On November 30, 2020 Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, reported that Gerri Henwood, the Company’s President and Chief Executive Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held virtually December 1-3, 2020 (Press release, Baudax Bio, NOV 30, 2020, View Source [SID1234572279]). The company will conduct institutional investor meetings on December 2, 2020; meetings may be requested through Piper Sandler.

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A pre-recorded fireside chat with Ms. Henwood is now available on the Piper Sandler conference site and on the "Events" page within the Investors section of the Baudax Bio website at View Source The recording will be available for a period of 30 days following the event.

On November 30, 2020 AP Biosciences reported In recent years, an increasing number of drugs have been granted breakthrough therapy designation in the United States, encouraging more companies to propose novel cancer treatment solutions (Press release, AP Biosciences, NOV 30, 2020, View Source [SID1234572009]). Currently, there are two companies in Taiwan that are accelerating the development of these therapies and provide innovative treatments.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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AP Biosciences’ target-dependent T-cell activating bi-specific antibodies

AP Biosciences (APBio) is a discovery-stage immunotherapeutic company developing mono- and bi-specific antibodies for various forms of treatment. One of the company’s major products, T-Cube bsAbs, involves bi-specific antibodies that lead T cells to cancer cells. They do so by bridging the T cells to unique antigens found on the surface of cancer cells, resulting in T cell activation which kills the cancer cells.

Unlike many current immune-therapeutic drugs (which activate the immune system to combat cancer cells while inducing a cytokine storm accompanied by strong side effects), APBio’s antibody drugs would benefit patients via improved specificity, leading to higher efficacy and a more favourable safety profile.

"T-Cube bi-specific antibodies activate cytotoxic and memory T cells upon binding to targeted cancer cells. In short, we’re creating better antibodies for better cures," explained Dr. Jeng Her, CEO of APBio. "In the near term, we see these treatments benefiting patients with liver, kidney, and lung cancers. Superiority in efficacy, safety, and cost is what makes our solutions unique and exciting to the medical community."

The strategy employed by APBio has attracted companies such as Innovent Biologics and Tasly Biopharmaceuticals to become development partners for several bi-specific antibodies. IBI302, a bi-specific antibody licensed to Innovent for the wet form of age-related macular degeneration (wet AMD), entered Phase I of clinical trials in April 2019. Further, APBio recently raised US$19.5 million in its series B funding round for the development of three in-house T-Cube antibodies, targeting human trials as early as Q4 2021.

LuminX provides cell GPS positioning in vivo

Most breakthrough therapy designations are granted to cell therapies. These therapies face great challenges in pre-market certification, owing to the difficulty of pre-clinical PK/PD data collection.

LuminX aims to accelerate and fine-tune cell therapies through better understanding of processes in the preclinical stage. With the help of an innovative cell-tracking method, live cells can be detected through fluorescence, thus making them easier to track for an extended period of time. This visibility helps scientists and researchers understand how therapeutic cells are distributed either in vivo or in vitro, how long they survive, and recognize what the cells’ eventual biological fate might be in a research or hospital setting.

According to Dr. Long-Jyun Su, CEO of LuminX, the company’s solution involves labelling cells with LuminX-tracking reagents that are non-toxic and non-genotoxic. The outcome sees labelled cells glow red for easy visual identification and remain potent long thereafter. The executive said that other techniques require 100, 1,000, or even 10,000 cells to elicit detection, whereas LuminX’s method only requires 10.

Dr. Su explained, "LuminX’s cell-tracking service is able to quantify the number of therapeutic cells in an individual organ, allowing us to obtain data on cell biodistribution and PK/PD. This means we’re able to study the movement of drugs through the animal model in the preclinical stage. Additionally for researchers and cell therapy companies, our tech will be a game-changer as it drastically cuts down the time and money otherwise needed for research and development."

On November 30, 2020, Anixa Biosciences, Inc. (the "Company") reported that it entered into an exclusive license agreement (the "Agreement") with The Cleveland Clinic Foundation, a nonprofit Ohio corporation (the "Licensor") (Filing, 8-K, Anixa Biosciences, NOV 30, 2020, View Source [SID1234572027]). Pursuant to the Agreement, the Company has been granted (i) an exclusive worldwide license to certain patents and patent applications (the "Licensed Patents") pertaining to the use of vaccines for the therapeutic treatment or prevention of ovarian cancer and other types of cancers which express the anti-mullerian hormone receptor 2 protein, including an anti-mullerian hormone receptor 2 protein containing an extracellular domain (the "Fields") and (ii) a non-exclusive worldwide license to use certain know-how related to the Licensed Patents that was not previously known by the Company (the "Licensed Know-How" and collectively, with the Licensed Patents, the "Licensed Technology") to make, have made, use, offer to sell, sell and import Licensed Products (as hereinafter defined) in the Fields. The Licensor has also granted the Company the right to sublicense the Licensed Technology in certain circumstances upon receipt of Licensor’s written consent.

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In consideration of its license of the Licensed Technology to the Company, the Company will pay to the Licensor a non-refundable cash fee for the issuance of the license. In addition, the Company has agreed to pay to the Licensor a royalty on the "net sales" (as such term is defined in the Agreement) on (i) any product or part of a product in the Fields the making, use, sale, offer to sell, or import of which infringes or would be expected to infringe a valid claim on the Licensor’s rights, but for the license granted in the Agreement (a "Licensed Patent Product") and (ii) any product or part of a product in the Fields that is sold, transferred, or otherwise disposed of in a jurisdiction where (1) a Licensed Patent has expired; (2) patent protection is not pursued, but the product or part of a product sold, transferred, or otherwise disposed of would be expected to infringe any valid claim on the Licensor’s rights; or (3) that was derived from, utilizes, uses, is used, or made through use of, embodies, contains, incorporates (in each case, in whole or in part), or uses any element of any of the Licensed Know-How (a "Licensed Know-How Product," and collectively with any Licensed Patent Product, the "Licensed Products"). The Company has also agreed to pay to the Licensor a lesser royalty on "net sales" on any Licensed Product that is sold, transferred or otherwise disposed of in a particular territory where no valid claim exists covering the sale of such Licensed Product in such territory.

In addition to the foregoing consideration, the Company will also pay to the Licensor certain cash payments following the completion of certain regulatory milestones with respect to each Licensed Product. Following the first commercial sale of any Licensed Products, the Company will be required to make certain minimum annual royalty payments to the Licensor. In addition, the Company has agreed to pay to the Licensor an annual maintenance fee related to the Licensed Technology. In the event that the Company sublicenses any of the Licensed Technology in accordance with the Agreement, the Company will pay to the Licensor a percentage of revenue received from any sublicense based upon certain milestones.

The Agreement is effective as of October 20, 2020 and will remain in effect, unless earlier terminated, until the later of (i) the five (5) year anniversary of the expiration of the last to expire valid claim that the Licensor has with respect to the Licensed Patents or (ii) the ten (10) year anniversary of the first commercial sale in each jurisdiction. The Licensor may also terminate the Agreement if, among other things, the Company fails to make certain payments under the Agreement, becomes insolvent, or breaches certain of the terms and provisions of the Agreement (subject, in certain circumstances, to a cure period). The Company has the right to terminate this agreement upon any material breach of the Agreement by the Licensor.

The Company has also agreed to certain commercialization and development milestones with respect to the Licensed Technology. If the Company fails to meet these milestones (including following any permissible cure period or following a mutually agreed upon extension), and such failure is not the result of an unforeseeable event, the Agreement may be terminated by the Licensor.

The Licensor is responsible for prosecution of the Licensed Patents, provided that the Company is responsible for all costs associated with such prosecution. The Company is also responsible for all other patenting costs associated with the Licensed Patents and has agreed to reimburse the Licensor for certain costs incurred prior to the Agreement related to the Licensed Patents.

The Company and Licensor will work in tandem to develop Licensed Products. The Company will be responsible for paying the costs associated with any additional development of Licensed Products.

The Company has agreed to indemnify the Licensor in connection with the Agreement and has also agreed to maintain certain insurance.

The Agreement contains typical representations, warranties and covenants. Pursuant to the Agreement, Licensor retains the right to continue to conduct research relating to the License Products in the Fields, provided that the Licensor does not have the right to practice or use the Licensed Technology in connection with the commercial sale of any product or service. Licensor also retains the right to publish the results of its research, even if such research contains Licensed Know-How, provided that the Company has the right to review and delay the publication if there is patentable subject matter in the research such that the Company can file a patent application over such matter.

On November 30, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that it has partnered with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, to commercialize margetuximab in the United States, if approved (Press release, MacroGenics, NOV 30, 2020, View Source [SID1234572016]).

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Margetuximab is an investigational, monoclonal antibody derived from MacroGenics’ proprietary Fc-Optimization technology platform. A Biologics License Application (BLA) for margetuximab for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020.

"We believe that margetuximab, if approved, could become a valuable treatment option for patients living with this devastating disease," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are excited to partner with EVERSANA and leverage their integrated commercial services to efficiently launch margetuximab. We have been working closely with EVERSANA to fully align our commercialization strategies to educate healthcare providers and ensure patient access to margetuximab, while maintaining MacroGenics’ cash runway to fund our broader portfolio."

Jim Lang, CEO of EVERSANA, added, "We’ve built a suite of comprehensive commercial services for biopharmaceutical innovators like MacroGenics and look forward to entering this risk-sharing arrangement with MacroGenics to support the commercialization of margetuximab, if approved. Our partnership with MacroGenics puts the patient first by supporting broad market access and comprehensive patient support services. We will work closely with MacroGenics on each stage of the product launch and roll-out."

Under the terms of the agreement, MacroGenics maintains ownership of margetuximab, including all manufacturing, regulatory and development responsibilities for the product. This includes MacroGenics’ continued development of margetuximab in combination with immune checkpoint inhibitors in gastroesophageal cancer in the Phase 2/3 MAHOGANY study, as well as other ongoing studies. EVERSANA receives a co-exclusive right to conduct approved commercialization activities. EVERSANA will utilize its internal capabilities to support sales and marketing, market access, channel management services, data and analytics, medical affairs, and other patient access related services. MacroGenics will book sales for margetuximab. Upon the potential approval of margetuximab, EVERSANA and MacroGenics will equally share in funding EVERSANA’s commercialization expenses. In exchange for co-funding these expenses, EVERSANA will earn future revenue share payments which shall be capped at 125% of EVERSANA’s cumulative service fees. The term of the agreement is five years following the date of FDA approval, subject to predefined termination provisions.

About HER2-Positive Breast Cancer
Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Antibody-based therapies targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an area of unmet need and ongoing HER2 blockade is recommended for the treatment of patients with relapsed or refractory disease.

About Margetuximab
Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics’ Fc Optimization technology. Margetuximab is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer (NCT04082364), and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART molecule) in various HER2+ indications (NCT03219268). For more information, please visit www.clinicaltrials.gov.

On November 30, 2020 AP Biosciences reported In recent years, an increasing number of drugs have been granted breakthrough therapy designation in the United States, encouraging more companies to propose novel cancer treatment solutions (Press release, AP Biosciences, NOV 30, 2020, View Source [SID1234572009]). Currently, there are two companies in Taiwan that are accelerating the development of these therapies and provide innovative treatments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AP Biosciences’ target-dependent T-cell activating bi-specific antibodies

AP Biosciences (APBio) is a discovery-stage immunotherapeutic company developing mono- and bi-specific antibodies for various forms of treatment. One of the company’s major products, T-Cube bsAbs, involves bi-specific antibodies that lead T cells to cancer cells. They do so by bridging the T cells to unique antigens found on the surface of cancer cells, resulting in T cell activation which kills the cancer cells.

Unlike many current immune-therapeutic drugs (which activate the immune system to combat cancer cells while inducing a cytokine storm accompanied by strong side effects), APBio’s antibody drugs would benefit patients via improved specificity, leading to higher efficacy and a more favourable safety profile.

"T-Cube bi-specific antibodies activate cytotoxic and memory T cells upon binding to targeted cancer cells. In short, we’re creating better antibodies for better cures," explained Dr. Jeng Her, CEO of APBio. "In the near term, we see these treatments benefiting patients with liver, kidney, and lung cancers. Superiority in efficacy, safety, and cost is what makes our solutions unique and exciting to the medical community."

The strategy employed by APBio has attracted companies such as Innovent Biologics and Tasly Biopharmaceuticals to become development partners for several bi-specific antibodies. IBI302, a bi-specific antibody licensed to Innovent for the wet form of age-related macular degeneration (wet AMD), entered Phase I of clinical trials in April 2019. Further, APBio recently raised US$19.5 million in its series B funding round for the development of three in-house T-Cube antibodies, targeting human trials as early as Q4 2021.

LuminX provides cell GPS positioning in vivo

Most breakthrough therapy designations are granted to cell therapies. These therapies face great challenges in pre-market certification, owing to the difficulty of pre-clinical PK/PD data collection.

LuminX aims to accelerate and fine-tune cell therapies through better understanding of processes in the preclinical stage. With the help of an innovative cell-tracking method, live cells can be detected through fluorescence, thus making them easier to track for an extended period of time. This visibility helps scientists and researchers understand how therapeutic cells are distributed either in vivo or in vitro, how long they survive, and recognize what the cells’ eventual biological fate might be in a research or hospital setting.

According to Dr. Long-Jyun Su, CEO of LuminX, the company’s solution involves labelling cells with LuminX-tracking reagents that are non-toxic and non-genotoxic. The outcome sees labelled cells glow red for easy visual identification and remain potent long thereafter. The executive said that other techniques require 100, 1,000, or even 10,000 cells to elicit detection, whereas LuminX’s method only requires 10.

Dr. Su explained, "LuminX’s cell-tracking service is able to quantify the number of therapeutic cells in an individual organ, allowing us to obtain data on cell biodistribution and PK/PD. This means we’re able to study the movement of drugs through the animal model in the preclinical stage. Additionally for researchers and cell therapy companies, our tech will be a game-changer as it drastically cuts down the time and money otherwise needed for research and development."