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 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]).

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!

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 25, 2022 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, MAR 25, 2022, View Source [SID1234610959]).

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!

"The positive proof-of-concept data we announced in 2021 demonstrating the competitive profile of eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor, has allowed us to launch our Phase 2b program in atopic dermatitis as well as start exploring additional indications driven by Type 2 inflammation, many of which are associated with atopic dermatitis and the ‘atopic march’. In the fourth quarter, we expanded our US presence and have welcomed new senior hires, strengthening our management team as we advance our portfolio into late-stage studies. The Phase 2b TREK-AD study of eblasakimab is fully underway and we are making good progress as we open enrolment in sites throughout North America, Europe and Asia Pacific," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals.

Fourth quarter 2021 and recent business highlights

Q4 and recent clinical developments

In October 2021, the Company announced a collaboration with renowned inflammatory skin disease expert Dr Emma Guttman-Yassky, MD, PhD, to conduct research that will continue throughout the Company’s Phase 2b program to identify and characterize the effects of eblasakimab on disease-associated skin and serum-biomarkers in adults with moderate-to-severe AD.

In October 2021, the Company hosted the first in its series of Key Opinion Leader (KOL) webinars, the "A4 Series: Aspects of Atopic Dermatitis and ASLAN004". In the first webinar, Associate Professor Jonathan Silverberg, MD, PhD, MPH discussed the heterogeneity in AD. The second webinar was hosted in January 2022, during which Dr April Armstrong, MD, MPH discussed the key clinical study parameters likely to impact patient responses and clinical trial outcomes in AD. Replay for the first webinar is available here, and replay for the second webinar is available here. The replays can also be found on the "Events and Presentations" section in ASLAN’s Investor Relations website at View Source Replays will be archived until the end of March.

In January 2022, the TRials with EblasaKimab in Atopic Dermatitis (TREK-AD) Phase 2b trial was initiated to evaluate the efficacy and safety of eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor, in patients with moderate-to-severe AD, and the first patient was screened. The randomized,

double-blind, placebo-controlled, multi-center, dose-ranging clinical trial is evaluating five treatment arms (four active treatment arms and one placebo arm) and is expected to enroll approximately 300 patients across sites in North America, Europe and Asia Pacific. Topline data from the study is expected in the first half of 2023.

In January 2022, results of an interim analysis of the completed Phase 1b proof-of-concept study of eblasakimab in AD were accepted for poster presentation at the 2022 Winter Clinical Dermatology Conference – Hawaii.

In March 2022, an abstract highlighting key efficacy and safety data from the completed Phase 1b proof-of-concept study for eblasakimab in AD was accepted for late-breaking oral presentation at the 2022 American Academy of Dermatology Annual Meeting, to be held March 25-29, 2022.

Corporate updates

In October 2021, the Company opened a new office in the US in Menlo Park, California.

In December 2021, the Company announced a strategic collaboration with IQVIA Biotech, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. As part of this collaboration, IQVIA Biotech is supporting the Phase 2b TREK-AD trial of eblasakiumab and will work closely with management to oversee clinical operations and the recruitment of patients across sites in the United States, Canada, Europe and Asia Pacific.

In March 2022, Alex Kaoukhov, MD, was appointed as Chief Medical Officer based in the Company’s US office. Alex has more than 20 years of global drug development experience in the US and Europe, and was most recently Head of Clinical Development, Senior Vice President at Bioniz Therapeutics where he established and managed a team responsible for the development of therapeutic assets for the treatment of skin and gastrointestinal autoimmune diseases. Prior to this, Alex served as Head of Global Development at Almirall where he oversaw global clinical and non-clinical development programs. He also was responsible for business development activities including the in-licensing of lebrikizumab for Europe. Prior to Almirall, Alex was Associate Vice President of Clinical Development at Allergan and has served in clinical development leadership roles at Novartis and Galderma.

Anticipated upcoming milestones

Initiation of Phase 2 study of farudodstat, also known as ASLAN003, in inflammatory bowel disease is planned for the first half of 2022.

Topline data from the Phase 2b TREK-AD study of eblasakimab is expected in the first half of 2023.

Fourth quarter 2021 financial highlights

Cash used in operations for the fourth quarter of 2021 was US$11.9 million compared to US$5.1 million in the same period in 2020.

Research and development expenses were US$9.0 million in the fourth quarter of 2021 compared to US$2.9 million in the fourth quarter of 2020. The increase was driven primarily by the increase of clinical development expenses and manufacturing costs related to eblasakimab and the initiation of the TREK-AD Phase 2b trial.

General and administrative expenses were US$2.2 million in the fourth quarter of 2021 compared to US$3.0 million in the fourth quarter of 2020.

Net loss attributable to stockholders for the fourth quarter of 2021 was US$8.9 million compared to a net loss of US$5.7 million for the fourth quarter of 2020.

The weighted average number of American Depositary Shares (ADS) outstanding in the computation of basic loss per share for the fourth quarter of 2021 was 69.6 million (representing 348 million ordinary shares) compared to 39.8 million (representing 199 million ordinary shares) for the fourth quarter of 2020. One ADS is the equivalent of five ordinary shares.

Full year 2021 financial highlights

Cash used in operations for the year ended December 31, 2021, was US$34.0 million compared to US$15.1 million in 2020.

Research and development expenses were US$22.0 million for the year ended December 31, 2021, compared to US$9.3 million in 2020. The increase was driven primarily by the clinical trials development expenses and manufacturing costs related to eblasakimab and the TREK-AD trial.

General and administrative expenses were US$11.8 million for the year ended December 31, 2021 compared to US$7.2 million in 2020. The increase in general and administrative expenses was due to the offering costs related to various fundraising activities in 2021, the increase in headcount in the US and related office administration costs.

Net loss attributable to stockholders for the year ended December 31, 2021, was US$31.3 million compared to a loss of US$16.2 million in 2020.

Cash and cash equivalents totaled US$90.2 million as of December 31, 2021, compared to US$14.3 million as of December 31, 2020. Total proceeds of approximately $117.0 million was raised in the year ended December 31, 2021. Management believes that the Company’s cash and cash equivalents will be sufficient to fund operations through late 2023.

The weighted average number of ADSs outstanding in the computation of basic loss per share for the year ended December 31, 2021, was 65.1 million compared to 38.4 million for 2020.

On March 25, 2022 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the European Commission to approve Kymriah (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy (Press release, Novartis, MAR 25, 2022, View Source [SID1234610997]).

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!

"Follicular lymphoma patients will often relapse, many having shorter responses to treatment with each subsequent line of therapy," said Catherine Thieblemont, MD, PhD, Professor of Hematology in the Paris VII- University, France and Head of the Hemato-Oncology Unit of St-Louis Hospital in Paris. "If approved, Kymriah may offer an effective new option with potentially definitive results for these patients with a highly favorable safety profile."

The CHMP positive opinion is based on results from the global Phase II ELARA trial, in which 94 infused patients were evaluated for efficacy with a median follow-up of approximately 17 months. Among patients treated with Kymriah, 86% had a response, including 69% who experienced a complete response (CR). Prolonged durable response to treatment was demonstrated with an estimated 87% of patients who experienced a CR still in response nine months after initial response1.

In the ELARA trial, for the 97 patients evaluable for safety, the safety profile of Kymriah was remarkable. Within eight weeks of infusion, 49% of patients experienced cytokine release syndrome (CRS) and there were no reported cases of high-grade (grade 3 or higher) CRS, as defined by the Lee scale. Grade 3 or 4 neurological events occurred in 3% of patients within eight weeks of infusion1.

"With today’s positive opinion, we are closer to bringing the life-changing potential of Kymriah to patients with advanced follicular lymphoma in the EU who are in need of a treatment that may provide long-lasting remission," said Susanne Schaffert, PhD, President, Novartis Oncology. "We are proud to bring our transformative cell therapy innovation to more people around the world who continue to have unmet medical needs."

If approved, r/r FL would be the third indication for which Kymriah is available to patients in the European Union (EU). Kymriah is currently approved for the treatment of pediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post transplant or in second or later relapse, and adult patients with r/r diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.

The European Commission will review the CHMP recommendation and deliver a final decision in approximately two months. The decision will be applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein. Additional regulatory filings are underway with other health authorities worldwide.

About follicular lymphoma
While follicular lymphoma is typically an indolent type of cancer, patients with FL may be exposed to a median of four lines of treatment, with an upper range of 13 lines3,4. Although there are multiple systemic therapies available, the efficacy of these regimens drops rapidly in later lines5.

About Novartis commitment to Oncology Cell Therapy
As part of the unique Novartis Oncology strategy to pursue four cancer treatment platforms – radioligand therapy, targeted therapy, immunotherapy and cell and gene therapy – we strive for cures through cell therapies in order to enable more patients to live cancer-free. We will continue to pioneer the science and invest in our manufacturing and supply chain process to further advance transformative innovation.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of the Novartis commitment to CAR-T cell therapy.

We have made strong progress in broadening our delivery of Kymriah, which is currently available for use in at least one indication in 30 countries and at more than 365 certified treatment centers, with clinical and real-world experience from administration to more than 6,200 patients. We continue to pioneer in cell therapy, leveraging our vast experience to develop next-generation CAR-T cell therapies. These therapies will focus on new targets and utilize our new T-Charge platform being evaluated to expand across hematological malignancies and bring the hope for a cure to patients with other cancer types.

Novartis has a comprehensive, integrated global CAR-T manufacturing footprint that strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain.

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.

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!

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"