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Sandoz announces agreement to acquire Aspen’s Japanese operations and associated assets, strengthening position in world’s third largest generics market

On November 11, 2019 Sandoz reported that it has entered into a binding agreement for the planned acquisition of the Japanese business of Aspen Global Incorporated (AGI), a wholly owned subsidiary of Aspen Pharmacare Holdings Limited (Press release, Novartis, NOV 11, 2019, View Source [SID1234550854]). The planned acquisition consists of shares in Aspen Japan K.K. and associated assets held by AGI. Pursuant to the agreed terms of the transaction, on closing Sandoz will pay an initial cash consideration of EUR 300 million. Sandoz has also agreed, upon certain conditions being fulfilled after closing, to pay certain deferred consideration to AGI. It is currently anticipated that the amount of deferred consideration to be paid will not exceed EUR 100 million.

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The acquisition will enable Sandoz to expand its presence in the third largest worldwide generics marketplace. The acquisition would complement the Sandoz broad portfolio and pipeline of hospital generic and biosimilar products with a dedicated sales, marketing and medical organization; thereby enhancing its ability to serve patients and customers in the hospital channel. Completion of the transaction is conditional upon certain customary conditions precedent being fulfilled and is expected to occur in the first half of 2020.

Aspen’s portfolio in Japan consists of off-patent medicines with a focus on anesthetics and specialty brands. Additionally, AGI has entered into a five year manufacturing and supply agreement (with an additional two year extension option) with Sandoz, which will take effect from completion of the transaction, for the supply of active pharmaceutical ingredients, semi-finished and finished goods related to the portfolio of divested brands.

"The acquisition of Aspen’s Japanese operations would significantly strengthen our position in this country, a stable but growing generics market. We are committed to helping address patient and customer needs in the market as we aspire to become the world’s leading and most valued generics company," said Sandoz CEO Richard Saynor.

Aspen’s portfolio in Japan comprises approximately 20 products, now off-patent branded medicines with a focus on anesthetics (including Xylocaine), specialty brands (including Imuran) and local brands. Full-year sales for the fiscal year ending in 2019 were EUR 130 million.

Aspen Japan K.K. is a wholly owned subsidiary of AGI and forms part of the Aspen Group which is headquartered in Durban, South Africa.

Celyad Highlights Safety and Clinical Activity of CYAD-101, a First-In-Class, Non-Gene Edited Allogeneic CAR-T Therapy for mCRC, from SITC 34th Annual Meeting

On November 11, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported highlights from the company’s NKG2D-based CAR-T clinical candidates for the treatment of metastatic colorectal cancer (mCRC), including its novel, off-the-shelf cell therapy CYAD-101 and alloSHRINK dose-escalation Phase 1 trial (Press release, Celyad, NOV 11, 2019, View Source [SID1234550849]). Results were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, held in Washington D.C. from November 6-10, 2019.

Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, "We are encouraged by the latest results from the alloSHRINK trial in metastatic colorectal cancer patients previously exposed to oxaliplatin- and irinotecan-based chemotherapies, including the tolerability profile and early antitumor activity of CYAD-101 with prior FOLFOX preconditioning chemotherapy. In particular, the lack of clinical and laboratory evidence of graft-versus-host-disease for CYAD-101, which incorporates our proprietary T-cell receptor inhibitory molecule to reduce signaling of the TCR complex, establishes proof-of-concept for this industry-leading, off-the-shelf CAR-T approach. In addition, any host-versus-graft reaction against the allogeneic CAR-T product candidate appears to be controlled by the non-myeloablative FOLFOX chemotherapy. Overall, these encouraging data from the alloSHRINK trial warrant further evaluation of CYAD-101."

Filippo Petti, CEO of Celyad, stated, "Treatment of advanced metastatic colorectal cancer patients beyond the second line of metastatic chemotherapy remains a high unmet medical need. Our confidence in CYAD-101 has continued to build as data from the alloSHRINK trial have emerged over the past year. We look forward to the planned expansion segment of the alloSHRINK trial to further evaluate the CAR-T product candidate for refractory mCRC patients as we continue to execute on the company’s vision for the treatment of patients with advanced solid tumors with allogeneic CAR-T therapies."

alloSHRINK Phase 1 Trial Update

Safety and Tolerability

To date, a total of 12 patients with relapsed/refractory mCRC who progressed after previous treatment with oxaliplatin or irinotecan have been enrolled in the ongoing dose-escalation Phase 1 alloSHRINK trial evaluating three consecutive dose levels of CYAD-101 administered concurrently with FOLFOX chemotherapy. The number of prior therapies received by patients enrolled in the trial ranged from one to six with a mean of three.
No clinical evidence of graft-versus-host disease (GvHD) has been observed following 35 injections of CYAD-101. These data continue to support the ability of the company’s novel inhibitory peptide T cell receptor (TCR) inhibiting molecule (TIM) to reduce signaling of the TCR complex through a non-gene edited approach.
Treatment with CYAD-101 in association with FOLFOX chemotherapy was well-tolerated, with no report of dose-limiting toxicity. Six of 12 patients enrolled in the trial reported at least one treatment-related adverse event (AE), however all AEs reported were grade 1 or 2 including one patient who experienced cytokine-release syndrome (grade 1). No patient discontinued treatment due to AEs.
Clinical Activity

Encouraging anti-tumor activity was observed in the trial with two patients who achieved a confirmed partial response (PR) according to RECIST 1.1 criteria and five patients achieved stable disease (SD) of more than or equal to three months of duration. Tumor burden decrease was observed in six out of 12 patients in total.
Cell Kinetics

Host-versus-graft (HvG) reaction against the allogeneic CYAD-101 cells appears to be controlled by the non-myeloablative FOLFOX chemotherapy as evidenced by similar levels of CYAD-101 cell engraftment following the second and third infusions of the allogeneic cell product candidate.
Following administration of FOLFOX chemotherapy, CYAD-101 cells demonstrate similar kinetics as the autologous NKG2D-based CAR-T therapy CYAD-01 as evaluated in the Phase 1 SHRINK trial.
Next Steps

An additional three patients have been enrolled at dose level three (one billion cells per infusion) of the trial for a total of nine patients in the cohort, as planned per protocol. Preliminary results from the completed dose-escalation segment of the alloSHRINK trial are expected in first half 2020.
Based on the encouraging data observed to date for the Phase 1 alloSHRINK trial, the Company plans to expand the trial to further evaluate CYAD-101 with prior FOLFOX chemotherapy in refractory mCRC patients. Enrollment in the expansion segment of the trial is expected to begin in mid-2020 following the production of additional CYAD-101 cells planned during first half 2020.
About CYAD-101 and alloSHRINK Trial

CYAD-101 is an investigational, non-gene edited, allogeneic (healthy donor derived) CAR-T therapy engineered to co-express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibitory Molecule). The expression of TIM reduces signalling of the TCR complex, which is responsible for GvHD.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of three consecutive administration of CYAD-101 every two weeks administered concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy in patients with refractory mCRC.

About Colorectal Cancer

Colorectal cancer is the third most common type of cancer among both men and women worldwide and is the fourth in terms of mortality. In 2018, approximately 1.8 million people were diagnosed with colorectal cancer with about 140,000 and 500,000 diagnoses in the United States and Europe, respectively. According to data from the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), approximately 40% of patients are diagnosed with early-stage, localized-stage disease. The five-year survival rate of localized disease is approximately 90%. In patients where the cancer has spread to distant parts of the body, as in metastatic colorectal cancer, the five-year survival rate drops to approximately 15%.

Stone Capital Partners Biosyngen to Setup US$50 Million Biopharmaceutical Investment Fund in Singapore

On November 10, 2019 Stone Capital and Biosyngen reported have partnered to establish a Biopharmaceutical Investment Fund in Singapore, the signing ceremony was held in Ascendas One Hub of Sino-Singapore Guangzhou Knowledge City (Press release, Stone Biostatistics, NOV 10, 2019, View Source [SID1234550834]). The key investment targets of the biopharmaceutical fund of US$50 million raised is for Biosyngen biopharmaceutical technology transfer platform and to incubate companies.

Biosyngen has been an angel investment platform for biopharmaceutical projects, who has formed projects with selected early stage technologies after stringent screening process. This fund allows Biosyngen to take advantage of Singapore pool of talent, technology, regulations, government support and other industrial resources, in particular cell therapy technologies, Biosyngen provides high-efficient incubation support and clinical transformation of the projects. The Company is also taking advantage of the Chinese government’s policy support, environment and the rich clinical trial resources in China. When the projects reach certain level of maturity, they will be further developed and commercialised in China and ASEAN, thereby meeting the needs of both markets.

Mr. Wang Liqun, Chairman of Stone Capital and Director of Biosyngen; Dr. Victor Li Lietao, Founder and CEO of Biosyngen,; and Mr. Wang Shuli, Chairman of Biosyngen attended the event to witness a milestone in the progress of the company. As a well-known successful investor, Mr. Wang expressed his appreciation for Biosyngen on the competency of project transformation over the past three years. He also generously shared his management experience and made suggestions to Dr. Li. Dr. Li expressed his sincere gratitude to Mr. Wang for coming onboard Biosyngen as a Director as this will enhance the function of Biosygnen biopharmaceutical technology transfer platform which will accelerate the business development of Biosyngen.

Bolt Biotherapeutics Presents Preclinical Data Showing Eradication of Large Resistant Tumors with ISAC Monotherapy at SITC 2019

On November 9, 2019 Bolt Biotherapeutics, Inc., a private biotechnology company focused on using its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to unleash the power of the immune system to treat cancer, reported new preclinical data demonstrating profound antitumor efficacy for its lead HER2 ISAC therapeutic program, when administered as a monotherapy, resulting in the complete eradication of large tumors (Press release, Bolt Biotherapeutics, NOV 9, 2019, View Source [SID1234550864]). The poster presentation entitled "HER2-targeting TLR7/8 immune-stimulating antibody conjugates elicit robust myeloid activation and anti-tumor immune responses in a TLR- and FcR- dependent manner" was presented at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in National Harbor, Maryland.

"These exciting preclinical data provide a strong rationale for moving our ISAC cancer immunotherapy platform into clinical testing and I’m pleased to report that we expect to initiate our first clinical trial for our HER2 monotherapy in early 2020," stated Randall Schatzman, Ph.D., chief executive officer of Bolt. "While much progress has been made in cancer immunotherapy, there still remains a significant need for single-agent therapies that can impact well-established tumors and provide durable efficacy in tumors that are refractory to standard of care therapies. Our proprietary Boltbody ISACs embody all of these components, and we are highly optimistic about the future of this platform to impact cancer."

"We believe such profound antitumor activity is unprecedented, including complete tumor eradication in large tumors, with an immunotherapeutic systemically administered as a monotherapy," stated David Dornan, Ph.D., senior vice president of research at Bolt Biotherapeutics. "Our data define the details of the mechanism of action by which our Boltbody technology is able to eliminate these hard to treat solid tumors, while generating immunological memory to suppress recurrence."

In the series of studies presented at SITC (Free SITC Whitepaper), key preclinical data show:

ISAC antitumor activity requires tumor target expression, interaction with Fc gamma receptors on immune cells, and TLR7/8 engagement
Single-agent anti-HER2 ISAC treatment led to in vivo tumor regression and clearance in models with large tumor burden and are resistant to anti-HER2 naked antibody treatment
Immunological memory was achieved as measured by protection from subsequent tumor growth. In syngeneic tumor models in which anti-HER2 ISAC treatment led to tumor clearance, hosts that were re-challenged with the parental tumor cell line lacking HER2 antigen expression were resistant to tumor growth. This protection was mediated by T cells as evidenced by the ability to re-establish tumors after the deletion of CD4 and CD8 T cells.
About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

Akeso, Inc. Completed Series-D Private Financing for close to US$150 Million

On November 9, 2019 Akeso,Inc. (hereinafter referred to as "Akeso"), a Chinese biopharmaceutical company focusing on new innovative antibody drug discovery and development in oncology and immunology therapeutic areas, reported the completion of its Series-D private financing for nearly US$150 million on November 1, 2019 (Press release, Akeso Biopharma, NOV 9, 2019, View Source [SID1234550837]).

The investment was led by Loyal Valley Capital ("LVC") and Sino Biopharmaceutical Co. Ltd. ("Sino Biopharm"), and co-invested by leading international healthcare specialists including Lake Bleu Capital, AIHC Capital, OrbiMed, along with other famed investors including Shenzhen Capital Group Co., Ltd ("SCGC"), CDG International Company limited, and etc.

The proceeds will fuel the clinical trials of new drug programs and the development of the Company’s R&D of innovative drugs pipelines. The funding will also help Akeso to continue to expand its global footprint including new clinical trials in USA, as well as to expand our manufacturing capabilities.

"We are very pleased to have received great recognitions from top investment institutions in biopharmaceutical industry. This round of financing has successfully drawn continuous supports from industry-renowned long-term investment funds, famous strategic investors, top-tier healthcare specialist funds widely recognised in the capital market, influential family office fund from Hong Kong and a multitude of existing shareholders," said Dr. Xia Yu, CEO, President and founder of Akeso,

With a vision of providing high quality and affordable antibody drugs for patients worldwide, Akeso is a clinical-stage biopharmaceutical company in China committed to in-house discovery and development of innovative mono- and bi-specific antibody drugs. Since its establishment in 2012 in China, Akeso has developed a broad product portfolio consisting of over 30 programs in oncology and immunology therapeutic areas. Many of these potential drug candidates are first-in-class globally including PD1/CTLA4, and PD1/VEGF. Akeso’s strong and comprehensive R&D capability is well recognized in the industry and endorsed by out-licensing AK107, an in-house discovered CTLA-4 monoclonal antibody drug candidate, to Merck in November 2015, and signing exclusive partnership agreement with Sino Biopharmaceutical Co. Ltd. (1177.HK) in June 2019 to co-develop and commercialize its internally developed AK105 (PD-1).

Ms. Iris Wang, Managing Director at OrbiMed commented, "OrbiMed seeks to invest in biopharmaceutical companies pursuing high-potential new drugs for important diseases with unmet needs. Akeso has developed a broad and innovative portfolio in both oncology and immunology therapeutic areas, and is showing promising results in clinical trials. We are excited to participate in this."

"We are very honoured to invest in Akeso. LVC focuses on supporting companies pursuing excellence and creating a world-class business. With a vision to become a global leader in the biopharmaceutical industry, Akeso has developed a comprehensive, strong and highly efficient in-house drug discovery and development platform since its inception. We are very impressed by its dedicated and highly experienced management team and the Company’s commitment of developing high quality, affordable, innovative antibody drugs for patients worldwide is very much in line with our investment philosophy. We look forward to sharing our experience and resources with Akeso and supporting the Company’s continuous growth," said Loyal Valley Capital’s managing partner Mr. Lin Lijun.

Mr. Tse Hsin, vice president of Sino Biopharm, said: "This is the Sino Biopharm’s first time as lead investor to invest in late stage financing of a private biotech company. This is another significant collaboration milestone between both companies after our joint-venture agreement in June to co-develop and commercialize Akeso in-house developed AK105 (PD-1). Sino Biopharm strives to develop drugs with outstanding clinical value, particularly innovative medicines. Our investment in Akeso is in line with our overall innovative strategies. Our investment symbolises that both companies are making solid progress towards developing pharmaceutical ecosystem, which aims to benefit more patients in China and beyond."

"Akeso has had a remarkable record of brilliant execution in the service of an ambitious vision. It is great pleasure to see a company with this much existing success as well as massive potential to achieve more," said Dr Li Bin, founder of Lake Bleu Capital.