On June 10, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the publication of clinical data across multiple programs at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held June 9-12, 2022 (Press release, Autolus, JUN 10, 2022, View Source [SID1234615884]).

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Autolus will hold a conference call on Monday June 13 2022 at 7:30 am EST / 12:30 pm BST, which will include participation from; Dr. Steven Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center; Dr. Kate Cwynarski, Chair UK T cell Lymphoma Group, Consultant Hematologist, University College London Hospital; and Autolus’ management team.

"We are excited to be presenting this first clinical data for two new product candidates, AUTO4 with its unique targeting approach for T cell lymphoma and AUTO1/22 a dual targeting CAR T product for the treatment of children with ALL," said Dr. Christian Itin, CEO of Autolus. "With obe-cel progressing towards pivotal data in the FELIX trial in adult patients with ALL, we are pleased to show obe-cel’s broader utility in B-NHL patients, mirroring the high level of activity and well manageable safety profile we have seen in previous trials."

"This year’s EHA (Free EHA Whitepaper) is an important meeting for Autolus with four presentations providing updates from ongoing clinical studies," said Dr. Martin Pule, Chief Scientific Officer of Autolus. "In an oral presentation we will present AUTO4 clinical data for the first time. These data suggest that AUTO4 has the potential to become an important therapeutic option for patients with T cell lymphoma. In a second presentation, we will present our finding from clinical testing of AUTO1/22. These data show that AUTO1/22 can induce remission in children with B-ALL, including in those whose disease was not successfully treated with commercial CAR T product. Further, data suggest that AUTO1/22 can prevent antigen escape. In two additional presentations, we demonstrate incremental obe-cel data in B-NHL and B-CLL, as well as some early data in PCNSL. Obe-cel continues to have consistent safety and efficacy data across these indications."

"As clinicians, we are always searching for new strategies to address unmet needs in aggressive blood cancers," said Dr. Steven Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York. "T Cell Lymphomas are particularly challenging, and I’ve been following Dr. Pule’s strategy of CAR T targeting based on the mutually exclusive expressions of TRBC1 or TRBC2 with great interest. Any advance in bringing new effective therapies to patients with T cell lymphomas is of great importance."

Data presentations:

Title: Safety and preliminary efficacy findings of AUTO4, a TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive selected T Cell Non-Hodgkin Lymphoma
Session Title: Gene therapy and cellular immunotherapy – Clinical 2
Session date and time: Saturday, June 11, 2022 16:30 – 17:45 CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S261
Presenting Author: Kate Cwynarski
Conclusions: As of April 26 2022, 10 patients with TRBC1-positive r/r T-cell lymphoma (Peripheral T-cell lymphoma Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL), Anaplastic Large cell lymphoma (ALCL)) have been treated with AUTO4 in a Phase I dose escalation trial. Three patients had prior stem cell transplantation. After lymphodepletion with Flu/Cy, patients received either 25, 75, 225 or 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) and no Grade 3 or higher infections. CRS was only seen at the highest dose level of 450 x 106 CAR T cells (Grade 3 in 1 patient; Grade 1-2 in 3 patients). As of 26 April 2022, 9 patients were evaluable for efficacy. At the highest dose level 3 of the 3 patients dosed achieved a complete metabolic remission (CMR) at 1 month. 2 of these patients remain in ongoing CMR by PET-CT at Month 3 and 6 respectively, whilst the 3rd relapsed at 3 months.
Title:Dual antigen targeting with co-transduced CD19/22 CAR T cells for relapsed/refractory ALL (AUTO1/22)
Session Title: Gene therapy and cellular immunotherapy – Clinical 1
Session date and time: Saturday, June 11, 2022 11:30 – 12:45 CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S259
Presenting Author: Sara Ghorashian
Conclusions: As of May 27 2022, in 11 treated patients, we have reproducibly generated a product that is balanced in CD19 and CD22 CAR expression, with predominance of dual CAR T cells and having a mostly central memory phenotype. To date and in Kymriah-ineligible patients, AUTO1/22 has demonstrated a favorable safety profile. There have been no incidences of severe CRS, and one Grade 4 ICANS which was indistinguishable from chemotherapy-related leukoencephalopathy. We have seen excellent CAR T expansion, with only 4 patients losing CAR T persistence at the last follow up. Overall, 9 out of 11 patients achieved complete response, and there were 2 non-responders. Notably, 2 out of 3 patients with CD19-ve disease achieved complete response demonstrating the efficacy of the CD22 CAR. Two patients relapsed with CD19+CD22+ disease, a further patient had emergence of molecular MRD and all these events were associated with lack of CAR T Cell persistence. No antigen negative relapses were seen in responding patients. At a median follow up of 8.7 months, 6 of 9 responding patients were in MRD-negative complete remission (1-12 months) and the median duration of b-cell aplasia has not been reached.
Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory Primary CNS Lymphoma
Session Title: Poster session
Session date and time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Final Abstract Code: P1460
Presenting Author: Claire Roddie
Conclusions: Excellent AUTO1 expansion was observed in the peripheral blood by qPCR, with persistence in all treated patients at last follow-up. No grade >/=3 CRS was observed using IV or I-VEN AUTO1 administration. Two cases of grade 3 ICANS were reported following IV infusion. In the first case the patient had several neurological deficits that evolved despite ICANS treatment and were compatible with progressive PCNSL, as confirmed with the month 1 MRI scan. The second case was a patient whose neurological deficits improved with steroids/anakinra. Encouraging response rates were observed: of 6 patients evaluable for efficacy following IV AUTO1, the ORR was 4/6 (67%), with 2 CRs and 2 PRs. These four responding patients are without disease progression at last follow up. Two patients died from progressive PCNSL on study. Longer follow-up is needed and enrolment of additional patients is ongoing.
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)
Session Title: Poster session
Session date and time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Final Abstract Code: P1459
Presenting Author: Claire Roddie
Conclusions: AUTO1 continues to display a favorable safety profile with no ICANS or Grade ≥ 3 CRS. Long term persistence of AUTO1 in the peripheral blood was demonstrated by qPCR. Of the 20 patients evaluable for efficacy, the overall response rate was 18/20 (90%). In the B-NHL cohorts the CRR was 16/17 (94%) (FL: 7/7, MCL: 3/3, DBCL: 6/7). In the CLL cohort a best response of a PR was achieved in 2/3 patients, notably both achieved MRD-negativity in their marrow and both remain in PR at 10 and 6 months respectively. Of the responding MCL, DLBCL, FL and CLL patients, 17/18 (94%) are without disease progression at last follow-up. One MCL patient relapsed six months following treatment and 1 FL patient died in CR from COVID-19. Longer follow-up and enrolment of additional MCL, FL, DLBCL and CLL patients is ongoing.
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 June 10, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the Company will host a virtual R&D Day today, Friday, June 10th from 10:00 a.m. to 1:00 p.m. ET (Press release, SpringWorks Therapeutics, JUN 10, 2022, View Source [SID1234615859]).

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SpringWorks’ R&D Day will feature presentations by Saqib Islam, Chief Executive Officer; Badreddin Edris, PhD., Chief Operating Officer; L. Mary Smith, PhD, Chief Development Officer; Bhavesh Ashar, Chief Commercial Officer; Mike Burgess, MBChB, PhD, Head of R&D; and Jim Cassidy, MD, PhD, Chief Medical Officer. The event will also include presentations from two external key opinion leaders: Breelyn Wilky, MD, Director of Sarcoma Medical Oncology at the University of Colorado, Denver (CU Denver) and Neal Rosen, MD, PhD, Director of the Center for Mechanism-Based Therapy and the Enid A. Haupt Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center (MSKCC).

"SpringWorks is at an exciting juncture in terms of data generation, regulatory discussions, and launch preparations. Our goal is to provide the first approved therapy for patients with desmoid tumors in 2023, and we expect to have two approved products with the potential to serve patients across four distinct oncology indications by 2025," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are confident that our strong execution across our R&D programs, our disciplined, rigorous approach to business development, and our focused commercial buildout will drive our success in 2022 and beyond."

Agenda

Introduction and Business Overview (Saqib Islam, Badreddin Edris, PhD)
KOL Presentation: Unmet Need in Desmoid Tumors (Bree Wilky, MD, CU Denver)
Nirogacestat
Clinical Experience in Desmoid Tumors (L. Mary Smith, PhD)
Desmoid Tumor Commercial Opportunity (Bhavesh Ashar)
Additional Expansion Opportunity (Badreddin Edris, PhD)
BCMA Therapy Combination Development (Mike Burgess, MBChB, PhD)
Mirdametinib
NF1-PN (L. Mary Smith, PhD)
Additional Expansion Opportunities (Jim Cassidy, MD, PhD)
Mirdametinib + Lifirafenib: Combination Development (Jim Cassidy, MD, PhD)
KOL Presentation: Introduction to BGB-3245 (Neal Rosen, MD, PhD, MSKCC)
BGB-3245
Initial Clinical Data and Program Update (Jim Cassidy, MD, PhD)
Preclinical
TEAD and EGFR Inhibitor Program Overview (Mike Burgess, MBChB, PhD)
Closing Remarks and Q&A (Saqib Islam)
Webcast and Conference Call Information:
The Company’s R&D Day will be held today, Friday, June 10th, from 10:00 a.m. to 1:00 p.m. ET. The webcast can be accessed here. Participants can also listen to the event by dialing + 1 (844) 946-0285 (domestic) or +1 (602) 585-9676 (international) and providing the conference ID 4453188. A replay will be available on the SpringWorks website for a limited period of time following the event.

On June 10, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, reported that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225 (Press release, Fusion Pharmaceuticals, JUN 10, 2022, View Source [SID1234615885]). Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave’s capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion’s needs.

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"As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies," said Fusion Chief Executive Officer John Valliant, Ph.D. "We continue to prioritize manufacturing and access to actinium as a critical component of Fusion’s platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic."

"The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion’s progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey."

Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form.

Fusion currently has existing actinium supply arrangements with TRIUMF and the U.S. Department of Energy (DOE).

On June 10, 2022 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 47 cents per share (Press release, Abbott, JUN 10, 2022, View Source [SID1234615861]).

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This marks the 394th consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Aug. 15, 2022, to shareholders of record at the close of business on July 15, 2022.

Abbott has increased its dividend payout for 50 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have increased dividends annually for at least 25 consecutive years.

On June 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 poster at the Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) in Vienna, Austria (Press release, Affimed, JUN 10, 2022, View Source [SID1234615886]). The data demonstrate the cytotoxic potential of the CD123/CD16A-targeting bispecific innate cell engager (ICE) AFM28 which is in development as a novel treatment for patients with myeloid diseases, e. g. relapsed/refractory (R/R) acute myeloid leukemia (AML). AFM28 binds to natural killer (NK) cells and CD123-positive tumor cells and demonstrated the induction of tumor cell killing in vitro and a good tolerability and strong anti-tumor activity in vivo.

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"It is widely acknowledged that targeting CD123 holds significant untapped promise in developing better AML therapies. We believe our differentiated approach in targeting CD123 has the potential to provide a novel, innate immune system-engaging therapy to improve clinical outcomes," said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. "Following these encouraging pre-clinical proof-of-concept data and the experience we have gained from our AFM13 studies so far, we will be launching a first-in-human clinical study to investigate the compound’s safety, efficacy and biological activity as monotherapy later this year and in combination with adoptive NK cells soon after." The data presented at EHA (Free EHA Whitepaper) today provide validation of the mechanism of action (MoA) as well as preclinical proof-of-concept for AFM28 in a range of in vitro and in vivo assays. AFM28 exhibited high-affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention in comparison to Fc-enhanced anti-CD123 antibody. Moreover, AFM28 demonstrated the ability to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity (ADCC).

Importantly, AFM28 was active irrespective of mutational status of tumor cells and also induced depletion when CD123 expression was very low. Strikingly, AFM28 was also active against cells not killed by an Fc-enhanced CD123-targeting comparator antibody suggesting the potential for improved clinical effectiveness. Moreover, AFM28 also depleted leukemic cells from patient bone marrow without destroying CD34-positive/CD123-negative cells, suggesting sparing of hematopoietic stem and progenitor cells.

In vivo studies in an AML murine model demonstrated anti-tumor efficacy, and cynomolgus toxicology models predicted pharmacodynamic activity with a well-tolerated safety profile and low risk of cytokine release syndrome.

Efficient depletion of leukemic blasts and leukemic stem cells is critical for inducing long-term remission in AML patients. As both cell types express CD123, AFM28’s ability to redirect NK cells to this target killing both leukemic blasts and leukemic stem cells makes this an attractive treatment strategy. Currently, there are no curative immunotherapies available, the only option is allogenic hematopoietic stem cell transplantation (allo-HSCT). Affimed plans to initiate clinical development of AFM28 with a first-in-human phase 1 monotherapy trial in adult patients with R/R AML in the second half of 2022. In addition, Affimed plans to investigate AFM28 in combination with allogeneic NK cell therapy after a safe starting dose has been determined.

The full poster is accessible through the following link: Publications and Posters – Affimed

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 treatment 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-positive leukemias.