On January 20, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported today the filing of a provisional patent application covering the use of survivin-engineered dendritic cells and exosomes for stimulation of anti-cancer immunity (Press release, Regen BioPharma, JAN 20, 2023, View Source [SID1234626424]). The intellectual property provides additional means of stimulating specific elements of the immune system to selectively seek and destroy cancer cells without harming healthy tissue.

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Dendritic cells are the most potent immune cell capable of activating T cells. T cells are the effectors of the immune system and in the present case are the cells that are involved in killing survivin-expressing tumor cells. The cancer marker survivin appears to be present on most of the major cancers but not on non-malignant tissues.

The Company has previously designed dendritic cells for treatment of breast cancer utlizing a process called gene silencing. The current work capitalized on lessons learned in developing DCellVax[1], as well as novel findings regarding utilizing of exosomes, naturally occurring nanoparticles with ability to modulate the immune system.

"The field of immunotherapy is expanding at an unprecedented rate and this is exemplified by the astronomical rise in the use of immunotherapeutic drugs, which now are believed to possess a 100 billion global annual market[2]," said David Koos, CEO and Chairman of the Company. "Through positioning ourselves to control multiple means of inducing immunity to survivin, we are seeking to concurrently advance our science, diversify our portfolio and provide possible new revenue streams to shareholders."

On January 20, 2023 Duality Biologics ("DualityBio"), a clinical-stage biotech company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment (Press release, Duality Biologics, JAN 20, 2023, View Source [SID1234626423]). DB-1303 is a novel antibody-drug conjugate comprised of anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003. It is designed to have potent anti-tumor activity and bystander killing effect, high plasma stability, low free payload in circulation and wide therapeutic index.

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Dr. John Zhu, CEO of DualityBio, said: "The FDA’s decision to grant FTD underscores the potential for DB-1303 to address the unmet medical need and potentially serve as a new therapeutic option for patients with advanced, recurrent or metastatic endometrial carcinoma." "We are committed to advance this investigational drug to help those patients who are suffering from cancers. We will work closely with clinical investigators and health authorities to unlock the full potential of DB-1303 in patients with malignant tumors."

DualityBio is currently evaluating DB-1303 in an ongoing Phase I/IIa clinical trial for preliminary safety and efficacy in advanced/metastatic solid tumors with Her2 expression, including both HER2 positive and HER2 low patients.

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About Endometrial Carcinoma

Endometrial carcinoma (EC) is the most common cancer of the female genital tract in USA. On January 1, 2019, there were an estimated 822,388 people living with uterine corpus cancer in the U.S. (View Source), and it is estimated that 66200 new uterine corpus cancer cases will occur with 13030 deaths resulting from the disease in 2022. Around 1 in 4 women with endometrial cancer may experience a recurrence or be diagnosed with advanced disease. In endometrial cancer, approximately 60%–70% of high-grade carcinomas appear to overexpress HER2. There is no accepted standard of care and limited therapeutic options for the patients with recurrent or metastatic EC who have failed previous platinum-based systemic therapy with or without immunotherapy. DualityBio is working to develop treatments for the disease to fill this significant unmet medical need.

About DB-1303

DB-1303, a 3rd generation HER2 ADC molecule built from Duality Biologics’ Proprietary DITAC platform, exhibited potent antitumor activity in both HER2 positive and HER2 low tumor models with superior efficacy, safety and expanded therapeutic window. Both preclinical data and preliminary clinical data from DB1303 suggest the potential of DB-1303 to address unmet medical needs in various HER2 expressing cancers.

On January 20, 2023 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that a poster presentation highlighting the Phase 1 preliminary results of a recombinant humanized anti-claudin18.2 monoclonal antibody (AB011), as monotherapy and combination therapy, for patients with advanced solid tumors was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium ("ASCO GI"), in San Francisco, California, during January 19-21, 2023 (Press release, Carsgen Therapeutics, JAN 20, 2023, View Source [SID1234626422]).

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Details for the presentation are as follows:

Poster Presentation: A Multicenter, Phase 1 Study of AB011, a Recombinant Humanized Anti-CLDN18.2 Monoclonal Antibody, as Monotherapy and Combined with Capecitabine and Oxaliplatin (CAPOX) in Patients with Advanced Solid Tumors (Abstract #391, Poster #G13)

Presenter: Jin Li MD

Session Title: Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

About AB011

AB011 is a humanized Claudin18.2 monoclonal antibody (mAb) product that has received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for the treatment of Claudin18.2 positive solid tumors. CARsgen is conducting a Phase I clinical trial of AB011 for the treatment of Claudin18.2 positive solid tumors in China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 infusion.

On january 20, 2023 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported the grant of inducement awards to two new employees (Press release, Savara, JAN 20, 2023, View Source [SID1234626421]).

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On January 17, 2023, the Compensation Committee of Savara’s Board of Directors granted the inducement awards to two new employees who recently joined the Company. The inducement awards consist of options to purchase an aggregate of 195,000 shares of the Company’s common stock and restricted stock units (RSUs) covering an aggregate of 60,000 shares of the Company’s common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules as an inducement material to the employee’s acceptance of employment with the Company.

The options have an exercise price of $1.89 per share, the closing trading price of the Company’s common stock on the NASDAQ Global Market on the grant date. Each option has a 10-year term and vests as to 1/16th of the number of shares subject to the option on each quarterly anniversary of the employee’s first day of employment, subject to the employee’s continued employment on each such vesting date. The RSUs vest in full on the two-year anniversary of the employee’s first day of employment, subject to the employee’s continued employment on such vesting date.

On January 20, 2023 NETRIS Pharma, a clinical-stage private biopharmaceutical company developing a new class of drugs based on dependence receptor biology, reported that a consortium of leading European academic institutions and biotech companies have been awarded a €1.2 million Eurostar grant for ACTaNet (Press release, Netris Pharma, JAN 20, 2023, View Source [SID1234626420]). The ACTaNet project aims to generate preclinical proof-of-concept (PoC) for NP137, NETRIS Pharma’s lead product, as a high-potential drug candidate for the treatment of arthritis and metastatic bone cancer related chronic pain. NP137 is an antibody therapeutic that targets netrin-1, a protein ligand over-expressed in many cancers.

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The consortium gathers unique experience and knowledge in the field of pain-related indications from the Karolinska Institutet in Sweden, University of Copenhagen in Denmark, CRCL in France as well as biotechnology expertise in the field of biomarkers (Nordic Bioscience) and preclinical and clinical development of drugs (NETRIS Pharma).

ACTaNet aims to demonstrate the efficacy of NP137 against chronic pain caused by bone-associated cancer and arthritis in preclinical models and subsequently advance the drug candidate towards the Investigational New Drug (IND) application. In addition, the project aims to validate relevant non-invasive translational biomarkers, such as collagen fragments, that may be used as a tool for better understanding of treating chronic pain, as well as to predict and monitor the efficacy of NP137.

« We are very pleased to be part of this collaboration. Pain is a common and debilitation symptom of joint and bone disorders and an important unmet medical need » said said Anne-Marie Heegaard, Associate Professor at the University of Copenhagen.

« The members of the consortium are uniquely positioned with complementary expertise. Working together will make a difference and maximize the chances of moving NP137 towards clinical development in these indications » added Camilla Svensson, Professor at the Karolinska Institutet.

The Project includes a special attention to biomarkers as noted by Nicholas Willumsen, Director, Oncology, at Nordic Bioscience: « Non-invasive biomarkers validated in a chronic pain setting can help to objectively facilitate an accurate diagnosis and evaluate efficacy of intervention. In the ActaNet project we will look for and evaluate biomarkers related to netrin-1 and their role in pain ».

« Netrin-1 has been initially identified as a neuronal guidance cue during embryogenesis and we are very excited about the recent discoveries on the role of netrin-1 in pain conduction, and on the possibility of our lead asset, NP137, to inhibit pain » said Patrick Mehlen, CEO of NETRIS Pharma.

« This €1.2 million Eurostar grant obtained by NETRIS Pharma and the members of the consortium is validation of the growing interest of targeting netrin-1 in inflammatory conditions » added Christophe Guichard, CFO of NETRIS Pharma.