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ADC Therapeutics Announces Abstracts to be Presented at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022)

On September 21, 2022 ADC Therapeutics SA (NYSE: ADCT) reported that ZYNLONTA (loncastuximab tesirine-lpyl) and camidanlumab tesirine (Cami) abstracts have been accepted for presentation at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022), which will be held in Houston, Texas from September 28–October 1, 2022 (Press release, ADC Therapeutics, SEP 21, 2022, View Source [SID1234621319]).

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"We are looking forward to sharing the encouraging initial safety run-in results from our LOTIS-5 Phase 3 clinical trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma at SOHO 2022," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "This is one of several clinical studies of ZYNLONTA in combination with other drugs intended to evaluate ZYNLONTA in earlier lines of treatment. "

LOTIS-5 Initial Safety Run-In Results

LOTIS-5 is a Phase 3, randomized, open‐label, two‐part, two‐arm, multicenter study of loncastuximab tesirine in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Twenty patients were enrolled in part 1 in a nonrandomized safety run‐in. In part 2, approximately 330 patients will be randomized 1:1 to receive Lonca‐R or rituximab‐gemcitabine‐oxaliplatin (R‐GemOx).

The 20 patients in the safety run‐in were a median age of 74.5 years (range 35‐93) and received a median of 1 previous therapy (range 1‐6). As of the February 28, 2022, data cutoff:

The overall response rate by central review was 15/20 (75%). A total of 8/20 (40%) and 7/20 (35%) patients attained complete response and partial response, respectively.
The most common all‐grade TEAEs, regardless of the relationship to the study treatment, were rash (5 [25%]), fatigue (4 [20%]), and increased gamma-glutamyl transferase (4 [20%]). The most common grade ≥3 TEAEs were increased gamma-glutamyl transferase (3 [15%]), increased alanine aminotransferase (2 [10%]), and neutropenia (2 [10%]).
These data will be presented in the following poster:

Initial Safety Run‐In Results of the Phase 3 LOTIS‐5 Trial: Novel Combination of Loncastuximab Tesirine With Rituximab (Lonca‐R) Versus Immunochemotherapy in Patients With R/R DLBCL
Poster Number: ABCL-320

Details of ADC Therapeutics’ other poster presentations:

A Phase 2, Open-Label Study of Loncastuximab Tesirine in Combination with Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients with Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9) (Encore data, first time as presentation)
Poster Number: ABCL-272

Health-Related Quality of Life and Tolerability in Patients With/Without Skin Toxicity During Loncastuximab Tesirine Treatment in a Phase 2 Clinical Trial (LOTIS-2)
Poster Number: ABCL-316

Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Encore data, first time as presentation)
Poster Number: ABCL-334

All posters will be presented on Wednesday, September 28 from 5:05 to 6:30 p.m. CT in Ballroom of Americas on Level 2 of the Hilton-Americas Houston. Posters will remain in the poster hall for viewing throughout the day on Thursday and Friday. Online access to posters for registered attendees will begin on Thursday, September 29.

Details of ADC Therapeutics’ oral presentation:

Camidanlumab Tesirine: Updated Efficacy and Safety in an Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore)
Date and Time: Friday, September 30, 5:48-5:58 p.m. CT
Location: Grand Ballroom G-L, 4th floor
Presenter: Alex Herrera, MD, City of Hope, Duarte, California, USA
Session XII: Hodgkin Lymphoma

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 DLBCL not otherwise specified, 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.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

Novocure Announces Creation of U.S. CNS Cancers Franchise Intended to Renew Focus on Growth in Glioblastoma Business

On September 21, 2022 Novocure (NASDAQ: NVCR) reported the creation of its U.S. CNS (central nervous system) Cancers Franchise (Press release, NovoCure, SEP 21, 2022, View Source [SID1234621318]). This new organization will add resources, streamline decision-making and improve coordination across Novocure’s U.S. CNS business, and is intended to renew focus on growth in Novocure’s glioblastoma (GBM) business .

"Frank has been a tremendously successful business leader throughout his tenure at Novocure, always driving teams to produce impactful results. I look forward to Frank’s dedicated focus on GBM and CNS cancers and to our company’s continued pursuit of extending survival in some of the most aggressive forms of cancer."

Frank Leonard, who served as Novocure’s Chief Development Officer since 2020, is named President, CNS Cancers U.S., effective September 19, 2022. Mr. Leonard will be responsible for the entirety of the U.S. CNS business including U.S. GBM Sales and Marketing, Regional Marketing, Learning & Development, Maxpoint, Government Affairs and U.S. CNS Medical teams. Pritesh Shah, Novocure’s Chief Commercial Officer, will retain responsibility for global commercial strategy and brand management, the EMEA and APAC regions and future indications.

"I am very pleased with the creation of the U.S. CNS Cancers Franchise, specifically focused on delivering Tumor Treating Fields therapy to additional GBM patients," said Asaf Danziger, Novocure’s Chief Executive Officer. "Frank has been a tremendously successful business leader throughout his tenure at Novocure, always driving teams to produce impactful results. I look forward to Frank’s dedicated focus on GBM and CNS cancers and to our company’s continued pursuit of extending survival in some of the most aggressive forms of cancer."

Nucleai and Propath UK announce partnership for end-to-end AI-powered spatial analysis of a 30-plex immunofluorescence immuno-oncology panel

On September 21, 2022 Propath UK, Europe’s leading CRO for spatial biology, and Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking spatial biology insights from pathology data, reported their collaboration to develop and validate a 30-plex immunofluorescence (IF) panel focused on protein targets relevant to immuno-oncology (Press release, Nucleai, SEP 21, 2022, View Source [SID1234621317]). For our pharmaceutical and biotechnology partners, this groundbreaking panel, in conjunction with Nucleai’s validated AI assay, can be used to unlock insights from immunotherapy trials and inform the development of novel biomarkers and companion diagnostics (CDx).

"Our strategic partnership with Propath has far-reaching implications in biomarker discovery," said Avi Viedman, CEO of Nucleai. "The collaboration allows us to develop and deploy AI-based multi-modal models to identify unique sets of previously unavailable biomarkers and drug targets. Together, we are pushing the boundaries of pathology tissue analytics."

Applying its expertise in multiomic spatial biology and high-plex immunofluorescence, Propath will develop a novel protocol using the innovative Lunaphore COMET platform for analysis of 30 high-value protein targets from a single tissue section. The COMET enables rapid development of highly multiplexed panels, with robust and reproducible staining. Propath UK will use experience gained across a range of spatial proteomic and transcriptomic projects completed on its in-house multiomic platforms.

"Spatial biology is transforming biopharma research by enabling deeper analysis of cell phenotypes with full spatial context in the tissue microenvironment," commented Dr Krish Soni, Chief Executive of Propath UK. "We are delighted to collaborate with Nucleai on this ambitious project which will empower researchers to unlock the potential of spatial biology, with relevance to programs from discovery through to translational and clinical research."

Nucleai’s collaboration with Propath comes on the heels of the recent news announcement that it made with Lunaphore, announcing their partnership to provide AI-powered spatial biology analysis to accelerate drug discovery. This three-way synergy between Propath, Lunaphore and Nucleai brings new capabilities to pharma companies. The partnership utilizes Lunaphore’s flagship COMET platform for hyperplex staining and imaging with Nucleai’s cutting-edge AI spatial models to derive new insights from tissue biopsies, including novel drug targets, mechanisms of action, and biomarkers to advance the field of precision medicine. Demonstrating the utility of the technology, Propath provides high-plex tissue analytics using the Lunaphore COMET as a fully managed service.

Nucleai’s proprietary AI-powered, pathology-based biomarker discovery platform combined with Propath’s multiomic spatial biology and high-plex immunofluorescence will accelerate the pharmaceutical industry’s drug development and research programs. A fundamental aspect of precision oncology is predicting drug response for a patient cohort. The combined expertise will allow computational analysis of the tumor microenvironment, feature selections to predict disease prognosis and drug response including cancer sub-type determination, to stratify patients and support early detection and prognosis.

CARsgen Presents North America Phase 2 Updates for CT053 BCMA CAR T at the 7th Annual CAR-TCR Summit

On September 21, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that at the 7th Annual CAR-TCR Summit, in Boston, Massachusetts, the Company gave an oral presentation on the North America Phase 2 clinical trial of zevorcabtagene autoleucel ("zevor-cel", R&D code: CT053), an autologous CAR T-cell product candidate against BCMA (Press release, Carsgen Therapeutics, SEP 21, 2022, View Source [SID1234621316]). This multi-center, open-label, Phase 1b/2 study (NCT03915184) is being conducted to evaluate the safety and efficacy in North American patients with relapsed and/or refractory multiple myeloma (R/R MM).

As of August 31, 2022, 17 patients with R/R MM received zevor-cel infusion in the Phase 2 portion of the clinical trial and have been followed for a median of 113 days (range: 9 to 373). Of these 17 patients, five patients (29.4%) had extramedullary disease (EMD; ≥1 plasmacytoma) and nine patients (52.9%) had high-risk cytogenetic features. Patients were heavily pretreated with a median of six prior lines of therapy (range: 4 to 17). All patients were refractory to their last line of therapy. Prior to zevor-cel infusion, patients received lymphodepletion regimen of fludarabine (30mg/m2 for three consecutive days) and cyclophosphamide (500mg/m2 for two consecutive days).

Efficacy

In the 11 evaluable patients who had at least eight weeks follow-up, including four patients with EMD, the objective response rate was 100% (very good partial response, complete response, or stringent complete response) and responses deepened for patients with longer follow-up. Since all responses are ongoing, the median progression-free survival, median overall survival and median duration of response have not been reached, and the complete response/stringent complete response rate is not mature. All patients with available MRD results at week 4 were MRD negative by next-generation of sequencing.

Safety

No death occurred and no patient experienced Grade 3 or higher cytokine release syndrome. Cytokine release syndrome was observed in 10 of 17 patients (59%), all reported as Grade 1 or 2. One transient Grade 3 immune effector cell-associated neurotoxicity syndrome event was reported and the patient fully recovered; no neurological toxicity with parkinsonian features was observed. For the management of post-infusion symptoms, five of 17 patients (29%) received tocilizumab and one patient (5.9%) received corticosteroids. Notably, three patients have received outpatient zevor-cel treatment in this study, and the two patients were admitted into the hospital for symptom management for 1 or 2 days.

Conclusion

Zevor-cel at a dose of 1.8×108 CAR T cells was well tolerated in the initial 17 Phase 2 patients with R/R MM, with promising efficacy and MRD negativity. Outpatient treatment is currently undergoing further exploration.

Dr. Raffaele Baffa, Chief Medical Officer of CARsgen Therapeutics, said: "Multiple myeloma is the second most common hematologic malignancy. People in the United States (US) living with or in remission from multiple myeloma is expected to increase to about 160 thousand in 2024. There remains a significant unmet medical need of multiple myeloma patients that call for alternative options. The results of the initial 17 patients treated with zevor-cel in the LUMMICAR-2 Phase 2 clinical trial, reported at the CAR-TCR Summit, indicates a consistent trend of clinical benefit with the data of earlier trials conducted on zevor-cel, such as the investigator-initiated trials and LUMMICAR-1 phase 1 trials in China as reported previously in ASH (Free ASH Whitepaper). We are very encouraged by the competitive efficacy and favorable safety profiles and will continue to dedicate our efforts in successfully developing and launching zevor-cel for multiple myeloma patients worldwide."

About Zevor-cel

Zevor-cel (CT053) is a fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. CARsgen is conducting a Phase 1b/2 clinical trial (LUMMICAR STUDY 2) in North America to evaluate the safety and efficacy of zevor-cel for R/R MM. The Company also plans to conduct additional clinical trials to develop zevor-cel as an earlier line of treatment for multiple myeloma.

Zevor-cel received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) in 2019, as well as the PRIority MEdicines (PRIME) and Orphan Medicinal Product designations from the European Medicines Agency (EMA) in 2019 and 2020, respectively. Zevor-cel also received Breakthrough Therapy designation from the NMPA in 2020.

The Company believes that zevor-cel is well positioned to potentially reshape the treatment paradigm for multiple myeloma and become a foundational treatment for multiple myeloma patients.

Abpro Finalizes Strategic Partnership with Celltrion for Worldwide Development and Commercialization of a Cancer Treatment Bispecific Antibody

On September 21, 2022 Abpro, a biotech company with the mission of improving the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies, reported a strategic partnership with Celltrion, a biopharmaceutical company headquartered in Incheon, South Korea, today, for its cancer molecule ABP 102, an antibody therapy for patients suffering from HER2+ cancer, including breast, gastric, and pancreatic cancer (Press release, Abpro Therapeutics, SEP 21, 2022, View Source [SID1234621315]). Through this global partnership, Abpro will receive payments from Celltrion of up to $1.75 Billion, including an equity investment, development and commercial milestone payments and worldwide profit sharing. Celltrion will be in charge of the development of ABP 102 following the completion of in vitro studies by Abpro and will have world-wide commercialization rights. HER2+ type cancer is implicated in up to 30% of all cases in breast, gastric, pancreatic, and other forms of cancer.

"We are thrilled to be able to enter this collaboration with Celltrion and are excited to work with such an excellent partner on bringing this treatment to market. Through our commitment to patients, we strive to enable them to live life to the fullest, and this collaboration with Celltrion, a world class pharmaceutical company, will help us meet that goal," said Ian Chan, co-founder and CEO of Abpro. "This is a significant validation of our technology platform and also our pipeline of t-cell engagers. We aim to deliver therapies to help patients facing severe disease that leads to a better quality of life."

"Abpro’s ABP 102 molecule has shown preliminary data of better efficacy and less toxicity compared to other therapies treating the same indication," said Dr. Sooyoung Lee, VP and head of the new drug research division of Celltrion. "We are confident this partnership will allow us to deliver the best possible care to patients suffering from HER2+ cancer. Abpro’s platform looks highly promising and potentially best-in-class. Together, we will go great lengths to ensure people live longer, healthier lives."