1stOncology™: Cancer Intelligence Service – Page 8642 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Alphamab Oncology and CSPC Achieved an Licensing Cooperation on Anti-HER2 Bispecific Antibody KN026 in Mainland China

On August 24, 2021 Alphamab Oncology (stock code: 9966 HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab" or "the Company"), a wholly-owned subsidiary of Alphamab Oncology, signed a contract with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of the company’s proprietary anti-HER2 bispecific antibody KN026 in Mainland China (Press release, Alphamab, AUG 24, 2021, View Source [SID1234586905]). The totaldeal size reaches 1 billion RMB, and the Company will receive a double-digit royalty based on sales revenue.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in mainland China (excluding Hong Kong, Macau and Taiwan), and bear the cost of all planed clinical trials in territory; In addition, JMT-Bio will devote joint efforts with Alphamab to develop more potential indications of KN026 single agent or combo treatment in other solid tumors . Alphamab Oncology will receive 150 million RMB upfront payment, with up to 850 million RMB development and sales milestone payments, and will receive a double-digit royalty based on sales revenue.

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). It can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated equivalent efficacy compared with the combination of Trastuzumab and Pertuzumab and was superior to either single agent in HER2-positive tumor cell lines. Data from several clinical studies have shown that in patients with HER2-positive GC/GEJ or breast cancer, even after first-line or multi-line treatment, KN026 still demonstrated positive data, especially for patients with GC/GEJ.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

Quest Diagnostics Acquires Boca Raton-Based Nationwide Laboratory Services

On August 24, 2021 Quest Diagnostics, the nation’s leading provider of diagnostic information services, reported it has acquired select assets of Nationwide Laboratory Services (NLS), an independent clinical diagnostics laboratory headquartered in Boca Raton, FL with over 25 years of patient centric service throughout the country (Press release, Quest Diagnostics, AUG 24, 2021, View Source [SID1234586900]).

With the acquisition, Quest will broaden access to diagnostic innovation and insights empowering better health for more communities in South Florida. Testing services provided by NLS will transition to Quest’s full-service laboratory in Miramar, FL. Quest will also acquire select patient service sites in South Florida.

"Access to quality, innovative and cost-effective laboratory services is more important now than ever, given the twin health threats of COVID-19 and delays in medical care caused by the pandemic," said Alan Myers, Vice President and General Manager, Southeast Region, Quest Diagnostics. "We look forward to delivering diagnostic insights for COVID-19 and a range of other medical conditions to help empower better care and outcomes, particularly for communities in South Florida."

"It was vital to pass our valued clients and patients to an organization with the same guiding principles and patient-centric focus," said Dean Morris, CEO and Corporate Counsel, Nationwide Laboratory Services. "It was a competitive bidding process, but Quest’s vision, reputation and leadership made the choice clear cut."

Based in Secaucus, NJ, Quest Diagnostics operates major laboratory facilities in Tampa as well as Miramar and over 50 patient sites across Florida. Its services include COVID-19 testing through several leading retail providers and its own QuestDirect consumer-initiated testing platform, which offers a $0 out-of-pocket cost test option.

In addition, Quest collaborates with community and healthcare organizations to help close gaps in care for underserved communities in Florida through its Tackle Your Testing program.

ERYTECH Hosting Key Opinion Leader Webinar on Eryaspase in Pancreatic Cancer

On August 1, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company, leader in red blood-cell based cancer therapeutics, reported it will host a key opinion leader webinar on its lead product candidate eryaspase, L-asparaginase encapsulated in donor-derived red blood cells, on Wednesday, September 1, 2021 at 10:00am Eastern Time (Press release, ERYtech Pharma, AUG 24, 2021, View Source [SID1234586878]). The webinar will feature a presentation by KOLs and also the Principal Investigators of the TRYbeCA-1 and rESPECT studies, respectively; Dr. Manuel Hidalgo Medina, M.D., Ph.D., Weill Cornell Medicine/NewYork-Presbyterian Hospital, and Dr. Marcus Noel, M.D., Georgetown University.

UPMC Launches Novasenta to Develop Targeted Immunotherapy Drugs for Cancer

On August 24, 2021 As part of its commitment to investing in translational science that significantly improves the lives of patients, UPMC reported that it has launched Novasenta, a drug discovery and development company seeking novel and effective treatments for cancer (Press release, UPMC Enterprises, AUG 24, 2021, View Source [SID1234586865]).

Based on years of cancer research by renowned University of Pittsburgh scientists and a machine-learning-enabled platform that drives the discovery of potential drug targets, Novasenta focuses on the tumor microenvironment – or the ecosystem that surrounds and constantly interacts with the tumor inside the body – to develop immunotherapies.

"Novasenta has the ability to analyze the tumor microenvironment of a wide variety of cancers due to our strong research and clinical relationships with Pitt and UPMC," said Mani Mohindru, Ph.D., Novasenta’s recently hired chief executive officer and a veteran biotechnology leader. "This allows us to capitalize on the critical relationship between disease, immune response and metabolism when assessing the tumor microenvironment for the discovery of novel druggable targets, which will help us develop treatments that benefit patients with cancer."

Co-founded in late 2018 by Robert Ferris, M.D., Ph.D., Dario Vignali, Ph.D., and Greg Delgoffe, Ph.D., all of the UPMC Hillman Cancer Center and Pitt, Novasenta is currently focused on T-cell targets and rapidly advancing programs with the goal of launching its first clinical trial by the end of 2023.

"We are building on decades of successful research from our founders in the fields of tumor biology, immunology, computational biology and drug discovery. Our expanding team brings a broad set of skills and expertise to our unique platform, allowing us to integrate a wide range of relevant disease data into our discovery and validation processes to develop more effective cancer therapies," added Mohindru.

UPMC invested in Novasenta through the health system’s innovation and venture capital arm, UPMC Enterprises. Novasenta is one of three local life science start-ups incubated by UPMC Enterprises in collaboration with Pitt over the last four years and is adding to a growing number of preclinical development programs this partnership is rapidly advancing. The company recently celebrated the opening of its new office and laboratory space at The Riviera in Pittsburgh’s South Oakland neighborhood, part of a growing hub of biomedical activity in the city.

"As both a caregiver and investor, UPMC is excited about the characteristics that make Novasenta so promising: Unmatched clinical and scientific expertise paired with computational innovation have the potential to identify transformative therapies in record time," said Jeanne Cunicelli, president of UPMC Enterprises. "The launch of this company will benefit not only our region but cancer patients everywhere."

Nouscom announces first patient dosed in a Phase 1b Trial with NOUS-PEV, a novel personalized cancer immunotherapy, in advanced melanoma or lung cancer

On August 24, 2021 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, reported that the first patient has been dosed in a Phase 1b clinical trial evaluating NOUS-PEV (Press release, NousCom, AUG 24, 2021, View Source [SID1234586864]). In this first-in-human trial NOUS-PEV, a personalized neoantigen cancer vaccine, is being administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab to patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1.

NOUS-PEV-01(NCT04990479) is a multicenter Phase 1b open-label study, assessing the safety, feasibility and preliminary efficacy as per RECIST 1.1 criteria of the NOUS-PEV vaccine, in combination with pembrolizumab. The study will evaluate vaccine-induced immune responses, as well as preliminary signs of anti-tumor activity in treated patients. The PEV vaccines will be prepared on an individual basis, following a tumor biopsy performed at the time of screening to identify patient-specific tumor mutations. The trial will enroll patients from Spain, Belgium and the UK.

The principal investigator (PI) of the trial is Stefan Symeonides M.D., a Medical Oncologist and Clinical Scientist in the Department of Oncology at The University of Edinburgh.

Stefan Symeonides, M.D. and PI of the trial, said: "There is still a significant unmet medical need for new therapeutics to overcome tumor resistance to anti-PD1 immunotherapies. Vaccination, and especially personalized vaccination, has huge potential and Nouscom’s innovative technology has unique features that are promising for a best-in-class platform. It is excellent news that the first patient has now been dosed with NOUS-PEV. We expect this trial to deliver important initial clinical data for the development of NOUS-PEV and I really look forward to seeing preliminary results in 2022.”

NOUS-PEV is a personalized cancer vaccine based on patient-specific neoantigens sourced from individual patient tumor mutanomes[1]. The identified neoantigens are encoded in Nouscom’s heterologous prime boost platform comprising a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara vector (MVA). Each of the two viral vector systems encodes multiple personalized neoantigens selected by a proprietary algorithm (VENUS[2]), which prioritizes up to 60 mutations that represent the most immunogenic neoantigens. Including a large number of neoantigens in NOUS-PEV aims to ensure broad and deep immune responses, potentially overcoming issues of tumor heterogeneity and escape through immunoediting.

Patricia Delaite, M.D., Chief Medical Officer of Nouscom, said: "NOUS-PEV leverages our heterologous prime boost platform to enable the fastest in class ‘needle-to-needle’ turn-around timelines, while subsequently inducing a broad and potent anti-tumor T cell response. Having now successfully designed, manufactured and dosed an individualized cancer vaccine, we look forward to progressing the Phase 1b clinical study and gathering important patient data in the coming months."

Dr. Marina Udier, Chief Executive Officer of Nouscom, added: "The initiation of this study represents a significant milestone for Nouscom, as it marks the second clinical program to emerge from our proprietary platform based on uniquely engineered viral vectors that are optimized for the efficient expression of tumor neoantigens. We look forward to presenting the preliminary data in 2022."

About NOUS-PEV

NOUS-PEV is a personalized cancer immunotherapy designed for each patient based on selection and prioritization of mutations unique to that patient’s tumor. The strategy is based on Nouscom’s heterologous prime boost platform already clinically validated by its lead off-the-shelf clinical development program NOUS-209. The platform is composed of a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara vector (MVA). Each of the two viral vector systems encodes multiple personalized neoantigens selected with a proprietary algorithm (VENUS), which prioritizes up to 60 mutations that represent the most immunogenic neoantigens.

NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) commenced in 2021 and is currently enrolling patients across multiple clinical sites in Europe.