On June 10, 2022 Zai Lab Limited, a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy (EXP-2) and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4) (Press release, Zai Laboratory, JUN 10, 2022, View Source [SID1234633496]). The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.

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"Since repotrectinib received Breakthrough Therapy Designation by the CDE earlier this year for ROS1-positive TKI-naïve patients, today’s recognition further supports repotrectinib as a potential best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China," said Alan Sandler, M.D., President and Head of Global Development, Oncology at Zai Lab. "There remain significant unmet needs for ROS1-positive NSCLC patients, and we look forward to our continued partnership with regulatory authorities in China to bring this important medicine to patients in need as soon as possible."

The Breakthrough Therapy Designation review policy is designed to facilitate the development and expeditious review of novel medicines that are intended for the prevention or treatment of serious, life-threatening diseases or diseases that severely impact the quality of life for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over currently available treatment options. Drugs granted Breakthrough Therapy Designations receive priority communications and guidance from the CDE to promote and expedite the drug development process.

Lung cancer is both the most commonly diagnosed cancer type and the leading cause of cancer death in China. The incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths1. NSCLC accounts for approximately 85% of lung cancer, and about 70% of NSCLC is locally advanced or metastatic at initial diagnosis. In China, ROS1 rearrangements occur in 2-3% of patients with advanced NSCLC.

1Globocan 2020.

About Repotrectinib

Repotrectinib is a next-generation kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of NSCLC and advanced solid tumors. Tumors with mutations to their ROS1 and NTRK genes have a higher likelihood of developing resistance to existing targeted therapies. In many cases, these mutations prevent existing medicine from targeting and binding to the tumor as effectively as tumors that do not carry the mutations. Repotrectinib is designed to be smaller and less bulky than existing targeted therapies and may circumvent some of the resistance mechanisms found in tumors with ROS1 and NTRK mutations. Zai Lab and Turning Point Therapeutics, Inc. are studying repotrectinib in TRIDENT-1, a registrational Phase 1/2 study in adults, and CARE, a Phase 1/2 study in pediatric patients. The compound has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. Zai Lab is enrolling patients in the registrational Phase 2 portion of TRIDENT-1 in Greater China, while Turning Point Therapeutics is enrolling patients in other regions of the world.

Repotrectinib has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration in: ROS1-positive metastatic NSCLC patients who have not been treated with a ROS1 TKI; patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK TKIs, with or without prior chemotherapy, and have no satisfactory alternative treatments; and ROS1-positive metastatic NSCLC patients who have previously been treated with a ROS1 TKI and who have not received prior platinum-based chemotherapy. Additionally, repotrectinib was previously granted four Fast-Track designations in: ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy; and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments. Repotrectinib was also granted an Orphan Drug designation in 2017.

Zai Lab has an exclusive license agreement with Turning Point Therapeutics to develop and commercialize repotrectinib in Greater China.

On June 10, 2022 Ratio Therapeutics Inc. reported its launch with a mission to develop best-in-class targeted radiopharmaceuticals for the treatment of cancers (Press release, Ratio Therapeutics, JUN 10, 2022, View Source [SID1234633188]). Founded by entrepreneurial scientists Jack Hoppin, Ph.D., and John Babich, Ph.D., Ratio emerges from stealth mode with more than $20 million in seed funding, fully funded development alliances with Bayer AG and Lantheus Holdings Inc., a robust portfolio of assets developed with two proprietary technologies, and a growing team of world-class experts in radiopharmaceuticals discovery and development. The company’s near-term plans call for the submission of its first investigational new drug (IND) applications, which are expected this quarter, and the initiation of clinical trials later this year. Based in Boston, Ratio is set to move to a new 19,000-square-foot headquarters and research facility in the Seaport District in January.

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Ratio’s radiopharmaceuticals strategy is focused on optimizing tumor localization while minimizing uptake by normal tissues. To achieve this, the company uses its proprietary technology platform called Trillium that is based on Dr. Babich’s prior research at Weill-Cornell Medical College and first developed and validated by the founders in a previous venture. Trillium is a trifunctional small molecule scaffold that can be fine-tuned to alter its plasma clearance, target affinity and therapeutic payload. Each component of the scaffolding can be independently optimized to boost tumor uptake over normal tissue uptake, thereby maximizing therapeutic index. Ratio has successfully applied this framework to several tumor targets and multiple therapeutic payloads.

In addition, Ratio is developing a technology platform to take advantage of the tumor killing power of the alpha emitter, Actinium-225. This proprietary technology is called the Macropa chelate platform. Ratio’s scientists have already successfully incorporated Macropa into the Trillium platform as well as several peptides and antibodies. Macropa’s unique chemistry enables ease of manufacture and robust in vitro and in vivo stability of the resulting radiotherapeutic compound.

"The ability to fine-tune our targeted radiotherapeutics using Trillium and Macropa enables us to address head-on the trifecta of typical challenges we see with most radiopharmaceuticals: delivery, safety and efficacy," said Dr. Babich, Ratio’s President and Chief Scientific Officer. "Over the past year, we have generated significant preclinical data that demonstrate our ability to create excellent performing drug candidates that now are advancing into the clinic. Our goal is to become the partner of choice for pharmaceutical companies committed to this area of cancer therapy by enabling the optimization of a broad array of targeting compounds. We will shepherd these therapies through early clinical studies on our own or in collaboration."

Dr. Hoppin, Ratio’s Chairman and Chief Executive Officer, added, "Targeted radiotherapy is an exciting and emerging field where chemistry meets physics meets medicine. We have assembled and will continue to build a world-class interdisciplinary team of researchers and developers with a singular focus on delivering these treatments to cancer patients. It isn’t often that a start-up company has in place the early financial backing and industry support to advance entirely new drug discoveries to clinical development at this pace. It is with great pride that we announce our formal launch and exit from stealth mode."

In collaboration with Bayer, Ratio has leveraged its Trillium platform for the identification of lead prostate-specific membrane antigen (PSMA)-targeted therapeutic compounds for prostate cancer. At the same time, Ratio is working with Lantheus to develop a lead fibroblast activation protein (FAP)-targeted PET diagnostic compound for a broad array of epithelial-derived cancers, such as breast, pancreatic, lung and stomach cancer. Both collaborations are fully funded and reflect the types of partnerships that Ratio is currently pursuing with other companies.

On June 10, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it is presenting new long-term follow-up results and subanalyses from clinical trials of its approved therapies, as well as data on investigational medicines from its broad blood cancer portfolio, at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress in Vienna (Press release, Hoffmann-La Roche, JUN 10, 2022, View Source [SID1234616240]). Data include five-year results from the phase III CLL14 study of fixed-duration Venclexta/Venclyxto (venetoclax) plus Gazyva/Gazyvaro (obinutuzumab) in previously untreated chronic lymphocytic leukaemia (CLL); the final analysis of the phase III GALLIUM study of Gazyva/Gazyvaro plus chemotherapy in people with previously untreated advanced-stage follicular lymphoma (FL); and subanalyses from the phase III POLARIX study of Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Roche will also present data from its T-cell engaging bispecific antibody development programmes including Lunsumio (mosunetuzumab) and glofitamab in patients receiving later lines of therapy for non-Hodgkin lymphoma (NHL) and investigational medicines cevostamab and RG6234 in relapsed or refractory (R/R) multiple myeloma (MM).

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"Blood cancers remain challenging to treat at all stages, but by improving frontline treatment options we aim to increase the likelihood of meaningful clinical outcomes for these patients," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "With these new long-term data and other studies of fixed-duration therapies in our portfolio, we are working to lessen the treatment burdens associated with long-term cancer care."

Improving clinical outcomes with effective frontline treatment options
Five-year results of phase III CLL14 study of Venclexta/Venclyxto plus Gazyva/Gazyvaro (Abstract #S148)
After a median of 65.4 months following treatment with Venclexta/Venclyxto plus Gazyva/Gazyvaro, results confirm the combination continues to be an effective fixed-duration and chemotherapy-free option for patients with previously untreated CLL and coexisting conditions. The estimated investigator-assessed progression-free survival (PFS) rate at this follow-up was 62.6% with Venclexta/Venclyxto plus Gazyva/Gazyvaro and 27.0% with Gazyva/Gazyvaro plus chlorambucil, and the estimated overall survival (OS) rate was 81.9% versus 77.0% (HR 0.72; 95% CI: 0.48-1.09; p=0.12). In addition, the analysis found that 72.1% of patients in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm did not require another treatment for CLL in the five years following initial treatment (HR 0.42; 95% CI: 0.31-0.57; p<0.0001). No new safety signals were observed.[1] The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, M.D., University of Cologne.

Final analysis of phase III GALLIUM study of Gazyva/Gazyvaro (Abstract #S206)
After eight years of follow-up in people with previously untreated FL, a meaningful improvement in PFS was maintained with Gazyva/Gazyvaro plus chemotherapy, confirming its role as a standard of care for first-line treatment. Seven-year investigator-assessed PFS was significantly improved with Gazyva/Gazyvaro plus chemotherapy (63.4%) compared with MabThera/Rituxan plus chemotherapy (55.7%; HR 0.77; 95% CI: 0.64-0.93; p=0.006). This translated into a longer time to next anti-lymphoma treatment. At seven years, 74.1% of patients receiving Gazyva/Gazyvaro plus chemotherapy had not started new anti-lymphoma therapy compared to 65.4% receiving MabThera/Rituxan plus chemotherapy (HR 0.71; 95% CI: 0.58–0.87; p=0.001). The incidence of serious adverse events was 48.9% with Gazyva/Gazyvaro plus chemotherapy and 43.4% with MabThera/Rituxan plus chemotherapy.[2]

Subgroup analyses of pivotal phase III POLARIX study (Abstract #P1192)
Exploratory subgroup analyses of the phase III POLARIX study of Polivy with R-CHP compared to the current standard of care, MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated DLBCL further support the potential for Polivy to transform the standard of care for people with this aggressive type of lymphoma. One of the datasets being presented is an analysis of study participants from Asia (China, Hong Kong, Japan, South Korea and Taiwan). Among this subgroup, results showed a significant improvement in PFS with Polivy plus R-CHP versus R-CHOP, reducing the risk of disease progression, relapse or death by 36% (HR 0.64; 95% CI: 0.40-1.03). The safety profile was generally comparable for both regimens.[3]

Based on the positive POLARIX results from the overall study population, the European Commission (EC) approved Polivy plus R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL.

Providing novel bispecific antibodies for patients receiving later lines of therapy in lymphoma and beyond
Pivotal data from phase II NP30179 expansion study of glofitamab (Abstract #S220)
The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL and showed fixed-duration glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, induced high and durable complete response (CR) rates. After a median follow-up of 12.6 months, 39.4% of patients (n=61/155) achieved a CR (primary efficacy endpoint) and half of them (51.6%; n=80/155) achieved an overall response (the percentage of patients with a partial or CR; secondary efficacy endpoint), as assessed by an independent review committee. Cytokine release syndrome (CRS) was the most common adverse event, occurring in 63.0% of patients.[4] These data were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting and have been submitted for approval to the European Medicines Agency (EMA). Submissions to additional health authorities worldwide, including the U.S. Food and Drug Administration (FDA), are planned this year.

Subgroup analysis and Lunsumio retreatment from pivotal phase II GO29781 study (Abstracts #P1126 and #P1124)
An exploratory subgroup analysis showed Lunsumio could be an efficacious and tolerable option in patients aged <65 and ≥65 years who had R/R FL and had received two or more prior therapies. Patients ≥65 years old achieved a higher objective response rate (ORR) than those <65 years old (87.0% vs 77.0%, respectively). Lower rates of CRS and serious adverse events were observed in patients ≥65 years old (37%) compared to those <65 years old (52%).[5] Additional data from the GO29781 study showed that retreatment with Lunsumio in patients who achieved a CR but whose disease subsequently progressed was effective and the safety of retreatment was consistent with initial treatment.[6]

The EC recently approved Lunsumio for the treatment of people with R/R FL who have received at least two prior systemic therapies.

The data being presented at EHA (Free EHA Whitepaper), as well as phase III studies currently underway, will expand the understanding of glofitamab and Lunsumio and their impact in both later and earlier lines of treatment, with the aim of providing robust and durable treatment outcomes for people with different types of lymphomas.

Early data from novel investigational bispecific antibodies in R/R MM (Abstracts #P962 and #S180)
In line with Roche’s commitment to improving outcomes and personalising care for people with blood cancer, the company has expanded beyond lymphoma and leukaemia, evaluating two investigational medicines in MM. This is the third most common type of blood cancer, diagnosed in more than 170,000 people around the world each year and involves plasma cells (antibody-producing cells in the bone marrow).[7,8] Although advances in treatment have improved outcomes, MM remains an incurable disease characterised by multiple relapses, with an overall five-year survival rate of about 55%.[9] Roche is presenting data at EHA (Free EHA Whitepaper) on cevostamab, an investigational FcRH5xCD3 T-cell engaging bispecific antibody that is being evaluated as a monotherapy and in combination with other medicines to treat people with R/R MM, and on RG6234, a novel GPRC5DxCD3 T-cell engaging bispecific antibody that is being studied in a phase I trial in people with R/R MM. While early, the clinical activity and safety profiles observed with these molecules look encouraging and support further exploration.[10,11]

About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to help restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and commercialised by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood cancers.

In the US, Venclexta has been granted six Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL, two for previously untreated acute myeloid leukaemia, and one for myelodysplastic syndromes.

About Gazyva/Gazyvaro (obinutuzumab)
Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system. Gazyva/Gazyvaro is part of a collaboration between Roche and Biogen.

In the US, Europe and multiple other countries, Gazyva/Gazyvaro is currently approved in combination with chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL). It is also approved in combination with bendamustine, followed by Gazyva/Gazyvaro maintenance for the treatment of follicular lymphoma (FL) patients who did not respond to a MabThera/Rituxan (rituximab)-containing regimen, or whose FL returned after such treatment and in combination with chemotherapy for previously untreated advanced FL.

Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About Polivy (polatuzumab vedotin)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies.[12,13] Polivy is designed to bind to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.[14,15] Polivy is being developed by Roche using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.

About Roche’s investigational CD20xCD3 bispecifics in haematology
Roche is currently developing two CD20xCD3 T-cell engaging bispecific antibodies, Lunsumio (mosunetuzumab) and glofitamab, designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Lunsumio and glofitamab differ in their structures, and both are being developed by Roche as part of our ongoing strategy to explore multiple bispecific formats in order to identify those that maximise potential clinical benefits for patients. Lunsumio has a structure similar to that of a natural human antibody in that it has two ‘Fab’ regions but is different from naturally-occurring antibodies in that one ‘Fab’ region targets CD20 and the other ‘Fab’ region targets CD3. Glofitamab is based on a novel structural format that we call ‘2:1,’ which refers to the structure of the antibody. It is engineered to have two ‘Fab’ regions that bind to CD20 and one ‘Fab’ region that binds to CD3. The clinical development programmes for Lunsumio and glofitamab include ongoing investigations of these molecules as monotherapies and in combination with other medicines for the treatment of people with CD20-positive B cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma.

On June 10, 2022 Massive Bio co-founder and Chief Medical Officer Arturo Loaiza-Bonilla, MD, MSEd, reported that it will be a panelist at the BIO International Convention, which will take place June 13 – 16 at the San Diego Convention Center in San Diego, California (Press release, Massive Bio, JUN 10, 2022, View Source [SID1234616003]).

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Presented by the Biotechnology Innovation Organization, the BIO International Convention brings together thousands of biotech and pharmaceutical executives. At the event, where Venus Williams and Erin Andrews will be featured as keynote speakers, Dr. Loaiza-Bonilla will participate in a panel discussion titled "The Roles of Artificial Intelligence and Big Data in Precision Healthcare: Perspectives from the Pathway to Drug Development and the Patient Journey." This panel discussion, which will be held on June 15, will examine the roles of Big Data and artificial intelligence (AI) at every stage of the drug development pathway, which is simultaneously intertwined with the patient’s journey as part of the evolving precision healthcare space.

You can follow the entire schedule of events on the BIO International Convention website. Tag @MassiveBio and use #BIO2022 to connect to Twitter and other social media websites during the BIO International Convention from June 13 – 16.

About Dr. Arturo Loaiza-Bonilla
Dr. Arturo Loaiza-Bonilla is a dedicated practicing clinician and precision oncology expert with experience at the Abramson Cancer Center of the University of Pennsylvania, University of Miami, Johns Hopkins and the National Institute of Health. His major interest focuses in the field of innovative approaches to optimize clinical workflows and matching for oncology patients to hase 1–3 clinical and translational research cancer trials, integrating next-generation personalized molecular diagnostics, immunotherapy, biomarkers, previous therapies, and the patient’s overall status under an Artificial Intelligence-based / machine learning platform, which integrates to the electronic medical record. Dr. Loaiza-Bonilla is Principal and co-investigator on several Phase I/III clinical trials in several malignancies at Cancer Treatment Centers of America, with emphasis in new targeted therapies, novel molecules and immunotherapy, tailored to specific tumor type, its genomics and protein expression profiles. He is also a passionate advocate for improved access to medical care, precision oncology, technology, wearables, medical education, blockchain, organized medicine leadership and health policy, having been awarded the ‘Top 40 Under 40’ award by the Philadelphia Business Journal, AMA Foundation Leadership Award, Fellowship of the American College of Physicians, and holding a Master’s in Medical Education (M.S.Ed) degree from the University of Pennsylvania. In 2015, he founded Massive Bio with Dr. Selin Kurnaz and Çağatay Çulcuoğlu.

About The BIO International Convention
BIO is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

On June 10, 2022 3B Pharmaceuticals GmbH (3BP) reported that a Platinum Sponsor of the 6th Theranostics World Congress1 which will be held from 24th to 26th June at the RheinMain CongressCenter Wiesbaden, Germany (Press release, 3B Pharmaceuticals, JUN 10, 2022, View Source [SID1234615919]). The event celebrates 25 years of Peptide Receptor Radionuclide Therapy (PRRT) in Germany and provides the opportunity for mutual exchange on scientific and clinical development in Theranostics and Radiomolecular Precision Oncology.

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The symposium entitled "3BP’s innovation alliances-Tailoring compounds to the needs of theranostic radiopharmaceuticals" will take place on June 25, from 09:00 am to 09:55 am CEST. Clinical and industry expert chairs and speakers will be giving insightsinto the translation from early development stages towards successful clinical application of 3BP’s innovative peptide-based radiopharmaceuticals.

"We are proud to witness the successful translation of our peptide tracers into clinical development and how the first patients benefit from treatment with our innovative compounds" said Ulrich Reineke, Managing Director of 3BP. "The innovation alliances with our equally enthusiastic development partners who share our passion for radiopharmaceuticals are at the core of our mission to help patients suffering from cancer indications with high medical need."

Symposium & Speaker Details:

Dr. Ulrich Reineke will give the welcome address and the symposium will be opened by Dr. Christiane Smerling outlining 3BP’s discovery engine and the partnership with Fusion Pharmaceuticals. Dr. Antoine Attinger will give an insight into how radioligands can address hypoxic tumors as a cancer treatment strategy. Dr. Lindsey Rolfe will present first data from the phase 1/2 LuMIERE study on treatment of advanced or metastatic solid tumors using 177LuFAP-2286. The session will be chaired by Prof. Wolfgang Weber and John Carney.

The symposium is free to all conference attendees and breakfast will be provided. Speakers will be available for a Q&A session at the end of the event.