On January 3, 2022 Asieris Pharmaceuticals (Asieris), a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors, reported that the world’s first patient dose has been administered in U.S. for its oral APL-1202 in combination with BeiGene’s tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, JAN 3, 2022, View Source [SID1234597987]). The investigational new drug (IND) application was approved by the U.S FDA in June and the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in October last year respectively.

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!

This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients; to determine the recommended Phase 2 dose (RP2D), and to assess efficacy as neoadjuvant therapy for MIBC.

"APL-1202 in combination with tislelizumab as neoadjuvant therapy has the potential to be the best treatment option for MIBC patients, we are very pleased that the first patient has administrated in U.S.," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "We managed to advance the trial amidst the COVID-19 pandemic which demonstrates not only the efficient execution of our team, but also our commitment to improve human health."

APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in Phase III/pivotal clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

On January 3, 2022 Akeso (09926.HK) reported that Cadonilimab (PD-1/ CTLA-4 bi-specific antibody), the first-inclass novel immuno-oncology drug independently developed by the Company, combined with concurrent chemoradiotherapy obtained approval from the Center for Drug Evaluation (‘CDE’) of the National Medical Products Administration of the People’s Republic of China (”China”) to initiate a phase III clinical trial for the treatment of locally advanced cervical cancer (Press release, Akeso Biopharma, JAN 3, 2022, View Source [SID1234597986]). This is the first phase III clinical trial for locally advanced cervical cancer immunotherapy in China.

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 data in the Guidelines for the Diagnosis and Treatment of Cervical Cancer (2021) issued by the Gynecological Oncology Committee of the Chinese Anti-Cancer Association (中國抗癌協會婦科腫瘤專業委員會), there are about 604,000 new cases of cervical cancer and 341,000 deaths each year, both of which rank fourth in the incidence and mortality of gynecological tumors.

Relevant statistics also show that the incidence of locally advanced cervical cancer accounts for about 44.9% of those of all cervical cancers, and most of them recur within two to three years after treatment. In particular, the five-year survival rate of stage IIIA-IVA locally advanced cervical cancer is less than 60%, where currently concurrent chemoradiotherapy is considered to be the standard treatment for such patients.

Immune checkpoint inhibitors combined with radiotherapy for solid tumors have been proved to prolong patient survival, but no immune checkpoint inhibitors for locally advanced cervical cancer have been approved globally. The initiation of the phase III clinical trial of Cadonilimab combined with concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer is expected to achieve higher clinical benefits, further improving the survival of patients with locally advanced cervical cancer, and becoming a better targeted treatment option for the majority of cervical cancer patients in the near future.At the same time, the initiation of this clinical trial will further improve the indications layout of Cadonilimab in the field of cervical cancer.

Based on the positive effects of Cadonilimab obtained in the clinical trial of recurrent/ metastatic cervical cancer, CDE accepted the new drug application of Cadonilimab for the treatment of recurrent/metastatic cervical cancer in September 2021 and granted priority review designation. Cadonilimab is therefore expected to be the world’s first-in-class PD-1 based bi-specific antibody approved for market launch.

In addition, a global phase III clinical trial of Cadonilimab plus platinum-based chemotherapy combined with/without bevacizumab in the first-line treatment of persistent, recurrent or metastatic cervical cancer was initiated in May 2021. This is the first phase III clinical trial of first-line bi-specific antibody immunotherapy for cervical cancer in China.

On January 3, 2022 GC Cell (KOSDAQ:144510) and Rivaara Immune Private Limited reported that they have entered into an exclusive licensing agreement, pursuant to which Rivaara Immune has agreed to develop and commercialize Immuncell-LC in India, Sri Lanka, and Bangladeshi (Press release, GC Cell, JAN 3, 2022, View Source [SID1234597985]). Developed by GC Cell, Immuncell-LC is a patient-derived autologous T-cell immunotherapy for liver cancer, which was approved by the Korean MFDS back in 2007.

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!

Under the terms of the agreement, Rivaara Immune has obtained the exclusive right to develop and commercialize Immuncell-LC within India for liver cancer. In return, GC Cell is entitled to receive an undisclosed upfront payment, as well as payments for the achievement of commercial milestones, with royalties based upon the sales.

In addition, GC Cell will also receive a partial stake of Rivaara Immune and exclusive rights to supply media which is essential for the production of Immuncell-LC.

The number of cancer patients in India is more than 1.3 million, about 6 times that of Korea, and India’s liver cancer market is 2.3 times that of Korea’s. Notably, 5-year liver cancer survival rate is 4%, which is very low compared to 37% of Korea, so new treatments are urgently needed.

"Immuncell-LC’s overseas expansion is based on its domestic success, pushing for technology transfer by country, and signing contract with Rivaara Immune in India is the first outcome," said Dae-woo Park, CEO of GC Cell. "Both companies will cooperate in a win-win strategic partnership, and are also closely discussing with a number of partners in China and other countries in the Middle East."

"Rivaara Immune is pleased to partner with GC Cell, a leader in Immune Cell Therapy in Korea. With this partnership we will be among the first, to bring to the Indian market, customized solutions to cater to the unmet needs of the liver cancer sufferers," said Syd Daftary, Director of Rivaara Immune.

About Immuncell-LC

Immuncell-LC is a customized anti-cancer drug that is made from a patient’s blood. Professionals extract a sample of a patient’s T-cells from the blood and genetically modify it into a robust immune cell that has maximized anticancer functions and is incubated for about two weeks before they infuse it into the patient. Immuncell-LC received approval for the liver cancer immunotherapy from the Korean MFDS in 2007. It also received FDA Orphan Drug Designation for the Treatment of liver cancer, brain tumor, and pancreatic cancer. More than 7800 individuals have been treated with Immuncell-LC which recorded the highest selling of anti-cancer immune cell therapy in Korea.

On January 3, 2021 Amberstone Biosciences (www.amberstonebio.com), an emerging biotherapeutics company with unique expertise in conditionally active immunotherapeutics, reported the completion of a $12 million Series A financing round (Press release, Amberstone Biosciences, JAN 3, 2022, View Source [SID1234597984]). The funding was led by Viva BioInnovator, Co-win Ventures and Sinovation Ventures, with additional support from ChangRong Capital, Lifespan Investments and existing shareholders.

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!

Amberstone will use the proceeds from the financing to advance its highly differentiated tumor microenvironment activated therapeutic programs including bispecific antibodies and immunocytokines to the investigational new drug application (IND) enabling stage.

"We are tremendously grateful for the strong support from our new and existing investors," said Amberstone Biosciences President and CEO, George Wu, PhD. "With our unique Tumor Microenvironment Activated Therapeutics (T-MATE) programs, we aim to develop safer and more effective therapies to benefit cancer patients. The funding and broad expertise and resources in the field provided by our investors will take us another step closer to our mission."

"Amberstone’s T-MATE therapeutic molecules enabled by its innovative single-cell discovery engine represents a real breakthrough in immune-oncology. We are thoroughly impressed by Amberstone team’s rich experience in the cancer biology space. Viva is excited to work with Amberstone and syndicate partners to support its mission to provide next-generation innovative treatment options to patients," said Han Dai, PhD, Chief Innovation Officer of Viva Biotech and Head of Viva BioInnovator.

"T cell immunotherapy has encountered great challenges in the complex microenvironment of solid tumors. The T-MATE molecules discovered through Amberstone’s world-leading cross-disciplinary drug discovery engine will break through the bottleneck of traditional methods and bring new hope to the treatment of solid tumors. Co-win Ventures is thrilled to work with Amberstone’s team and co-investors to explore the next generation of immunotherapies in solid tumors," said Xin Huang, MD/PhD, a managing partner of Co-win Ventures.

"The expertise and strengths of Amberstone core team synergize well with one another. We are optimistic with the company’s uncapped growth potential. Amberstone exemplifies our firm’s investment strategy and mission to support deep-tech innovative entrepreneurs and companies," said Sinovation Ventures’ partner in healthcare, Mr. Peter Wu.

On January 3, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the Company will participate in the following upcoming virtual investor conferences (Press release, Innate Pharma, JAN 3, 2022, View Source [SID1234597983]):

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!

ODDO BHF Digital Forum
Event Date: January 6, 2022
H.C. Wainwright BIOCONNECT Virtual Conference
Fireside Chat: January 10, 2022
Innate Pharma Virtual Corporate Access Event
Event Date: January 10-13, 2022