On March 27, 2022 Ascletis Pharma Inc. (HKEX:1672) reported that the latest preclinical research results of the company’s two novel anti-cancer drug candidates, ASC61, an oral PD-L1 inhibitor and ASC60, an oral fatty acid synthase (FASN) inhibitor have been selected for presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (the "2022 AACR (Free AACR Whitepaper) Annual Meeting"), and the abstracts have already been published on AACR (Free AACR Whitepaper)’s official website (Press release, Ascletis, MAR 27, 2022, View Source [SID1234611019]).

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The AACR (Free AACR Whitepaper) annual meeting is one of the world’s largest and long-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. The AACR (Free AACR Whitepaper) annual meeting for this year will be held in New Orleans, Louisiana on April 8 to 13, 2022 CDT.

The abstracts selected for poster presentations at the 2022 AACR (Free AACR Whitepaper) Annual Meeting are as follows:

（1） ASC61

Abstract Title: In vivo efficacy evaluation of ASC61, an oral PD-L1 inhibitor, in two tumor mouse models

Presentation Type: Poster Presentation
Abstract Number: 5529
Session Category: Immunology
Session Title: Preclinical Immunotherapy
Presentation time: April 8, 2022, 12:00PM – 1:00 PM CDT
Presenter/Authors: Jinzi J. Wu, Handan He. Ascletis BioScience Co., Ltd.
ASC61 is an oral potent and highly selective PD-L1 small molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. Preclinical studies showed that ASC61 demonstrated significant antitumor efficacies and were well-tolerated in both syngeneic and humanized tumor mouse models. ASC61 was found to have favorably comparable antitumor activities as the U.S. Food and Drug Administration (FDA) approved PD-L1 therapeutic monoclonal antibody (mAb), Atezolizumab. The Phase I study of ASC61 in advanced solid tumors has received the U.S. IND approval by FDA, and the first patient is planned to be enrolled in the second quarter of 2022.

（2） ASC60

Abstract Title: Efficacy of ASC60, an oral fatty acid synthase inhibitor, in two tumor mouse models

Presentation Type: Poster Presentation
Abstract Number: 5466
Session Category: Experimental and Molecular Therapeutics
Session Title: Small Molecule Therapeutic Agents
Presentation time: April 8, 2022, 12:00PM – 1:00 PM CDT
Presenter/Authors: Jinzi J. Wu, Handan He. Ascletis BioScience Co., Ltd.
ASC60 is a potent, selective and safe oral small molecule inhibitor of FASN. ASC60 can disrupt metabolism and tumor-associated signal transduction in tumor cells through inhibition of de novo lipogenesis (DNL). Preclinical studies showed that ASC60 could suppress tumor growth and enhance the antitumor activities of mPD-1 antibody in tumor mouse models. The application of the Phase I study of ASC60 in patients with advanced solid tumors has been submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

"It is our great pleasure to have the research results of our drug candidates selected by the AACR (Free AACR Whitepaper) annual meeting," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "ASC61, an oral PD-L1 inhibitor, and ASC60, an oral FASN inhibitor, have better patient compliance and are easier to be combined with other oral anti-tumor drugs. These studies deepened our understanding of our drug candidates’ mechanism of actions and anti-tumor activities in animal models as well as advanced our clinical development of Company’s oncology pipelines. As we are advancing the Phase III clinical trial of ASC40, another FASN inhibitor, in combination with Bevacizumab for the treatment of recurrent glioblastoma (rGBM), we are exploring opportunities for all-oral combinations between ASC61 and ASC40 (or ASC60) as well as other oral anti-tumor drugs from our business partners."

On March 27, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY) reported that in light of both parties’ shared commitment to continue bringing innovative medicines to benefit Chinese patients and to leverage the strengths of each party in a win-win manner, parties will now expand the strategic partnership through (Press release, Innovent Biologics, MAR 27, 2022, View Source [SID1234611017]):

i) an agreement for Innovent to obtain the sole commercialization rights to import, market, promote, distribute and detail Cyramza (ramucirumab) and Retsevmo (selpercatinib) once approved in Mainland China, and
ii) a right of first negotiation granted to Innovent for potential future commercialization of Pirtobrutinib in Mainland China.

Cyramza (ramucirumab) was the first U.S. Food and Drug Administration (FDA) approved treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior chemotherapy and the first FDA approved biomarker-driven therapy in patients with advanced hepatocellular carcinoma (HCC). In China, Cyramza (ramucirumab) in combination with paclitaxel was approved by National Medical Products Administration (NMPA) for second-line treatment in patients with advanced or metastatic GEJ adenocarcinoma in March 2022, making it the first and only drug approved for the second-line treatment of advanced gastric cancer in China. The New Drug Application (NDA) for Cyramza (ramucirumab) as second-line treatment in patients with HCC with baseline alpha-fetoprotein (AFP) ≥400ng/mL following first-line sorafenib was accepted by NMPA in September 2021. Gastric cancer and liver cancer are the third and fifth largest cancers in terms of incidence with a total of approximately 900,000 new cases yearly in China. Most of the patients experience disease progression on or after first-line treatment. There is an unmet medical need for new treatment options to improve outcomes in these patients.

Retsevmo (selpercatinib) is a highly selective and potent rearranged during transfection (RET) inhibitor. It was approved by FDA, under the brand name Retevmo, as the first therapy specifically indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In China, the NDA for Retsevmo (selpercatinib) for the above indications was accepted by NMPA and granted priority review in August 2021.

According to the agreement, Innovent has the sole commercialization rights for both Cyramza and Retsevmo, once approved in China, of which Innovent will be fully responsible for the pricing, importation, marketing, distribution and detailing of these two products. With a further expanded oncology product portfolio, Innovent intends to use its experienced oncology commercial team to leverage its broad commercial coverage in hospitals and pharmacies at various tiers to make these novel treatment options available to cancer patients in China.

In addition, Lilly has granted a right of first negotiation to Innovent for the potential future commercialization of pirtobrutinib in China. Pirtobrutinib is an investigational, oral, highly selective, non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor being studied globally for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

Under the terms of the agreement, upon regulatory approvals of Cyramza in the hepatocellular carcinoma indication and Retsevmo in the non-small lung cancer indication, Innovent will make payments of US$45 million in total and then intends to commercialize Cyramza and Retsevmo in China.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "With our long-term strategic partnership with Lilly as a strong foundation, we are excited to further expand our productive relationship through this agreement. Innovent has built up a robust oncology pipeline of over 20 clinical stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of about 3,000 people. Lilly and Innovent have jointly launched and marketed TYVYT (sintilimab) and HALPRYZA (rituximab biosimilar) successfully in China. The addition of Cyramza and Retsevmo, two potential differentiated products, will potentially further expand our oncology portfolio to seven commercialized products by this year, enabling us to provide integrated patient solutions with strong portfolio synergies while enhancing our franchise in large cancer indications including NSCLC, GC and HCC, and potentially in hematological malignancies as well. With Innovent and Lilly’s joint commitment and effort, we hope to make these new treatment options available to benefit more cancer patients in China as soon as possible."

Julio Gay-Ger, President and General Manager of Lilly China, said, "We are very proud of this agreement with Innovent, which is a key long-term strategic partner in China. Oncology is one of Lilly’s core therapeutic areas globally, in which the partnership between the two parties has seen rich fruits in the past several years. We are very confident that through this agreement, Innovent can bring forward Lilly’s innovative medicines to potentially be able to benefit Chinese patients with gastric cancer and lung cancer, helping them live better lives and help realize the ‘Healthy China 2030’goals."

On March 25, 2022 Aucentra Therapeutics (View Source) reported the appointment of Mr. Joe Bayer as Chief Executive Officer to lead the company in its growth and commercial phase (Press release, Aucentra, MAR 25, 2022, View Sourceaucentra-therapeutics-appoints-joe-bayer-as-chief-executive-officer/ [SID1234611024]). Aucentra Therapeutics is a clinical stage Australian Biotech company with a pipeline of innovative therapeutics targeting the most difficult to treat cancer types including brain tumor and pancreatic cancer.

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Joe has 30 years’ experience in senior executive roles in the healthcare, consumer products and pharmaceutical industries both in domestic and international markets. He brings to the Aucentra team extensive experience in global executive leadership and corporate governance. His wide skillset covers expertise in business strategy, M&A activity and business operations with a specialized focus in the commercialisation of healthcare and pharmaceutical products.

He has acted in a wide variety of CEO and Board positions with listed and private companies. Prior to his appointment at Aucentra, Joe worked with a number of SME’s to assist in capital funding and strategic advice. He also served as Executive Chairman at Innovaderma Plc, a London Stock Exchange listed healthcare company where he oversaw the development of the business from its early stages through to acquisitions and the UK listing and prior as CEO of Kain Lawyers, a leading Adelaide corporate and commercial law firm. Joe has previously held the positions of Executive General Manager at Faulding and Mayne Pharma responsible for Australia and Southeast Asia, and general management positions at Fletcher Building and CSR based throughout Australia and Asia.
Joe is graduate of the University of South Australia, Fellow Certified Practising Accountants (FCPA), graduate of the Australian Institute of Company Directors (GAICD) and alumni of the Australian Graduate School of Management.

Professor Shudong Wang, Founder and Director, Aucentra Therapeutics, said
"With his impressive track record in global executive leadership, corporate governance, and commercialisation, Joe brings valuable expertise and knowledge to the company. His appointment as CEO will help Aucentra to realize its potential and progress towards the commercialisation of our pipeline drug programs"

Joe Bayer, said
"I am delighted to be leading Aucentra at this exciting stage of the company’s development. The company is extremely well placed with Professor Wang and the world class research group complimenting a great commercial team. The robust pipeline of cancer drugs in both pre-clinical and clinical phases positions Aucentra to be a world leader in providing therapies for difficult to treat cancers, something of which I have great passionate for"

On March 25, 2022 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported full year financial results for the quarter and year ended December 31, 2021 and provided an update on its business strategy and corporate progress (Press release, Exicure, MAR 25, 2022, View Source [SID1234611018]).

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"This past year brought significant challenges to our organization that prompted strategic decisions at year-end to refocus our business strategy on our next generation pipeline and investments in neuroscience in order to be cash efficient," said Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. "Entering 2022, I believe we are off to a good start as we have now fully aligned our resources to support development of our preclinical programs targeting SCN9A for the treatment of pain and advancement of ongoing discovery associated with our Ipsen and AbbVie partner programs. I want to acknowledge our team for their commitment to moving our company forward during this difficult time and thank them for their continued dedication in our mission to pursue treatments for patients with unmet medical needs," concluded Dr. Schroff.

Corporate Progress

Corporate highlights for 2021 include:

•Entered into an exclusive collaboration targeting rare neurodegenerative disorders with Ipsen in July 2021 to research, develop, and commercialize novel Spherical Nucleic Acids (SNAs) as potential investigational treatments for Huntington’s disease (HD) and Angelman syndrome (AS).
•Completed a strategic review in fourth quarter of 2021, which resulted in a restructuring and pipeline focus on preclinical programs targeting SCN9A in pain and partnered programs.
•Completed a $11.5 million registered direct offering in December 2021.

Priorities for 2022 include:

•Advancement of the Company’s SCN9A preclinical discovery program. Exicure anticipates results from initial in vivo animal studies by year-end 2022 with goal of therapeutic candidate selection in the second half of 2023.
•Progressing work with the Company’s partnered programs, with plan of meeting potential pre-clinical milestones in 2023.
•Actively pursuing strategic out-license opportunities for cavrotolimod.
•Ongoing pursuit of near-term partnering opportunities for pain and other neuroscience programs.

2021 Financial Results

Cash Position: Cash, cash equivalents and short-term investments were $48.3 million as of December 31, 2021, as compared to $83.3 million as of December 31, 2020. The Company expects that its cash and cash equivalents will fund its current operations into the fourth quarter of 2022.

Revenue: Revenue was $(0.5) million during the year ended December 31, 2021, reflecting a decrease of $17.1 million from revenue of $16.6 million for the year ended December 31, 2020. The decrease in revenue is mostly due to a decrease in non-cash revenue of $19.3 million associated with the Company’s collaboration with AbbVie partially offset by the recognition of non-cash revenue of $2.3 million associated with the Company’s collaboration with Ipsen. Revenue recognized (reversed) associated with the Company’s collaboration with AbbVie for the year ended December 31, 2021 reflects the cumulative catchup adjustment (reduction) of revenue in connection with the change in estimate that resulted from a change in workplan related to the Company’s collaboration with AbbVie during the third quarter of 2021.

Research and Development (R&D) Expense: Research and development expenses were $49.0 million for the year ended December 31, 2021, as compared to $32.1 million for the year ended December 31, 2020. The increase is due to an increase in clinical trial activities during the year as well as the impact of higher than average headcount during 2021 as compared to the prior year period.

General and Administrative (G&A) Expense: General and administrative expenses were $13.1 million for the year ended December 31, 2021, as compared with $10.0 million for the year ended December 31, 2020. The increase is mostly due to costs related to new hires needed to grow the Company as it evolved, one-time severance costs of $0.6 million associated with the December 2021 restructuring, as well as higher legal costs and other costs associated with being a public company.

Net Loss: The Company had a net loss of $64.1 million for the year ended December 31, 2021, as compared to a net loss of $24.7 million for the year ended December 31, 2020. The increase in net loss was primarily driven by lower non-cash revenue during the period largely impacted by the reversal of non-cash revenue in 2021 associated with Exicure’s collaboration with AbbVie as well as higher R&D and G&A costs as discussed above.
Going Concern: The Company’s expectation to continue to generate operating losses and negative operating cash flows in the future and the need for additional funding to support its planned operations raise substantial doubt regarding its ability to continue as a going concern within one year after the date that its consolidated financial statements for the year ended December 31, 2021 are issued. The Company will require additional financing to address the Company’s working capital and other financing needs.

On March 25, 2022 Broncus Medical (02216HK), Inc., developer of diagnostic and therapeutic technology for a variety of lung diseases, reported online publication in the Respirology journal of a global, multicenter study demonstrating the effectiveness of the company’s Archimedes Virtual Bronchoscopic Navigation (VBN) System in guiding the sampling of peripheral pulmonary lesions (Press release, Broncus Technologies, MAR 25, 2022, View Source [SID1234611005]).

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The prospective, single-arm, multicenter study of 104 patients studied biopsy yield (biopsy forceps and/or needle), sampling yield (including cytologic sampling) and diagnostic yield using the Archimedes System to guide bronchoscopic transparenchymal nodule access (BTPNA) and guided transbronchial needle aspiration (TBNA). The global study took place at:

U.S. – Beth Israel Deaconess Medical Center, Cancer Treatment Centers of America at Southwestern Regional Medical Center, Duke University, Houston Methodist Hospital, Temple University Hospital, University of Pennsylvania
China – The First Affiliated Hospital of Guangzhou Medical University, Shanghai Chest Hospital
Germany – ThoraxKlinik
Hong Kong – Hong Kong Sanatorium and Hospital
The study’s authors concluded that, "BTPNA and TBNA contribute to safe and effective sampling of peripheral pulmonary lesions. A relatively high biopsy yield was obtained independent of the presence or absence of a bronchus sign, and high sampling yield and diagnostic yield were obtained independent of location, lesion size and presence or absence of a broncus sign."

The Archimedes VBN System combines fused fluoroscopy, real-time bronchoscopy and virtual bronchoscopic navigation for 3D views and access to nodules anywhere in the lung, with the ability to avoid major blood vessels through vessel mapping. Archimedes uniquely enables BTPNA, a sampling method that enables a surgeon to precisely and quickly access a lesion via tunneling when the lesion is not adjacent to an airway.

The study showed that BTPNA enabled a sampling yield of 90.2 percent and a biopsy yield of 86.3 percent, while the sampling yield across both BTPNA and guided TBNA was 93.9 percent. This was achieved with a low pneumothorax rate of only 1.9 percent. The diagnostic yield from more than one-year follow-up across both procedures was 75.4 percent and 72.8 percent, respectively, on the high and low estimate. Sufficient histologic and/or cytologic samples were obtained in 107 of 124 lesions, resulting in a technical success rate of 86.3 percent.

"Despite new technologies to improve bronchoscopic diagnosis, their results are limited by their reliance on the presence of an airway leading to the lesion. The BTPNA approach using virtual bronchoscopic navigation is exciting as it is demonstrating the ability to achieve a very high biopsy yield no matter where the lesion is located, while avoiding blood vessels and minimizing the risk of pneumothorax," said Gerard Criner, MD, Chair and Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University and Director, Temple Lung Center. "Seeing these results in a global multicenter study in a real world setting is very encouraging as we look to advance the care we can provide every day to lung cancer patients."

"In this study, BTPNA showed a superior biopsy yield when compared to today’s bronchoscopic diagnostic approaches. While BTPNA is an emerging approach, its capabilities will become even more valuable with the advent of new therapeutics in the near future, when both diagnosis and treatment will be able to be accomplished bronchoscopically, no matter where the lesion is located in the lung," said Brandon Markle, Senior Director of Global Sales and Marketing, Broncus Medical.