On June 29 2022 Akeso, Inc. (9926.HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology reported that its PD-1/CTLA-4 bi-specific antibody开坦尼 (Candonilimab injection, AK104) has received marketing approval from China Medical Products Administration (NMPA), for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy (Press release, Akeso Biopharma, JUN 29, 2022, View Source [SID1234616389]).

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开坦尼 is a novel, first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug in-house developed by Akeso. It is globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing . This approval not only marks China’s innovative biotech companies starts to reap the fruits after years of R&D investments, but also demonstrates that Chinese biotech companies represented by Akeso are closing the gap with global pharmaceutical companies rapidly in innovative drug development.

The approval of 开坦尼 by NMPA is based on the positive results across a pivotal Phase II clinical study on Cadonilimab for treatment of R/M CC patients who progressed on or after platinum-based chemotherapy. The results were presented at 2022 Society of Gynecologic Oncology(SGO) Annual Meeting[1].

Among 100 evaluable patients with tumor assessment, the Objective Response Rate (ORR) confirmed by Independent Radiography Review Committee (IRRC) was 33.0%, the complete response (CR) rate was 12.0% and the Duration of Response (DoR) rates at 6 and 12 months were 77.6% and 52.9% respectively. The median Progression-free Survival (PFS) was 3.75 months. The median Overall Survival (OS) was 17.51 months.
In the subgroup analysis, among the 64 patients with PD-L1 positive (CPS ≥ 1), ORR was 43.8%, median PFS was 6.34 months and median OS was not reached.
Among the total 111 enrolled patients, the incidence rate of Grade≥3 treatment related adverse events(TRAEs) was 27.0%.
China has the second largest population of cervical cancer patients in the world, with 110,000 new cases in 2020.There is no standard treatment for R/M CC patients who has progressed on or after platinum-based chemotherapy, and monotherapy is a common clinical treatment option with limited efficacy and obvious toxicity. The approval of 开坦尼 addresses a huge unmet medical needs for advanced cervical cancer in China.

"Cadonilimab represents an important step forward for R/M CC treatment, and it’s a more effective treatment option for all patients with advanced cervical cancer," said Professor Wu Xiaohua, Director of Oncology and Gynecology at the Cancer Hospital Affiliated to Fudan University. Findings from the study showed that Cadonilimab has superior anti-tumor effecacy in both PD-L1 positive and negative subjects with R/M CC who progressed on previous first-line platinum-based chemotherapy."

"Regarding approved therapies in China, the median OS of cervical cancer patients after second-line treatment is about 5 to 9 months. In contrast, Cadonilimab has extended the OS by about 8~13 months," said Professor Wu Xiaohua. "Cadonilimab is a safe, and efficient therapy that clinicians can choose with trust."

"We are thrilled to see the success of Cadonilimab in second-or third-line R/M CC," said Professor Wang Jing, Vice President of Hunan Cancer Hospital. "After its marketing approval, the gradual accumulation of medical evidence in the clinical application of Cadonilimab will not only help promote the ongoing Phase III clinical study on Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M cervical cancer, but also further increase the confidence of clinicians and patients in selecting it when it’s used in future first-line treatment."

"In the Phase II study on Cadonilimab for the first-line treatment of R/M CC in combination with platinum-based chemotherapy +/- Bevacizumab[2], ORR was 79.3% regardless of PD-L1 expression; ORR was 82.4% for patients with CPS ≥ 1, and 75.0% for patients with CPS ＜ 1. Its safety profile is better than that shown in the disclosed data of clinical studies on other tumor immunotherapies combined with chemotherapy +/- Bevacizumab," said Professor Wang Jing. "This result continues Cadonilimab’s excellent performance as monotherapy in second-or third-line R/M CC and heralds the significant clinical value of Cadonilimab with its great potential to cover the full spectrum of R/M CC population."

"I’m glad that 开坦尼 has been approved for marketing in China. As a first-in-class bi-specific antibody, 开坦尼 fully exploits the synergistic anti-tumor effect of two immune checkpoint inhibitors, PD-1 and CTLA-4, with significantly fewer side effects than the combined use of monoclonal antibodies with two targets," said Dr. Michelle Xia, Founder, Chairwoman and CEO of Akeso. "We believe its promising anti-tumor efficacy and safety profile will provide tangible clinical benefits to a wide range of oncology patients worldwide. We have established a professional and efficient commercialization team in China and will make this innovative drug available to patients as quickly as possible. Meanwhile we are accelerating its clinical research in lung cancer, liver cancer, gastric cancer, and other malignant tumors, while advancing the early-line treatments. We are confident to surpass existing therapy and promote tumor immunotherapy into the 2.0 era."

Currently, multiple clinical trials of Cadonilimab has been conducted in major cancer indications including lung, liver, stomach, cervical, renal cancer, and others. Among them, a global phase III trial of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer has completed patients enrollment, and a phase III trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is ongoing. In addition, two phase III trials of Cadonilimab to treat early-stage hepatocellular carcinoma (HCC) and gastric (G) or gastroesophageal junction (GEJ) cancer are also ongoing.

On June 29, 2022 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the second quarter ending June 30, 2022 on Wednesday, July 27, 2022 at 8:00 a.m. EDT (Press release, Boston Scientific, JUN 29, 2022, View Source [SID1234616388]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on July 27 prior to the conference call.

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A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.

On June 29, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported a peer-reviewed publication highlighting the potential of its proprietary Cas-CLOVER Site-specific Gene Editing System as a high-efficiency platform for the production of allogeneic CAR-T cells (Press release, Poseida Therapeutics, JUN 29, 2022, View Source [SID1234616386]). The paper, titled "Cas-CLOVER is a novel high-fidelity nuclease for safe and robust generation of TSCM-enriched allogeneic CAR-T cells," was published online today in Molecular Therapy – Nucleic Acids. The paper will appear in print in the September 2022 issue of the journal.

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"We are excited to publish data from this very comprehensive study of our gene editing system in T cells," said Eric Ostertag, M.D., Ph.D., Executive Chairman of Poseida Therapeutics. "This publication validates the precision of our proprietary Cas-CLOVER system, which is utilized in the manufacture of our fully allogeneic product candidates currently in clinical trials, including P-BCMA-ALLO1 for relapsed/refractory multiple myeloma and P-MUC1C-ALLO1 for multiple solid tumor indications."

Cas-CLOVER is a novel, high-fidelity gene editing system that can be used for high-efficiency gene editing in T cells to create allogeneic CAR-T products. In these published studies, Cas-CLOVER was used for multiplexed gene editing in resting T cells, which resulted in allogeneic product candidates with a high percentage (45%-70%) of desirable T stem cell memory (Tscm) cells. Using next-generation sequencing, off-target activity was measured at a rate between 0.012% and 0.089%, which is significantly lower than many other gene editing platforms. In addition, off-target translocations, which are undesirable chromosomal abnormalities, approached the lower limit of detection at a frequency of less than 0.01%.

"Cas-CLOVER is a highly versatile and precise system that can be used to make site-specific deletions, insertions and knock-ins and works in multiple cell types," said Blair Madison, Ph.D., Vice President, Genetic Engineering at Poseida Therapeutics, first author of the publication. "We continue to innovate, including the enhancement of Cas-CLOVER, to create potentially transformative treatments for patients in oncology and rare diseases."

On June 29, 2022 CanariaBio Inc. (developing its biotechnology assets through its subsidiaries, MH C&C and OncoQuest Pharma US Inc.) reported that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy (carboplatin and paclitaxel) for the treatment of front-line advanced ovarian cancer patients (Press release, CanariaBio, JUN 29, 2022, View Source [SID1234616385]).

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This double blind and placebo controlled multinational trial (FLORA-5, GOG-3035, NCT04498117) is currently accruing patients at over 137 centers in Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan and US; with additional sites in India and Romania being activated. This study seeks to confirm the observations of Brewer et al (Gynecology Oncology 2020 156:523-529) that demonstrated oregovomab in combination with carboplatin and paclitaxel improved both progression free and overall survival relative to chemotherapy which was statistically significant and clinically meaningful in the absence of incremental toxicity.

For this ongoing Phase-III study, the last Independent Data Safety Monitoring Board (IDSMB) meeting held in March 2022 identified no safety concerns and IDSMB recommended to continue the study without modifications.

"We are excited about reaching this important milestone, which is a testament of the hard work that all our investigators, GOG leadership, team members and collaborators has put in, and are grateful to the patients that have participated in the study," said Dr. Sunil Gupta MBBS, FRCPC, Chief Medical Officer of OncoQuest Pharma US, Inc. (a subsidiary of CanariaBio Inc.) "We remain on track with our projected enrollment, and we are excited about the potential benefits that our drug may bring to patients with ovarian cancer."

About Oregovomab.
Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in a phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab in combination with chemotherapy had demonstrated a highly statistically significant and clinically meaningful outcome for both progression-free and overall survival compared to standard of care chemotherapy (carboplatin and paclitaxel). The risk of progression and of death was reduced by more than 50% when compared to control arm, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively. To learn more, visit www.FLORA-5.com.

On June 29, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that its novel inhibitor of the embryonic ectoderm development (EED) protein, APG-5918, has been cleared by the US Food and Drug Administration (FDA) to enter a first-in-human (FIH) study that will assess the safety, pharmacokinetics, and preliminary efficacy of APG-5918 in patients with solid tumors or hematologic malignancies (Press release, Ascentage Pharma, JUN 29, 2022, View Source [SID1234616384]).

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This multicenter, open-label Phase I study is designed to assess the safety and tolerability, and determine the dose-limiting toxicity, maximum tolerated dose, and recommended Phase II dose (RP2D) of orally administered APG-5918. Prof. Joseph Paul Eder, Clinical Director of the Early Drug Development Program at Yale Cancer Center will be the Principal Investigator of this multicentric clinical trial.

EZH2, which is highly expressed in multiple tumors in humans, was found to promote the development and progression of tumors, and the targeted inhibition of EZH2’s methyltransferase activity has already been proven as an effective mechanistic approach for cancer treatment. However, the secondary mutation of EZH2 may lead to acquired drug resistances, while the homologous EZH1 also has methyltransferase activity that could limit the effects of EZH2 inhibitors. Furthermore, EED protein can stimulate the methyltransferase activity of EZH2, thus making the allosteric targeting of EED an effective approach. EED inhibitors have shown good therapeutic potential in many kinds of solid tumors and hematologic malignancies.

Discovered and developed by Ascentage Pharma, APG-5918 is an orally active, potent, selective, small-molecule EED inhibitor with high binding affinity. As an allosteric inhibitor, APG-5918 selectively binds to the EED protein. By regulating tumor epigenetics and microenvironment, APG-5918 can potentially overcome tumor resistance and deliver complete and durable tumor regression.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "I am excited that we are poised to initiate the FIH study of APG-5918 under the leadership of Prof Paul Eder. In preclinical studies, APG-5918 showed potent binding activity with the EED protein, in vitro antiproliferative activity, and in vivo antitumor activity."

"We look forward to advancing the clinical development of APG-5918 to hopefully bring clinically meaningful benefits to patients as early as possible", added Prof Paul Eder.