On January 26, 2022 Luye Pharma Group reported that the first patient has been enrolled in a Phase I clinical trial for BA1105, an investigational anti-Claudin18.2 antibody developed by its subsidiary Boan Biotech (Press release, Luye Pharma, JAN 26, 2022, View Source [SID1234638771]). The Phase I clinical trial is designed to evaluate the safety, tolerance and pharmacokinetics of BA1105 in patients with advanced solid tumors.

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BA1105 is a recombinant human anti-Claudin18.2 IgG1 monoclonal antibody for treating Claudin18.2-positive advanced solid tumors. Claudin18.2 is a potential target for treating gastrointestinal tumors. It is consistently and highly expressed in gastrointestinal tumors. Research shows that 70% of gastric cancer patients, 50% of pancreatic cancer patients and 30% of esophageal cancer patients are Claudin18.2 positive.

The incidence of gastrointestinal tumors in China is very high, and there are many unmet needs of patients to be addressed. According to data from the International Agency for Research on Cancer (IARC), gastric cancer, esophageal cancer, and pancreatic cancer are among the 10 most common malignant cancers in China, with the number of new cases in 2020 being approximately 480,000, 320,000, and 120,000, respectively1. More than 40% of the new gastric cancer cases worldwide are in China. Due to the lack of early diagnosis, most gastric cancer patients are diagnosed at an advanced stage. There are limited therapy options for advanced gastric cancer and more effective therapies are needed to improve patient survival. Antibodies targeting Claudin18.2 are promising drugs against gastrointestinal tumors.

Unlike the common ADCC-enhancing technique that decreases the antibody’s fucose level through cell engineering, BA1105 enhances ADCC by inducing amino acid mutations in the Fc region. These mutations increase BA1105’s affinity to the agonistic Fc receptor without altering its affinity to the inhibitory receptor CD32b, to prevent the drug’s antitumor activity from being inhibited by the inhibitory receptor.

An in vivo efficacy study for BA1105 showed that it demonstrated a high antitumor activity in tumor models with low or high Claudin 18.2 levels either alone or in combination with chemotherapeutic agents. In vitro efficacy studies showed that BA1105 was 10-fold more potent than the reference antibody against cancer cells with either low or high Claudin 18.2 levels. BA1105 is expected to become the best-in-class targeted therapy for certain cancers such as the metastatic pancreatic cancer, the advanced gastric cancer, and the gastro-esophageal junction (GEJ) adenocarcinoma.

Boan Biotech has been building a diversified product portfolio focusing on innovative biologics. In addition to BA1105, the company’s R&D pipeline also includes more than 10 other proprietary innovative antibody candidates and various biosimilar candidates, and some of them are undergoing clinical trials in the United States, Europe, China, and other countries and regions around the world. The company is accelerating its global development, and is committed to serving patients around the world with high-quality biopharmaceutical products.

On January 26,2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various immune-oncology products, is pleased to reported the development of AccuVAC-PT009, a new protein-based HPV vaccine, leading to a humoral response bypassing Gardasil-9 (Merck) immunogenicity in animals (Press release, Defence Therapeutics, JAN 26, 2022, View Source [SID1234626246]).

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ACCUMTM is a platform technology 100% owned by Defence Therapeutics. ACCUMTM is an enabling technology as it can be used to enhance the intracellular accumulation of various proteins of pharmacological interests into any target cells. As such, it is currently used by Defence for the development of several anti-cancer and COVID vaccines, as well as for the improvement of approved or in development antibody-drug conjugates.

To further demonstrate the ACCUMTM versatility, the Defence research and development team designed and engineered a HPV vaccine (a mix of the same 9 HPV-derived L1 proteins used in Gardasil-9) and compared its immunogenicity to a group of Gardasil-9-immunized animals. Compared to Gardasil-9, AccuVAC-PT009 triggers an impressive 27-and 36-fold increase in antibody titer at 4-and 6-weeks post-immunization respectively.

"We are extremely proud to demonstrate again how ACCUMTM can be exploited and applied to significantly improve any protein-based vaccine. Not only can this vaccine have a tremendous impact on improving the immunogenicity of the commercialized Gardasil-9, but it can in addition lower the dosing regimen (at least by 10-fold) yet triggering similar or more potent humoral response", says Mr. Plouffe, the CEO of Defence.

According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Bn in 2019 & is projected to reach $12.69 Bn by 2027, with a CAGR of 16.3%.

Defence Therapeutics is currently working on various scenarios. Although its initial intent is to pursue the development of its AccuVAC-PT009 HPV vaccine candidate or even adding other subtypes currently not covered by Gardasil-9, the company is actively looking for to establish partnerships with major pharmaceuticals players to bring forward its vaccine portfolio.

On January 26, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, will provide a clinical update during today’s conference call and webcast at 4:30 p.m. EST. Live and archived versions of the event can be accessed via the Company’s website (Press release, Cue Biopharma, JAN 26, 2022, View Source [SID1234608262]).

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Members of the Cue Biopharma executive management team will provide an update from the Company’s ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of third line and beyond HPV+ recurrent/metastatic head and neck squamous cell carcinoma. The discussion will focus on recent data updates from the Phase 1b monotherapy dose expansion trial and the dose escalation combination trial evaluating CUE-101 front line with Merck’s KEYTRUDA (pembrolizumab). Management will also provide an update on the Company’s pipeline development progress from the IL-2 based CUE-100 series including CUE-102, with an Investigational New Drug (IND) filing planned for the first quarter of 2022, as well as updates on its strategic objectives and anticipated milestones.

Webcast Details

Wednesday, January 26, 2022 at 4:30 p.m. EST
Investors: 877-407-9208
International: 201-493-6784
Conference ID: 13726509
Webcast: View Source;tp_key=7a7d92f501

On January 26, 2022 Aclys Bio Corp ("Aclys"), a company discovering and developing precision biologics for the treatment of cancer, earlier this month reported a new exclusive research and commercial license option agreement with Genmab A/S (Nasdaq: GMAB), an international biotech company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, Celdara Medical, JAN 26, 2022, View Source [SID1234608166]).

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Under the terms of the agreement, Genmab secures exclusive rights to Aclys antibodies (specific to an undisclosed target) for further research in conjunction with Genmab’s proprietary platforms. Genmab is also granted the option to advance development and commercialization of resulting products.

Aclys has built a broad range of antibodies using its PILA platform to create targeted therapeutics for solid tumors. The agreement with Genmab recognizes the capability of the Aclys PILA platform to identify novel precision targets.

"We have differentiated, high value targets, unique antibody engineering capabilities, and a team that has delivered some of the most valuable monoclonal antibodies currently in development.", said Dr. Tony Cooper, Aclys Cofounder and CEO. "This agreement with Genmab is integral to advancing our goal of delivering life-saving therapies to patients." Aclys is a leader in the emerging field of precision immune medicine. Aclys utilizes a proprietary set of patient molecular data to select differentiated targets and create precision biologics with the safety profile and response rates only achievable with precision biologics.

On January 26, 2022 Nordic Pharma reported that on the 24th of January, the European Commission (EC) approved the new indication for Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity (Press release, Nordic Pharma, JAN 26, 2022, View Source [SID1234607539]).

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Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Based on this approval, Teysuno will be indicated in adults:

for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting

New fluoropyrimidine for patients with metastatic colorectal cancer

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In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: "This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication."

Iris van Lakerveld, Global Oncology Lead added: "Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.