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2seventy bio Reports Third Quarter Financial Results and Recent Operational Progress

On November 7, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the third quarter ended September 30, 2022 (Press release, 2seventy bio, NOV 7, 2022, View Source [SID1234623216]).

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"In our first year of operations, 2seventy bio has made tremendous progress in our mission of delivering more time to patients with cancer," said Nick Leschly, chief kairos officer. "Abecma has exceeded our expectations and is gaining momentum with potential to become a multi-billion dollar product. We now have hundreds of patients treated in the commercial setting and importantly we continue to see consistent efficacy and safety results between our clinical trials and our real-world data. We are excited to share our plans to initiate the KarMMa-9 study in newly diagnosed patients, in partnership with BMS. In addition, we have made important progress towards establishing a highly differentiated pipeline and sustainable product engine: our DARIC-33 and bbT369 studies in AML and B-NHL, respectively, are enrolling patients and our solid tumor programs with Regeneron are fast approaching the starting line with our MUC-16 CAR program. More broadly, we have made great progress on building translational throughput capacity with our internal drug product manufacturing facility nearing completion and we expect our strategic collaboration with JW Therapeutics to accelerate solid tumor development starting with putting our MAGE-A4 program into the clinic. Taken together, we believe we are on track to establishing a unique end to end cell therapy product engine, exploring four clinical-stage assets by 2024 and continuing to expand Abecma into earlier lines. As we wrap up 2022, we look forward to presenting important Abecma data at ASH (Free ASH Whitepaper) and more broadly on our pipeline in 2023."

RECENT PIPELINE HIGHLIGHTS

STRATEGIC PARTNERSHIP WITH JW THERAPEUTICS – Last month, 2seventy bio and JW Therapeutics announced a strategic alliance to establish a translational and clinical cell therapy development platform designed to more rapidly explore T cell-based immunotherapy therapy products in the Chinese mainland, Hong Kong (China), and Macao (China). The initial focus of the collaboration is 2seventy bio’s MAGE-A4 t cell receptor (TCR) program in solid tumors which is being developed as part of a collaboration with Regeneron. Under the terms of the agreement, 2seventy bio will grant JW Therapeutics a license for the MAGE-A4 cell therapy in the Chinese mainland, Hong Kong (China), and Macao (China). JW Therapeutics will be responsible for development, manufacturing, and commercialization within China. 2seventy bio is eligible to receive milestones and royalties on product revenues in China.
ADDITIONAL PROGRESS – 2seventy bio’s clinical studies of DARIC-33 in acute myeloid leukemia (AML) and bbT369 in B cell non-Hodgkin lymphoma (B-NHL) are open and enrolling. We plan to share clinical data from these programs in the future. The company continues to execute pre-investigational new drug (IND) work to support a MUC-16 IND in 2023.
Abecma Commercial Summary
Our partner, Bristol Myers Squibb (BMS) reported total U.S. Abecma (idecabtagene vicleucel; ide-cel) third quarter revenues of $75 million. Based on strong commercial demand for Abecma, we remain on track to achieve the upper end of our stated 2022 U.S. Abecma revenue guidance of $250-300 million. Given the continued strong demand for Abecma and our growing belief in its potential to play an important role in earlier lines of therapy, we plan to initiate the KarMMa-9 study in partnership with BMS in patients with newly diagnosed multiple myeloma who have a suboptimal response to transplant and we are continuing to advance our manufacturing strategy to expand capacity across the supply chain.

We reported collaborative arrangement revenue of $4.1 million for the third quarter, which includes our share of gross profit/loss less costs associated with the commercialization of Abecma in the U.S. Vector and drug product supply remains on track to meet our commercial plan for 2022 and we are continuing to invest in increasing manufacturing capacity in the future.

ABECMA HIGHLIGHTS

KARMMA-2 DATA AT ASH (Free ASH Whitepaper) – Earlier this month, 2seventy bio announced that data from two cohorts of the KarMMa-2 study of Abecma (idecabtagene vicleucel), conducted in partnership with BMS, in patients who have suboptimal response to transplant or early relapse will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Data from KarMMa-2 Cohorts 2a and 2c suggest the potential for early treatment with Abecma in patients with second-line and newly diagnosed multiple myeloma, and that promising outcomes can be achieved treating patients with suboptimal response after transplant. These results support further evaluation of Abecma in patients with newly diagnosed multiple myeloma in the KarMMa-9 study.
KARMMA-9 STUDY IN NEWLY-DIAGNOSED MULTIPLE MYELOMA – In September, 2seventy bio announced plans to initiate the KarMMa-9 study, in partnership with BMS, to evaluate Abecma in newly diagnosed multiple myeloma patients who have suboptimal response to transplant. The company intends to provide additional information about the design and timing of the study at the earliest upcoming opportunity
SELECT THIRD QUARTER 2022 FINANCIAL RESULTS

Our partner, BMS, reported total U.S. revenues of $75 million for Abecma for the three months ended September 30, 2022. 2seventy bio and BMS share equally in all profits and losses related to development, manufacture and commercialization of Abecma in the U.S. We reported collaborative arrangement revenue of $4.1 million for the three months ended September 30, 2022. For the first and second quarters of 2022, we reported a share of collaboration loss of $5.4 million and $4.3 million, respectively.
Total 2seventy bio revenues were $13.4 million for the three months ended September 30, 2022 compared to $19.3 million for the three months ended September 30, 2021. Total revenues were $35.3 million for the nine months ended September 30, 2022 compared to $38.5 million for the nine months ended September 30, 2021. The decrease for the three-month period was primarily driven by a decrease in Abecma collaborative arrangement revenue and the decrease for the nine-month period was largely attributable to a decrease in ide-cel ex-U.S. service revenue and royalty and other revenue.
Research and development expenses were $61.7 million for the three months ended September 30, 2022 compared to $61.1 million for the three months ended September 30, 2021. Research and development expenses were $199.4 million for the nine months ended September 30, 2022, compared to $202.4 million for the nine months ended September 30, 2021. The slight increase for the three-month period was primarily driven by increases in IT and other facility-related costs and collaboration research funding costs, partially offset by decreased license and milestone fees. The decrease for the nine -month period was primarily driven by decreased collaboration research funding costs due to a decrease in our share of research and development costs under our collaboration with BMS, partially offset by an increase in IT and other facility-related costs.
Selling, general and administrative expenses were $19.6 million for the three months ended September 30, 2022, compared to $23.0 million for the three months ended September 30, 2021. Selling, general and administrative expenses were $60.7 million for the nine months ended September 30, 2022, compared to $69.0 million for the nine months ended September 30, 2021. The decrease for both the three- and nine-month periods was primarily driven by decreased employee compensation expenses, reflective of efforts to streamline 2seventy bio’s operating model and a decrease in IT and other facility-related costs.
Net loss was $67.9 million for the three months ended September 30, 2022, compared to $60.0 million for the three months ended September 30, 2021. Net loss was $231.0 million for the nine months ended September 30, 2022, compared to $231.2 million for the nine months ended September 30, 2021.
2seventy bio ended the third quarter of 2022 with cash, cash equivalents and marketable securities of $324.5 million.

Tessa Therapeutics, Baylor College of Medicine Execute Agreement For Global Commercial Rights to ‘Off-the-Shelf’ CAR-T Platform

On November 7, 2022 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported the execution of an exclusive agreement with Baylor College of Medicine for worldwide commercial rights to the allogeneic Epstein-Barr virus specific T-cell (EBVST) technology platform developed jointly by Tessa’s Scientific Co-Founder, Malcolm Brenner, M.D., Ph.D., and his colleagues Cliona Rooney Ph.D. and Helen Heslop M.D., D.Sc. at Baylor College of Medicine (Press release, Tessa Therapeutics, NOV 7, 2022, View Source [SID1234623204]). Tessa is currently advancing a pipeline of products that utilize CD30.CAR-modified EBVSTs, including its lead allogeneic cell therapy, TT11X, which is being co-developed for the treatment of relapsed or refractory CD30-positive lymphomas.

CD30.ALLO Virus specific T-cells (VSTs) are highly specialized T cells that can recognize CD30+ tumors. CD30 Allogeneic VSTs without genetic modification have demonstrated a strong safety profile and efficacy in early trials with minimal risk of Graft vs Host Disease (GVHD). During the development of the allogeneic technology platform, Tessa and Baylor College of Medicine had an exclusive option agreement for commercial rights to the technology.

Clinical data from an ongoing Phase 1 study of TT11X in CD30-positive lymphomas (BESTA) has demonstrated a favorable safety profile and encouraging signs of efficacy with clinical responses observed in seven of nine patients, including a complete disappearance of tumors reported in four patients. TT11X was recently recognized in the "Most Promising Off-the-Shelf Therapies" category at the Asia-Pacific Cell & Gene Therapy Excellence Awards (ACGTEA) 2022.

"Allogeneic or ‘off-the-shelf’ CAR-T therapies have the potential to change the paradigm of cancer treatment, and we believe the allogeneic EBVST platform developed at the Center for Cell and Gene Therapy, at Baylor College of Medicine places Tessa at the forefront of a very substantial therapeutic and business opportunity," said Thomas Willemsen, Tessa’s President and Chief Executive Officer. "Securing exclusive worldwide commercial rights for therapies developed using the EBVST platform is an important value driver for Tessa as we continue to advance TT11X as a potential treatment for CD30-positive lymphomas, while exploring opportunities to extend the technology to other cancer indications, including solid tumors."

Leap Therapeutics to Present Updated Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab and Preclinical Data in Colorectal Cancer Models at the SITC Annual Meeting

On November 7, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting updated data from Part B of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, in second-line gastroesophageal adenocarcinoma (GEA) cancer patients whose tumors express high levels of DKK1 (DKK1-high) at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held in Boston, MA on November 8-12, 2022 (Press release, Leap Therapeutics, NOV 7, 2022, View Source [SID1234623194]).

Leap is also presenting preclinical DKN-01 data supporting the DeFianCe study, a Phase 2 study of DKN-01 in combination with bevacizumab and standard of care chemotherapy in patients with advanced colorectal cancer (CRC) who have received one prior systemic therapy.

"The combination of DKN-01 plus tislelizumab continues to demonstrate a well-tolerated and active combination in previously treated, DKK1-high, anti-PD-1/PD-L1 naïve GEA cancer patients," said Samuel Klempner, MD, Associate Professor at Harvard Medical School who leads the gastric and esophageal cancer program at Massachusetts General Hospital Cancer Center and is a principal investigator on the DisTinGuish study. "In Keynote-061, anti-PD-1 monotherapy generated a 2% ORR in second-line GEA patients with PD-L1 expression combined positive score (CPS) < 1 and a 24.5% ORR in patients with CPS > 10. As DKK1-high patients appear to have more aggressive disease, the updated second-line DKN-01 plus tislelizumab Part B data provides further evidence of activity in this difficult-to-treat patient population, particularly among the DKK1-high/PD-L1-high patients. These results continue to support the decision to start Part C, the randomized controlled clinical trial in first-line patients."

"The preclinical results in CRC models showed impressive monotherapy and chemotherapy combination activity in multiple xenograft models, including those that are resistant to 5-FU treatment, which is commonly used to treat metastatic disease," said Cynthia Sirard, MD, Chief Medical Officer of Leap Therapeutics. "Colorectal cancer is the third most frequent cancer globally and the second leading cause of death. We enrolled our first patient in the Phase 2 DeFianCe study in October evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with CRC and look forward reporting initial data in mid-2023."

Key Findings DisTinGuish

DKN-01 and tislelizumab administered in DKK1-high (H-score > 35), PD-1 naïve patients were well tolerated at both 300mg and 600mg DKN-01 doses
Higher DKN-01 dose at 600mg was not associated with higher frequency of adverse events (AEs)
There were no Grade 5 treatment-emergent AEs (TEAE) and no TEAEs leading to study drug discontinuation or dose reduction
High and durable 27% overall response rate (ORR) in evaluable anti-PD-1/PD-L1 naïve mITT population (n=43)
55% ORR, 73% disease control rate, and 7.7 months median progression-free survival in DKK1-high/PD-L1-high vCPS ≥ 10 patients (n=12: 6 PR, 2 SD, 3 PD, 1 NE)
27% ORR in DKK1-high/PD-L1-negative vCPS < 1 patients (n=11: 3 PR, 1 SD, 7 PD)
Overall, 7 of 10 responders remain on therapy
Key Findings Preclinical CRC

DKN-01 showed additive activity with 5-fluorouracil (5-FU) and can overcome 5-FU-resistance in two CRC xenograft models, resulting in tumor regressions
5-FU-resistant models are reflective of a second-line CRC population currently being recruited in the DeFianCe study (NCT05480306)
DKN-01 as monotherapy or in combination with anti-PD-1 resulted in tumor regression in a CT26 syngeneic CRC model
Treatment increased PD-L1 immunoreactivity
Promoted substantial tumor necrosis which was associated with a robust immune cell infiltrate
Tumor immune infiltrate contained a substantial number of CD3+ and CD8+ cells, implying the presence of an adaptive immune response to tumor antigen
Leap Poster Details:

Title: DKN-01 and Tislelizumab as a Second-line (2L) Investigational Therapy in Advanced DKK1-high Gastroesophageal Adenocarcinoma (GEA): DisTinGuish Trial
First Author: Samuel J. Klempner, Harvard Medical School
Session Category: Poster Session
Session title: Immune-stimulants and immune modulators
Date and time: Thursday, November 10, 2022, at 9:00 a.m. ET
Poster Number: 553

Title: DKN-01 Demonstrates Immune Modulatory Activity and Robust Efficacy in Colorectal Cancer Models
First Author: Michael Haas, Leap Therapeutics
Session Category: Poster Session
Session title: Immune-stimulants and immune modulators
Date and time: Thursday, November 10, 2022, at 9:00 a.m. ET
Poster Number: 1141

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in three parts in the United States and the Republic of Korea. Part A has been completed with 25 first-line HER2- GEA cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B has completed enrolling patients with second-line DKK1-high GEA cancer. Part C of the study is enrolling approximately 160 first-line patients in a randomized controlled trial of DKN-01 in combination with tislelizumab and chemotherapy compared to tislelizumab and chemotherapy. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene.

About the DeFianCe Study

The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy. The study is designed with an initial 20 patient cohort and to then expand into a 130-patient randomized controlled trial against bevacizumab and standard of care chemotherapy.

Hummingbird Bioscience Announces Two HMBD-002 Poster Presentations at the Society for Immunotherapy of Cancer 2022 Annual Meeting

On November 7, 2022 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, reported two poster presentations for HMBD-002, a unique anti-VISTA antibody, at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 10-12, 2022 in Boston (Press release, Hummingbird Bioscience, NOV 7, 2022, View Source [SID1234623193]). The company will present a Trials in Progress poster summarizing the Phase 1 clinical trial design for HMBD-002 (NCT05082610) and a poster examining the anti-tumor effects of VISTA blockade by HMBD-002 in preclinical studies.

The first poster describes the Phase 1, open-label, multi-center, first-in-human trial evaluating HMBD-002 as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab). The pembrolizumab combination arm of the study will be conducted in collaboration with Merck & Co., Inc., Rahway, NJ, USA.

The second poster shares preclinical data demonstrating that VISTA blockade with HMBD-002 reprograms tumor-associated macrophages to an inflammatory phenotype and promotes cytotoxic T-cell response. HMBD-002 in combination with anti-PD-1 treatment shows enhanced anti-tumor efficacy compared to monotherapy arms.

"As we gain a better understanding of the complex biology of VISTA, our confidence regarding the potential benefit of VISTA blockade to cancer patients who do not respond to current therapies continues to grow," said Jerome Boyd-Kirkup, Ph.D., Hummingbird Bioscience’s Chief Scientific Officer. "We are excited to share the compelling new preclinical data for HMBD-002, our potential first-in-class anti-VISTA antagonist antibody with a unique epitope and antibody format and look forward to discussing longer-term clinical development plans and combination strategies with the wider immuno-oncology community at SITC (Free SITC Whitepaper)."

SITC Trials In Progress Poster Details:

Abstract Title: A phase 1 first-in-human study of HMBD-002, an IgG4 monoclonal antibody targeting VISTA, as a monotherapy and combined with pembrolizumab in patients with advanced solid malignancies

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About HMBD-002

HMBD-002 is an investigational IgG4 anti-VISTA antagonist antibody produced by our Rational Antibody Discovery ("RAD") platform to target the region where VISTA interacts with binding partners that have been shown to play an important role in modulating T cell activity, potentially unlocking the immune system to attack cancer cells. Due to complex biology, VISTA has not been adequately drugged to date. We believe HMBD-002 is the first Fc-independent anti-VISTA antibody designed to bind a computationally predicted functional epitope distinct from the epitopes of other known anti-VISTA antibodies in development. In the Company’s preclinical studies, HMBD-002 demonstrated potent anti-tumor activity both as monotherapy and in combination with pembrolizumab, in multiple syngeneic and humanized mouse models of cancers. HMBD-002 is being developed for various VISTA-expressing cancers, both as a monotherapy and in combination with pembrolizumab. The development of HMBD-002 is supported in part by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT, DP190027).

GSK provides update on DREAMM-3 phase III trial for Blenrep in relapsed/refractory multiple myeloma

On November 7, 2022 GSK plc (LSE/NYSE: GSK) reported that DREAMM-3, the phase III open-label, randomised head-to-head superiority trial of Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma (RRMM), did not meet its primary endpoint of progression-free survival (PFS) (Press release, GlaxoSmithKline, NOV 7, 2022, View Source [SID1234623192]).

In the DREAMM-3 trial, the primary endpoint of PFS demonstrated a hazard ratio (HR) of 1.03 (95% CI: 0.72 1.47). The observed median progression-free survival was longer for belantamab mafodotin vs PomDex (11.2 months vs 7 months). Secondary endpoints include overall response rate (ORR), duration of response (DOR) and overall survival (OS). The ORR was 41% for belantamab mafodotin and 36% for PomDex. Belantamab mafodotin demonstrated a deeper response rate when compared with PomDex (25% VGPR or better with belantamab mafodotin compared to 8% with PomDex). The median follow-up was 11.5 months for belantamab mafodotin and 10.8 months for PomDex; the median DOR was not reached for belantamab mafodotin (95% CI: 17.9, –) vs 8.5 months (95% CI: 7.6, –) for PomDex; DOR rates at 12 months were 76.8% and 48.4% for belantamab mafodotin and PomDex respectively. The safety and tolerability profile of belantamab mafodotin was consistent with the known safety profile, and no new safety signals were identified. Overall rates of grade 3 keratopathy are consistent with prior reported data.

At the time of the primary analysis, the OS data had only achieved 37.5% overall maturity. The median OS was 21.2 and 21.1 months for belantamab mafodotin and PomDex, respectively, with an HR of 1.14 (95% CI: 0.77, 1.68).

Blenrep was granted accelerated approval by the US Food and Drug Administration (FDA) as a monotherapy for treating adult patients with RRMM who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The accelerated approval was based on the results of the DREAMM-2 overall response rate, DOR and contingent upon a confirmed clinical benefit from a randomised phase III clinical trial. Data from DREAMM-3 is in the process of being shared with health authorities. Discussions with health authorities are currently ongoing.

Additional trials within the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme will continue. These trials are designed to demonstrate the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimisation to maintain efficacy while reducing corneal events. Data from the DREAMM-7 and DREAMM-8 phase III trials are anticipated in the first half of 2023.

About DREAMM-3
The DREAMM-3 phase III trial is an open-label, randomised trial evaluating the efficacy and safety of single-agent belantamab mafodotin compared to PomDex in patients with RRMM. A total of 325 participants were randomised in a 2:1 ratio to receive either single agent belantamab mafodotin administered as a 2.5 mg/kg dose every three weeks (Q3W), or PomDex. Pomalidomide was administered daily on days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (days 1, 8, 15, and 22 of each cycle). The primary endpoint was PFS. Secondary endpoints include safety, OS, overall response rate, DOR and assessment of minimal residual disease.

About DREAMM-7
DREAMM-7 is evaluating the safety and efficacy of belantamab mafodotin in combination with bortezomib and dexamethasone versus daratumumab in combination with bortezomib and dexamethasone.

About DREAMM-8
DREAMM-8 is assessing the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of a combination of pomalidomide, bortezomib and dexamethasone in participants with relapsed/refractory multiple myeloma.

About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[1],[2] In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.[3] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[4]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[5]

About Blenrep
Blenrep is an antibody drug conjugate comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc. a member of the Kyowa Kirin Group.

GSK in oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, and antibody-drug conjugates, either alone or in combination.