On April 30, 2021 Shaperon, a new drug development bio company, reported that it would sign a business agreement (MOU) with Dong-A ST for the joint development of new bio drugs (Press release, Shaperon, APR 30, 2021, View Source;idx=45&pNo=3&code=press_en [SID1234629321]).

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!

This joint development agreement was made with the goal of jointly developing treatments for cancer and inflammatory diseases using nanobody-based biopharmaceuticals. Nanobodies are antibodies that are 1/10 the size of existing antibodies, and are attracting attention as a key technology for next-generation immuno-oncology drugs because of their excellent stability and water solubility, high production yield, and high homology with human antibodies, making it easy to develop therapeutics and diagnostic platforms.

The two companies will develop new bio drugs by combining Chaperone’s nanobody technology and Dong-A ST’s new drug development platform. Chaperone builds a nanobody library based on its own technology, develops an antibody suitable for the selected target, verifies the effect at the cellular level, and then proceeds with the effect verification in an animal model in collaboration with Dong-A ST. When efficacy verification is completed in an animal model, Dong-A ST will be in charge of building a cell line for the nanobody antibody. In addition, the two companies plan to jointly discover anti-cancer targets throughout the preclinical process and evaluate the efficacy of candidate antibodies.

Lee Myung-se, CEO of Chaperone, said, "Through this MOU, we expect to see results such as the development of new biologics to treat cancer and chronic inflammation and the creation of corporate value through technology transfer." We will do our best to succeed in commercialization," he said.

Chaperon is the only domestic company that has nanobody development platform technology. In the trend of new drug development, where the structure of protein-based drugs such as bispecific antibodies or antibody drug conjugates is becoming more complex, the side effects and low production efficiency of existing antibodies can be overcome, and various routes of administration such as oral or inhalation are available. It is high tech. Based on the nanobody platform, Chaperon is developing various pipelines such as immune checkpoint inhibitory bispecific antibodies and coronavirus neutralizing antibodies.

On April 30, 2021 PCI Biotech’s (OSE: PCIB) reported that first quarter 2021 interim report will be released on 7 May 2021 at 07.00 CEST. The interim report and presentation will be made available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585160]).

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!

A results presentation (in English) will be held through a live webcast at 08.30 CEST the same day. The webcast can be accessed through www.pcibiotech.com. There will be a Q&A session at the end of the presentation. It will be possible to post written questions through the webcast console or through a teleconference facilitated for investors intending to ask questions verbally during the Q&A session.

On April 30, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that the first US patient has been enrolled into the fimaChem pivotal RELEASE study with registration intent in inoperable bile duct cancer patients (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585158]). The RELEASE study spans across Europe, USA and Asia, with patient enrolment initiated in all continents.

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!

Per Walday, CEO, said: "It is reassuring to see screening activity and enrolment picking up across the geographies of the RELEASE study, despite Covid-19 still having an impact on the healthcare systems. We are focused on optimal execution of the RELEASE study, to bring a new treatment option to a patient group with a high unmet medical need."

On April 30, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, APR 30, 2021, View Source [SID1234584739]).

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!

"This latest approval is another meaningful extension of our bendamustine franchise. We believe this expanded label will significantly increase the market opportunity for TREAKISYM in Japan. Based on this additional indication, as well as the anticipated approval of the ten-minute RI liquid formulation, we are reiterating our belief that the combined royalty and milestones revenue from these products will generate $25 million at peak," stated Scott Tarriff, Chief Executive Officer.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

SymBio received approval for the TREAKISYM RTD (250 ml) liquid formulation in September 2020 and is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation, for which it plans to seek approval in the second half of 2022.

Key benefits to patients and healthcare providers of these products include eliminating the need for manual reconstitution and significantly reducing preparation time as compared to the lyophilized formulation.

On April 30, 2021 Alkermes plc (Nasdaq: ALKS) reported that it has reached an agreement with Sarissa Capital Management LP ("Sarissa Capital"), a beneficial owner of approximately 5% of the company’s outstanding ordinary shares, pursuant to which Sarissa Capital has the right to designate a director to the company’s Board of Directors (the "Board")(Press release, Alkermes, APR 30, 2021, View Source [SID1234584050]).

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!

This agreement follows constructive dialogue between the parties related to the company’s strategic priorities and ongoing Board refreshment efforts. Alkermes initiated a robust board refreshment program two years ago and has since added four new independent directors to the Board. This agreement with Sarissa Capital is a continuation of those efforts.

"We view our Board as one of Alkermes’ strategic assets. We value the opinions and input of Sarissa Capital and our other shareholders in identifying qualifications for new directors to help advance our business strategy to create shareholder value," said Richard Pops, Chief Executive Officer and Chairman of Alkermes. "Our considerable and thoughtful board refreshment efforts over the last two years demonstrate our commitment to maintaining a strong, independent board with expertise and skills to develop and support our strategic priorities."

Alex Denner, Ph.D., Founder and Chief Investment Officer of Sarissa Capital, stated, "Alkermes has attractive and underappreciated assets that can drive meaningful value creation. We look forward to working with the Board to focus on optimal capital allocation and operational excellence and to create shareholder value.