On March 9, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that the US Patent Office has granted US Patent no 10,940,203 (Press release, Targovax, MAR 9, 2021, View Source [SID1234576289]). The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors (CPI).

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Torbjørn Furuseth, Chief Financial Officer of Targovax, said: "We are delighted that this US patent has been granted, further strengthening Targovax’s intellectual property portfolio covering the very important combination of ONCOS-102 and anti-PD1 checkpoint inhibitors. The results from our melanoma trial presented in December 2020, confirmed ONCOS-102’s ability to turn refractory tumors into response. Securing this patent protects our innovative oncolytic immunotherapy platform and strengthens our market position."

In December 2020 Targovax announced that the combination of ONCOS-102 and checkpoint inhibitor pembrolizumab (Keytruda) demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma patients. Systemic effects were also observed in multiple patients, including two examples where a non-injected lesion completely regressed. In this open label phase 1 trial the combination of ONCOS-102 and the anti-PD1 checkpoint inhibitor pembrolizumab has been tested in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 checkpoint inhibitor. This is a particularly challenging patient population, which is refractory to approved immunotherapies and has few treatment alternatives available.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system. On the back of very encouraging data in several indications, in monotherapy and in multiple combination, the planned development steps for ONCOS-102 is a registrational-directed trial in checkpoint inhibitor refractory melanoma.

On March 9, 2021 Novartis reported the Phase III CANOPY-2 study evaluating canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS)1 (Press release, Novartis, MAR 9, 2021, https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-study-evaluating-canakinumab-acz885-second-or-third-line-treatment-combination-chemotherapy-non-small-cell-lung-cancer [SID1234576288]). The trial was conducted among 237 adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy4. Two Phase III CANOPY trials continue, evaluating canakinumab in first-line and adjuvant settings2,3. Novartis and CANOPY-2 investigators will analyze the study data and are expected to submit its findings for presentation at an upcoming medical meeting.

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"While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1β inhibition," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. "Ongoing Phase III studies in non-small cell lung cancer continue, evaluating canakinumab in earlier treatment settings. We sincerely thank the patients and clinical investigators involved in the CANOPY-2 study for their partnership."

CANOPY-1, a Phase III study evaluating canakinumab in combination with immunotherapy and chemotherapy, is expected to report final results before the end of the year2. CANOPY-A, another Phase III study, is investigating canakinumab as an adjuvant therapy and has enrolled more than 950 patients to date and is expected to enroll a total of 1,500 patients3.

About canakinumab (ACZ885)
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1β)6,7 and neutralizes IL-1β activity by blocking its interaction with its receptors8. By neutralizing IL-1β, preliminary evidence suggests that canakinumab inhibits pro-tumor inflammation (PTI) to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis8. Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses9,10. Canakinumab is a first-in-class interleukin-1beta (IL-1β) inhibitor of PTI in non-small cell lung cancer10.

About the CANOPY program
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack (CRP≥2 mg/L)8,9. Patients in the CANTOS trial were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk factors8,9. Based on these findings, Novartis launched three, large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in non-small cell lung cancer (NSCLC).

CANOPY-1 (NCT03631199) is a Phase III trial evaluating canakinumab as a first-line treatment for locally advanced or metastatic NSCLC in combination with pembrolizumab and platinum-based doublet chemotherapy2
CANOPY-2 (NCT03626545) is a Phase III trial investigating the role of canakinumab in combination with the chemotherapy agent docetaxel in second- or third-line therapy versus docetaxel alone in NSCLC. Part 1 of the CANOPY-2 trial – a safety run-in study to determine the appropriate dosage, was previously presented at ASCO (Free ASCO Whitepaper) 2019. Part 2 of the trial, reported today, evaluated overall survival (OS)4
CANOPY-A (NCT03447769) is a Phase III trial studying canakinumab in the adjuvant setting, following surgical resection and cisplatin-based chemotherapy. The adjuvant study is designed to determine if treatment with canakinumab can prevent cancer relapse3
CANOPY-N (NCT03968419) is a non-registrational Phase II neoadjuvant trial evaluating canakinumab in combination with pembrolizumab among patients with resectable NSCLC prior to their planned surgery5

Novartis and Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year11. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)12. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year11,13. Currently, the five-year survival rate for lung cancer is less than 20%14, decreasing further when the disease is diagnosed at later stages15. The majority of people with NSCLC are diagnosed with advanced or Stage III or IV disease16, and treatment options are limited for people with lung cancer who experience cancer growth or progression while on standard of care treatments17-19. More people die of lung cancer every year than any other cancer type11. Novartis is committed to developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine and the role of newer, immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust in the industry. With research activities informed by long-term relationships with leading lung cancer thought leaders and patient advocates, Novartis is focused on reimagining the treatment of lung cancer.

On March 9, 2021 Race Oncology Limited (ASX: RAC) reported the final results of our collaborative preclinical research program with the eminent cancer researcher, Associate Professor Nikki Verrills of The University of Newcastle and Hunter Medical Research Institute (Press release, Race Oncology, MAR 9, 2021, View Source [SID1234576285]).

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The aim of this research program was to identify combinations of existing breast cancer drugs which when paired with Bisantrene show equivalent or better efficacy to existing treatment options, but with reduced side effects. Activity of Bisantrene alone against a range of breast cancer genetic subtypes, including those resistant to standard of care drug treatments, was also explored.

The interim results demonstrated that Bisantrene was an effective chemotherapeutic agent across a wide range of genetically distinct breast cancer subtypes (ASX announcement: 24 Nov 2020). Bisantrene was able to kill some cancer subtypes that were resistant to the currently used anthracyclines doxorubicin and epirubicin. Importantly, Bisantrene showed near identical additive benefit when used in combination with cyclophosphamide to that seen with either doxorubicin or epirubicin.

Final results showed Bisantrene to be an effective chemotherapeutic agent across a diverse panel of genetically defined breast cancer subtypes and to also kill breast cancer cells resistant to a wide range of breast cancer treatment drugs.

Race’s CSO Dr Daniel Tillett commented "The final results from Nikki’s team highlights Bisantrene’s potential use in breast cancers resistant to current treatments. Not only does Bisantrene offer a potentially safer alternative to existing chemotherapeutic drugs, it may also help patients who have exhausted other treatment options."

Race’s CEO Mr Phillip Lynch added, "This new research underscores our confidence in moving Bisantrene into Phase II breast cancer trials and continues to build on the body of evidence we have supporting Bisantrene’s broader applications. Our aim here is to bring a valuable new treatment forward for the management of breast cancer."

On March 9, 2021 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported the appointment of K. Peony Yu, M.D. as Chief Medical Officer (Press release, Apollomics, MAR 9, 2021, View Source [SID1234576259]). Dr. Yu will assume the role on March 16, 2021. Apollomics also announced that Sophie (Zhengjie) Sun has been named as Senior Vice President, Corporate Development and will be based in the Company’s China office. Both executives report to Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer of the Company.

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"Dr. Yu joins us with an incredible leadership and global drug development background that is a perfect fit for Apollomics, and we are thrilled to welcome her to our team," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "Peony’s extensive cross border experience includes managing teams in both the U.S. and China and overseeing multiple functions including clinical development, regulatory strategy and medical affairs. Peony will be instrumental in our efforts to advance our current assets and expand our development pipeline."

"Apollomics patient centric focus aligns with my priorities and I am excited to join the team. The Company’s precision medicine approach targeting specific mutations, amplifications and resistance mechanisms is technology that I believe can make a difference and bring transformative therapies to cancer patients. I look forward to contributing to this effort and advancing the clinical development programs globally," added K. Peony Yu, M.D.

Dr. Guo-Liang Yu, concluded, "Since inception, Apollomics has built numerous partnerships and we continuously explore options to broaden our portfolio. We are excited to welcome Sophie Sun who will be responsible for corporate strategy, business development, and strategic collaboration. Her diversified career covers three continents and her leadership in strategy, partnering, and commercialization will be a valuable resource as we continue our fight against cancer."

Peony Yu, M.D.

Dr. Yu spent 12 years at Fibrogen where she served in multiple roles of increasing responsibility culminating in her appointment as Chief Medical Officer in 2016. She brings leadership and expertise in design and execution of clinical development programs in all phases of development, including clinical and regulatory strategy, and interactions with global regulatory authorities.. Prior to joining Fibrogen, Dr. Yu was Vice President and Head of Clinical Research at Anesiva, Inc. (formerly known as Corgentech, Inc., (NASDAQ: ANSV)), where she was responsible for management of clinical research, statistics/data management, clinical operations, and medical affairs/medical information for all clinical programs. Dr. Yu received a Doctor of Medicine degree from the University of California, Davis. She completed her residency training at Stanford Medical School.

Sophie (Zhengjie) Sun, MBA

Sophie Sun joins Apollomics from Merck KGaA, where she was most recently Vice President & Managing Director, Innovation Hubs China. In this role, Ms. Sun oversaw Merck KGaA’s development partnerships in China for China and global markets. She was with Merck KGaA for twelve years holding multiple roles of increasing responsibility including participation in nine new product launches. Prior to Merck KGaA, Ms. Sun spent over eight years at marketing agencies Interpublic Group (IPG) and WPP, where she consulted for many Fortune 500 companies covering a wide range of industries. Ms. Sun received a Master’s degree from Remin University of China, and a Master of Business Administration from MIT Sloan School of Management.

On March 9, 2021 Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that it has entered into a license agreement with Biokit, a Werfen Company, to incorporate Affimer reagents into a Biokit in-vitro diagnostic (IVD) product (Press release, Avacta, MAR 9, 2021, View Source [SID1234576250]).

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Biokit is recognised and renowned as a Centre of Excellence with consolidated experience worldwide in research, development and manufacturing of assays and biomaterial solutions for IVD use.

The license agreement follows an extensive evaluation by Biokit of certain Affimer reagents to detect a key analyte. Under the terms of the agreement Biokit has the right to develop, manufacture and commercialise through original equipment manufacturer (OEM) partners a diagnostic immunoassay for this analyte.

Avacta will receive royalties on future sales of any products brought to market following completion of product development and regulatory approvals. Financial details of the agreement were not disclosed.

Dr Alastair Smith, Chief Executive of Avacta Group commented:

"I am delighted to have established this partnership with Biokit, a world-renowned IVD company, which further validates the Affimer reagent platform for diagnostics. Avacta’s diagnostics business model combines development of a wholly owned pipeline of products, including the SARS-CoV-2 rapid antigen test, with licensing of Affimer reagents to diagnostic development partners such as Biokit.

Biokit will develop an automated clinical assay using the Affimer reagents that Avacta has developed for them and I look forward to the successful conclusion of that development process and product launch. There is also potential for the partnership between our two companies to continue and expand to include other diagnostic targets and future Affimer-based IVDs."

Dr Marta Palicio, Innovation Director of Biokit commented:

"Biokit is very pleased to have reached this agreement with Avacta. The agreement will increase the competitiveness of our customized assay offering for our partners. Avacta’s technology also enables us to innovate our assays with new reagents like Affimer reagents, an alternative to antibodies. We can now move onto the next stage of development, incorporation of this technology into new products. We hope this is the first of many assays containing Affimer reagents which will be developed by Avacta".