On January 27, 2022 InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral valve disease, reported the closing of its Series C financing with granting an exclusive licensing agreement to Grand Pharmaceutical Group Limited, (Grand Pharma) for its proprietary Saturn device in Greater China (Press release, China Grand Pharmaceutical, JAN 27, 2022, https://www.innovheart.com/innovheart-raises-55-million-in-series-c-financing-to-further-develop-the-trans-septal-saturn-transcatheter-mitral-valve-replacement-system/ [SID1234607467]).

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The transaction pulled in more than $55 million in equity, upfront licensing fees, milestone payments and structured royalties.

Series C equity round was led by Grand Pharma, together with the existing investors Genextra, Panakes Partners and Indaco Venture Partners confirming their ongoing support by joining this investment round. Under the license agreement, Grand Pharma is entitled to develop, manufacture and commercialize the Saturn device in Mainland China, Hong Kong, Macau and Taiwan.

‘Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential, estimated to reach $17.4 billion globally in future years. This strategic agreement will provide InnovHeart with resources that will accelerate the development of the trans-septal version of the Saturn system into First-in-Human clinical trials, as well as access to the dynamic Chinese structural heart market’, said Keith D. Dawkins MD, Chairman of InnovHeart Board of Directors.

Commenting on this new collaboration, Shawn Chen, Senior management of the Medical Device Division of Grand Pharma, said, ’We are very excited about this collaboration. The successful closing of this transaction demonstrates that Grand Pharma has completed the strategic layout in our cerebro-cardiovascular high-end medical devices sector. InnovHeart Saturn technology is one of the most promising TMVR technologies in the market. I am confident that with InnovHeart’s expertise in this field and Grand Pharma’s strong capability and resources, we will bring this innovative clinical solution to Chinese patients soon’.

’InnovHeart has already demonstrated excellent mid-term (>1 year) results with the trans-apical version. This low profile, adaptive valve design decreases the risk of LVOT obstruction and will be implanted transeptally in FIH in 2022’, said Paolo Denti MD, Cardiac Surgeon, San Raffaele University Hospital, Milan, Italy.

On January 27, 2022 Biogen Inc. (Nasdaq: BIIB) reported that they have entered into an agreement whereby Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to USD $2.3 billion (Press release, Biogen, JAN 27, 2022, View Source [SID1234607484]).

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Biogen and Samsung Bioepis have built the industry leading anti-TNF portfolio in Europe1. Upon the acquisition of Biogen’s stake, the companies will continue with their exclusive agreements, including commercialization of their current portfolio. This includes marketed products BENEPALI (etanercept), a biosimilar referencing ENBREL, IMRALDITM (adalimumab), a biosimilar referencing Humira, and FLIXABI (infliximab), a biosimilar referencing Remicade. Additionally, Biogen will also retain commercial rights for BYOOVIZTM (ranibizumab-nuna), an approved biosimilar referencing LUCENTIS (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing EYLEA.

"We are thankful to Samsung Biologics for a productive collaboration since 2012," said Michel Vounatsos, Chief Executive Officer at Biogen. "We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen."

Samsung Biologics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones. Closing of the transaction is contingent on the effectiveness of a securities registration statement filed by Samsung Biologics and satisfaction of certain regulatory and other customary closing conditions. Upon closing, Biogen will recognize a GAAP gain on disposal within other income (expense), net in its consolidated statement of income.

About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings and increased patient access. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

On January 27, 2022 Case Western Reserve University reported that About 1.2 million people with HIV in the United States live relatively normal lives with uncompromised immune systems and the virus medically controlled (Press release, Case Western Reserve University, JAN 27, 2022, View Source [SID1234607435]).

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But there are two rising concerns, said Ge Jin, a professor in the Department of Biological Sciences at the Case Western Reserve University School of Dental Medicine.

"One, they are aging and will develop all the diseases or illnesses of the general population, like you or me," he said. "The other problem—those morbidities, like cancer or co-infection with other viruses, happen at an earlier stage, occur at a higher rate and are more severe (for people with HIV)."

With two new research grants totaling $3.7 million from the National Institutes of Health (NIH), Jin and his co-investigators hope to learn why.

The new grants will focus on identifying the reasons for higher rates of cancers in the head and neck within this population, as well as co-infection with the herpes virus (Kaposi sarcoma herpesvirus or KSHV).

Jin, also a member of the Case Comprehensive Cancer Center’s Molecular Oncology Program, received:

A five-year, $3.3 million grant from the National Cancer Institute at NIH to investigate the mechanisms underlying transmission of KSHV in the oral cavity in people living with HIV.
KSHV causes Kaposi sarcoma (KS), one of the most common malignancies in people living with HIV. While the oral cavity contains the highest levels of infectious KSHV—and saliva is the most common way to transmit the infection—how that happens isn’t understood.

Jonathan Karn, professor and chair of the Department of Molecular Biology and Microbiology at the School of Medicine and director of the Case Center for AIDS Research, is co-investigator on this project.

A related $401,000 grant from the National Institute of Dental and Craniofacial Research at NIH to study why cases of oral diseases, like lesions that could develop into oral cancers, are increasing as people with HIV age—and then identify new therapies. Michael Lederman, professor emeritus at the School of Medicine, is co-investigator.
This new round of funding builds on a $3.7 million grant Jin and his research team received from NCI in July 2020 to study HIV and lung cancer—specifically why lung cancer rates are higher for people living with HIV, and the mechanism and markers to predict and treat the disease.

HIV infects immune cells; cancers in the lung and oral cavity affect epithelial cells. If researchers can figure out the link between HIV and higher cancer rates—and how to break that connection—then the next step would be to focus on therapies to treat the diseases.

"The first thing is," Jin said, "identifying how and why they can talk with each other."

On January 27, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the company will participate in the 2022 B. Riley Securities Oncology Investor Conference being held virtually from January 27-28, 2022 (Press release, Sierra Oncology, JAN 27, 2022, View Source [SID1234607452]). President and Chief Executive Officer Stephen Dilly, MBBS, PhD, will provide an overview of the company at 2:30 pm ET on Friday, January 28, 2022.

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A replay of the presentation will be available following the conference on the Investors section of Sierra’s corporate website in the Events & Webcast tab. The replay will be available for approximately 30 days following the presentation.

On January 27, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer (Press release, Oncolytics Biotech, JAN 27, 2022, View Source [SID1234607436]). Dosing in the trial’s first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.

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"Initiation of the bridging trial’s second dose escalation cohort is an important advancement that reflects the positive safety findings observed in the trial to date," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "Completion of the bridging trial will allow future Chinese regulatory submissions that will include previously reported clinical data demonstrating pelareorep’s potential to substantially benefit metastatic breast cancer patients. This may accelerate pelareorep’s development in rapidly growing pharmaceutical markets such as China, which is the second largest in the world after the United States. Looking ahead, we will continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in these jurisdictions and maximize its potential therapeutic impact."

The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics’ randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories.

The first of Oncolytics’ randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics’ second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4. Oncolytics believes completion of BRACELET-1 represents the last major clinical step on pelareorep’s path to a registrational study in metastatic breast cancer in the United States.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the U.S. in 20201. In China, breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 20202.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) gets worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.