On May 12, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the online publication of four abstracts submitted to the European Hematology Association (EHA) (Free EHA Whitepaper) Congress to be held June 9-12, 2022. Autolus plans to present more detail on these programs and the next steps in a conference call following the EHA (Free EHA Whitepaper) presentations, on June 13, 2022, details below (Press release, Autolus, MAY 12, 2022, View Source [SID1234614415]).

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"We are delighted to be presenting encouraging early clinical data from four of our pipeline programs, including important additive safety and efficacy data from our lead asset obe-cel in indications beyond adult r/r B-ALL. These data demonstrate the inherent value in both our pipeline and our technology base from which it originates," said Dr. Christian Itin, Chief Executive Officer of Autolus. "With oral presentations on the early safety, tolerability, feasibility and preliminary efficacy of AUTO4 and AUTO1/22, we’re in a great place to evaluate the next strategic steps for these candidates and further build on the data presented here."

Abstracts to be presented:

Title: Safety and preliminary efficacy findings of AUTO4, a TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive selected T Cell Non-Hodgkin Lymphoma LINK
Session Title: Gene therapy and cellular immunotherapy – Clinical 2
Session date and time: Saturday, June 11 – 16:30 – 17:45 CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S261
Presenting Author: Kate Cwynarski
Summary: Peripheral T cell lymphomas (PTCL) are typically aggressive, treatment resistant, and associated with poor prognosis. Finding the right target is challenging because there is a lack of tumor-specific antigens, and pan-T cell depletion leads to immunosuppression. T cell lymphoma is clonal, and tumor cells express either TRBC1 or TRBC2. AUTO4 targets TRBC1+ cells, which allows part of the T cell compartment to be retained. As of 9 February 2022, 9 patients screened for r/r TRBC1+ peripheral T-cell lymphoma have been treated with AUTO4. Two patients had prior stem cell transplantation. After lymphodepletion with Flu/Cy, 3 patients received 25 x 106 CAR T cells, 2 patients received 75 x 106 CAR T cells, 1 patient received 225 x 106 CAR T cells and 3 patients received 450 x 106 CAR T cells. AUTO4 demonstrated a tolerable safety profile, with no patient experiencing any dose limiting toxicities, and no neurotoxicity/immune effector cell-associated neurotoxicity (ICANS). Three patients experienced cytokine release syndrome (CRS) (1 patient with Grade 1, 1 patient with Grade 2 and 1 patient with Grade 3). Of the 9 patients treated, 5 patients had achieved complete metabolic responses (CMR) by PET-CT at Month 1, 1 patient remains with a partial response (PR) 6 months post AUTO4 infusion, and 3 patients did not respond. All 3 patients at the highest dose level achieved a CMR at Month 1.

Title: Dual antigen targeting with co-transduced CD19/22 CAR T cells for relapsed/refractory ALL (AUTO1/22) LINK
Session Title: Gene therapy and cellular immunotherapy – Clinical 1
Session date and time: Saturday, June 11 – 11:30 – 12:45 CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S259
Presenting Author: Sara Ghorashian
Summary: CD19 negative escape is a major cause of relapse after CD19 CAR T cell therapy for relapsed/refractory (r/r) pediatric ALL. To overcome this challenge, AUTO1/22 builds on the favorable safety profile and excellent persistence of obe-cel by combining it with an additional CD22 targeting CAR. As of 8 February 2022, 10 pediatric ALL patients have been treated with AUTO1/22 and 8 are evaluable with >1 month follow-up. 5 of 8 patients had relapsed post allogeneic stem cell transplant (SCT), 4 had received prior Blincyto and 3 had relapsed after prior Kymriah. CRS occurred in 7/8 patients (grade 1 n=2, grade 2 n=5), but severe CRS was not seen. 7 of 8 evaluable patients achieved MRD negative complete response (CR) at 1 month post infusion. Overall, at a median follow up of 4.8 months, 5/8 patients remain in MRD negative CR at last follow up. The study results demonstrate that dual CD19/22 targeting CAR T cells generated by co-transduction show an acceptable safety profile, with robust expansion/persistence and early efficacy in a heavily pre-treated cohort. To date with limited follow-up we have not observed antigen negative relapse but longer follow up is needed.

Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory Primary CNS Lymphoma LINK
Session Title: Poster session
Session date and time: Friday, June 10 – 16:30 – 17:45 CEST
Final Abstract Code: P1460
Presenting Author: Claire Roddie
Summary: Relapsed/refractory primary central nervous system lymphoma (PCNSL) has a median overall survival of 2-8 months and few therapeutic options. obe-cel (AUTO1) has previously demonstrated high remission rates, low incidence of CRS/ICANS and long-term persistence, making it a viable treatment option for PCNSL. As of 14 February 2022, the CAROUSEL study enrolled 6 patients with r/r PCNSL where the median prior lines of treatment was 2. 5 patients were infused with IV AUTO1 and 1 patient with intraventricular AUTO1. Following CAR T infusion, Grade 1 and 2 CRS affected 1 and 3 patients respectively and any Grade ICANS was observed in 2 patients with 2 Grade 3 events. AUTO1 engraftment and response was evaluable in 4 patients at 1 month following iv infusion. 2 of 4 patients had no measurable disease at 2 and 6 months of follow up respectively. AUTO1 showed encouraging remission rates and excellent CAR T engraftment/expansion in the blood and CSF. Intraventricular administration was well-tolerated and showed that AUTO1 has activity via that route in a patient who failed IV therapy. Additional patients updated biological data and longer follow up will be presented.

Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory B-Cell Non-Hodgkin’s Lymphoma (B-NHL), and chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) LINK
Session Title: Poster session
Session date and time: Friday, June 10 – 16:30 – 17:45 CEST
Final Abstract Code: P1459
Presenting Author: Claire Roddie
Summary: obe-cel (AUTO1) has demonstrated an excellent safety profile in previous trials, with low levels of CRS/ICANS and long-term engraftment of CAR T cells, making it an ideal CAR T candidate to evaluate in B-NHL, CLL/SLL. As of 8 February 2022, 19 patients had been infused with AUTO1; 10 with low grade NHL, 6 with DLBCL and 3 with CLL. Patients treated had received a median of 3 prior lines of treatment. Grade 1 CRS was reported in 6/19 and Grade 2 CRS in 3/19. No ICANS was observed in the B-NHL and CLL cohorts. In the lg-NHL and DCBCL cohorts, 10/10 and 4/5 evaluable patients respectively were in CMR post-treatment. Responses were ongoing in 9/10 lg-NHL at 12 months and in 4/4 DLBCL at months 1,3,3 and 6. In the CLL cohort, 2/3 evaluable patients achieved MRD negative remission in the bone marrow with residual small volume lymph nodes by CT at 6 and 3 months of follow up respectively. AUTO1 demonstrated a tolerable safety profile in patients with r/r B-NHL and CLL despite high disease burden. Early data shows excellent complete remission rates and CAR engraftment/expansion. Additional patients, updated data and longer follow up will be presented.
Conference Call

Management will host a conference call and webcast on June 13, 2022 at 7:30 am ET/12:30 pm BST to discuss the EHA (Free EHA Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID: 6594553. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID: 6594553.

On May 12, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that results from the follicular lymphoma ("FL") cohort of the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL") were selected for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress ("EHA2022") taking place June 9-12, 2022, both virtually and in Vienna, Austria (Press release, Mustang Bio, MAY 12, 2022, View Source [SID1234614413]).

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The on-site presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center ("Fred Hutch") and University of Washington will provide updated data on patients with FL beyond what is available in the abstract published today on the EHA (Free EHA Whitepaper)2022 website and what was presented at the recent Tandem meetings. MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

"Acceptance for oral presentation at major international meetings such as EHA (Free EHA Whitepaper)2022 is a prestigious accomplishment, and we’re pleased that the Scientific Program Committee has granted Dr. Shadman this highly visible opportunity to present Fred Hutch’s compelling data on patients with relapsed or refractory follicular lymphoma in the ongoing Phase 1/2 clinical trial of MB-106," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "Furthermore, as we present our data to more investigators at peer-reviewed meetings, we are encouraged by the enthusiasm of these investigators for the durability of the responses and for the expansion of enrollment at Fred Hutch from CAR T naïve follicular lymphoma patients to patients previously treated with CAR Ts and to patients with other CD20-positive histologies such as diffuse large B cell lymphoma, Waldenstrom macroglobulinemia and CLL. Finally, as Mustang continues to advance our CD20-targeted CAR T cell therapy program, we look forward to the planned dosing of the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND this quarter."

Details of the presentation are as follows:

Title: Efficacy and Safety of a Third Generation CD20 CART (MB-106) for Treatment of Relapsed/Refractory Follicular Lymphoma (FL)
Session: Indolent and mantle-cell lymphoma
Session Date and Time: Saturday, June 11, 11:30 am – 12:45 pm Central European Time
Session room: Hall C1
Abstract Code: S207

For more information about EHA (Free EHA Whitepaper)2022, please visit: View Source

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter Phase 1/2 clinical trial to be initiated shortly under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trial can be found at View Source using the identifier NCT03277729.

On May 12, 2022 Novartis reported that highlights data from across its oncology portfolio at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (Press release, Novartis, MAY 12, 2022, View Source [SID1234614412]). With nearly 130 abstracts from Novartis-sponsored and investigator-initiated trials accepted, the data showcase research across over 20 compounds in key disease areas, including breast, lung and prostate cancers, leukemia, lymphoma, multiple myeloma and other blood disorders.

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"We continue to push the boundaries of science with advanced therapies and novel combinations to help address the individual needs of patients," said Marie-France Tschudin, President, Innovative Medicines International and Chief Commercial Officer, Novartis. "We are particularly excited about the latest data on CDK recycling with Kisqali, and first results for Tafinlar + Mekinist in a rare pediatric brain cancer."

Key highlights of data accepted by ASCO (Free ASCO Whitepaper):

Medicine Abstract Title Abstract Number/ Presentation Details
Kisqali (ribociclib)*

A randomized phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor positive (HR+), HER2 negative metastatic breast cancer (MBC): MAINTAIN trial† Abstract # LBA1004
Oral Presentation:
Saturday, June 4, 1:15 PM – 4:15 PM CDT

Kisqali (ribociclib)* Impact of ribociclib (RIB) dose modifications (mod) on overall survival (OS) in patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA (ML)-2 Abstract #1017
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT
Kisqali (ribociclib)*

Quality of life (QOL) with ribociclib (RIB) plus aromatase inhibitor (AI) vs abemaciclib (ABE) plus AI as first-line (1L) treatment (tx) of hormone receptor–positive/human epidermal growth factor receptor–negative (HR+/HER2−) advanced breast cancer (ABC), assessed via matching-adjusted indirect comparison (MAIC) Abstract #1015
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT

Piqray (alpelisib) Alpelisib (ALP) + Fulvestrant (FUL) in Patients (pts) With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2−), Advanced Breast Cancer (ABC): Biomarker (BM) Analyses by Next-Generation Sequencing (NGS) From the SOLAR-1 Study Abstract #1006
Oral Presentation:
Saturday, June 4, 1:15 PM – 4:15 PM CDT
Piqray (alpelisib)

Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–), PIK3CA-mutated (mut) advanced breast cancer (ABC): Baseline biomarker analysis and progression-free survival (PFS) by duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in the BYLieve study Abstract #1018
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT

Scemblix (asciminib) Efficacy and safety results from ASCEMBL, a phase 3 study of asciminib vs bosutinib (BOS) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after ≥2 prior tyrosine kinase inhibitors (TKIs): wk 96 update Abstract #7004
Oral Presentation:
Tuesday, June 7, 9:45 AM – 12:45 PM CDT
Tafinlar (dabrafenib) / Mekinist (trametinib) Primary analysis of a phase II trial of dabrafenib + trametinib (dab + tram) in BRAF V600–mutant pediatric low-grade glioma (pLGG) Abstract #2002
Oral Presentation:
Monday, June 6, 11:30 AM – 2:30 PM CDT
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) 177Lu-PSMA-617 in PSMA-positive metastatic castration-resistant prostate cancer: prior and concomitant treatment subgroup analyses of the VISION trial

Abstract #5001
Oral Presentation:
Sunday, June 5, 8:00 AM – 11:00 AM CDT

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Tolerability of 177Lu-PSMA-617 by treatment exposure in patients with metastatic castration-resistant prostate cancer (mCRPC): a VISION study subgroup analysis Abstract #5047
Poster available:
Monday, June 6, 1:15 PM – 4:15 PM CDT
Locametz (kit for the preparation of gallium Ga 68 gozetotide injection)** 68Ga-PSMA-11 PET baseline imaging as a prognostic tool for clinical outcomes to 177Lu-PSMA-617 in patients with mCRPC: a VISION sub-study Abstract #5002
Oral Presentation:
Sunday, June 5, 8:00 AM – 11:00 AM CDT
Lutathera (lutetium Lu 177 dotatate)*** Effectiveness and safety of re-treatment with lutetium Lu 177 dotatate in patients with progressive neuroendocrine tumors in the United States: a retrospective real-world study Abstract #e16215

Key highlights of data accepted by EHA (Free EHA Whitepaper):

Medicine Abstract Title Abstract Number/ Presentation Details
Scemblix (asciminib) Efficacy and safety results from ASCEMBL, a phase 3 study of asciminib vs bosutinib in patients with chronic myeloid leukemia in chronic phase after ≥2 prior tyrosine kinase inhibitors: week 96 update Abstract #S155
Oral Presentation:
Sunday, June 12, 11:30 AM – 12:45 PM CEST
Scemblix (asciminib) Asciminib provides durable molecular responses in patients (Pts) with chronic myeloid leukemia in chronic phase (CML-CP) with the T315I mutation: Updated efficacy and safety data from a Phase 1 trial Abstract #P704
Poster Available:
Friday, June 10, 4:30 PM – 5:45 PM CEST
Kymriah
(tisagenlecleucel) Tisagenlecleucel in pediatric and young adult patients (Pts) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Final analyses from the ELIANA study Abstract #S112
Oral Presentation:
Sunday, June 12, 11:30 AM – 12:45 PM CEST

YTB323 Phase I study of YTB323, a chimeric antigen receptor (CAR)-T cell therapy manufactured using T-Charge, in patients with relapsed/refractory diffuse large B-cell lymphoma Abstract #S212
Oral Presentation:
Saturday, June 11, 11:30 AM – 12:45 PM CEST
PHE885 Phase I study data update of PHE885, a fully human BCMA-directed CAR-T cell therapy manufactured using the T-Charge platform for patients with relapsed/refractory (R/R) multiple myeloma (MM) Abstract #P1446
Poster Available:
Friday, June 10, 4:30 PM – 5:45 PM CEST
Sabatolimab First results of a Phase II study (STIMULUS-AML1) investigating sabatolimab + azacitidine + venetoclax in patients with newly diagnosed acute myeloid leukemia Abstract #P582
Poster available:
Friday, June 10, 4:30 PM – 5:45 PM CEST

Promacta/Revolade
(eltrombopag) Sustained response off treatment in eltrombopag-treated patients with ITP who are refractory or relapsed after first-line steroids: primary analysis of the phase II TAPER trial Abstract #S292
Oral Presentation
Saturday, June 11, 11:30 AM – 12:45 PM CEST
Product Information
For full prescribing information, including approved indications and important safety information about marketed products, please visit View Source

On May 12, 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 an upcoming poster presentation demonstrating the cytotoxic potential of its CD123/CD16A-targeting innate cell engager (ICE) AFM28 at the Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Vienna, Austria on June 9 – 12, 2022 (Press release, Affimed, MAY 12, 2022, View Source [SID1234614411]).

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AFM28 is designed as a novel treatment for patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).

Redirecting innate immune cells, particularly NK cells, to CD123 is very attractive as a novel treatment strategy in AML because both leukemic blasts and leukemic stem cells express this receptor and an efficient depletion of both cell types is critical for inducing long-term remission.

The data to be presented in a poster session at the EHA (Free EHA Whitepaper) on June 10, 2022 summarize the preclinical proof-of-concept and toxicology studies for AFM28. The CD123 and CD16A targeting ICE exhibited high-affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention.

In in vitro assays, AFM28 engaged NK cells to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity (ADCC), even when CD123 was expressed at low levels.

Moreover, AFM28 demonstrated the ability to deplete leukemic cells from patient bone marrow without lysing CD34-positive/CD123-negative cells suggesting sparing of hematopoietic stem and progenitor cells. In toxicology models using cynomolgus monkeys, AFM28 demonstrated highly effective target cell depletion which was associated with good tolerability and only minimal release of the inflammatory cytokine IL-6.

"CD123 is a highly interesting tumor antigen in AML that hasn’t reached its full therapeutic potential. We believe that engaging innate immune cells represents a differentiated therapeutic strategy to access the value of this target. Building on the promising data we have seen with AFM28 to date, we are excited to be preparing a first-in-human clinical study to investigate the safety, efficacy and biological activity of AFM28 as monotherapy. In parallel, we are planning a study to investigate AFM28 in combination with adoptive NK cell therapies," said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. "NK cell therapies have already demonstrated promising clinical activity in relapsed/refractory AML and we believe that AFM28 will improve this effect."

The abstract is accessible here: View Source

Poster details:
Title: Novel bispecific innate cell engager AFM28 for the treatment of CD123-positive acute myeloid leukemia and myelodysplastic syndrome
Authors: Jana-Julia Siegler, Nanni Schmitt, Jens Pahl, Torsten Haneke, Izabela Kozlowska, Séverine Sarlang, Alexandra Beck, Stefan Knackmuss, Paulien Ravenstijn, Uwe Reusch, José Medina-Echeverz, Jan Endell, Thorsten Ross, Daniel Nowak, and Christian Merz
Final abstract code: P482
Session date and time: Poster session on Friday, June 10th, 10:30 – 11:45 a.m. EDT / 16:30 – 17:45 CEST

About AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE developed on Affimed’s ROCK platform, is designed to bring a new immunotherapeutic approach to patients with CD123+ myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123+ leukemias.

On May 12, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported financial results and business highlights for the quarter ended March 31, 2022 (Press release, Aptevo Therapeutics, MAY 12, 2022, View Source [SID1234614410]).

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Business Highlights

Earned and collected a $10 million non-dilutive milestone payment related to 2021 sales of RUXIENCE. Additionally, based on RUXIENCE 2021 fourth quarter and full-year sales results, the Company is optimistic about the potential to earn additional non-dilutive milestones totaling $22.5 million over the next two years
Reported that two patients with relapsed/refractory acute myeloid leukemia (AML) in its on-going Phase 1b trial evaluating adult patients with AML, achieved transplant-eligible status, and have received allogeneic stem cell transplants:
One patient received APVO436 in a monotherapy cohort of the trial and experienced significant reduction in bone marrow blasts
Another patient received APVO436 in a combination therapy cohort of the trial and experienced a complete remission
Continued enrollment in the Company’s Phase 1b expansion trial evaluating APVO436 in adult patients with AML
Presented preclinical data for APVO442 in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
The poster highlighted the potential of APVO442 to treat prostate cancer indications such as metastatic castration-resistant prostate cancer with increased benefit and decreased side effects relative to other potential therapeutics in the bispecific category
APVO442 is a bispecific therapeutic candidate targeting prostate-specific membrane antigen (PSMA) and CD3, designed to redirect the patient’s T cell-mediated tumor-fighting responses against PSMA-expressing solid tumors (prostate cancer)
"The first quarter was productive as we continued to advance both clinical and pre-clinical assets, all of which are based on the Company’s proprietary ADAPTIR and ADAPTIR-FLEX platforms. Our Phase 1b expansion trial continues to enroll patients and we reported that two patients advanced to transplant after receiving APVO436 – one as a monotherapy and the other as a combination therapy. We were also happy to report we earned a $10 million milestone payment related to 2021 sales of RUXIENCE. Receipt of this non-dilutive payment underscores our ongoing commitment to delivering value to shareholders," said Marvin White, President and CEO of Aptevo. "Looking ahead, we continue to progress the ALG.APV-527 program toward the clinic and remain on track for an IND submission and clinical trial initiation, later this year. We also plan to release interim data from the APVO436 expansion trial and announce the addition of a new molecule to the preclinical pipeline later this year."

First Quarter 2022 Financial Results Summary

Cash Position: Aptevo had cash and cash equivalents as of March 31, 2022 totaling $36.3 million, including restricted cash of $1.3 million. $0.5 million of the restricted cash was released in April 2022 and the remaining $0.8 million is expected to be released over the next twelve months.

Royalty Revenue: For the three months ended March 31, 2022, royalty revenue increased by $0.7 million, or 29%, to $3.1 million from $2.4 million for March 31, 2021. Royalty revenue relates to the royalty from Pfizer on global net sales of RUXIENCE (rituximab-pvvr), a biosimilar to the drug RITUXAN, launched by Pfizer in early 2020.Due to the nature of the transaction, which includes a cap on HCR’s return from royalties, constituting continuing involvement under the Collaboration and License Agreement originally between Trubion and Wyeth, we continue to recognize royalty revenue on net sales of RUXIENCE and record the royalty payments to HCR as a reduction of the liability when paid. As such payments are made to HCR, the balance of the liability will be effectively repaid over the life of the HCR royalty purchase agreement. RUXIENCE is a trademark of Pfizer; RITUXAN is a trademark of Biogen.

Research and Development Expenses: For the three months ended March 31, 2022, research and development expenses decreased by $0.5 million, to $4.9 million from $5.4 million for March 31, 2021. The decrease was primarily due to lower spending on preclinical projects and employee costs. The decrease was partially offset by higher spending on our APVO436 clinical trial as we continue to advance that trial and continue to dose patients in our Phase 1b Expansion program.

General and Administrative Expenses: For the three months ended March 31, 2022 and 2021, general and administrative expenses were $3.9 million.

Other Expense, Net: Other expense, net consists primarily of gains or losses realized on foreign currency revaluation, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $2.3 million for the three months ended March 31, 2022 and $0.8 million for the three months ended March 31, 2021. The increase in other expense, net is primarily related non-cash interest expense for the HCR royalty purchase agreement. The increase was partially offset by lower interest expense for the MidCap Credit Agreement due to payments made towards principal.

Discontinued Operations: For the three months ended March 31, 2022, we collected $0.2 million in deferred payments from Medexus related to IXINITY sales. For the three months ended March 31, 2021, we collected $0.2 million related to the sale of hyperimmune business to Saol as a result of the collection of certain accounts receivable and a deferred payment of $0.2 million received from Medexus related to IXINITY sales. Pursuant to our LLC Purchase Agreement, the rate for deferred payments will increase from 2% to 5% of net sales no later than June 30, 2022.

Net Loss: Aptevo’s net loss for the three months ended March 31, 2022 was $7.7 million or $1.55 per share, as compared to a net loss of $7.3 million or $1.64 per share for the corresponding period in 2021.

Liability Related to Sale of Future Royalties: We treat the Royalty Purchase Agreement with HCR as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. We will periodically assess the expected royalty payments using projections from external sources. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. We are not obligated to repay the proceeds received under the Royalty Purchase Agreement with HCR.