On June 1, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma (Press release, Johnson & Johnson, JUN 1, 2021, View Source [SID1234583357]). This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11th received by Janssen’s Oncology Therapeutic Area.

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"We are pleased to have received Breakthrough Therapy and PRIME Designations for our novel bispecific antibody, teclistamab," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This program exemplifies our commitment to advancing science for patients living with multiple myeloma, and it builds upon our robust portfolio in this disease."

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.1 PRIME designation offers enhanced interaction and early dialogue to optimize development plans and speed up the evaluation of scientific advances that target a high unmet medical need.2

The Breakthrough and PRIME designations are supported by data from the Phase 1 MajesTEC-1 study (NCT03145181), an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or be intolerant of those established multiple myeloma therapies.3

Updated results from the MajesTEC-1 study will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 8.

About Teclistamab
Teclistamab is an off-the-shelf, T-Cell redirecting, bispecific antibody targeting both BCMA and CD3 receptors. BCMA is expressed at high levels on multiple myeloma cells.4,5,6,7,8 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.5,6 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.6

Teclistamab is currently being evaluated in a Phase 2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT04557098) and is also being explored in combination studies (NCT04586426, NCT04108195, NCT04722146). In 2020, the European Commission and the U.S. Food and Drug Administration each granted teclistamab orphan drug designation for the treatment of multiple myeloma. In January 2021, teclistamab was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA). PRIME offers enhanced interaction and early dialogue to optimize drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.9

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.10,11 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2021, it is estimated that nearly 35,000 people will be diagnosed and more than 12,000 will die from the disease in the U.S.12 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.13

On May 31, 2021 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 31, 2021, View Source [SID1234583294]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from May 24, 2021 to May 28, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 254,206 shares as treasury shares, corresponding to 0.39% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On May 31, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and ITO EN, LTD. (Headquarters: Tokyo, President: Daisuke Honjo, "ITO EN") reported that both parties have entered into a business alliance agreement concerning the initiatives for supporting people living with and preventing dementia with the aim of realizing a healthy and long-lived society (Press release, Eisai, MAY 31, 2021, View Source [SID1234583295]).

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Through this alliance, Eisai and ITO EN aim to contribute to the solution of dementia, which is one of the important social issues, with integrating Eisai’s wealth of experience and knowledge in drug creation and disease awareness activities in the area of dementia, as well as Eisai’s solution measures such as digital technology, and ITO EN’s customer network through its community-based sales activities, as well as ITO EN’s problem-solving project related to cognitive function based on abundant research on Matcha (powdered green tea). The specific initiatives planned are as follows.

1. Providing the packaged solution

As support for holding seminars on exercise and food related to dementia disease awareness and brain health by local governments for residents, the packaged solution plans to be provided through ITO EN’s 186 business offices nationwide. The packaged solution includes Eisai’s information materials for disease awareness, opportunities for checking brain performance using Eisai’s brain performance (brain-health) self-check tool "NouKNOWTM" (pronounced "NOH-NOH", non-medical equipment), and ITO EN ‘s information and services related to Matcha and health.

2. Providing a set of products focusing on brain health

A set product which includes the Foods with Function Claims "Oi Ocha OMATCHA POWDER (stick 1.7g x 32)" produced by ITO EN, a prepaid card that can be used for "NouKNOW" and Eisai’s information materials related to brain health will be distributed in Japan.

3. Providing an opportunity to check brain performance at events and campaigns hosted by ITO EN

At the events and campaigns hosted by ITO EN, participants will be provided with the information on brain health and the opportunity to check brain performance using "NouKNOW".

4. Initiation of brain performance check trial internally at ITO EN, towards the future utilization of brain performance checks in corporate health examinations

As a trial for the utilization of "NouKNOW" in corporate health examinations, verification of the effects of health consciousness and behavioral changes based on regular brain performance checks among willing ITO EN employees has been ongoing.

Eisai, which aims to eliminate the diverse anxieties of each individual (The People) by constructing a dementia ecosystem through coexisting with other industries and organizations, and ITO EN, which explores the potential of tea and aims to be a health creation company that contributes to the era of 100 years of life, will promote co-creation of value toward the realization of a healthy and long-lived society so that people can lead a happy life in their own way by combining the strengths of both company.

On May 31, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) reported that the publication of the 1st quarter 2021 financial results, which had been scheduled for June 1, 2021, will be postponed until June 25, 2021 (Press release, Vivoryon Therapeutics, MAY 31, 2021, View Source [SID1234583296]).

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In accordance with the decree of May 27, 2021 on amending some expiry dates of legal provisions made in connection with the COVID-19 outbreak as published on May 31, 2021, the Temporary COVID-19 Justice and Safety Act (Tijdelijke wet COVID-19 Justitie en Veiligheid) (the COVID Act) has been extended. Therefore, the annual general meeting will be held on Monday, June 28, 2021, at 10:30 a.m. (CEST) as a virtual meeting via an audio webcast which will be available, along with all relevant documents, on the company’s website at: View Source As there will be no physical meeting, it will not be possible to attend the meeting in person..

On May 31, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and AnHeart Therapeutics Co., Ltd. ("AnHeart"), a clinical stage oncology company focused on underserved patients in global markets, reported an exclusive license agreement for the co-development and commercialization of AnHeart’s lead drug candidate, taletrectinib – a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK – in Greater China, including mainland China, Hong Kong, Macau and Taiwan (Press release, Innovent Biologics, MAY 31, 2021, View Source [SID1234583297]).

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Under the terms of the agreement, Innovent will obtain exclusive rights to co-develop and commercialize taletrectinib in Greater China. AnHeart will continue to be responsible for the development of taletrectinib up to regulatory approval in mainland China and for supplying taletrectinib for both developmental and commercial purposes in Greater China. Innovent has the right to co-develop taletrectinib in Hong Kong, Macau and Taiwan up to regulatory approval.

According to the agreement, AnHeart will receive an upfront payment, R&D fees, and potential milestone payments totaling USD189 million in addition to tiered royalties based on annual net sales of taletrectinib in Greater China.

Taletrectinib is currently undergoing three phase 2 studies, including (i) the phase 2 study for first line treatment of TKI-naive and second line treatment of TKI-pretreated ROS1-positive non-small cell lung cancer (NSCLC) in China, (ii) the phase 2 study for NTRK-positive solid tumors in China, and (iii) the phase 2 study for first line and second line treatment of ROS1-positive NSCLC globally.

"We are excited to collaborate with Innovent, a leading biopharmaceutical company which has demonstrated outstanding development and commercialization capabilities, to commercialize taletrectinib in greater China," said Jerry Junyuan Wang, PhD, CEO and co-founder of AnHeart. "Following the first commercial partnership in Korea we entered into with NewG Lab in July 2020, our collaboration with Innovent further advances our mission to accelerate global patient access to taletrectinib upon approval."

Dr. Yong Jun Liu, president of Innovent, stated, "We are very pleased to enter a collaboration with AnHeart. We have been impressed with our partner’s capability to advance the global development of taletrectinib and we are excited to help bring taletrectinib to patients in Greater China. This collaboration further strengthens our position in oncology by adding a late stage and potential best-in-class targeted therapy into our portfolio. At the same time, it further proves that Innovent is an ideal partner for biopharmaceutical companies in terms of accelerating development and commercialization progress."

About Taletrectinib

Taletrectinib is an investigational next-generation TKI designed to effectively target ROS1 and NTRK with potential to treat TKI-naïve or pretreated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK fusion is estimated to be an oncogenic driver in approximately 0.5 percent of patients across multiple advanced solid tumors. There’s very limited approved therapy available for advanced ROS1-positive lung cancer patients and NTRK-positive cancer patients in Greater China. After treatment with existing therapies, most patients eventually acquire resistance for which there are significant unmet medical needs globally.

AnHeart has observed a 100% overall response rate (ORR) by investigator review from 11 ROS1-positive NSCLC patients who were not previously treated with a tyrosine kinase inhibitor (TKI) utilizing a January 15, 2021 data cut-off from the Phase 2 portion of the ongoing taletrectinib TRUST trial. Taletrectinib was also generally well-tolerated. These data demonstrate the potential for taletrectinib to be a best-in-class treatment. Data with more patient from first line (ROS1 TKI naive) and second line (ROS1 TKI pretreated) will be published during the 2021 ASCO (Free ASCO Whitepaper).

More information about the ongoing TRUST study of taletrectinib may be found by searching clinical trial identifier NCT04395677 at View Source