On March 31, 2022 Canthera Discovery reported that its predecessor, Cancer Therapeutics CRC, received the Cooperative Research Australia (CRA) Excellence in Innovation Award for Research Commercialisation at an award ceremony at Parliament House in Canberra on Thursday night (Press release, Canthera Discovery, MAR 31, 2022, View Source [SID1234611332]).

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Cancer Therapeutics CRC, ran for 13 years (2007-2020) and was recognised for landing deals in ground-breaking cancer therapies with pharma giants for a headline value of close to A$1.4bn. It has 7 licensed programs in active development, including two currently in clinical trials.

"The CRC Program funded Cancer Therapeutics CRC with $71m over 13 years. In potentially returning some ten times that investment and counting in licensing deals, Cancer Therapeutics CRC and Canthera Discovery have been a shining example of the strength of the CRC Program in bridging the gap between domestic world class research and innovation, and global commercialisation," CRA CEO Jane O’Dwyer said.

"Cooperative Research Australia is delighted to present Canthera Discovery and Cancer Therapeutics CRC with the Award for Research Commercialisation," she said.

Brendon Monahan, Chief Scientific Officer, Canthera Discovery
Upon receiving the award, Brendon Monahan, Canthera Discovery Chief Scientific Officer commented, "Drug discovery requires a multi-disciplinary approach and collaboration is at the centre of everything we do. We would like to thank and acknowledge our Research Partners: WEHI, CSIRO, Monash University, Griffith University, Children’s Cancer Institute, and the Peter MacCallum Cancer Centre. Our CRC commercialisation partners SYNthesis Research and Oncology One. And all of our CRC participants."

"It is no secret that what has driven the success of Cancer Therapeutics CRC and now Canthera, is its people. The KAT6 project alone, which entered clinical trials in 2020, involved over 100 people, across 16 organisations, 10 research laboratories, and 11 different general fields combining science, business, and data management. We thank everyone, past and present, who have contributed expertise, creativity, and passion to our organisation and projects."

On March 31, 2022 Insud Pharma reported that it has entered into an agreement with Fresenius Kabi (Press release, mAbxience, MAR 31, 2022, View Source [SID1234611328]). Under the terms of the agreement Fresenius Kabi will acquire 55% of mAbxience, the global fully-fledged biotech company of the Spanish group.

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Founded in 2010, mAbxience has over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. The company operates three state-of-the-art and R&D manufacturing facilities, located in Spain and Argentina, and has been developing a range of biopharmaceutical products focused on multiple therapeutic areas. mAbxience also offers contract development and manufacturing (CDMO) services to customers.

The company has successfully established alliances with key partners which have enabled multiple biosimilars to be launched across international markets allowing patients access to high quality biopharmaceutical products on a global basis.

As a result of this agreement, mAbxience will continue its ambitious growth plans and will keep its well-defined corporate identity, and team of around 600 professionals, ensuring continuity of its current business strategy. The boards of directors of both companies have unanimously approved the transaction, which is expected to close by midyear 2022, subject to regulatory and other conditions customary for a transaction of this type.

With this alliance, Insud Pharma plans to accelerate its biotech unit, bringing new and exciting opportunities to mAbxience customers and increasing its research activities – at the beginning of May, it is expected to open a new R&D facility in Spain-.

Furthermore, this transaction will be meaningful for the Spanish group Insud Pharma, which will continue to grow and invest worldwide, whilst entering into new activities.

"We’re delighted to announce our combination with Fresenius Kabi for the future development of mAbxience. This collaboration recognizes mAbxience’ s capabilities in biopharmaceuticals and our strong team of dedicated employees. This transaction is a tremendous opportunity to add further value to the industry, to make mAbxience bigger and stronger and to collaborate and work together with a company such as Fresenius Kabi", stated Lucas Sigman, CEO at Insud Pharma.

"mAbxience is the perfect example of how innovation, cutting-edge R&D and manufacturing platform technology is used to deliver high quality medicines to patients, provide cost-effective alternatives to healthcare systems and guarantee its sustainability. Today’s announcement is testament to the hard work of our people that have grown mAbxience from its inception to the leading business it is today", stated Sigman.

He continued "Furthermore, this is also great news for Insud Pharma. This transaction will give our company the chance to continue investing more and to open the door to faster expansion into new areas and opportunities. As joint partners with Fresenius Kabi, we fully expect to further accelerate our mission to deliver affordable medicines to patients worldwide", stated Sigman.

Emmanuelle Lepine, mAbxience CEO, said "We believe this new strategic partnership with Fresenius Kabi represents the best possible next step in line with mAbxience´s strategic growth plan. This partnership will allow the further progression of our development pipeline and will enable the acceleration of our capacity expansion, both of which will benefit patients, customers, and health systems. This new stage in the evolution of our company will bolster opportunities to grow our biopharmaceutical platform in key areas of high technological development and manufacturing, as well as accelerate access in strategic markets, adding a key collaboration to our already strong global partnership base".

She continued "Driven by a shared value in people and purpose, this partnership with Fresenius Kabi will enable mAbxience to advance towards its vision of bringing biopharma solutions that are Affordable, Accessible and Across the globe. We are convinced that this partnership will enhance our commitment to the long-term sustainable growth potential for the business and will be highly beneficial to the growth and development of the whole team".

Goldman Sachs acted as exclusive financial advisor to Insud Pharma, while Baker McKenzie acted as legal advisor.

On March 31, 2022 Gnubiotics Sciences SA, a biotech company pioneering immunomodulatory glycopeptides reported a poster presentation on the use of Glycopeptides to promote anti-cancer immune response against solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, scheduled for April 8-13, 2022 in New Orleans, Louisiana (USA) (Press release, Gnubiotics Sciences, MAR 31, 2022, View Source [SID1234611322]).

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"Our poster presentation at the AACR (Free AACR Whitepaper) will showcase the immunomodulatory and therapeutic potential of our proprietary glycopeptide assets to boost directed anti-tumor immune responses in anti-PD-1 resistant solid tumors. Our innovative Glycopeptides with Tumor and Antigen Associated Delivery (GLAAD) technology has been shown to have the power, through molecular mimicry, to reduce tumor size, either in combination with existing anti-PD-1 treatment or as a monotherapy. The pre-clinical study carried out in collaboration with the University of Zurich indicates that GLAAD treatment may be a safe and effective strategy to potentiate immune checkpoint inhibitor (ICI) therapies in a resistant setting. We expect our GLAAD approach to have a broader utility in immuno-oncology treatments, for example in enabling the efficacy of CAR-T therapies against solid tumors." stated Yemi Adesokan, Ph.D., Gnubiotics` Chief Executive Officer.

The authors on the poster are: Marianne R. Spalinger, Romain Wyss, Sara Vidal, Yong Miao, Michael Scharl, Yemi Adesokan.

The Poster, abstract number 5600, will be made available for browsing on April 8, the first day of the AACR (Free AACR Whitepaper) Annual Meeting 2022 and will remain available for viewing through July 13. Viewers will have the possibility to e-mail questions

On March 31, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma (Press release, JW Therapeutics, MAR 31, 2022, View Source [SID1234611321]).

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B-cell lymphoma is a group of malignant B-cell monoclonal amplified heterogeneous malignancies, accounting for approximately 85% of non-Hodgkin lymphoma (NHL)[1]. Large B-cell lymphoma (LBCL) is the most common subtype of NHL world-wide, accounting for 35% to 50% of all newly diagnosed cases in China[2]. 50% of patients could be cured by current standard of care (R-CHOP) chemotherapy[3]. Nevertheless, R-CHOP was found to be inadequate in 30% to 40% patients[4]. R-CHOP failures were principally due to either primary refractoriness or relapse after reaching a complete response (CR), resulting in little benefit for those failure patients from conventional chemotherapy. Previous study demonstrate that for patients who could not achieve CR or maintain CR less than one year, overall response rate (ORR) of received second-line treatment was about 29%, median progression-free survival (PFS) was about 3 months, and median overall survival (OS) was about 10 months[5]. High unmet medical needs are to be addressed for those patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) from first-line treatment.

This is a multi-centre, randomized, open label phase 3 study to compare the efficacy and safety of Carteyva to standard second-line therapy in adult subjects with relapse/refractory large B-cell lymphoma (r/r LBCL), not reaching CR after first-line therapies (including anthracyclines and rituximab or other CD20-targeted agents) or relapsed within 12 months of CR. Eligible adults will be randomized at the 1:1 ratio to control group and Carteyva group. Subjects in the control group will receive standard second-line therapy. Subjects in the Carteyva group will receive 100×106 CAR+ T cell Carteyva infusion. The primary endpoint is event-free survival (EFS) assessed by Independent Review Board (IRC), and the secondary endpoints include complete response rate (CRR), PFS, OS, duration of response (DOR), pharmacokinetics, and safety.

References

张慕晨;赵维莅;;B细胞淋巴瘤之治疗展望[J];中国肿瘤临床;2016年14期
中华人民共和国国家卫生健康委员会，淋巴瘤诊疗规范，2018年
Sehn, L. H., & Gascoyne, R. D. (2015). Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood, 125(1), 22-32. doi:10.1182/blood-2014-05-577189
Coiffier, B., & Sarkozy, C. e. (2016). Diffuse large B-cell lymphoma: R-CHOP failure-what to do? Hematology Am Soc Hematol Educ Program, 2016(1), 366-378.
van Imhoff, G. W., McMillan, A., Matasar, M. J., Radford, J., Ardeshna, K. M., Kuliczkowski, K., Hagenbeek, A. (2017). Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study. J Clin Oncol, 35(5), 544-551. doi:10.1200/JCO.2016.69.0198
About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About JWCAR029-010 Study

This is a randomized multicenter phase 3 trial to compare the efficacy and safety of Carteyva to standard of care in adult subjects with high-risk, relapsed in 12 months or refractory from first-line treatment (including anthracyclines and rituximab or other CD20-targeted agents), aggressive r/r LBCL.

On March 31, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 2:15 p.m. Eastern Time (Press release, Personalis, MAR 31, 2022, View Source [SID1234611320]).

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