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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.

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]).

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!

invIOs goes live with unique cell therapy platform and clinical-stage immuno-oncology pipeline

On December 16, 2021 invIOs (innovative Immuno-Oncology) GmbH, a privately held biotechnology company developing novel therapies for cancer, reported it will commence operations on 1 January 2022 (Press release, Apeiron Biologics, DEC 16, 2021, View Source [SID1234597288]).

invIOs, a fully owned subsidiary of APEIRON Biologics AG has been assigned APEIRON’s innovative cancer immunotherapy activities and all related clinical and preclinical R&D projects.

invIOs’ CEO Peter Llewellyn-Davies and his management team have taken this step to realize the full potential of its cutting-edge development projects and to create an early clinical-stage focused entity to allow investors to benefit from significant upside potential, especially specialized international biotech investors.

The proprietary cell therapy technology platform for the modulation of intracellular Immuno-Oncology targets enables rapid treatment of patients using their own cells with short out-of-body time in an out-patient setting. The groundbreaking concept allows access to indications that have previously not been addressable by earlier cell therapy approaches.

The first clinically validated target is the immune master-checkpoint Cbl-b; the clinicalstage lead candidate APN401 will show results in the near term on safety with data from an ongoing Phase 1b trial to be finalized in Q2 2022. A discovery pipeline with two additional promising candidates could give rise to new effective therapies for cancer patients, namely INV441 aiming to activate TILs (tumor-infiltrating lymphocytes) in solid tumors and INV501, an oral small molecule for tumor specific immune activation.

Peter Llewellyn-Davies, CEO of invIOs, comments: "Our passion is to develop life-saving therapies for patients suffering from cancer where there currently exist only limited treatment options. invIOs’ highly experienced team has a proven track-record of taking drugs to market with a core competency in immuno-oncology. The new company is geared towards enabling innovation and growth and will facilitate access to funding from specialized investors and partners. invIOs’ novel approach represents an investment opportunity with significant upside potential and important benefits for healthcare professionals and patients."

invIOs is headquartered in Vienna, Austria and will streamline the development of novel therapies in immuno-oncology backed by the acumen of the existing team. Accordingly, all current APEIRON employees are assigned to invIOs.

Anixa Biosciences to Participate in Upcoming January Investor Conferences: LifeSci Partners Annual Corporate Access Event and H.C. Wainwright BioConnect Conference

On December 16, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the Company is participating in the LifeSci Partners 11th Annual Corporate Access Event, which will be held virtually from January 5-7, 2022, and the H.C. Wainwright BioConnect Conference, which will be held January 10-13, 2022 (Press release, Anixa Biosciences, DEC 16, 2021, https://ir.anixa.com/news/detail/989/anixa-biosciences-to-participate-in-upcoming-january-investor-conferences-lifesci-partners-annual-corporate-access-event-and-h-c-wainwright-bioconnect-conference [SID1234597287]).

Participation and presentation details are below:

LifeSci Partners Corporate Access Event:
Dr. Amit Kumar, Chairman, President and Chief Executive Officer of Anixa Biosciences will present on a panel entitled, "Cancer Vaccines: Promises, Promises…Has Their Day Come?" on Friday, January 7th, 2:00 pm ET.
During the duration of the LifeSci Corporate Access Event, the Anixa Biosciences management team will be available for 1×1 meetings with interested investors. Register here to submit a meeting request or to hear the panel discussion.
H.C. Wainwright BioConnect Conference:
Anixa Biosciences will present at the H.C. Wainwright BioConnect Conference and a recording of the presentation will be accessible beginning January 10th at 7:00 am ET. To listen to the presentation, visit the Investor Relations/Events & Presentations portion of Anixa’s company website.
The Anixa Biosciences management team will be available for 1×1 meetings with interested investors. Register here for the conference.

Alpine Immune Sciences and Horizon Therapeutics plc Announce Exclusive License and Collaboration Agreement to Develop Novel Protein-Based Therapies for Autoimmune and Inflammatory Diseases

On December 16, 2021 Alpine Immune Sciences, Inc. (Nasdaq: ALPN) and Horizon Therapeutics plc (Nasdaq: HZNP) reported an exclusive license and collaboration agreement for the development and commercialization of up to four preclinical candidates generated from Alpine’s unique discovery platform (Press release, Alpine Immune Sciences, DEC 16, 2021, View Source [SID1234597286]). The overall agreement includes licensing of a lead, potential first-in-class preclinical candidate, as well as a research collaboration to jointly generate additional novel candidates. These candidates include previously undisclosed multi-specific fusion protein-based therapeutic candidates for autoimmune and inflammatory diseases.

"We are extremely pleased to enter into this collaboration with Horizon, and look forward to working with its talented research and development team," said Stanford Peng, M.D., Ph.D., Alpine’s President and Head of R&D. "With our combined expertise, we hope to accelerate and expand the potential clinical impact of our discovery platform on autoimmune and inflammatory diseases."

"This partnership represents an opportunity to advance our research efforts, moving our mechanistic insights into innovative molecules utilizing Alpine’s expertise and proven ability to design multi-specific protein-based immunotherapies," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "This collaboration will expand Horizon’s early pre-clinical pipeline with complementary mechanisms of action to our current clinical stage therapeutics and provide our first pre-clinical, multi-specific development candidate."

Under the terms of the agreement, Horizon will make an upfront payment to Alpine of $25 million as well as an equity investment in Alpine of $15 million at a 25 percent premium to the 30-day volume-weighted average share price. In addition, Alpine is eligible to receive up to $381 million per program, or approximately $1.52 billion in total, in future success-based payments related to development, regulatory and commercial milestones as well as tiered royalties on global net sales. Under the agreement, Alpine will advance candidate molecules to pre-defined preclinical milestones. Horizon will then assume responsibility for development and commercialization activities and costs.

Similar to changes at other peer companies, beginning in the fourth-quarter 2021, Horizon will no longer exclude upfront and milestone payments related to collaboration and license agreements from non-GAAP R&D expense, adjusted EBITDA and other non-GAAP financial measures and has filed a Form 8-K today with additional details.