On September 21, 2022 US Medical Innovations, LLC (USMI), a subsidiary of US Patent Innovations, LLC, reported it has secured a $10.2 million private placement deal from multiple sources including existing partners and new investors (Press release, US Medical Innovations, SEP 21, 2022, View Source [SID1234621321]). USMI will be using these funds to ramp-up manufacturing of its newly-released Canady Plasma XL-1000 SMART Electrosurgical Generator (XL-1000) and support the development and release of its Canady Helios Cold Plasma Generator (CHCP) and robotic delivery system for the selective treatment of cancer.

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CEO Dr. Jerome Canady commented, "We are pleased to have closed this round of private financing at such a critical time in our development efforts. We see this investment by seasoned investors as a strong vote of confidence in our mission to develop disruptive technology that will change the landscape of electrosurgery and cancer therapy."

In April 2021, USMI completed the first FDA-IDE-approved clinical trial to evaluate cold atmospheric plasma (CHCP) for the treatment of cancer and is preparing for the launch of several Phase II multi-center international trials starting in Q/1 2023. The Company has recently released its new XL-1000 featuring Canady Hybrid Plasma Technology, a high-definition touchscreen, built-in surgical Apps, and a variety of safety and security features. Hybrid Plasma electrosurgery technology is used in more traditional surgeries such as hip and knee replacements.

Dr. Canady continued, "This investment, along with our additional sales revenue will allow us to continue to develop and refine our Cold Plasma technology for treating cancer as well as progress with our strategic plans for a 2023 IPO."

On September 21, 2022 AccessHope, LLC, a company that provides cancer expertise to employers who offer employer sponsored insurance programs, payers, and other health and wellness organizations, reported a new foundational collaboration with Fred Hutchinson Cancer Center (Fred Hutch) that extends the organization’s reach across key geographic regions of the United States, allowing more people living with complex cancers to access specialized cancer expertise with the aim of improving their cancer outcomes (Press release, Fred Hutchinson Cancer Research Center, SEP 21, 2022, View Source [SID1234621320]).

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Fred Hutch becomes AccessHope’s fifth collaboration with a National Cancer Institute (NCI)-Designated Comprehensive Cancer Center, a selective list that has grown since AccessHope was first founded and launched by City of Hope. Through the new collaboration, cancer specialists from Fred Hutch will provide specialized cancer expertise for AccessHope’s core services: Accountable Precision Oncology, Expert Advisory Review and Cancer Support Team.

"This collaboration helps further our goal at AccessHope of ensuring that cancer expertise is accessible to everyone, no matter where they live," said Mark Stadler, Chief Executive Officer of AccessHope. "Fred Hutch’s deep expertise, and the organization’s research in precision medicine to inform individualized cancer treatment recommendations, make the organization an incredibly valuable partner to us and to those who benefit from their deep bench of experts."

"AccessHope’s relevance to employers continues to grow as our national footprint expands. Cancer is now the leading driver of healthcare costs to employers1. At the same time, they’re looking for solutions to issues like health equity and affordability," said Harlan Levine, M.D., chair of the board for AccessHope. "AccessHope was founded to meet these top-of-mind concerns, providing needed support for employees and family members with cancer, and now, with the addition of Fred Hutch as a foundational partner, we are better positioned to serve plan members and their treating oncologists in the Northwest; we are honored to have them join us."

The collaboration between AccessHope and Fred Hutch will help inform plan members and their treating oncologists of the latest cancer research and personalized treatments.

"Ensuring that anyone who is facing a cancer diagnosis has access to leading-edge cancer care is paramount to everything we do at Fred Hutch," explained Tom Purcell, MD, MBA, Chief Medical Officer, Fred Hutchinson Cancer Center. "Entering into this collaboration with AccessHope enhances that goal. Collaborating with employers and payers involved with AccessHope, Fred Hutch physicians will play a critical role in supporting patients in our region and across the country through sharing key insights and knowledge that will help inform treatment plans, clinical trial opportunities and improve overall outcomes for cancer patients."

Fred Hutch is the only National Cancer Institute-Designated Cancer Center in Washington and brings together leading research teams and cancer specialists who translate science discovery into leading-edge cancer treatments. The organization provides every patient with an individualized care plan and is a leader in developing and offering access to groundbreaking clinical trials and immunotherapy.

Patients who receive care at an NCI-Designated Cancer Center or National Comprehensive Cancer Network facility have significantly better outcomes, including improved long-term survival and strengthened treatment guideline adherence. Yet, patients who do not receive treatment at one of these elite facilities have less access to insights on the latest breakthrough medications and targeted therapies. AccessHope’s ability to connect patients to remote cancer support services aims to extend oncology expertise across the United States, in every state and ZIP code, reducing health disparities while allowing plan members to stay close to home, supported by their families and under the care of their local oncologist.

AccessHope serves approximately 3.5 million plan members who have its cancer support services through more than 80 employers including 22 of the Fortune 500, and collaborative relationships with a growing number of health plans, third-party administrators, health care platforms, consumer-driven pharmacy benefit managers and health care services companies.

To learn more about AccessHope and its services, visit myaccesshope.org. To learn more about Fred Hutchinson Cancer Center, visit www.fredhutch.org.

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

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)
Poster Number: HL-339

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.

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 .

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"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."

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).

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"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.