On September 27, 2021 Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy (Press release, Astellas, SEP 27, 2021, View Source [SID1234590281]). The New Drug Application received priority review.

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Radically unresectable urothelial carcinoma is urothelial cancer that cannot be treated by surgical removal of the urinary bladder or the kidney and the ureter due to tumor growth.

"Unfortunately, advanced urothelial cancer has a relatively poor prognosis and can be challenging to treat with currently available therapies," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The MHLW’s review of enfortumab vedotin in just six months, supported by overall survival data from a pivotal Phase 3 clinical trial, reflects the seriousness of this condition and the potential benefit of enfortumab vedotin for patients in Japan."

The approval is primarily based on the global Phase 3 EV-301 clinical trial, which included sites in Japan. The trial evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received enfortumab vedotin (n=301) in the trial lived a median of 3.9 months longer than those who received chemotherapy (n=307). Median overall survival was 12.9 vs. 9.0 months, respectively [Hazard Ratio=0.70 (95% Confidence Interval [CI]: 0.56, 0.89), p=0.001]. The most common (≥20%) adverse reactions included alopecia, peripheral sensory neuropathy, pruritus, fatigue, decreased appetite, diarrhea, dysgeusia and nausea.

Each year in Japan, more than 24,300 people are diagnosed with bladder cancer and an estimated 9,500 die from the disease.1 Enfortumab vedotin is the subject of a robust clinical development program aimed at addressing unmet needs across the continuum of urothelial cancer and in other solid tumors.

On September 27, 2021 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported the successful installation of its neutron beam system at Xiamen Humanity Hospital, the most advanced accelerator-based BNCT facility in Greater China, newly built in partnership with Neuboron Medical Group (Press release, TAE Life Sciences, SEP 27, 2021, View Source [SID1234590272]).

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TLS’ Neutron Beam System enables a new treatment modality for patients diagnosed with the most aggressive and recurrent cancers such as gliomas, head and neck tumors, and melanomas, by delivering more precise, targeted radiation to cancer cells while sparing damage to surrounding healthy tissue. This technique holds promise in treating patients with cancer for whom other treatment options have been exhausted or are unavailable.

"The installation of our NBS at Xiamen Humanity Hospital represents a tremendous milestone in our mission to improve the lives of people diagnosed with invasive, recurrent and difficult to treat cancers," said Bruce Bauer, Chief Executive Officer of TAE Life Sciences. "TAE Life Sciences is also developing comprehensive boron target drugs and a neutron technology product portfolio to enable BNCT as a new cancer treatment modality for patients globally. With the global pandemic challenging our installation plans along with restrictions in travel, this milestone is even more meaningful, and we want to thank our colleagues at Xiamen Humanity Hospital and our partner in China, Neuboron, for all of their efforts in helping to make this possible."

Accelerating New Hope in the Fight Against Cancer: Presentations at ICNCT19

Committed to developing a new generation of targeted radiotherapy for patients with cancer, TAE Life Sciences will present 5 oral presentations at the19th International Congress on Neutron Capture Therapy (ICNCT19) on BNCT, occurring virtually September 27 – October 1, 2021.

Product and Facility Design Optimization for an Accelerator BNCT Building Expansion Project in Pavia, Italy
Development of new small molecule drugs for Boron Neutron Capture Therapy
Target selection and development of antibody boron conjugates for boron neutron capture therapy of head and neck cancer
Application of high fidelity radiation transport models to facility design, material selection, and shielding concepts for p-7Li accelerator based BNCT
Architecture, Implementation and First Performance Results of a Neutron Beam System for Accelerator BNCT
In addition, TLS’s partner for China, Neuboron, will be presenting an update on the design and installation of the BNCT facility at Xiamen Humanity Hospital.

For presentation details, visit: View Source

About Biologically Targeted Radiation Therapy (BNCT)

BNCT is a non-invasive, biologically targeted particle therapy that combines a non-toxic compound containing boron-10 and a low-energy, epithermal neutron beam. This combination generates a therapeutic dose at the cellular level that destroys tumor cells while sparing healthy tissues surrounding the tumor. This results in less toxicity for the patient and the potential to escalate the therapeutic dose to the cancer cells. BNCT has the potential to treat undetected metastases in the local region of the tumor in the same treatment session, which is difficult to impossible for conventional radiotherapy because of the logistical patient treatment setup barriers and the amount of radiation that would be delivered to healthy cells. In addition, BNCT may be utilized for several cancers which are resistant to many, if not all, current cancer therapies available, such as glioblastoma multiforme.

On September 27, 2021 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it will be providing a presentation at the Proactive Investors Lifesciences Webinar at 12:00 pm AEST on Tuesday 28 September 2021 (Press release, Amplia Therapeutics, SEP 27, 2021, View Source;[email protected] [SID1234590271]). The webinar will include results from the Company’s successful Phase 1 clinical trial of AMP945 and its plans for a Phase 2 clinical trial in first-line pancreatic cancer that is scheduled to commence in early 2022.

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To join the webinar, please register at: View Source

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

On September 26, 2021 JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported updated 1-year follow-up result of relmacabtagene autoleucel injection (relma-cel) for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) at the 24th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) (Press release, JW Therapeutics, SEP 26, 2021, View Source [SID1234590275]).

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RELIANCE Study was a phase II, open-label, single-arm, multi-center clinical study in China, which included 59 adult patients with r/r LBCL who had failed at least 2 lines of previous treatment. As of the December 31st, 2020 data cut-off, in 58 evaluable patients, results include:

Relma-cel showed durable responses and long-term survival benefit; the Best Overall Response Rate was 77.6%, the Best Complete Response Rate was 51.7% and 1-year Overall Survival (OS) was 76.8% with a median follow-up of 17.9 months;
Relma-cel was generally well-tolerated with a safety profile including a low severe Cytokine Release Syndrome (≥grade 3) of 5.1% and a low severe neurotoxicity rate (≥grade 3) of 3.4%, and no new safety signals with a median of 17.9 months of follow up;
Long-term follow-up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment, which also was associated with low rates of CAR-T-associated toxicities.
"Large B-cell lymphoma (LBCL) is the most common and aggressive type of non-Hodgkin lymphoma and most patients relapse after initial therapies with limited treatment options with standard therapies and a median survival of approximately 6 months," said Mark J. Gilbert, Chief Medical Officer of JW Therapeutics, "These long-term follow-up data reported from the RELIANCE study have confirmed the durability of responses after relma-cel treatment, representing a potentially important treatment option for these patients that appears to offer clear hope of longer survival in these patients."

Reference:

Crump M, Neelapu SS, Farooq U, Van Den Neste E, Kuruvilla J, Westin J, Link BK, Hay A, Cerhan JR, Zhu L, Boussetta S, Feng L, Maurer MJ, Navale L, Wiezorek J, Go WY, Gisselbrecht C. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017 Oct 19;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. Epub 2017 Aug 3. Erratum in: Blood. 2018 Feb 1;131(5):587-588. PMID: 28774879; PMCID: PMC5649550.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy products that was independently developed by JW Therapeutics based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). 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 a 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 RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of relmacabtagene autoleucel injection (relma-cel) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. At the time it was conducted, this study was the largest clinical study of CAR-T cell therapy in China under the Investigational New Drug (IND) pathway.

RELIANCE study enrolled 59 patients with r/r LBCL who had failed at least two lines of therapy, including a CD20 agent and anthracycline, and patients continue to be monitored for up to 2 years and beyond for long term outcomes. As of the December 31st, 2020 data cut-off, the Best Overall Response Rate was 77.6% with a Best Complete Response Rate of 51.7%, and 12-month Overall Survival (OS) was 76.8% in 58 evaluable patients; With a median follow-up of 17.9 months, of 59 treated patients, 5.1% and 3.4% of the patients experienced Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) of Grade 3 or above, respectively. Rates for any severity grade CRS and NT were 47.5% and 20.3%, respectively. Long term follow up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment, which also was associated with low rates of CAR-T-associated toxicities.

On September 26, 2021 GenScript ProBio and AskGene reported that signed a license agreement for GenScript ProBio’s single-domain antibody (sdAb) targeting an immune checkpoint target. GenScript ProBio grants a non-exclusive global license to AskGene to use GenScript ProBio’s sdAb targeting immune checkpoint target for discovery, development and commercialization of its antibody and derivative products (Press release, GenScript, SEP 26, 2021, View Source [SID1234590274]). In the future, GenScript ProBio will be the preferred partner for CMC development, clinical and commercial manufacturing of this product.

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AskGene, founded in 2012 in Los Angeles, California, is aspired to become the leader in the cytokine prodrug field. The sdAb involved in this license agreement will be paired with AskGene’s proprietary next-generation cytokine therapeutics for cancer immunotherapy and other applications. Compared with traditional antibodies, single-domain antibodies feature lower molecular weight, higher stability, and easier recombinant expression.

Since the establishment of its sdAb discovery platform in 2010, GenScript has accumulated over 11 years of sdAb research and development experience. At present, GenScript ProBio has built up integrated sdAb immune library, sdAb naïve library, sdAb humanization, antibody screening and functional validation platforms. GenScript ProBio has so far reached 6 licensing deals on sdAb products with global biotech and pharma.

"We are very glad to cooperate with AskGene, a team of experienced scientists, and we feel so honored to provide support for the promising next-generation cytokine therapeutic projects," Dr. Brian Min, CEO of GenScript ProBio said. "I believe the cooperation will further show the technology and platform advantages of both parties. We will keep an eye on the progress of this project and look forward to using GenScript ProBio’s solid CMC development experience to accelerate the project to clinic application and benefit patients."

AskGene’s Jeff Lu, Ph.D., CEO, said, "GenScript ProBio has profound accumulation and core competitiveness in single domain antibody discovery. We are very pleased to cooperate with this highly professional CDMO company to support us in developing the promising next-generation cytokine therapeutics to benefit patients. We look forward to cooperating with GenScript ProBio to jointly accelerate the transformation of medicine and create a better future."