On November 12, 2020 RemeGen, a Yantai biotech approaching commercial stage, reported that it completed a $515 million IPO on the Hong Kong exchange in the largest biotech IPO of the year (Press release, RemeGen, NOV 12, 2020, View Source [SID1234570901]). Founded in 2008, RemeGen is developing a portfolio of ten novel mAbs, fusion proteins, antibody-drug conjugates (ADCs) and bifunctional antibodies. Two of its candidates are under NDA review in China: telitacicept for autoimmune diseases (systemic lupus erythematosus) and disitamab vedotin for HER2 cancers. The company’s shares have traded 34% higher since the IPO, giving RemeGen a market capitalization of $4.3 billion.

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On November 12, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, reported that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sugemalimab (CS1001, an anti-PD-L1 monoclonal antibody) combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (NSCLC) patients (Press release, CStone Pharmaceauticals, NOV 12, 2020, View Source [SID1234570899]). This is the first NDA for sugemalimab submitted by CStone worldwide and also the sixth NDA worldwide and the third in Mainland China submitted by CStone this year.

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The acceptance of NDA was based on the results of CS1001-302, a Phase III trial of sugemalimab combined with chemotherapy for the first-line treatment of squamous and non-squamous NSCLC patients. This study enrolled both squamous and non-squamous NSCLC in the same study, which saved time and cost of development significantly. As reported in August, in the planned interim analysis of this clinical trial, the pre-specified primary endpoint was reached as assessed by independent Data Monitoring Committee (iDMC). Compared with placebo in combination with chemotherapy, sugemalimab in combination with chemotherapy significantly improved progression-free survival (PFS) and reduced the risk of disease progression or death by 50%. Subgroup analysis showed that sugemalimab has demonstrated its clinical benefits in squamous or non-squamous NSCLC patients with PD-L1 expression >=1% or PD-L1 expression <1%. Sugemalimab in combination with chemotherapy showed a favorable safety profile and no new safety signals have been found. An oral presentation of specific clinical trial data will be given in Proffered Paper session (Late-Breaking Abstract) of ESMO (Free ESMO Whitepaper) Asia Congress on November 21st.

Professor Caicun Zhou, Principal Investigator of CS1001-302 Study and Director of the Department of Oncology, Shanghai Pulmonary Hospital, said, "We are very excited to see that NMPA has accepted the NDA of sugemalimab. In Phase III clinical trial with the inclusion of squamous and non-squamous NSCLC patients, sugemalimab showed potent antitumor activity and a favorable safety profile. Advanced squamous and non-squamous NSCLC still faced a significant unmet medical need in China. We are looking forward to the launch of sugemalimab and its clinical benefits for patients."

Dr. Frank Jiang, Chairman and CEO of CStone, said, "The NDA acceptance of sugemalimab marks another important milestone for CStone Pharmaceuticals, demonstrating our commitment to bring innovative oncology therapies to cancer patients worldwide. We expect sugemalimab can be launched as soon as possible and benefit more cancer patients in China and potentially abroad."

Dr. Jason Yang, Chief Medical Officer of CStone, said, "With the unique mechanism of action and best-in-class clinical data in multiple tumors, sugemalimab has the potential to become the best-in-class PD-L1 monoclonal antibody. We appreciate the dedication of our CStone team and the strong support from clinical investigators and patients, which made it possible to accomplish this phase III study from first patient enrollment to NDA acceptance in less than 2 years. Currently, registrational studies of sugemalimab for hematological malignancy, stage III NSCLC, advanced gastric cancer and esophageal cancer are progressing smoothly."

About NSCLC
In recent years, the incidence of lung cancer has been continuously increasing in China. As reported, in 2018, there were approximately 770,000 new cases of lung cancer in China and 690,000 death cases caused by lung cancer. Lung cancer is the leading cause of cancer-related death in both men and women, and non-small cell lung cancer comprises the most common form of lung cancer in China.

CS1001-302 Study
CS1001-302 is a multicenter, randomized, double-blind Phase III clinical trial (CS1001-302; clinicaltrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452), designed to evaluate the efficacy and safety of CS1001 in combination with chemotherapy versus placebo in combination with chemotherapy in first-line naïve patients with stage IV NSCLC. The primary endpoint of the trial was PFS as assessed by the investigators; the secondary endpoints include overall survival, PFS and the safety profile as assessed by BICR committee.

About Sugemalimab
Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.
Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and Phase 1b of the study, sugemalimab showed good antitumor activity and tolerability in multiple tumor types.
Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase 1 bridging study in the U.S., the clinical program in China includes one multi-arm Phase 1b study for several tumor types, one Phase 2 registrational studies for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV NSCLC, gastric cancer, and esophageal cancer. The phase III clinical trial of sugemalimab in the treatment of stage IV non-small cell lung cancer reached the primary endpoint. China’s National Medical Products Administration (NMPA) has accepted the company’s New Drug Application (NDA) for sugemalimab.

On November 12, 2020 amcure GmbH, a biopharmaceutical company developing first-in-class cancer therapeutics, and Hinova Pharmaceuticals Inc. (Chengdu, China), one of the fastest growing start-up drug discovery and development companies in China, reported that it entered into an exclusive license agreement for AMC303 to further develop, manufacture and commercialize the peptide inhibitor in the Greater China region (Mainland China, Hong Kong SAR, Macau SAR, and Taiwan) (Press release, amcure, NOV 12, 2020, View Source [SID1234570898]).

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Under the terms of the agreement, Hinova will develop, manufacture and commercialize AMC303 for the Greater China market with an initial focus on esophageal metastatic squamous cancer. China is projected to be the largest market globally for esophageal squamous cancer treatments. Additional cancer indications and combination therapies will be jointly evaluated by the companies. amcure retains all rights to AMC303 outside of the Greater China region. As part of the agreement, amcure will receive an upfront payment, plus development and commercial milestone payments as well as royalties on net sales.

The first-in-class drug candidate AMC303 targets CD44v6, a splice variant of the CD44 family of transmembrane glycoproteins that is involved in many processes relevant for tumor progression, including EMT, cell migration and invasion. By binding CD44v6, AMC303 blocks signaling via the three tyrosine kinases VEGFR-2, c-MET and RON and thus, strongly inhibits tumor growth and metastasis in squamous tumors. In animal models, AMC303 has shown synergistic effects with other anti-tumor agents. This novel mode of action has been proven in preclinical and clinical studies. In the first completed Phase I/Ib study in Europe, AMC303 was shown to be safe and well tolerated with a manageable adverse event profile and indicated single-agent antitumor activity. These results together with the unique mode of action suggest AMC303 to be a good candidate for combination treatments in squamous cancer.

"This agreement between amcure and Hinova represents an important milestone for the development of our lead candidate AMC303 and is a strong validation from an innovative China-based biotech company with management experience from renowned international pharmaceutical companies," said Dr. Klaus Dembowsky, CEO of amcure. "Hinova’s proven expertise in developing novel oncology treatments, their development capabilities, and knowledge of the Chinese market plus their promising pipeline of research projects, make them the ideal partner for us."

"We are pleased to partner with amcure to bring AMC303 to the Greater China region for the benefit of patients with esophageal squamous cancer," noted Yuanwei Chen, President and CEO of Hinova Pharmaceuticals. "amcure is a specialist in development of macrocyclic peptides. The collaboration will enrich Hinova’s oncology pipeline and provide more treatment options for the unmet clinical needs in the Chinese market."

Liberi Group’s CEO, Frans Trouwen ([email protected]; www.LiberiGroup.com) acted as deal facilitator for this agreement on behalf of amcure.

On November 12, 2020 Silverback Therapeutics reported that more than $160 million in venture capital this year, the immuno-oncology biotech filed on Tuesday to raise up to $100 million in its Wall Street debut (Press release, Silverback Therapeutics, NOV 12, 2020, View Source [SID1234570871]). The funds will bankroll early-phase trials for its lead antibody-drug conjugate and preclinical work for its other programs.

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The lead program, SBT6050, targets TLR8 in solid tumors that express the HER2 gene. The antibody makes sure the payload is delivered only to the HER2-expressing cancer cells, while the TLR8 agonist activates immune cells called myeloid cells to attack the tumor and "reprogram" the tumor microenvironment.

RELATED: RemeGen grabs one of the world’s largest-ever biotech IPOs

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It’s an improvement on previous efforts with TLR8 agonists, which must be given systemically and cause side effects that can limit the amount of drug a patient can take, Valerie Odegard, Ph.D., Silverback president and chief scientific officer, in a previous interview.

Silverback plans to fund the ongoing phase 1 study with the IPO proceeds, including an expansion into specific tumors and a phase 1b study in combination with a PD-1 inhibitor.

The funds will also push a second program toward an IND filing in the fourth quarter of 2021 and into phase 1, according to a securities filing. The treatment, SBT6290, also targets TLR8, but in solid tumors expressing Nectin4 rather than HER2.

Finally, the IPO will fuel a third TLR8-targeting program, but not in oncology. The ADC combines the payload with a monoclonal antibody targeting ASGR1 for the treatment of chronic hepatitis B infection. It hopes to file an IND for the program, SBT8230, in the second half of 2022, according to the filing.

RELATED: Shawver takes the wheel at I-O biotech Silverback Therapeutics

Beyond Hep B, Silverback is also working on treatments that "localize therapies to modulate important pathways in additional oncology and fibrosis indications," the company said in the filing.

Silverback’s work is based on its ImmunoTAC platform, which attaches antibodies to small molecules that adjust the immune system, instead of cytotoxic, or cell-killing, drugs. This approach allows Silverback to target pathways that have previously been out of reach for small molecules because of their side effects.

The IPO comes six months after biopharma veteran Laura Shawver, Ph.D. took the company’s helm and joins an ever-growing list of biotech companies who have gone public, or sought to do so, during the COVID-19 pandemic.

On November 12, 2020 Jubilant Therapeutics Inc. (‘Jubilant’), a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, and OneThree Biotech, a company redesigning drug discovery with biology-driven artificial intelligence, reported their collaboration and the successful completion of a study focused on the identification of specific biomarkers for new indications in targeted oncology patient populations (Press release, Jubilant Therapeutics, NOV 12, 2020, View Source [SID1234570857]).

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As part of the collaboration, Jubilant Therapeutics sought to determine the mechanism for its potentially first-in-class dual epigenetic inhibitor targeting melanoma, myelodysplastic syndrome (MDS), and acute myeloid leukemia (AML) and select solid tumor subsets. Utilizing the OneThree Biotech platform, they were able to:

Generate new data to support the dual inhibition (LSD1 and HDAC6) to drive inhibition
Pinpoint molecular markers that could be used to identify patients who might benefit from the dual inhibition
Determine additional target indications for future trials
"The convergence of biology and scalable data science is enabling new approaches to de-risk early-stage programs through biomarker discovery and patient selection," said Syed Kazmi, President and CEO of Jubilant Therapeutics. "Jubilant Therapeutics has a strong biomarker-driven innovation platform and we are pleased to collaborate with OneThree Biotech in the application of their proven biology-driven AI approach to streamline the delivery of right medicines to right patients who may not be currently benefiting from available cancer therapies."

"We’ve been incredibly impressed with Jubilant Therapeutics’ approach of combining focused experimentation with mechanistic biology and how they have re-thought the drug development process through the inclusion of new technology like AI. We’ve seen how results from this partnership can shape downstream clinical development and are excited to see it continue to evolve." said Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech.

A challenge in traditional drug development is generating an understanding of the biological mechanisms that drive the efficacy of a small molecule compound. OneThree Biotech has built an AI-powered platform that integrates over 40 data types to understand these underlying mechanisms and how they link drugs, targets and patients. This comprehensive approach enables delivery of informed insights to biopharma partners at critical stages of the development process.

JBI-802 is currently being evaluated in IND-enabling studies for the treatment of hematological and select solid tumors with specific gene signatures and first-in-human clinical studies are expected in 2021. Jubilant Therapeutics Inc. is developing a pipeline of novel, differentiated therapeutic assets; for partnership opportunity inquiries please contact [email protected].