On June 10, 2022 Imago BioSciences, Inc. ("Imago" or the "company") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with advanced myelofibrosis (MF) (Press release, Imago BioSciences, JUN 10, 2022, View Source [SID1234615858]).

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The data were presented in a poster session during the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting and Congress (EHA) (Free EHA Whitepaper), taking place 9-12 June 2022. Previously, a Phase 2 data set with a cut-off of 31 October 2021 was presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021.

Updated Highlights (as of 29 April 2022 data cutoff):

Of the evaluable patients at 24 weeks,
55% (28/51) showed a decrease in Total Symptom Score (TSS).
22% (11/51) showed a ≥50% decrease in TSS.
64% (32/50) showed spleen volume reductions.
52% (36/69) of patients had a decrease in mutant allele frequencies (MAFs) including driver mutations (e.g., JAK2) with the greatest reduction in ASXL1, a high molecular risk (HMR) mutation.
90% (37/41) of transfusion-independent patients had stable or improved hemoglobin at Week 12.
85% (50/59) of patients had an improved (19/59) or stable (31/59) bone marrow fibrosis score post-baseline.
No new mutations or transformation to acute myeloid lymphoma (AML) in patients with high risk of progression.
"The potential of bomedemstat to be a unique and differentiated monotherapy for patients living with advanced myelofibrosis is underscored by the data presented at EHA (Free EHA Whitepaper) today," said Hugh Young Rienhoff, Jr., M.D., CEO of Imago. "The data continue to show improvements across multiple hallmarks of disease, such as symptom scores, spleen volume, fibrosis, and anemia, while at the same time demonstrating a favorable safety and tolerability profile relative to the current available therapies. Of particular interest is the effect on patients with ASXL1 mutations, a mutation that confers an increased risk of leukemia. Importantly, these data also point to the potential utility of bomedemstat in other myeloproliferative diseases, such as polycythemia vera and essential thrombocythemia, with similar mutation profiles. Patients in this study will continue to be treated in an extension study while we further explore these patient responses and evaluate the added value of bomedemstat combined with ruxolitinib."

Safety & Tolerability

Bomedemstat was generally safe and well-tolerated in patients with myelofibrosis.
The most common non-hematologic adverse event (AE) related to bomedemstat was dysgeusia (altered taste), which occurred in 36% of patients and dysgeusia led to discontinuation in 1 patient
There were 14 serious adverse events (SAEs) deemed related to bomedemstat per the Investigator
Details on the Imago EHA (Free EHA Whitepaper) Presentation

Poster Presentation Title: A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients With Advanced Myelofibrosis
Session: 16. Myeloproliferative neoplasms – Clinical
Presenter: Harinder Gill, M.D., study investigator and presenter of the data, Department of Medicine, University of Hong Kong, Queen Mary Hospital, Pok Fu Lam, Hong Kong
Date & Time: Friday, June 10, 2022, at 10:30 AM ET

For further details, please see the EHA (Free EHA Whitepaper) 2022 abstract and presentation on the Imago website here.

Virtual Investor Event Details

Individuals interested in listening to the event at 10:30 a.m. ET on Saturday, June 11, 2022 may do so by dialing (844) 348-6880 for domestic callers, or +1 (914) 800-3944 for international callers, and reference conference ID: 3493998; or from the webcast link in the investor relations section of the company’s website at: www.imagobio.com. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

About the Imago Phase 2 Advanced Myelofibrosis Program

Myelofibrosis (MF) is a progressive cancer in which the bone marrow is gradually replaced by fibrous, scar-like tissue. There is a significant unmet need for a disease-modifying therapy. The need is greatest in patients with MF whose disease is not adequately managed with current JAK inhibitors, the current standard of care.

This Phase 2 multi-center, open-label study is designed to assess the safety, efficacy, pharmacodynamics, and spleen volume reduction of bomedemstat, an oral inhibitor of lysine-specific demethylase 1 (LSD1). Eligible patients aged 18 or older with MF who were refractory or resistant to, intolerant of, were inadequately controlled by or ineligible for approved therapies were considered for the study. Exploratory assessments include symptom reduction, changes in cytokine profiles, changes in the frequency of mutant alleles and bone marrow fibrosis. The trial was conducted in the United States, the United Kingdom, European Union, Australia, and Hong Kong. This 24-week study completed enrollment in May 2021 with a total of 89 patients.

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.