed standard of care treatment. We will continue to proceed the phase Ib expansion cohort study and further explore the safety and efficacy of IBI322 in multiple indications. By developing a comprehensive and advanced pipeline of next generation immune checkpoint inhibitors, we hope to bring clinical benefit to more patients."

About IBI322

IBI322 is a recombinant anti-human CD47/PD-L1 bispecific antibody developed by Innovent Biologics. As a bispecific antibody, IBI322 targets CD47 on the surface of tumor cells, blocks SIRPα/CD47 pathway and activates macrophages to attack the tumor cells. Furthermore, IBI322 target PD-L1 on the surface of tumor cells, blocks the PD-1/PD-L1 pathway, which counteracts the inhibition of T cells and activates the T cells to attack the tumor cells. By inhibiting two different targets, IBI322 can not only activate both innate immune pathway and adaptive immune pathway, which provides synergistic effect, but also reduce the red blood cell destruction. IBI322 has received IND approvals from both the NMPA and the U.S. FDA and has been actively developed globally.

On April 10, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported the publication of five posters that will be presented during the upcoming 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2022), taking place from April 8th to April 13th in New Orleans in person or via virtual attendance (Press release, Antengene, APR 10, 2022, View Source [SID1234611858]).

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"The preclinical studies that we are presenting at AACR (Free AACR Whitepaper) 2022 provide a window into five innovative programs in Antengene’s pipeline," said Bo Shan, Ph.D., Chief Scientific Officer of Antengene. "These programs target areas that we believe are very important in cancer drug development: Tumor microenvironment (TME) regulators (ATG-037), pathway inhibitors (ATG-018, ATG-022 and ATG-008), and ADCs (ATG-022). These studies have been instrumental in guiding our clinical development plans for each program, including selection of combination partners and biomarkers, that could be used to predict efficacy or improve the proportion of patients who respond to treatment. We are very pleased to share these results with the oncology community."

Details of the posters and corresponding abstracts are shown below:

ATG-037, a highly potent small molecule CD73 inhibitor has superior activity of reversing immunosuppression in higher-AMP environments compared with anti-CD73 antibodies

Abstract: 2576

Session: Cell Cycle, Replication Inhibitors, and Immunotherapy Agents

Date and Time: 9:00 AM – 12:30 PM CST, April 12, 2022

Venue: Poster Section 21

This study was designed to compare the T-cell rescue activity of ATG-037, a highly potent and selective oral small molecule inhibitor of CD73, and two CD73 blocking antibodies. CD73 is an enzyme that is highly expressed in the tumor microenvironment and enables the degradation of AMP into adenosine, resulting in immunosuppression and cancer progression. In vitro assays were used to assess each compound’s ability to inhibit CD73 enzyme activity and reverse AMP/adenosine mediated T-cell suppression. ATG-037 demonstrated more potent and complete inhibitory activity of cell surface CD73 in this study.

As shown in Figure, the authors found that ATG-037 had a stronger ability to restore T-cell function in higher-AMP environments compared with other clinical anti-CD73 antibodies. These data highlight the potential therapeutic advantages of small molecule inhibitors of CD73 over blocking antibodies. ATG-037 is being evaluated by Antengene in a Phase I trial as monotherapy and in combination with anti-PD-1 antibody in patients with locally advanced or metastatic solid tumors.

The novel ATR inhibitor ATG-018 is efficacious in preclinical cancer models

Abstract: 2604

Session: DNA Damage Response and Repair

Date and Time: 9:00 AM – 12:30 PM CST, April 12, 2022

Venue: Poster Section 22

In this study, the preclinical pharmacology data set supporting the development of ATG-018, a small molecule ATR inhibitor, was reviewed. Inhibiting ATR kinase (ataxia telangiectasia and Rad3 related kinase) leads to increased accumulation of double-strand breaks, particularly meaningful for tumor cells which rely on DNA damage response (DDR). ATG-018 was tested in a panel of 142 tumor cell lines and three CDX mouse models to assess anti-tumor efficacy and to identify potential predictive biomarkers. ATG-018 was a potent inhibitor of in vitro ATR activity inhibition and cell proliferation without significant impact on normal peripheral blood mononuclear cell (PBMCs) viability.

In addition, a series of genetic alterations were discovered that correlated with ATG-018 sensitivity and could be potential predictive biomarkers. As shown in Figure, the authors found that ATG-018 demonstrated potent in vivo efficacy in solid tumor/hematologic cancer models with certain DDR-related mutations. These data showed the potential of ATG-018 in synthetic lethality with homologous recombination deficiencies and promising application in a wide range of indications. With single-agent activity and no impact on PBMCs viability, ATG-018 may be well positioned for use in mono- or combination therapy in a wide range of tumors that rely on DDR. Development of a set of predictive biomarkers could enable its use as a precision-medicine. Antengene intends to file the first IND for ATG-018 in 2022.

ATG-022, an antibody-drug conjugate targeting Claudin 18.2, demonstrated potent in vivo efficacy in gastric cancer patient-derived xenografts

Abstract: 1143

Session: Preclinical and Clinical Pharmacology

Date and Time: 9:00 AM – 12:30 PM CST, April 11, 2022

Venue: Poster Section 25

In this preclinical study, ATG-022, an antibody-drug conjugate targeting Claudin18.2 (CLDN18.2), was evaluated in several gastric cancer patient-derived xenograft (PDX) models, to assess whether it had potential across a range of CLDN18.2 expression levels. Human CLDN18.2 is ectopically expressed in a large number of gastric and pancreatic cancers. Monoclonal antibody targeting CLDN18.2 demonstrated a promising clinical benefit when used in combination with chemotherapy. However, it showed suboptimal efficacy in patients with low CLDN18.2 levels.

In this study presented in the AACR (Free AACR Whitepaper), ATG-022 is reported to show high affinity (sub-nanomolar grade) against CLDN18.2 and demonstrated potent in vitro and in vivo antitumor effects, with in vivo efficacy observed in CLDN18.2 low expression PDX models. As shown in Figure, ATG-022 demonstrated much better in vivo efficacy compared with benchmark ADC. In addition, ATG-022 was highly specific for CLDN18.2, with virtually no effect on cells expressing CLDN18.1. In addition, ATG-022 has almost no impact on body weight, a proxy for safety. The authors concluded that ATG-022 shows promise for treating gastric cancer patients with a broad range of CLDN18.2 expression levels, a significant unmet need. Antengene is conducting preclinical studies for ATG-022.

Synergistic effects of the combination of Kras (G12C) with SHP2, ERK 1/2, mTORC1/2 or XPO1 inhibition for the treatment of Kras (G12C) mutated cancer

Abstract: 2679

Session: Signaling Pathway Inhibitors

Date and Time: 9:00 AM – 12:30 PM CST, April 12, 2022

Venue: Poster Section 25

This preclinical study was conducted to identify combination therapy regimen that could overcome the short progression free survival that is a characteristic of KRAS G12C inhibitors (linked to acquired resistance). The study evaluated the anti-tumor activity of ATG-012, a KRAS G12C inhibitor, with four other agents that are involved in the multiple pathways impacted by RASi: i) an SHP2 inhibitor (ET0038), ii) an ERK 1/2 kinase inhibitor (ATG-017), iii) an mTORC1/2 kinase inhibitor (ATG-008) or iv) the XPO-1 inhibitor, Selinexor, in preclinical solid tumor CDX models.

While ATG-012 monotherapy induced dose-dependent tumor growth inhibition at day 27, as shown in Figure, the authors also found strong in vivo synergism in 2-agent combinations. In particular, ATG-012 and clinical stage ERK inhibitor (ATG-017) demonstrate strong in vitro and in vivo synergism, suggesting potential clinical application which may overcome the rapid resistance of KRAS inhibitors. These data open the door to a range of combination partners for ATG-012 that could be fine-tuned to address drug resistance and potentially improve progression-free survival by matching tumor type/histology and combination partner for patients with the KRAS G12C mutation. Antengene is conducting preclinical studies for ATG-012.

Identification of MUC5B mutation as a positive predictive biomarker for mTORC1/2 inhibition by ATG-008 in lung cancer

Abstract: 4032

Session: Molecular Pharmacology

Date and Time: 9:00 AM – 12:30 PM CST, April 13, 2022

Venue: Poster Section 26

This study was designed to evaluate whether MUC5B could serve as a positive predictive biomarker for mTORC1/2 inhibition by ATG-008 (Onatasertib) in lung cancer. ATG-008 is a dual mTOR complex 1/2 kinase inhibitor. The mTOR complex regulates cell growth, metabolism, proliferation and survival. While the mTOR pathway is frequently deregulated in cancers, efficacy of mTOR inhibitors in lung cancer has been modest. In the study, 31 lung cancer cell lines were treated with ATG-008 to determine dose response and to correlate the gene mutation, amplification and expression with sensitivity to ATG-008.

As shown in Figure, the authors found that the presence of the MUC5B mutation correlates with more potent anti-tumor efficacy of ATG-008 in vitro and in vivo in lung cancer CDX models. The mucin MUC5B has a critical protective role in normal lung and has been identified as prognostic marker in multiple tumor types. One observation highlighted in the poster is that MUC5B is also mutated in melanoma, endometrial, colorectal, esophogastric and cervical cancers, vastly expanding the potential clinical utility of MUC5B mutation as the predictive biomarker for ATG-008. ATG-008 is being evaluated by Antengene in multiple Phase I and II clinical trials.

On April 10, 2022 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported promising preclinical results of its proprietary, non-viral gene monoclonal antibody (GMAB) platform in multiple solid tumor models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting (Press release, Gennao Bio, APR 10, 2022, View Source [SID1234611851]). The findings from these studies were reported and discussed in an oral presentation by Elias Quijano, M.D./Ph.D. candidate in the laboratory of Dr. Peter Glazer at the Yale School of Medicine, and co-founder of Gennao Bio, entitled, "Systemic targeting of therapeutic RNA to cancer via a novel, cell-penetrating and nucleic acid binding, monoclonal antibody."

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The preclinical results demonstrated GMAB’s ability to form non-covalent complexes with and systemically target and deliver 3p-hpRNA, a potent activator of the immune signaling RIG-I pathway, to solid tumors, including orthotopic mouse models of human pancreatic cancer (KPC) and medulloblastoma (DAOY). GMAB’s highly specific delivery into tumors is independent of the endocytic pathway and is uniquely enabled by targeting ENT2, a nucleoside transporter that is overexpressed in many tumors. In vitro studies of GMAB/3p-hpRNA demonstrated that delivery of a RIG-I agonist to tumor cells triggers an immune stimulating type-1 interferon response and triggers direct tumor cell death.

"These positive results further reinforce our strong belief in the broad therapeutic potential and diverse application of our GMAB platform in treating cancers with substantial unmet need," said Stephen Squinto, Ph.D., chief executive officer and chair of the board of Gennao Bio. "We expect to advance the humanized version of GMAB/3p-hpRNA, GMAB-7001, into Investigational New Drug (IND)-enabling studies in the second half of 2022 and will continue to assess additional oncology pipeline programs."

In the KPC pancreatic cancer model, multiple doses of GMAB/3p-hpRNA resulted in a significant survival benefit, driven in part by long-term increases in tumor-infiltrating lymphocytes, including CD45+, CD8+, CD4+, and CD19+ cells. GMAB/3p-hpRNA treatment also showed a statistically significant increase in tumor cell necrosis compared to the control group. Previous studies of a single dose administration of GMAB/3p-hpRNA in an orthotopic model of medulloblastoma demonstrated its ability to penetrate the central nervous system, reduce intracranial tumor burden by 50%, and prevent spinal metastases.

"The GMAB platform has the potential to address the challenges faced by alternative methods of delivery of immunostimulatory nucleic acids to tumors, which have been associated with systemic toxicities or rely on suboptimal intra-tumoral injections. Studies of single and multiple intravenous doses of GMAB/3p-hpRNA have shown targeted payload tumor delivery and resultant tumor growth suppression in several preclinical models of difficult-to-treat forms of cancer," said Mr. Quijano. "These promising monotherapy results, and the new data generated in a difficult-to-treat pancreatic cancer model, warrant continued research of the GMAB platform and development of this new class of targeted nucleic acid therapeutics for cancer."

A copy of the AACR (Free AACR Whitepaper) presentation can be found under the "News" section on the Company’s website, www.gennao.com.

On April 10, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported it will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 8-13, 2022 in New Orleans (Press release, Triumvira Immunologics, APR 10, 2022, View Source [SID1234611850]). The company will present an update from its ongoing TACTIC-2 clinical trial evaluating TAC01-HER2 in patients with HER2-positive solid tumors and new preclinical proof-of-concept data for its gastric cancer candidate, TAC-Claudin 18.2 (CLDN18.2).

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Triumvira’s TAC-T cell therapies feature TAC receptors that interact with the natural T cell receptor to uniquely help T cells recognize and eliminate cancer cells. They are designed to target specific cancer signatures, like HER2 and CLDN18.2. HER2 is commonly overexpressed in various solid tumors, including breast, ovarian and non-small cell lung cancers. CLDN18.2, by similar fashion, is a promising and reliable antigen selectively expressed on the surface of gastric tumor cells.

"We are very encouraged by the current progress of our clinical trial for TAC01-HER2, which has generated high levels of interest and momentum shown by the growing number of participating sites and noticeable increase in patient screening and enrollment by our investigators," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira. "This will enable us to discuss patient data over the coming months at major cancer conferences in the USA and Europe."

"Our new preclinical evidence bolsters the viability of targeting CLDN18.2 and further demonstrates the versatility of our TAC platform for difficult-to-treat cancers," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. "We plan to build on this success through an eventual IND filing for CLDN18.2 and look forward to expanding our novel platform to address additional targets."

Update on TACTIC-2 study

Triumvira will provide an update on its ongoing TACTIC-2 Phase 1/2 multicenter, open-label trial designed to evaluate the safety, tolerability and efficacy of TAC01-HER2 in patients with HER2-positive solid tumors. Recruitment is ongoing across four sites in the U.S. and Canada as Triumvira plans to enroll approximately 135 participants in total. Patient cohort 1 dose level has completed enrollment and treatment with TAC-T cell therapy and met the requirements for evaluation of dose-limiting toxicities. In addition, the data safety monitoring committee completed its review of safety data from cohort 1, and recommended initiating enrollment for cohort 2.

Session: PO.CT01.04 – Phase I Trials in Progress 2
Presentation Title: CT247 / 8 – A phase I/II trial investigating safety and efficacy of autologous TAC T cells targeting HER2 in relapsed or refractory solid tumors (TACTIC-2)
Date: April 13, 2022, 9:00 AM – 12:30 PM CT
Location: Section 35

TAC-Claudin 18.2 demonstrates strong and specific activity against CLDN18.2-expressing solid tumor models

In the preclinical study of CLDN18.2, strong and specific activity of TAC-T cells targeted against CLDN18.2 was shown through a variety of in vitro assays, including demonstrated TAC-T cell activation in target cells expressing CLDN18.2. Lack of activity and increases in cytokine levels were observed in control settings, indicating that the T cell response is specific to the CLDN18.2 antigen. In addition to positive in vitro results, intravenous administration of CLDN18.2-TAC T cells led to sustained anti-tumor responses in various in vivo CLDN18.2 mouse models.

Session: PO.IM02.02 – Adoptive Cell Therapy 2
Presentation Title: 572 / 7 – Pre-clinical evaluation of Claudin 18.2 TAC T cells for the treatment of gastric cancer
Date: April 10, 2022, 1:30 – 5:00 PM CT
Location: Section 37

On April 10, 2022 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, reported a data update from the ongoing study of the Company’s lead innate cell engager (ICE) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells (Press release, Affimed, APR 10, 2022, View Source [SID1234611846]). AFM13 is currently being investigated at The University of Texas MD Anderson Cancer Center in a phase 1/2 study in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas. The investigator-sponsored study is led by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The study shows a 100% objective response rate (ORR) and an improvement of complete response (CR) rate to 62% at the recommended phase 2 dose (RP2D) in 13 patients after 2 cycles of therapy. The results will be presented today during the Clinical Plenary Session on cellular immunotherapies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 and will also be covered during an AACR (Free AACR Whitepaper) press conference this morning.

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"The data that we report today are highly encouraging. All patients on this trial were refractory to all available treatment options. Still the combination of AFM13 and precomplexed NK cells resulted in a 100% response rate and a 62% rate of complete responses. We are excited to see a deepening of responses from partial responses to complete responses with a second cycle and have amended the study to allow patients to receive additional cycles, which may further increase the efficacy," said Dr Andreas Harstrick, Chief Medical Officer at Affimed. "To our knowledge, this is the highest response rate reported so far in Hodgkin Lymphoma patients with treatment refractory disease."

As of the cut-off date, the study had enrolled 22 patients with relapsed or refractory CD30+ Hodgkin and non-Hodgkin lymphoma having received a median of seven prior lines of therapy, of whom 19 were evaluable for response. Thirteen response-evaluable patients were treated at the RP2D, including 12 patients with Hodgkin Lymphoma and one patient with non-Hodgkin Lymphoma. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with AFM13. Three weekly infusions of AFM13 (200 mg) monotherapy are subsequently administered and responses are assessed by the investigator on day 28 by FDG-PET.

All 13 patients treated at the recommended phase 2 dose (108 NK/Kg) achieved a response by Lyric criteria. Of these 13 patients, 8 patients (62%) demonstrated a CR after two cycles of treatment, which represents an increase from 5 patients (38%) demonstrating CR after one cycle of treatment previously announced in December 2021.

For the 13 patients treated at the RP2D, median duration of response has not yet been reached. As of the cutoff date, assessment of durability shows:

Seven patients remain in CR at median follow-up of 6.5 months, including two patients who remain in response after 10 months and two patients who received stem cell transplant and remain in response at 6.5 months
One patient with a CR experienced disease progression after 7.9 months
Of the five patients with a PR, one remains in response at 6.3 months and four patients progressed between 2.9 and 4.3 months after initial infusion
The treatment was well tolerated, with minimal side effects beyond the expected myelosuppression from the preceding lymphodepleting chemotherapy. No instances of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host disease were observed. There were six infusion-related reactions in 110 infusions (5.4%) of AFM13 alone and no reactions to the cord blood-derived NK cells precomplexed with AFM13.

"A year ago, we were struck with hopeful optimism when the first four patients in the study all showed a response. Now, we are again presenting data at AACR (Free AACR Whitepaper) and the results not only hold strong in a larger patient population but also show an increasing number of CRs with early but encouraging durability," commented Dr. Adi Hoess, Chief Executive Officer at Affimed. "These ongoing successes with AFM13 represent an important milestone for Affimed and could mark a turning point in the innate immuno-oncology space, potentially setting the stage for expanding this approach to additional cancer indications. Our goal is to leverage the distinct features of our ROCK platform to generate best-in-class ICE molecules that drive effective innate immune cell activation for the benefit of broad patient populations, addressing hematologic and solid tumor malignancies."

The trial was originally designed to include up to two cycles. To assess durability beyond two cycles, an amendment has been approved by the U.S. Food and Drug Administration to increase the length of treatment from two up to four cycles, enabling longer follow up of patients.

AFM13, a bispecific tetravalent ICE molecule, is designed for high affinity binding, both to CD16A on NK cells and macrophages, and to CD30 on lymphoma cells. AFM13 is also being investigated as a monotherapy and can bind the patient’s own NK cells, thus boosting their existing capacity to fight cancerous cells. When precomplexed with AFM13, NK cells exhibit immediate expansion in the patient’s circulation which persists for at least two weeks.

Oral presentation details

Title: Innate cell engager (ICE) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma

Presentation: CT003

Session: Clinical Trials of Cellular Immunotherapies, Sunday, April 10, 1:00 – 3:00 p.m. CST

About the Phase 1/2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored Phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of pre-complexed NK cells, with patients receiving 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and activity and determine the recommended Phase 2 dose. In each cohort, the dose of the pre-complexed NK cells with AFM13 is to be followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28.

MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.

Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 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. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331).