On December 3, 2020 The Multiple Myeloma Research Foundation (MMRF) and Dana-Farber Cancer Institute reported a pioneering research collaboration in smoldering myeloma (SMM), a precursor disease to multiple myeloma (Press release, Multiple Myeloma Research Foundation, DEC 3, 2020, View Source [SID1234572143]). Combining the strengths of the MMRF, a leader in multiple myeloma data generation, and Dana-Farber, a leader in SMM research, the initiative aims to revolutionize how SMM patients are treated. The ultimate goal is to identify markers of high-risk SMM and develop new treatment strategies that could delay or prevent progression to active multiple myeloma.

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"Recent research efforts driven by the MMRF and our partners have identified potential genomic and immune markers that may drive myeloma risk and progression," said Daniel Auclair, Ph.D., Chief Scientific Officer of the MMRF. "This collaboration with Dana-Farber will accelerate and enhance our knowledge of risk factors, allowing us to more precisely identify those patients at higher risk of progression to active disease, and laying the groundwork for future transformative, and possibly curative, clinical trials."

Through this MMRF-funded initiative, 500 SMM patients enrolled in Dana-Farber’s PROMISE or PCROWD studies will now have the opportunity to join the MMRF CureCloud study (View Source) and donate their blood samples and medical records. Dana-Farber initiated the PCROWD (View Source) and PROMISE (View Source) studies to actively screen for and study patients with myeloma precursor diseases to help define how disease progression occurs and develop therapies to prevent it. CureCloud is a first-of-its-kind, direct-to-patient research initiative to create a massive hub of genomic and clinical data in myeloma that includes a first-of-its-kind in-home genomic test using a liquid biopsy (blood sample), producing results that are returned directly to patients and their physicians.

Participating patients will have their myeloma DNA sequenced in the CureCloud’s MM-70 genomic sequencing test and share data from their electronic health records (EHR). Dr. Auclair will present the MM-70 liquid biopsy assay at this year’s virtual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. These data will be linked with each patient’s whole-genome and whole-exome sequencing data, circulating tumor cell data, and single-cell RNA sequencing data from both tumor and immune cells, forming the most complete picture of SMM ever assembled. All patient data will be de-identified and securely stored in the CureCloud database.

Currently, the rate of progression from SMM to multiple myeloma is 10% per year, but some patients have a higher risk of rapid progression based on risk factors such as the presence of certain genomic abnormalities. While the current standard of care for SMM is to "watch and wait" until patients progress before providing treatment, recent clinical trials show that treating high-risk SMM patients can result in an increased time to progression from SMM to active multiple myeloma, giving patients more time before developing symptoms.

"This revolutionary collaboration with the MMRF will enable us to build the most comprehensive data set for smoldering multiple myeloma," said Irene Ghobrial, MD, Director of the Clinical Investigator Research Program at Dana-Farber and a Principal Investigator of the PROMISE and PCROWD studies. "Additionally, patients who participate will receive their genomic test results, which may be helpful in determining their risk of progression to active myeloma and identifying future clinical trials."

The MMRF has led research efforts to identify genomic and immune markers of high-risk multiple myeloma via their CoMMpass Study, a longitudinal observational study which follows over 1,100 myeloma patients from diagnosis over at least eight years of their disease course, gathering molecular, immune, and clinical data. This study, which is among the largest genomics data sets of any cancer, has led to more than 100 peer-reviewed abstracts and publications. The MMRF and Dana-Farber have led more recent efforts in the area of myeloma prevention in collaboration with the Perelman Family Foundation and several leading myeloma academic centers, resulting in discoveries around genomic markers of risk in precursor conditions such as SMM and MGUS (Monoclonal Gammopathy of Undetermined Significance), as well as potentially even earlier genomic predictors such as CHIP (Clonal Hematopoiesis of Indeterminate Potential).

On December 3, 2020 Australian clinical-stage drug development company, Noxopharm (ASX: NOX), reported that a discovery by Weill Cornell Medical College in New York, recently published in the prestigious scientific journal, Nature Immunology, significantly validates the novel DARRT anti-cancer treatment of its drug candidate, Veyonda, in producing radiation-induced abscopal responses, regarded by many as the ultimate form of treatment for metastatic cancer (Press release, Noxopharm, DEC 3, 2020, View Source [SID1234572142]).

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An abscopal response ⁠— an extraordinarily rare and elusive phenomenon ⁠— can follow the delivery of a low dose of radiation to a single tumor, triggering an immune response that results in other tumors throughout the body "melting" away in a matter of weeks. Patients who experience a complete abscopal response generally remain in remission for life. The radiation-induced abscopal response is highly prized as being the most cost-effective, least intrusive, and best-tolerated form of immuno-oncology therapy.

The Weill Cornell team identified radiation-induced damage to the cancer cells, and blocking their repair by a process known as autophagy, as fundamental to generating the abscopal response.

The active ingredient in Veyonda, idronoxil, is known to block autophagy.

"For the overwhelming majority of patients, once a cancer spreads from its point of origin and becomes metastatic, the best that current treatments offer is to delay the inevitable," said Graham Kelly, Noxopharm CEO and managing director. "But the clinical data shows that Veyonda very clearly is boosting the chances of triggering an abscopal response. The Weill Cornell discovery, combined with what we learned from the DARRT-1 study about Veyonda dosing, means we go into the upcoming DARRT-2 study with a high degree of confidence that we are on the edge of a major breakthrough in cancer therapy."

Noxopharm will now test the ability of Veyonda to induce abscopal effects in a Phase II study involving about 200 patients. DARRT-2 is a Phase II multinational study, currently being planned for a start in early 2021.

On December 3, 2020 McKesson Corporation reported the launch of Ontada, an oncology technology and insights business designed to support innovation, acceleration, and evidence generation to drive better outcomes for patients with cancer (Press release, McKesson, DEC 3, 2020, View Source [SID1234572141]).

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"Ontada reflects McKesson’s continued commitment and investment in the oncology community," said Brian Tyler, chief executive officer, McKesson. "As one of the largest healthcare companies, McKesson is at the center of care delivery, which provides a unique perspective on the complexities of cancer care and the growing needs among providers and life sciences companies. With the launch of Ontada, we can now build upon our differentiated assets in oncology and deliver innovative solutions that help improve patient outcomes."

Building on McKesson’s long history in community oncology, Ontada combines its real-world data and research capabilities with a leading suite of technologies for oncology clinicians – including the iKnowMed℠ electronic health record system and Clear Value Plus℠ regimen support tool – as well as a connection to a national community oncology network to transform the fight against cancer.

Ontada is uniquely positioned to advance cancer care by enabling deep collaboration between life sciences companies and oncology providers. Its team of data scientists and oncology experts help life sciences companies leverage evidence-based data and insights to accelerate innovation and improve cancer therapy, while empowering providers to deliver the best care and improved outcomes for patients. Ontada will provide a number of real clinical benefits to enable life sciences companies to help bring breakthrough oncology products to market sooner and better support the entire patient journey.

Through its deep connections to oncology practices, Ontada can help expand the reach of therapies with engagement and education opportunities with physicians. The benefits that Ontada can offer to providers are further enhanced through its strong relationship with McKesson’s The US Oncology Network, as well as other community oncology practices.

"At The US Oncology Network, we collaborate with practices to leverage evidence-driven care to deliver better patient outcomes," said Michael Seiden, M.D., Ph.D., president, The US Oncology Network. "We’re thrilled to have Ontada as a technology partner who shares our vision and will provide us with the tools and insights we need to put patients first."

On December 3, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy (Press release, Janssen Pharmaceuticals, DEC 3, 2020, View Source [SID1234572140]). The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.1 The Company has also established an expanded access program (EAP) [NCT04599712]2 for patients in the U.S. who may be eligible to obtain access to amivantamab during review of the BLA. For information about Janssen’s pre-approval access program, visit View Source

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Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications.3,4,5,6 In March 2020, amivantamab received Breakthrough Therapy Designation from the FDA for this population.7

"This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs."

The BLA submission for amivantamab is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-center, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib*, a novel third-generation EGFR tyrosine kinase inhibitor (TKI)8, in adult patients with advanced NSCLC.9 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumors Version 1.1** (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab.8,10 Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Abstract #9512).10

"Lung cancer remains the leading cause of cancer deaths worldwide. Given this significant unmet need, we at Johnson & Johnson are committed to improving outcomes for patients diagnosed with this complex, deadly disease. With today’s submission for amivantamab, we are one step closer to that goal," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "We are steadfast in our focus to advance novel therapeutics and medicines that will transform the trajectory of some of the most challenging and deadly diseases of our time, including lung cancer."

EGFR mutations, leading to uncontrolled cancer cell growth and division11, are some of the most common mutations in NSCLC.12 EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation.13 However, EGFR exon 20 insertion mutations are also often undetected.13 Next Generation Sequencing (NGS) is effective at detecting EGFR exon 20 insertion mutations and broader use of NGS can help to detect these mutations.14 Cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR TKI treatments and, in addition, carries a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.15 Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months16, which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months.17

*In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

**RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same, or get bigger.

About Amivantamab

Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.3,4,5,6 Amivantamab is pending regulatory review as a potential treatment for patients with NSCLC with EGFR exon 20 insertion mutations whose tumors typically do not respond to current standard of care. Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab. The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.

About the Amivantamab Expanded Access Program Protocol (EAP)

The amivantamab EAP is for U.S. patients 18 years of age or older who have histologically or cytologically confirmed unresectable or metastatic NSCLC with an EGFR exon 20 insertion mutations who are not amenable to curative therapy and whose disease has progressed during or after current standard of care platinum-based chemotherapy, who may benefit from treatment with amivantamab prior to its potential FDA approval.2 The EAP has specific inclusion and exclusion criteria for patients to be considered for enrollment in the program, and patients must not be eligible for another amivantamab study.2 Interested patients should contact their physician to discuss whether they may be a candidate for amivantamab through the EAP.2 Additional information about the expanded access protocol can be found on clinicaltrials.gov (NCT04599712) and at View Source

About Non-Small Cell Lung Cancer (NSCLC)

Worldwide, lung cancer is the most common cancer, and NSCLC makes up 80 to 85 percent of all lung cancers.18,19 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.19 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.11 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.20 The five-year survival rate for all patients with metastatic NSCLC with EGFR mutations treated with EGFR TKIs is less than 20 percent.21,22 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.11

On December 3, 2020 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, announced that the Board, at its meeting reported the appointment of Hedi Ben Brahim as the Company’s new Chairman and CEO, effective January 1st, 2021 (Press release, Transgene, DEC 3, 2020, View Source(Paris%3ATNG)%2C,effective%20January%201st%2C%202021. [SID1234572139]). Hedi Ben Brahim, who has been a member of Transgene’s Board since May 2019, will replace Philippe Archinard. Philippe Archinard has led the company since 2005 and will remain a member of the Board of Transgene.

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Alain Mérieux, honorary Chairman of Transgene, said: I would like to thank Philippe Archinard for his commitment to Transgene over the last 15 years. Under his leadership, the Company has demonstrated the potential of virus-based immunotherapies and developed world class innovative therapies that could be game-changers in the field of cancer treatment. Based on these achievements, I believe Transgene is now ideally placed to further demonstrate the value of its approaches. I am confident that Hedi Ben Brahim, together with Transgene’s highly skilled team, will build on this strong foundation to generate multiple novel virus-based immunotherapeutics that will both deliver important clinical benefits to cancer patients and value for shareholders."

"It is a great honor and pleasure to join the Transgene executive team. I am excited to take on this new role having seen the significant potential of Transgene’s technology platforms and their potential to bring improved clinical benefits to cancer patients globally. Trangene’s Invir.IO and myvac platforms are significant breakthroughs in multi-armed oncolytic virus therapy and individualized vaccines respectively. In addition, with the positive Phase 1b/2 data of TG4001, Transgene has established the relevance of its virus-based immunotherapy for HPV-positive cancer patients. I look forward to continuing the development of this promising candidate and further strengthen our exciting immune-oncology pipeline", added Hedi Ben Brahim.

Hedi Ben Brahim joins Transgene from Institut Mérieux where he was Vice-President for Immunotherapy since September 2018. In this role, he was the Chairman of ABL Inc., a contract research & development, and contract biomanufacturing organization (CRO/CMO). Prior to joining the Institut Mérieux, he was General Manager at a subsidiary of Vallourec, a solutions provider to the energy sector. Hedi began his career in the public sector at the Ministry of the Economy, Action and Public Accounts, then at the Ministry of Social Affairs and Health. He is a graduate of the École Polytechnique and the École Nationale Supérieure des Mines de Paris.

Philippe Archinard will become Executive Vice-President, Technological Innovation and Scientific Partnerships at Institut Mérieux. Philippe Archinard will remain Board Member of Transgene.

Transgene’s Board has also been notified of the change of the Director representing TSGH (Institut Mérieux); Dominique Takizawa is to be replaced by Sandrine Flory as of January 1st, 2021. Sandrine has been Chief Financial Officer of Institut Mérieux since March 2020. She has spent 18 years at bioMérieux, in various positions in finance. She was CFO for bioMérieux EMEA from 2014 to 2020. Prior to joining bioMérieux, Sandrine spent 9 years at PriceWaterhouseCoopers in France and Australia. Sandrine holds a master in Finance and Accounting and a MS in Business Valuation and Transmission from the Université Lyon 2 (France).