On June 22, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that updated interim results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma were presented in an oral presentation (Abstract 075) at the 16th Annual International Conference on Malignant Lymphoma (ICML) (Press release, ADC Therapeutics, JUN 22, 2021, View Source [SID1234584244]). The pivotal Phase 2 study is intended to support the submission of a Biologics License Application.

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"The interim results from our ongoing pivotal Phase 2 trial of Cami as a single agent for patients with relapsed or refractory Hodgkin lymphoma demonstrate that a significant number of patients experience long-lasting treatment effects," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "In Phase 2, we used the optimal Phase 1 dosing schedule based on activity and tolerability, and we are encouraged by the interim data that show the median duration of response has not been reached. We also note that the incidence of GBS in Phase 2 is consistent with Phase 1. We look forward to providing future updates on this pivotal program as the overall response rate and duration of response data continue to mature."

Cami is being evaluated in a multicenter, open-label, single-arm Phase 2 clinical trial in 117 patients with relapsed or refractory Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT), including prior treatment with brentuximab vedotin and a checkpoint inhibitor. The interim data cut includes 101 evaluable patients who had been in the study a median of 5.1 months. Patients were heavily pretreated with a median of 6 prior lines of systemic therapy.

Key data presented at ICML by Pier Luigi Zinzani, MD, PhD, IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli", and Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Università di Bologna, Bologna, Italy, include:

Overall response rate (ORR) was 66.3% (67/101 patients) with a complete response rate (CRR) of 27.7% and partial response rate (PRR) of 38.6%
Median duration of response has not been reached
No new safety signals have been identified and the most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were hypophosphatemia (7.7%), maculopapular rash (6.8%), thrombocytopenia (6.8%), anemia (6.0%) and lymphopenia (6.0%)
To date, nine patients (7.7%) were able to proceed to HSCT following Cami treatment
7/117 patients (6.0%) developed Guillain-Barre syndrome/Polyradiculopathy (consistent with the incidence in the Phase 1 Hodgkin lymphoma patients)
"Patients with relapsed or refractory Hodgkin lymphoma who have failed several lines of previous therapy such as brentuximab vedotin and PD-1 blockade have limited treatment options," said Dr. Zinzani. "The antitumor activity and safety profile of Cami continues to demonstrate that this novel CD25-targeted ADC has the potential to address the unmet need in heavily pre-treated patients."

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) 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 June 22, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome, reported that Christophe Carite, Development Director, will deliver a presentation on 4D pharma’s strategy and capabilities for the manufacturing of its Live Biotherapeutic drug candidates at the upcoming virtual Microbiome Movement Drug Development Summit, on Thursday, July 1 at 2.15pm EDT (7.15pm BST) (Press release, 4d Pharma, JUN 22, 2021, View Source [SID1234584243]). He will also participate in a microbiome therapeutics manufacturing roundtable panel session.

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The presentation will discuss 4D pharma’s strategies, technologies and facilities to address the challenges of clinical-grade manufacturing and scale-up of its LBPs as a novel therapeutic modality for the treatment of a range of indications with unmet needs, including oncology, asthma, Parkinson’s disease and irritable bowel syndrome. The Company has successfully conducted the manufacturing optimization and scale-up of multiple novel LBPs at its in-house cGMP facility, and to date has progressed four candidates into clinical trials with additional candidates expected to enter the clinic in 2022.

In addition, Christophe Carite will join a panel entitled ‘Effectively scaling up microbiome manufacturing’. This roundtable will discuss the future of GMP infrastructure for microbiome therapeutics, the most effective quality control processes and potency methods, and the merits of developing internal manufacturing facilities or using CDMO partners.

As 4D pharma has led the development of LBPs it has built leading drug discovery and development expertise in this new field. The Company has also developed unparalleled know-how, processes and facilities for the manufacture of its LBPs to the highest regulatory standards. 4D pharma has fully cGMP-certified facilities in Europe, housing two 3,000L fermenters and downstream processing facilities with production capacity sufficient for late clinical and early commercial scale. Further, 4D pharma management were previously invited to contribute to the drafting of the European Pharmacopoeia’s quality standards for Live Biotherapeutic products which became effective in 2019.

"4D pharma’s unique expertise in the efficient, scalable and reproducible manufacturing of single strain LBPs has been invaluable in supporting rapid clinical and pre-clinical progress across our pipeline," said Christophe Carite, Development Director, 4D pharma. "Having these capabilities in-house not only supports and accelerates progress, but also generates valuable know-how, intellectual property and competitive advantage. As Live Biotherapeutics near commercialization, manufacturing is increasingly recognized as a critical factor in the future of this novel drug class, and 4D pharma is well positioned to successfully manage this important aspect of drug development in-house."

On June 22, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a collaboration with Quest Diagnostics (NYSE: DGX) to provide laboratory testing services to Quest patients for its Target Selector NGS-based liquid biopsy targeted lung cancer panel (Press release, Biocept, JUN 22, 2021, View Source [SID1234584241]). Quest Diagnostics is the leading provider of diagnostic information services, including in advanced diagnostics.

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The Biocept Target Selector NGS-based liquid biopsy assay is a less invasive, lab developed test that can be used for genomic profiling in patients with advanced non-small cell lung cancer (NSCLC) to help qualify them for advanced targeted therapies and monitor the effectiveness of treatment. With a physician order, patients will be able to provide a blood specimen for testing at one of Quest’s 2,200 conveniently located patient service centers across the United States. The two parties expect the service to be available to Quest Diagnostics’ providers and patients in the fourth quarter of 2021.

"We are pleased to expand Biocept’s relationship with Quest Diagnostics, as we believe its expertise and reach will allow us to serve more patients and potentially grow our customer base," said Michael Nall, President and CEO of Biocept. "Quest shares our focus on improving care for patients with lung cancer, and this agreement provides a strong collaborator to help us provide oncologists with the answers they need to create more personalized, responsive treatment plans for their patients."

"Lung cancer is one of the most prevalent and deadliest cancers," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "Better tools to aid in therapy selection and monitoring are urgently needed to improve patient outcomes, which is why we are so excited to work with Biocept on this focused test. Quest has the national scale, oncology expertise and network provider relationships to broaden access to this important innovation in order to potentially improve care for patients in treatment for lung cancer."

Biocept Target Selector NGS-based targeted lung cancer panel includes the most prevalent clinically actionable genes for NSCLC. It combines Biocept’s liquid biopsy biomarker testing expertise with next-generation sequencing and decision support resources. The NGS solution is targeted and actionable—approximately 70% of the biomarkers investigated are based on National Comprehensive Cancer Center guidelines and/or FDA-approved therapies.

On June 22, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that adds two new products to its portfolio to help improve the management of patients with late-stage and metastatic cancers (Press release, Guardant Health, JUN 22, 2021, View Source [SID1234584240]). The Guardant360 Response test represents a breakthrough as the first commercially available, blood-only, liquid biopsy test that detects changes in circulating tumor DNA (ctDNA) levels to provide oncologists an early indication of a patient’s response to treatment . The Guardant360 TissueNext test, the company’s first tissue-based test, is now available, if needed, to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

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Both products expand on the trusted Guardant360 portfolio to offer oncologists end-to-end testing solutions, covering treatment selection, with the option of ordering tissue biopsy results if needed, and treatment response monitoring, to help improve clinical outcomes for patients with advanced cancer.

The Guardant360 Response liquid biopsy test detects changes in ctDNA levels from a simple blood draw, to assess treatment response up to eight weeks earlier than RECIST (Response Evaluation Criteria in Solid Tumors),1-11 giving oncologists a new tool to use when considering whether to continue, stop, or explore other treatment options for their patients with late-stage or metastatic cancer. Molecular responders (those with decreasing ctDNA levels) show significantly longer progression-free and overall survival rates, compared to molecular non-responders.1-12 In over 50 studies, Guardant Health has demonstrated that molecular response, as measured by changes in ctDNA levels, can help provide an early indication of treatment response across therapies (targeted, immunotherapy, and chemotherapy) and cancer types including non-small cell lung, colorectal, breast, and bladder.1-12

"Using circulating tumor DNA levels to monitor treatment response is a promising new approach in the management of patients with advanced cancer," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "We are delighted to offer oncologists a simple blood test that can provide an early assessment of whether their patient is responding to treatment, or not. Multiple studies using the Guardant360 Response test have shown that molecular response, as measured by circulating tumor DNA levels, can help predict clinical benefit, and longer progression-free survival."

The Guardant360 TissueNext test can now be ordered, alongside the Guardant360 CDx blood test, to prepare for cases when the Guardant360 CDx test does not find actionable biomarkers. While starting with the Guardant360 CDx blood test to perform complete genomic testing finds nearly 80 percent of patients with actionable biomarkers in only seven days,13-15 compared to finding only 50 percent of patients when starting with a tissue biopsy, and which can take two to four times longer,13-15 there are cases when results are needed from a tissue biopsy. The new Guardant360 TissueNext test offers oncologists the most efficient "blood-first, tissue-next" workflow to complete genomic testing, ensuring that as many patients as possible are identified who may benefit from biomarker-informed treatment.

"With the new Guardant360 Response blood test, we are excited to offer a cutting-edge test able to predict patient response to treatment sooner than standard radiographic assessment, to help inform clinical decisions and improve outcomes," said Helmy Eltoukhy, Guardant Health CEO. "By broadening our Guardant360 portfolio to cover not only treatment selection but treatment response, we provide oncologists a more complete view of their patient’s tumor evolution and resistance to interventional therapies, including immunotherapies. Furthermore, while starting with the Guardant360 CDx liquid biopsy for biomarker testing is shown to be more efficient than starting with an invasive tissue biopsy13-15 which has a longer turn-around time to return results, the addition of our new Guardant360 TissueNext test strengthens our treatment selection offering, by providing oncologists the benefits of ‘blood-first, tissue-next’ testing options to find as many patients as possible, who may benefit from biomarker-informed treatment."

The Guardant360 CDx test, the new Guardant360 TissueNext test, and the new Guardant360 Response test are all part of the Guardant360 portfolio, which provides oncologists a more complete genomic picture across the treatment journey. This comprehensive set of cancer tests empowers oncologists to optimize treatment, and know confidently what to do next. From fast treatment selection, starting first with the FDA-approved Guardant360 CDx test, to reflex testing with the Guardant360 TissueNext test, if needed, to early treatment response monitoring with the Guardant360 Response test, the Guardant360 portfolio helps oncologists unlock the full potential of precision oncology for their patients with late-stage and metastatic cancers.

On June 22, 2021 Legend Biotech Corporation (Legend Biotech, NASDAQ: LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the establishment of a state-of-the-art manufacturing facility in Belgium, as part of a joint investment with Janssen Pharmaceutica NV (Janssen), to expand global manufacturing capacity of innovative cellular therapies (Press release, Legend Biotech, JUN 22, 2021, View Source [SID1234584239]).

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Legend has a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel, an investigational CAR-T therapy currently under review by several health authorities around the world including the United States and Europe for the treatment of patients with relapsed and refractory multiple myeloma.

"The new location in Belgium is an ideal choice for Legend to launch our European manufacturing presence allowing us to tap into the area’s vast talent pool and leverage the strong Belgian life sciences ecosystem," said Liz Gosen, Senior Vice President, Global Technical Operations. "We are excited to expand our existing robust manufacturing network to support the production and delivery of cilta-cel for patients across the globe."

This facility adds to Legend’s existing manufacturing facilities and presence in Nanjing, China and in Raritan and Somerset, N.J., U.S. The facility is anticipated to be operational by 2023.