Successful Virtual Summit for Cancer Immunotherapy

On December 16, 2021 BioCanRx’s network community, stakeholders and sponsors met virtually for the fifth Summit for Cancer Immunotherapy (Summit4CI) – BioCanRx’s annual scientific conference. Summit4CI brought together close to 400 attendees including leading scientists, clinicians, trainees, economists and representatives from industry, patient groups, charities and government (Press release, BioCanRx, DEC 16, 2021, View Source;utm_medium=rss&utm_campaign=successful-virtual-summit-cancer-immunotherapy [SID1234597291]).

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The Scientific Programming Committee organized a great agenda including plenaries on Advances in Cellular Immunotherapy, Approaches to Making Cold Tumors Hot and Advances in Pediatric Immunotherapy. The Oxford-style Debate focused on "Who is driving the CAR: NK cells vs T Cells." It was Dr. Jean-Sébastien "T cells rule" Delisle VS Dr. Michele "NK cells rock" Ardolino. After a lively debate, with strong arguments presented on both sides, the audience voted and declared Dr. Ardolino the winner.

Our network trainees took part in an HQP Development Day including a Meet the Experts lunch and more. Again this year, the scientific posters by our trainees were of a high calibre. Learn more about the HQP activities at the 2021 Summit4CI.

The BioCanRx-Cancer Stakeholder Alliance Learning Institute was back for its fourth edition at Summit4CI. It brought together four patient/caregiver leaders (Patient Scholars) and four Highly Qualified Personnel (Academic Scholars) in a series of virtual interactive Knowledge Exchange Sessions with the purpose of teaching patients/caregivers about the emerging and innovative concepts in immune-oncology and providing HQP an opportunity to learn from patients and get feedback about their research. Each Patient Scholar was paired with an Academic Scholar and the pairs presented key takeaways in plain language of the scientific Summit talks during the Knowledge Exchange Sessions.

The Learning Institute participants also took part in the Patient-Researcher Roundtable – a workshop-style event where Patient Scholars and funded BioCanRx Investigators discussed actionable ways to involve patient partners in their research programs. The event was facilitated by Drs. Manoj Lalu and Justin Presseau, of the Ottawa Hospital Research Institute, and included engagement by BioCanRx’s Cancer Stakeholder Alliance working group members. "With great discussions and conversation, the Learning Institute brings to light the importance of patient collaboration in research, as well as the translation of scientific information into plain language that is easily understood by all," said Dr. Stéphanie Michaud, President and CEO of BioCanRx.

BioCanRx also held a Public Forum titled ‘Understanding Cancer Immunotherapy Clinical Trials in Canada: Are they Needed Now More than Ever?’ Speakers included a clinical trial doctor, a patient partner who has participated in a clinical trial and a scientist who spoke about the latest developments in immunotherapy cancer research and treatments. You can watch the forum here.

Many thanks to our Scientific Programming Committee and all our Summit4CI speakers, the HQP Working Group and our Learning Institute organizers. A big thank you to our 2021 sponsors and exhibitors – we could not hold the Summit without your strong support!

BioCanRx’s Summit4CI Speaker Series will be resuming in the new year! Stay tuned to the Summit4CI website cancersummit.ca or biocanrx.com for announcements.

We hope you’ll save the date for next year’s Summit4CI! We’ll be meeting ‘in-person’ in Montreal at the Fairmont The Queen Elizabeth Hotel – November 19 – 21, 2022!

Mustang Bio Added to the NASDAQ Biotechnology Index

On December 16, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has been added to the NASDAQ Biotechnology Index (NASDAQ: NBI) (Press release, Mustang Bio, DEC 16, 2021, View Source [SID1234597317]). The annual re-ranking of the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 20, 2021.

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The NASDAQ Biotechnology Index (NBI) is a modified market-cap weighted index designed to track the performance of a set of securities listed on the NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NBI is re-ranked each year and is calculated under a modified capitalization-weighted methodology. Companies in the NBI must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. Additionally, the NBI forms the basis for a number of Exchange Traded Funds (ETFs), including the iShares NASDAQ Biotechnology ETF (Nasdaq: IBB). More information about the NBI can be found at View Source

Volition Executes its First Supply and Licensing Contract for its Nu.Q® Vet Cancer Screening Test in Asia

On December 16, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose and monitor a range of cancers and other life-altering diseases in both humans and animals, reported that it has entered into its first contract for the Nu.Q Vet Cancer Screening Test, a supply and licensing agreement with SAGE Healthcare (Press release, VolitionRX, DEC 16, 2021, View Source [SID1234597349]).

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"With the global veterinary market being so fragmented, we determined the best way to ensure our test is accessible worldwide is to have multiple agreements with both large multi-nationals and regional players," commented Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development, LLC. "I am delighted to announce this agreement for centralized labs in Asia, a large and rapidly expanding pet care market. I expect this will be the first of many agreements, including with the big multi-nationals, so that we can cover the whole world through centralized labs and also with point of care."

View Source

An interview with Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC.

Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition commented "With rapid urbanization and rising disposable income, pets have become an important part of Asian families. Over half of the Asian population have a companion animal , with almost a third of households owning a dog. We believe that the opportunity for the Nu.Q Vet Cancer Screening Test is huge. SAGE Healthcare is one of the strongest and most respected distributors of leading veterinary brands in Singapore. We are pleased to appoint SAGE Healthcare to offer the Nu.Q Vet Cancer Screening Test widely in Singapore and later avail the Nu.Q Vet Cancer Screening Test in other countries in Asia."

"We are delighted to be appointed as a licensee and distributor of the Nu.Q Vet Cancer Screening Test in Singapore and other countries in Asia. Adding the Nu.Q Vet Cancer Screening Test to the routine wellness check-up for older dogs and at-risk breeds could help detect cancer early, when treatment is more effective and affordable. We believe that this is a clear unmet need in the veterinary space," commented Ms. Irene Kum General Manager for SAGE Healthcare Private Limited. "We are excited to launch the test in Singapore in the first quarter of 2022 and with planned subsequent launches in other Asian markets thereafter."

CB-103 has been granted an Orphan Designation for the treatment of Acute Lymphoblastic Leukaemia (ALL)

On December 16, 2021 Cellestia Biotech AG reported that the European Commission (EC) has granted CB-103 an orphan designation for the treatment of Acute Lymphoblastic Leukaemia (ALL) (Press release, Cellestia Biotech, DEC 16, 2021, View Source [SID1234597294]).

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This is the first Orphan Designation granted to CB-103. It is an important milestone in the development of CB-103, as it represents an official recognition from EMA that CB-103 looks promising in bringing significant benefit to those affected by ALL.

Vifor Pharma drives transformation with divestment of non-core finished drug manufacturing to Corden Pharma

On December 16, 2021 Vifor Pharma Group reported the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization (CDMO) of APIs, Excipients, Drug Products, and associated Packaging services (Press release, Vifor Pharma, DEC 16, 2021, View Source [SID1234597323]). This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio.

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"In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency," commented Abbas Hussain, CEO of Vifor Pharma. "With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders."

Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: "The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers."

Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg (including its Ettingen branch), and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement.

CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice (cGMP) and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them.

This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer.

Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions.