On March 9, 2021 Alphamab Oncology (stock code: 9966.HK) reported that U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application (IND) to initiate an open label, multi-center phase II pivotal clinical study (clinical trial No.: KN046-205) in the United States to evaluate the efficacy, safety and tolerability of KN046 (PD-L1/CTLA-4 bispecific antibody) for the treatment of thymic carcinoma (Press release, Alphamab, MAR 9, 2021, View Source [SID1234576358]).

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Thymic carcinoma is a rare but highly aggressive thymic tumor, and the most aggressive subtype of thymic epithelial tumors, accounting for about 20%. The number of patients with thymic carcinoma is about 4,200 to 6,000 in China per year, and 1,400 to 2,000 in the United States per year. Inoperable or metastatic thymic carcinoma has a very poor prognosis, and there is currently no approved standard treatment for patients who have failed platinum-based chemotherapy. The median overall survival after late-line chemotherapy or targeted therapy is less than 12 months, and there is an urgent need for better options to improve the efficacy.

KN046 is a bispecific antibody targeting PD-L1 and CTLA-4 immune checkpoints. It can more effectively activate T-cells and enhance the T-cells cancer killing ability. In a phase I clinical study conducted in Australia, KN046 showed a 75% disease response rate and 100% disease control rate in patients with thymic epithelial tumors. The research data was presented at the 21st World Conference on Lung Cancer (WCLC 2020). In September 2020, KN046 was granted the orphan drug designation by the FDA for the treatment of thymic epithelial tumors. In January 2021, the Phase II pivotal clinical trial of KN046 for the treatment of thymic carcinoma (clinical trial No.: ENREACH-Thymic) completed enrollment of the first patient in China.

About KN046
KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Two pivotal clinical trials are currently being conducted.

On March 9, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported a presentation that Joseph C. Papa, chairman and CEO, Sam Eldessouky, senior vice president and corporate controller, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to present at the Barclays Global Healthcare Conference today, March 9, 2021, at 2:25 p.m. ET (Press release, Bausch Health, MAR 9, 2021, View Source [SID1234576357]).

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The presentation, which provides an update on Bausch Health’s current pipeline for Salix, including an update regarding its rifaximin clinical development efforts, is available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source A live webcast and audio archive of the event will also be available on the Investor Relations page of the Company’s website.

On March 9, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the publication of a review article titled "Therapeutic Targeting of Checkpoint Receptors within the DNAM-1 Axis" reviewing the biology and therapeutic relevance of the DNAM-1 axis in cancer immunotherapy (Press release, Compugen, MAR 9, 2021, View Source [SID1234576356]). The peer-reviewed article, published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), was co-authored by Drew Pardoll, M.D., Ph.D., Professor of Oncology, Johns Hopkins University and Chairman of Compugen’s Scientific Advisory Board.

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Article highlights include:

Detailed overview of the DNAM-1 axis including axis checkpoint molecules: DNAM-1, TIGIT, PVRIG and CD96, along with their ligands PVR and PVRL2
Summary of recent studies outlining the ascendancy of the DNAM-1 axis as a potential new pathway in immuno-oncology, including ongoing clinical trials evaluating therapeutic antibodies directed against TIGIT and PVRIG
Author commentary on the rationale for testing combination regimens of DNAM-1 axis blockers in combination with PD-1/L1 agents and the overall promise of these emerging targets in cancer clinical trials
Author discussion of the potential biomarkers that can define patient populations most likely to respond to the blockade of each checkpoint pathway
"Our discovery of PVRIG as a distinct pathway in the DNAM axis has evolved into a deep and broad understanding of this potentially foundational axis in cancer immunotherapy," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Having spent several years studying PVRIG and TIGIT, the latter of which we discovered along with others, as well as their possible synergy with the PD-1 pathway, we are proud to now share our knowledge with the scientific and healthcare communities through this comprehensive review written with Dr. Pardoll, a world-renowned immuno-oncology thought leader and one of our trusted advisors and long-term collaborators. This article provides an overview of the biology that underlies our clinical strategy addressing the DNAM axis, including evidence that supports PVRIG and TIGIT as important and distinct immunotherapy checkpoints in oncology as well as their potential to expand immuno-oncology treatment options to new patient populations. Importantly, with wholly-owned clinical candidates targeting both PVRIG and TIGIT, we are uniquely positioned to evaluate the role of the DNAM axis in the clinic, specifically with our ongoing Phase 1/2 study, evaluating the triple simultaneous blockade of PVRIG, TIGIT and PD-1."

Dr. Pardoll added, "Our long-standing partnership with Compugen has led to important contributions in the immuno-oncology space, expanding the understanding of the biology of newly discovered immune checkpoints identified by Compugen, including PVRIG and TIGIT. This review highlights the power of these discoveries in the DNAM axis, and the potential of these axis members to translate to new immuno-oncology treatments."

On March 9, 2021 Genome and Company (KOSDAQ: 314130), a leading global microbiome anti-cancer drug development company, reported that signed a second clinical trial collaboration and supply agreement (CTCSA) with Merck KGaA, Darmstadt, Germany and Pfizer Inc. with the aim of developing the world’s first immuno-oncology microbiome therapeutic (Press release, Genome & Company, MAR 9, 2021, View Source [SID1234576355]). The collaboration follows in just a year after signing the first agreement with Merck KGaA, Darmstadt, Germany and Pfizer in December 2019 to conduct the first combination clinical trial of avelumab (BAVENCIO) and GEN-001 (NCT04601402, "Study 101").

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The objective of the clinical trial ("Study 201") under this newly entered CTCSA is to investigate the efficacy and safety of the combination of GEN-001 and avelumab for gastric and gastroesophageal junction adenocarcinoma that continue to be difficult to treat. This trial will be conducted simultaneously at six or more hospital and medical center sites in the Republic of Korea.

With this clinical trial, Genome and Company will proceed with Phase 2a to assess the efficacy and safety of the combination of GEN-001 and avelumab using the defined recommended phase 2 dose (RP2D) of GEN-001 in combination with avelumab. Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for use in the new company-led clinical trial, Study 201. The extended clinical collaboration between Genome and Company and Merck KGaA, Darmstadt, Germany and Pfizer marks the first time that two consecutive clinical development collaborations have been executed between combination partners for immuno-oncology microbiome treatment.

Genome and Company is developing GEN-001 through an efficient clinical development roadmap in cooperation with experts. The company is leading clinical trials in systematic approaches to immediately advance to phase 2 upon the completion of a phase 1 study. Also, the company has achieved IND clearance by the US FDA and MFDS in the Republic of Korea for a variety of patient demographics as well as cancer types.

Dr. Jisoo Pae, CEO of Genome and Company, said, "This second CTCSA with Merck KGaA, Darmstadt, Germany and Pfizer is the achievement of our outstanding R&D capabilities and the effective clinical collaboration that is established through the ongoing Study 101. We would be able to reach the oncology leadership position using immuno-oncology microbiome treatment especially in the Asian market through the additional clinical trial."

Under the terms of these agreements, Genome and Company will be the sponsor of the studies, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for both Study 101 and Study 201. Both parties will have access to the clinical data.

On March 9, 2021 ORCA Therapeutics B.V., a clinical-stage biopharmaceutical company developing oncolytic viruses to treat solid tumors, reported that, upon review of all safety data from the fully enrolled, low- and mid-dose patient cohorts of the ongoing Phase 1/2a clinical study of ORCA-010 in treatment-naïve patients with localized prostate cancer, the independent Data and Safety Monitoring Board (DSMB) unanimously recommended the continuation of the study without modification (Press release, Orca Therapeutics, MAR 9, 2021, View Source [SID1234576354]). From this recommendation, ORCA Therapeutics will initiate administration of the highest scheduled dose level of ORCA-010 in the single dose part of the study.

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Following this recommendation, ORCA Therapeutics B.V. has commenced enrollment in the highest-dose arm of the dose-escalation phase of this study, with the first patient scheduled for administration in March 2021. Upon conclusion of enrollment in the highest study arm, DSMB will conduct an additional review on ORCA-010 prior to starting the repeat dosing part of the trial.

At the lowest dose studied, ORCA-010 demonstrated strong single-agent antitumor activity in the first patient. Further, MRI data reflected an impressive and significant decrease in prostate volume returning to normal size, as well as continuing decreases in PSA. This pattern has been confirmed in the second patient who completed the 6-month follow-up MRI, and also showed prostate volume returning to near normal size.

Investors favorably viewed the DSMB recommendations and the recent clinical success by investing in another round of financing to progress ORCA-010’s development. ORCA-010 has garnered the attention of researchers, recently, ORCA Therapeutics B.V. has initiated discussions to prepare for a study in patients with unresectable/medically inoperable esophageal cancer.

"12% of all men will be diagnosed with prostate cancer in their lifetime. We are encouraged by the safety profile and preliminary efficacy of ORCA-010 and are excited to continue enrollment in the highest dose cohort of this Phase 1/2a study, our first clinical study with ORCA-010," said Kees Groen, ORCA Therapeutics’ CEO. "We are grateful for the continuous support from our investors. The generous contributions enable ORCA Therapeutics to progress ORCA-010’s development for treating prostate cancer."

ORCA Therapeutics B.V.’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of ORCA-010 in approximately 24 treatment-naïve patients with localized prostate cancer:

Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of ORCA-010 in treatment-naïve patients with localized prostate cancer. This phase is expected to enroll up to 12 patients in three dose cohorts.

Part B: A subsequent extension of the optimal dose level, as defined in the dose escalation phase, and given as two doses with 2 weeks interval. This phase is expected to enroll approximately 12 additional patients.