On November 4, 2021 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ending September 30, 2021 (Press release, Transgene, NOV 4, 2021, View Source [SID1234594537]).

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KEY EVENTS OF THE THIRD QUARTER 2021

In July 2021, Transgene announced its participation in PERSIST-SEQ, a new international consortium of academic and industrial leaders in the field of cancer research. This collaborative research program aims to provide the cancer research community with a new gold standard workflow for single-cell sequencing by developing and validating best practices as well as generating and analyzing high-quality data. The project aims to empower the scientific community to unravel drug resistance and develop smarter therapeutic strategies to better treat cancer and prevent resistance. PERSIST-SEQ is a five-year public-private partnership, funded by the Innovative Medicines Initiative (IMI), and led by the Oncode Institute and AstraZeneca.

In September 2021, Transgene presented initial Phase I data providing clinical proof of concept for the intravenous administration of Transgene’s patented oncolytic virus (Invir.IO platform) at the ESMO (Free ESMO Whitepaper) 2021 congress. These data demonstrate that the TG6002 Vaccinia Virus, which is the same viral backbone as the Invir.IO platform, can reach the tumor, replicate within its cancer cells and induce the local production of 5-FU when administered intravenously. These initial data support the feasibility of IV administration and aim to enlarge the number of solid tumors that could be addressed by Transgene’s oncolytic viruses.

UPCOMING MILESTONES EXPECTED
IN THE FOURTH QUARTER 2021

Transgene and BioInvent will present preclinical data on their novel dual mechanism-of-action oncolytic Vaccinia Virus BT-001 (Invir.IO platform) at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2021), which takes place on November 12–14, 2021.

The first data from the two ongoing Phase I clinical trials of the individualized cancer vaccine TG4050 (myvac platform) will be communicated in the second half of November 2021. Transgene expects to communicate safety and immunogenicity (T-cell induction) data.

OPERATING INCOME

During the first nine months of 2021, operating income amounted to €6.8 million compared to €7.8 million in the same period in 2020.

Revenue from collaborative and licensing agreements amounted to €1.6 million in the first nine months of 2021, compared with €2.7 million in the same period in 2020. These revenues are mainly derived from Transgene’s collaboration agreement with AstraZeneca on the Invir.IO program, whose recognized income represents €1.5 million as of September 30, 2021. This amount corresponds to €1.0 million recognized out of the initial payment of €8.9 million ($10 million) received in 2019 for the activity carried out over the period; the remaining corresponds to the payment of contract-defined milestones.
During the first nine months of 2021 government financing for research expenditures, mainly in the form of a research tax credit, amounted to €4.9 million, compared to €4.5 million for the same period in 2020.

CASH, CASH EQUIVALENTS
AND OTHER FINANCIAL ASSETS

Cash, cash equivalents and other financial assets stood at €40.9 million as of September 30, 2021, compared to €26.3 million as of December 31, 2020. In the first nine months of 2021, Transgene’s cash burn amounted to €18.7 million (excluding the net proceeds of €33.3 million from a private placement conducted in June 2021) compared to a positive €2.0 million for the same period in 2020 (including the receipt of a net amount of €18.2 million in July 2020, following the first partial sale of Transgene’s stake in Tasly BioPharmaceuticals).

In October 2021, the Company’s cash position was improved when it received €17.4 million following the second partial sale of Tasly BioPharmaceuticals shares signed in September 2021. Transgene still owns shares of this company, valued €18.2 million based on the price of the current share sale. This sale of Tasly BioPharmaceuticals shares led to the contractual cancellation of the €15 million credit facility with Natixis in October 2021.

Transgene has financial visibility until the end of 2023.

On November 4, 2021 Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for cancer, autoimmune and genetic blood disorders, reported that new data will be presented from a single-center Phase 2 trial and a multi-center Phase 1b trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Specifically, pooled data from patients treated with Orca-T, an investigational high-precision cell therapy product being studied in patients with hematologic malignancies, will be shared in an oral presentation (Press release, Orca Bio, NOV 4, 2021, View Source [SID1234594536]). Additionally, results of Orca-T in a subset of patients with myelofibrosis from those same trials will be shared in a poster presentation.

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"Our clinical experience with Orca-T has grown significantly over the past year and we are pleased to present data on an expanded group of patients who now have one year of follow-up with Orca-T," said Ivan Dimov, Ph.D., cofounder and chief executive officer of Orca Bio. "We look forward to presenting these important findings at ASH (Free ASH Whitepaper) as we continue to work to deliver on our promise of maximizing patient survival while minimizing the compromise of toxicities to enable better outcomes."

The ASH (Free ASH Whitepaper) abstracts are now available at www.hematology.org.

Details of the Orca Bio presentations follow:

Oral Presentation:

Orca-T Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies: Results of a Single Center Phase 2 and a Multicenter Phase 1b Study
Abstract Number: 98
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Prevention of graft vs. host disease after allogeneic hematopoietic cell transplantation
Presentation Date: Saturday, December 11, 2021, at 9:45 AM EST
Location: Georgia World Congress Center, B302-B303

Poster Presentation:

Outcomes for Myelofibrosis Patients Following Myeloablative Allogeneic Stem Cell Transplantation Using the Orca-T Graft from HLA-Matched Related and Unrelated Donors
Abstract Number: 1819
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I
Presentation Date: Saturday, December 11, 2021, at 5:30 PM – 7:30 PM EST
Location: Georgia World Congress Center, Hall B5

About Orca-T
Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

On November 4, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported abstracts for ZYNLONTA and ADCT-602 have been accepted for presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held virtually and in Atlanta, Georgia from December 11-14, 2021 (Press release, ADC Therapeutics, NOV 4, 2021, View Source [SID1234594535]).

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"We look forward to sharing data on our targeted ADCs as single agents and in innovative combinations at the 2021 ASH (Free ASH Whitepaper) Annual Meeting," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "This will include presentations from investigators on subset data from our pivotal Phase 2 study and data on the use of ZYNLONTA post-CAR-T. We are also encouraged by the anti-tumor activity and manageable safety profile of ZYNLONTA in combination with ibrutinib. The Phase 2 protocol has recently been amended with a higher and more frequent dose of ZYNLONTA to potentially enhance the response and to investigate this combination in earlier lines of therapy."

Details of ADC Therapeutics’ oral presentation are as follows:

Planned Interim Analysis of a Phase 2 Study of Loncastuximab Tesirine Plus Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma (LOTIS-3)
Abstract: 54
Date and Time: Saturday, December 11, 2021, 10:45 a.m. EST
Session: 627. Aggressive Lymphomas: Clinical and Epidemiological: Population data for Aggressive NHL Management
Presenter: Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital, Milan, Italy

Details of ADC Therapeutics’ poster presentations are as follows*:

Clinical Characteristics and Responses of Patients with Relapsed or Refractory High-Grade B-cell Lymphoma Treated with Loncastuximab Tesirine in the LOTIS-2 Clinical Trial
Abstract: 3575
Date: Monday, December 13, 2021
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III
Presenter: Juan Pablo Alderuccio, MD, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA

Combination of Loncastuximab Tesirine and Polatuzumab Vedotin Shows Increased Anti-Tumor Activity in Pre-Clinical Models of Non-Hodgkin Lymphoma
Abstract: 2273
Date: Sunday, December 12, 2021
Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

CD19-mediated DNA Damage Boost in Lymphoma Cells Treated with Loncastuximab Tesirine in Combination with PARP inhibitors
Abstract: 1342
Date: Saturday, December 11, 2021
Session: 622. Lymphomas: Translational—Non-Genetic: Poster I
Presenter: Stefania Fusani, PhD, Oncohematology Division, IEO Istituto Europeo di Oncologia IRCCS, Milano, Italy

Details of an independently developed ZYNLONTA poster are as follows:

The Anti-CD19 Antibody-Drug Conjugate Loncastuximab Tesirine Achieved Responses in Patients with Diffuse Large B-cell Lymphoma Who Relapsed After Anti-CD19 CAR T-Cell Therapy
Abstract: 2489
Date: Sunday, December 12, 2021
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II
Presenter: Paolo F. Caimi, MD, Cleveland Clinic/Case Comprehensive Cancer Center, Cleveland, OH, USA

Details of an independently developed ADCT-602 poster are as follows:

A Phase 1 Trial of ADCT-602, a CD22 Targeting Antibody Drug Conjugate Bound to PBD Toxin in Adult Patients with Relapsed or Refractory CD22+ B-Cell Acute Lymphoblastic Leukemia
Abstract: 1237
Date: Saturday, December 11, 2021
Session: 614. Acute Lymphoblastic Leukemias: Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Presenter: Nitin Jain, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

*Posters will be available in the poster exhibit hall in the Georgia World Congress Center on these dates: December 11: 9:00 a.m.–7:30 p.m. EST; December 12 & 13: 9:00 a.m.–8:00 p.m. EST. Presenters planning to attend in-person are expected to present during the final two hours of the noted viewing time.

The abstracts are available through the ASH (Free ASH Whitepaper) online meeting program and will be published in the November supplemental issue of Blood.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On November 4, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that data at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (December 11-14) will showcase continued leadership across both approved and investigational CAR T-cell therapies and medicines (Press release, Gilead Sciences, NOV 4, 2021, View Source [SID1234594534]). Gilead and Kite will present more than 20 abstracts, including a plenary presentation and six oral presentations, across several hematological malignancies including large B-cell lymphoma (LBCL), non-Hodgkin lymphoma (NHL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

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"This ASH (Free ASH Whitepaper) meeting illustrates the growing maturity of data regarding the potential of our CAR T-cell therapies to be used earlier in treatment along with long-term follow-up data," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "As we continue to build on the established strengths of Kite’s CAR T franchise, our goal is to provide differentiated treatment options to patients that have the potential to change standard of care and deliver the hope of survival to more people with blood cancers."

In cell therapy, Kite will present the first efficacy and safety results from the landmark ZUMA-7 study in LBCL as part of ASH (Free ASH Whitepaper)’s plenary sessions. Additional research from Kite, focused on long-term follow-up data and quality of life improvements for people with certain blood cancers treated with the company’s CAR T-cell therapies, will also be presented.

"The Gilead and Kite data presentations at ASH (Free ASH Whitepaper) reinforce our diverse oncology pipeline focused on helping bring more life to people with cancer, especially in areas where few options exist," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We see broad potential across our oncology portfolio as we advance transformative science for people with hard-to-treat blood cancers."

Researchers will also share early-stage research on magrolimab, an investigational CD47 inhibitor, both in an oral session and in an ASH (Free ASH Whitepaper)-EHA Joint Symposium. During the symposium, Targeting Macrophages and the Innate Immune System to Treat Hematologic Malignancies, potential new approaches to cancer therapies will be showcased. Early data suggest these approaches, including activating the innate immune system, could become foundational to the next generation of oncology treatment.

Dates and times for accepted abstracts and presentations of note are as follows:

Abstract Details

Titles

Plenary Session

Large B-cell Lymphoma

Abstract #2

Sunday, Dec 12

(2:00 pm ET / 11:00 am PT)

Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma

Oral Presentations

Large B-cell Lymphoma

Abstract #430

Sunday, Dec 12

(10:15 am ET / 7:15 am PT)

Patient-Reported Outcomes in a Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma (ZUMA-7)

Large B-cell Lymphoma

Abstract #530

Sunday, Dec 12

(4:45 pm ET / 1:45pm PT)

Real-World Outcomes of Axicabtagene Ciloleucel for the Treatment of Large B-Cell Lymphoma: Impact of Age and Specific Organ Dysfunction

Large B-cell Lymphoma

Abstract #739

Monday, Dec 13

(2:45 pm ET / 11:45 am PT)

Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel as First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma

Large B-cell Lymphoma

Abstract #901

Monday, Dec 13

(6:15 pm ET / 3:15 pm PT)

TNFR2 as a Target to Improve CD19-Directed CAR T-Cell Fitness and Antitumor Activity in Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Abstract #93

Saturday, Dec 11

(10:00 am ET / 7:00 am PT)

Long-Term Follow-Up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Investigator-Sponsored Research (ISR) Oral Presentation

Acute Myeloid Leukemia

Abstract #371

Sunday, Dec 12

(9:30 am ET / 6:30 am PT)

Phase I/II Study of Azacitidine with Venetoclax and Magrolimab in Patients with Newly Diagnosed Older/Unfit or High-Risk Acute Myeloid Leukemia (AML) and Relapsed/Refractory AML

Poster Presentations

Large B-cell Lymphoma
Abstract #1764

Saturday, Dec 11

(5:30 pm ET / 2:30 pm PT)

Long-Term (4- and 5-Year) Overall Survival in ZUMA-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL)

Large B-cell Lymphoma
Abstract #1424

Saturday, Dec 11

(5:30 pm ET / 2:30 pm PT)

Chimeric Antigen Receptor T-Cell Therapy Treatment Patterns: A Retrospective Cohort Analysis of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients in the US

Follicular Lymphoma
Abstract #1350
Saturday, Dec 11
(5:30 pm ET / 2:30 pm PT)

Safety and Effectiveness of Idelalisib in Patients with Double Refractory Follicular Lymphoma: A Pan European Cohort of 242 Patients

Large B-cell Lymphoma Abstract #2832

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma: One-Year Follow-Up of ZUMA-1 Cohort 6

Large B-cell Lymphoma
Abstract #151459

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

Profiling the Peripheral Blood Immune Cell Repertoire in Large B-Cell Lymphoma Patients Treated with CD19 CAR-T

Large B-cell Lymphoma

Abstract #2814

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

A Phase II Trial of Anakinra for the Prevention of CAR T-Cell Mediated Neurotoxicity

Large B-cell Lymphoma Abstract #2833

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

Prediction of Early Onset Cytokine Release Syndrome and Neurologic Events After Axicabtagene Ciloleucel in Large B-Cell Lymphoma Based on Machine Learning Algorithms

Follicular Lymphoma
Abstract #3543

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

A Comparison of Clinical Outcomes from Updated ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5 External Control Cohort in Relapsed/Refractory Follicular Lymphoma

Mantle Cell Lymphoma

Abstract #3844

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

The Comparison of KTE-X19 to Current Standards of Care: A Pre-Specified Synthetic Control Study Utilizing Individual Patient Level Data from Historic Clinical Trials (SCHOLAR-3)

Mantle Cell Lymphoma

Abstract #3849

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

Effects of Prior Exposure to Tec Kinase Inhibitors on KTE-X19 Products

Trials-In-Progress (TiP)

Multiple Myeloma

Abstract #2757

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients with Relapsed/Refractory Multiple Myeloma

Acute Myeloid Leukemia

Abstract #3424

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

A Phase 2, Open-Label, Multiarm, Multicenter Study to Evaluate Magrolimab Combined with Antileukemia Therapies for First-Line, Relapsed/Refractory, or Maintenance Treatment of Acute Myeloid Leukemia

Acute Myeloid Leukemia

Abstract# 3426

Monday Dec 13

(6:00 pm ET / 3:00 pm PT)

A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine in Previously Untreated Patients with TP53-Mutant Acute Myeloid Leukemia

Myelodysplastic Syndrome

Abstract #7055

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher-Risk (HR) Myelodysplastic Syndrome (MDS): The Phase 3 Randomized, ENHANCE Study

For more information, including a complete list of abstract titles at the meeting, please visit: View Source

On November 4, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported that new preclinical data on its small-molecule MALT1 inhibitors will be presented during a poster session at the American Society of Hematology (ASH) (Free ASH Whitepaper) 63rd Annual Meeting taking place virtually and in Atlanta, Georgia, December 11-14, 2021 (Press release, Schrodinger, NOV 4, 2021, View Source [SID1234594533]).

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Inhibiting MALT1 (mucosa-associated lymphoid tissue lymphoma translocation protein 1) is considered a potentially promising therapeutic approach for the treatment of certain subtypes of non-Hodgkin B-cell lymphomas and for chronic lymphocytic leukemia (CLL). Schrödinger has identified a number of small-molecule MALT1 inhibitors, the most advanced of which is expected to enter the clinic next year.

Details of the poster presentation are as follows:

Title: Characterization of Potent Paracaspase MALT1 Inhibitors for Hematological Malignancies
Abstract number: 1187
Date & time: Saturday, December 11, 5:30 p.m. – 7:30 p.m. EST
Location: Georgia World Congress Center, Hall B5