On September 29, 2021 BeBetter Medicine reported that according to the CDE website, Bebetter Med’ HDAC/PI3K dual-target inhibitor BEBT-908 is proposed for inclusion in the breakthrough therapy list for the third-line treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Press release, BeBetter Medicine Technology, SEP 29, 2021, View Source [SID1234633497]).

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BEBT-908 is Bebetter Med’s first HDAC/PI3K dual target inhibitor proposed for inclusion in the breakthrough therapy list Panacro, entrusted by Bebetter Med, has engaged in CRO services such as medical R&D strategy development, medical monitoring, data management and statistical analysis since September 25, 201

The technical team of Panacro responded quickly and solve the problems encountered in the clinical trials in a professional and efficient manner. In the NDA of breakthrough therapy, the medical division, data division and statistical division worked together to achieve a good presentation of the Phase IIa statistical analysis report and clinical study report in a short period of time, which was highly recognized by the sponsor and CDE.

"Currently, five clinical studies have been initiated with BEBT-908, among which, Phase II clinical studies targeting a variety of hematologic tumors such as follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Walden’s macroglobulinemia, marginal zone lymphoma, and peripheral T-cell lymphoma have been initiated, and solid tumor indications are also under clinical exploration, and Panacro is honored to participate,"said Du Xiaojian, Chief Medical Officer of Panacro.

In the future, Panacro, by leveraging its professional technical ability and quality service, will make persistent efforts to promote local innovative drugs to benefit the majority of patients as soon as possible!"

On September 29, 2021 Sihuan Pharmaceutical Holding Group Co., Ltd.,and WuXi XDC, a global CDMO company dedicated to end-to-end bioconjugates services under WuXi Biologics (Cayman) Inc. (Hong Kong Stock Exchange stock code: (2269), jointly reported that, Xuanzhu Kangming, the biological platform company of Xuanzhu Biopharmaceutical Co., Ltd, of Sihuan Pharmaceutical, and WuXi XDC to reach the R&D and manufacturing service collaboration for an innovative biological product KM501, a bispecific antibody drug conjugate (ADC) (Press release, XuanZhu Pharma, SEP 29, 2021, View Source [SID1234632638]).

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KM501 is a bispecific antibody drug conjugate for the treatment of low & medium expression of HER2 which independently developed by Xuanzhu Kangming. It is currently in the pre development stage of investigational new drug (IND).

Pursuant to the collaboration agreement, Xuanzhu Kangming will promote the R&D process of KM501 bispecific ADC through the integrated CMC service of WuXi XDC. WuXi XDC will provide end-to-end services such as antibody, linker, payload, analytical method and process development, conjugate DS and DP to support the IND application of KM501 ADC.

The establishment of this strategic collaboration with WuXi XDC will accelerate and empower the development of innovative KM501 bispecific ADC. As one of the important projects from Xuanzhu’s innovative development pipeline, we believe that WuXi XDC ‘s end-to-end service and the rich experiences in the field of antibody drug conjugate CDMO service will provide sufficient support for KM501 bispecific ADC development in order to successfully submit IND application in the near future, help to accelerate its entry into clinical trials, verify its clinical treatment potential as soon as possible, and solve the unmet clinical needs.

About KM501
KM501 is a bispecific antibody drug conjugate for HER2-HER2 independently developed by Xuanzhu Kangming, the biological platform of Xuanzhu Biopharmaceutical Co., Ltd. The antibody part of the product can simultaneously bind two non-overlapping epitopes of HER2, ECD4 (Trastuzumab targeting domain) and ECD2 (Pertuzumab targeting domain). This unique design can produce a variety of mechanism of actions, including dual HER2 signal blocking and enhancing the binding between antibody and HER2, so as to enhance the clearance of HER2 protein from cell surface and improve antibody mediated antitumor activity.

About HER2 Market Potential
HER2 positive, HR negative breast cancer is the largest application of therapeutic area of HER2, has several products. With its rich indications, the total sales in 2020 exceed US $10 Billion. HER2 bispecific ADC, as a new generation of HER2 ADC products, is expected to share the breast cancer market in the future and bring more gospel to breast cancer patients. At the same time, HER2 is also highly expressed in a variety of tumors, such as gastric cancer, bile duct cancer and colorectal cancer, which potentially show huge market space.

On September 29, 2021 – Defence Therapeutics Inc., a biotechnology Company working on cancer therapeutics and infectious diseases vaccines, reported that it will be conducting a series of final studies to complete all requirement needed to initiate a Phase I trial for one of its leading AccuTOX candidate against breast cancer (Press release, Defence Therapeutics, SEP 29, 2021, View Source [SID1234626238]).

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The AccumTM technology platform was initially designed to enhance the accumulation of specific proteins, antibodies (ADCs) or antigen in target cells. Studies conducted by Defence revealed a strong therapeutic function for AccumTM when delivered on its own. In other words, the delivery of free "naked" AccumTM (AccuTOX-001) triggered cell death of a variety of cancer cells, including breast cancer, and was well tolerated by animals under the same treatment regiment.

"We are actively pursuing our AccuTOX program to initiate a Phase I trial against breast cancer in Q1-Q2 of 2022" said Sebastien Plouffe, CEO of Defence Therapeutics. "We will re-enforce our data by showing how potent is AccuTOX-001 at killing of breast cancer in various animal models including the use of patient-derived xenografts (PDX). The secondary objectives would be to compare the potency of AccuTOX-001 as stand-alone or combination therapy with currently used immune-checkpoint inhibitors", he added.

The Defence team is currently working to demonstrate that AccuTOX-001 can trigger the death of pre-establish 4T1 breast cancer in immunocompetent mice alone or in combination with anti-PD1. In parallel, the potency of the leading drug will be demonstrated in previously characterized PDX models to ensure a good translation from mice to human studies. Once completed, this data along with the GLP study scheduled in Q4 of 2021 will be compiled and presented to the FDA to have clearance for a Phase I trial against breast cancer.

Defence continues extensive research and development programs with its AccumTM technology platform including the AccuTOX program. Defence has developed a DC cancer vaccine targeting 4 different indications (AccuVAC-D), two ADCs in late-stage pre-clinical development (AccuADC) and various protein-based vaccines against infectious diseases such as COVID and HPV (AccuVAC-PTs and AccuVAC-INs).

In line with the Company’s strategy for preparing a Nasdaq listing submission in the beginning of second quarter of 2022, Defence Therapeutics has retained Lifewater Media to introduce Defence and its products to the US investment community. The contract with Lifewater Media begins for a 30-day period, starting at $150,000 USD. Lifewater Media are well known professionals in the media industry with more than 40 years of combined experience. Lifewater Media is a pioneer in US marketing strategy and digital marketing.

On September 29, 2021 Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) (Theratechnologies), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it will report financial results for its third quarter of fiscal 2021 ended August 31, 2021 on Wednesday, October 13, 2021 (Press release, Theratechnologies, SEP 29, 2021, View Source [SID1234596231]).

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A conference call will be held on October 13, 2021 at 8:30 a.m. (ET) to discuss the results and recent business updates. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. Mr. Lévesque and other members of the management team will be available to answer questions from participants following prepared remarks.

The conference call can be accessed by dialing 1-844-400-1697 (toll free) or 1-703-736-7400 (International). The conference call will also be accessible via webcast at View Source An audio replay of the conference call will be available on the same day starting at 11:30 a.m. (ET) until October 20, 2021 by dialing 1-855-859-2056 (North America) or 1-404-537-3406 (International) and by entering the access code: 2420948. An archived webcast will also be available on the Company’s Investor Relations website under ‘Past Events’.

On October 29, 2021 HAMLET Pharma reported that The clinical trial program in bladder cancer is proceeding according to plan, using Alpha1H secured from previous production rounds (Press release, HAMLET Pharma, OCT 29, 2021, View Source;utm_medium=rss&utm_campaign=hamlet-pharma-secures-alpha1h-production-for-continued-clinical-trials [SID1234594655]). Larger amounts of Alpha1H will be needed moving forward, as the clinical trial program is expanding to involve larger patient numbers .

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As previously announced, Hamlet Pharma is collaborating with Rechon Life Science for the production and formulation of the drug candidate Alpha1H. Rechon Life Science AB is a manufacturer approved for pharmaceutical supply worldwide, including the US. Together with Hamlet Pharma, Rechon has now successfully established large scale Alpha1H production technology. Production is carried out in accordance with Good Manufacturing Practice (GMP) and Alpha1H, packaged for clinical use, will be distributed to the clinical trial site.

"Scaling up the production of of Alpha1H is essential for the growth of Hamlet Pharma and for future clinical trials" says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.

‘’Securing a robust production of our drug candidate is an important milestone for the company", says Mats Persson, CEO of Hamlet Pharma Ltd.