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."

On September 26, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, reported the interim clinical data from a Phase 2 trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, SEP 26, 2021, View Source [SID1234590273]). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on September 25-29, 2021.

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The scientific presentation entitled: "Taletrectinib (AB-106): Preliminary results from TRUST, Phase 2 trial of a new generation of potent ROS1/NTRK inhibitors in ROS1-positive non-small cell lung cancer (NSCLC)," summarized preliminary data from an ongoing Phase 2 trial of taletrectinib (NCT04395677).

As of June 16, 2021, 21 crizotinib treatment-naïve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1 fusion-positive. The key results are as follows:

In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21).
In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16).
Among the crizotinib pre-treated patient group (n=16), ROS1 G2032R resistant mutations were identified in three patients and all three patients experienced tumor regression, 2 patients reported a partial response (PR), and 1 patient stable disease (SD).
In patients with assessable brain metastasis pre-enrollment, intracranial objective response rate (assessed by investigator) was 83.3% (5/6).
Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.
Dr. Caicun Zhou, Director of the Department of Oncology in Shanghai Pulmonary Hospital, stated:"We are pleased with the interim Phase 2 data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer. Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are glad to see the interim Phase 2 data of taletrectinib presented at the CSCO meeting, one of the most authoritative clinical oncology conferences in China. In China, ROS1-positive patients currently have limited treatment options. Novel therapies are urgently needed, and taletrectinib has good efficacy and safety results, which offers hope to patients with ROS1 fusion-positive NSCLC."

Bing Yan, MD, Co-founder and Chief Medical Officer of AnHeart Therapeutics, stated: "Our team is focused on completing patient enrollment for our Phase 2 TRUST trial. The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs."

About Taletrectinib

Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at View Source

On September 25, 2021 Boan Biotech, a subsidiary of Luye Pharma Group, reported that it will orally present the pre-clinical data of its proprietary CD3+ T-cell engager platform and CEA/CD3 bispecific antibody at World Bispecific Summit 2021 (Press release, Boan Biotech, SEP 25, 2021, View Source [SID1234590276]).

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The annual World Bispecific Summit aiming to promote the development of bispecific antibody therapies will take place for the 12th time this year. It has become a prestigious platform in the industry for academic exchanges. The upcoming event will take place online from September 29 to October 1, 2021 Eastern Standard Time.

Details of the oral presentation by Boan Biotech are as follows:

Title: Optimization of CD3+ T-cell Engager to Improve Safety Profile
Session: T-cell Based Approaches for Oncology Therapeutics
Time: October 1, 2021

Background

CD3+ T-cell engagers are a group of the most promising bispecific antibodies for the treatment of cancers. But they face major challenges including the dose-limiting, life threatening cytokine release syndrome (CRS) toxicity, suboptimal potency, and the on-target off-tumor toxicity. To overcome those challenges, Boan Biotech developed an optimized platform for CD3+ bispecific T-cell engagers with a unique combination of high potency, reduced cytokine release and tumor-targeting selectivity.

The CEA/ CD3 bispecific antibody BA1202 is the first clinical candidate developed on the leading bispecific T-cell Engager platform. The pre-clinical research data of BA1202 showed a high potency in killing cancer cells, significantly reduced cytokine release, and superior efficacy.

In addition to BA1202, multiple bispecific antibody candidates with similar optimized format and the reduced CD3 affinity have been validated both in vitro and in vivo to have a similar advantage against different solid tumor targets. Boan Biotech plans to speed up the effort to take these bispecific T-cell engagers as investigational drugs to clinical trials, to address the huge unmet needs in treating patients with late-stage cancers.