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.

On September 24, 2021 Secura Bio reported that The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there (Press release, Secura Bio, SEP 24, 2021, View Source [SID1234590541]).

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Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology
Tuesday, October 12 | 11am ET / 8am PT
Development of HPAPIs presents unique challenges for product containment and requires special consideration in equipment selection, operating procedures, and safety processes. This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization. The speakers will also share the key advantages of using micronization technology for the development and manufacturing of HPAPIs.
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The FDA is gathering an oncologic drugs advisory committee meeting on Dec. 2 to review whether two drugs should keep their conditional approvals, the agency said (PDF) Friday. The products are Secura Bio’s Farydak for previously treated multiple myeloma, and Aurobindo Pharma’s Marqibo indication for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) following two or more lines of treatments.

In the spring, the FDA’s Oncology Center of Excellence launched an industry-wide review of accelerated approvals that haven’t shown clinical benefits in confirmatory trials. The campaign cost PD-1/L1 inhibitors from Merck, Bristol Myers Squibb, Roche and AstraZeneca several U.S. indications, including small cell lung cancer, stomach cancer, bladder cancer, liver cancer and triple-negative breast cancer.

RELATED: Subcutaneous Velcade more tolerable in multiple myeloma trial

Now Secura and Farydak will have to prepare for the same scrutiny. Secura bought worldwide rights to Farydak from Novartis in 2019. The drug’s original FDA nod in 2015 was a hard-fought one, given that the FDA’s external experts voted against its approval due to concerns about side effects. Farydak is indicated for use with Takeda’s Velcade and the steroid dexamethasone.

The latest data on Fradyak, released earlier this year, came from a phase 2 trial dubbed Panorama 3. The trial tested Fradyak with a subcutaneous version of Velcade, rather than its original intravenous formulation. It showed that Fradyak, at its approved dosing strength, produced a similar response rate with the new regimen as that shown in the original Panorama 1 trial, but that it had a longer duration of response. Patients taking the combination with subcutaneous Velcade reported fewer side effects, such as severe diarrhea, than what was observed in the earlier trial."

In a statement to Fierce Pharma, Secura chief medical officer David Cohan, M.D., said the company remains "committed to working with the FDA on fulfilling all post-marketing requirements for Farydak in a timely manner."

As for Marqibo, that drug got its FDA go-ahead in 2012 and has since changed hands twice, first from Talon Therapeutics to Spectrum Pharmaceuticals in 2013 and then to Aurobindo in 2019. The drug earned its third-line ALL approval after a single-arm phase 2 study recorded a 15.4% complete response rate.

The phase 3 Hallmarq trial in patients over 60 with newly diagnosed ALL was supposed to serve as Marqibo’s confirmatory trial. The plan was to enroll 348 patients and compare Marqibo, a targeted version of chemotherapy vincristine, with standard vincristine. But Spectrum terminated the study in 2015, after recruiting just 26 participants over three years, according to clinicaltrials.gov.

RELATED: Bristol Myers pulls an Istodax lymphoma use 10 years after FDA accelerated approval

The upcoming advisory committee meeting "will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted," the FDA said in a notice Friday.

Some pharma companies seem to be realizing that the FDA is moving its house-cleaning beyond immuno-oncology agents. And they’re getting ahead of any negative decisions. Bristol Myers in August said it’s withdrawing Istodax’s indication as a monotherapy for previously treated peripheral T-cell lymphoma after a recent confirmatory phase 3 trial flop in newly diagnosed patients.

On September 24, 2021 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its fourth quarter and fiscal year end 2021 operating results on Wednesday, September 29, 2021, before the open of the U.S. financial markets (Press release, Palatin Technologies, SEP 24, 2021, View Source [SID1234590262]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on September 29, 2021, at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

Audio Webcast Live and Replay Access

View Source

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source.