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AVEO Oncology Announces Participation at the H.C. Wainwright Virtual BioConnect 2022 Conference

On December 22, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that members of its senior management team will participate in the H.C. Wainwright Virtual BioConnect 2022 Conference, which is taking place from Monday, January 10th to Thursday, January 13th (Press release, AVEO, DEC 22, 2021, View Source [SID1234597594]).

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A webcast of the fireside chat with AVEO’s management team and H.C. Wainwright research analyst Swayampakula Ramakanth will be available on-demand as of 7 a.m. EST on Monday, January 10th, by visiting the Calendar of Events sub-section within the Investors section of the Company’s website at www.aveooncology.com.

PharmaMar signs a new licensing and commercialization agreement with Eczacibasi for lurbinectedin in Turkey

On December 22, 2021 PharmaMar (MSE:PHM) reported a new license and commercialization agreement with the Eczacıbaşı Pharmaceuticals Marketing Co. to commercialize the anticancer drug lurbinectedin in Turkey (Press release, PharmaMar, DEC 22, 2021, View Source [SID1234597593]).

Under the terms of the agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including regulatory and sales milestone payments. PharmaMar will retain production rights and will sell the product to Eczacıbaşı for its clinical and commercial use.

Eczacıbaşı will pursue the marketing authorization in Turkey and will have the right to commercialize the product on an exclusive basis, upon approval. In addition, a Named Patient Basis program is planned to be launched in Turkey via TEB (Turkish Pharmacy Association) to make lurbinectedin accessible to relapsed Small Cell Lung Cancer (SCLC) patients, who are unable to enter clinical trials and to whom no alternative treatments are available.

Luis Mora, General Manager of PharmaMar’s Oncology and Virology Business Units, said:

"This is the second agreement we have signed with Eczacıbaşı. We have great confidence in their team and we are confident that, if approved, they will bring lurbinectedin to SCLC patients in Turkey."

Basbug Oke, General Manager of Eczacıbaşı Pharmaceuticals Marketing Co., stated that "We are passionate about launching innovative medicines in Turkey and PharmaMar is a unique partner given their expertise in research and development. Lung cancer is the leading cause of cancer mortality accounting 37.000 deaths per year in Turkey and we believe lurbinectedin will be an important treatment option for Small Cell Lung Cancer patients. We look forward to working with PharmaMar closely to expeditiously bring lurbinectedin to patients in Turkey."

Lurbinectedin was granted accelerated approval by FDA (Food and Drug Administration) for the treatment of relapsed metastatic Small Cell Lung Cancer in 2020. In addition, in 2021, lurbinectedin has received marketing approval in the United Arab Emirates, Canada, Australia and Singapore.

IMV Appoints Andrew Hall as Chief Executive Officer

On December 22, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), ("IMV" or "the Company"), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid tumors and blood cancers, reported that its Board of Directors has appointed Andrew Hall to the role of Chief Executive Office and Director of the Board, effective January 1, 2022 (Press release, IMV, DEC 22, 2021, View Source [SID1234597592]).

"On behalf of the Board and the Company, I congratulate Andrew on his appointment to the Chief Executive Officer role. Over the last 5 months, Andrew has demonstrated strong leadership and refocused the Company to capitalize on its strengths in immuno-oncology, as well as a strategy designed to fully realize IMV’s clear potential," said Andy Sheldon, Chairman of IMV’s Board of Directors. "The Board and I thank Andrew for his hard work as interim CEO, during which time he gained the trust of both external stakeholders and the Company’s employees. Andrew has proven he is the right person to lead the Company at this key point in IMV’s development."

"I am very pleased to be named Chief Executive Officer and look forward to delivering on the promise of our technology," said Mr. Hall, Chief Executive Officer of IMV. "There is significant potential for IMV and the DPX platform to deliver differentiated therapies to treat a broad range of cancers. IMV is ending 2021 in a strong position. We have achieved our recent milestones, which included compelling clinical and translational data in two Phase 2 trials; initiated several new trials in the last month; and have submitted our Phase 2b protocol for our ovarian cancer program to the FDA. We have also lengthened our financial runway and are well-positioned to execute upon our vision for IMV as we move into 2022."

"I would like to thank the Board for its confidence in me to create value for all of our stakeholders and to help change patients’ lives for the better," Mr. Hall concluded.

Xspray Pharma enters Manufacturing Agreement with NerPharMa for its lead product candidate; HyNap-Dasa

On December 21, 2021 Xspray Pharma AB, a specialty pharmaceutical company, reported that it has signed a Manufacturing and Supply Agreement with NerPharMa S.r.l., a pharmaceutical manufacturing company in Milan, Italy, to manufacture its lead product candidate HyNap-Dasa (Press release, Xspray, DEC 21, 2021, View Source [SID1234649533]). The agreement covers the clinical and world-wide commercial supply of HyNap-Dasa, and includes production of both drug substance and the finished product. HyNap-Dasa is one of three product candidates that Xspray currently has under development. The company’s goal is to launch HyNap-Dasa in the US-market in 2021.
Under the terms of the agreement, Xspray has contracted NerPharMa to manufacture drug substance and the finished product to supply material for clinical programs and for future world-wide commercial sales. Xspray is developing HyNap-Dasa both as a completely interchangeable variant of Sprycel to be registered in the United States by the Abbreviated New Drug Application (ANDA) route or as an improved product by the 505(b)(2) procedure. NerPharMa is a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., Milan, Italy.

NerPharMa’s GMP manufacturing facility is approved by both the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, and the U.S. Food and Drug Administration (FDA).

"This contract is a significant step in our development of HyNap-Dasa," said Per Andersson, CEO of Xspray Pharma. "We are pleased to have secured access to GMP production of drug substance and finished product for our continued clinical program as well as to GMP quantities of HyNap-Dasa for future commercial activities in an US FDA approved manufacturing facility."

"We are pleased to be working with Xspray Pharma to manufacture and provide finished product for their investigational and commercial needs," said Angelo Colombo, CEO of NerPharMa.

Aptamer Science “Development of proprietary ApDC linker technology”

On December 21, 2021 Aptamer Science, a company specializing in aptamer platforms, reported that it has completed the development of its own linker technology to be applied to an aptamer-based drug delivery platform (Aptamer Drug conjugate (ApDC)) and has applied for domestic and PCT patents (Press release, Aptamer Sciences, DEC 21, 2021, View Source;idx=271 [SID1234641628]).

The linker technology developed this time is a dendrimer-type molecular structure that can load multiple payloads, and the number of loaded payloads can be adjusted depending on the number of branched branches.

The junction site with the aptamer is also designed to enable a click reaction mediated by a simple thiol group, which can further improve ApDC production and pharmacological efficacy.

ApDC technology, due to the nature of the aptamer structure, had to limit the drug loading location to the end, which also limited the number of drugs.

The company explains that through the development of this technology, the drug-aptamer ratio (DApR) can be increased by loading the desired amount of drug into ApDC.

An Aptamer Science official said, "In the case of antibody-drug conjugate (ADC) technology, aggregation occurs due to increased hydrophobicity when introducing multiple payloads, which has a significant impact on manufacturing and stability.

"In order to solve this problem, when introducing a hydrophilic group such as PEG, there was a difficulty in making the manufacturing process complicated," he said. "Because the aptamer material itself shows high hydrophilicity,

"It is possible to manufacture stable ApDC with a high drug loading rate using a simple linker without introducing additional functional groups."

The developed branched linker-payload technology is being applied to various ApDCs being developed by the company, such as CD25 and Trop2.

In addition, we plan to introduce it in the development of follow-up technologies, such as targeting immunostimulants (STING, TLR7/8) and targeting delivery of therapeutic radionuclides.

ADC, in which global big pharma companies are investing recently, is emerging as a technical limitation due to side effects such as interstitial lung disease (ILD) and complex manufacturing processes.

ApDC’s advantages over ADC include high cancer tissue penetration, low side effects, and high stability.

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