On July 9, 2021 ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC) (Press release, ABL Bio, JUL 9, 2021, View Source [SID1234584756]).

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Jointly developed with I-Mab (NASDAQ: IMAB), ABL503 is a bispecific antibody combining PD-L1 checkpoint pathway with 4-1BB agonistic activity to overcome the current limitation of PD-(L)1 therapy and 4-1BB related toxicity. Using ABL’s Grabody-T bispecific antibody platform technology, ABL503 induces 4-1BB activation only in the presence of PD-L1 expressing tumors to minimize the risk of 4-1BB related peripheral toxicity. ABL503 is currently being evaluated in a Phase 1 study in the U.S. in patients with locally advanced or metastatic solid tumors (NCT04762641).

The paper, "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade," was published in collaboration with Su-Hyung Park, PhD, Professor at the KAIST Graduate School of Medical Science and Engineering. The paper highlights key in vitro and in vivo research that demonstrate ABL503’s potential as a promising immunotherapeutic agent against cancer.

In the study, ABL503 induced complete tumor regression in humanized mice, which was superior to anti-PD-L1 or anti-4-1BB monotherapy. Moreover, no tumor growth was observed in these mice when they were rechallenged at 40 days after their first ABL503 treatment, demonstrating that ABL503 treatment yields a prolonged anti-tumor response despite a short-term administration schedule.

In addition, ABL503 was well-tolerated following a repeated high dose administration of ABL503 in monkeys. Monkeys treated with ABL503 exhibited overall good tolerance with normal liver functions.

"These published data validate our Grabody-T platform technology to achieve anti-tumor efficacy with a low risk of off-tumor liver toxicity and support the therapeutic value of ABL503 as a potential best-in-class treatment for cancer," said Sang Hoon Lee, PhD, CEO of ABL Bio. "We have great expectations for the program and look forward to further evaluating ABL503 in our Phase 1 study with I-Mab."

On July 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on July 9th 2021, that its Safety Monitoring Committee has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, JUL 9, 2021, View Source [SID1234584757]). The safety profile of RV001 was excellent and the Safety Monitoring Committee concluded the trial can continue without modifications.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for RV001 in this cancer indication. RhoVac currently estimates finalizing the patient recruitment for the study no later than September this year, and after that the study will run to completion, which is estimated to take 9-12 months after the closing of the recruitment. The objective of the study is to show that RV001 can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. As planned, an interim safety review was conducted today by the Safety Monitoring Committee, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.

RhoVac CEO, Anders Månsson, comments: "We had never anticipated anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence. Also, the fact that we have excellent patient compliance in the study in spite of the pandemic circumstances, is a sign of how motivated these patients are to receive the treatment. This will add to the interest we already experience in our drug candidate".

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 14:20 CET.

On July 9, 2021 HAMLET Pharma reported that All required milestones and deliverables to date are without any significant deviations (Press release, HAMLET Pharma, JUL 9, 2021, View Source;utm_medium=rss&utm_campaign=hamlet-pharmas-achievements-are-emphasized-after-eu-evaluation-the-company-has-fully-achieved-its-milestones-and-secured-the-second-payment [SID1234584810]). This is particularly impressive in light of the global Corona virus pandemic.

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To date, the beneficiary has succeeded in manufacturing the Investigational Medicinal Product (IMP) Alpa1H. The company has demonstrated non-clinical improvement of therapeutic efficacy of other cancer drugs like Mitomycin C and Epirubicin, when combined with Alpa1H and successfully continued with the Phase I/II study of Alpha1H in bladder cancer patients.

There is evidence of good financial management in this project. The amount of financial resources utilized to date is proportionate to the achievements of the project to date".

Hamlet Pharma will now receive the second payment from the EIC Accelerator Horizon 2020 fund of approximately 6,7 million SEK. The third payment is expected at the end of the program.

This disclosure contains information that Hamlet is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 09:47 CET.

On July 9, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the Ladenburg Thalmann 2021 Healthcare Conference being held virtually (Press release, TG Therapeutics, JUL 9, 2021, View Source [SID1234584742]). The fireside chat is scheduled to take place on Wednesday, July 14, 2021 at 12:30 PM ET.

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A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Following each event, an archive file will be available for thirty days.

On July 9, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported the signing of two new collaborations with emerging biotech companies in China to strengthen its next-generation innovation pipeline (Press release, I-Mab Biopharma, JUL 9, 2021, View Source [SID1234584759]).

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The collaborations with Immorna, an mRNA biotech company, and neoX Biotech, an AI-enabled R&D biotech company, allow I-Mab the access to transformative technologies in its quest to discover and develop novel oncology therapeutics. I-Mab will be developing novel anti-cancer antibody therapeutics through Immorna’s pioneering self-replicating mRNA platform. Moreover, through a strategic collaboration agreement, I-Mab will work with neoX Biotech for up to 10 novel biologics programs using neoX’s proprietary artificial intelligence algorithm. The announcement today is the new additions to the existing collaboration agreements with Complix for cell-penetrating antibody platform and Affinity for masking antibody platform in March 2021, positioning the Company to continually expand its globally competitive pipeline of next generation antibody assets enabled by transformative technologies.

"Since the launch of our discovery initiative earlier this year, we have identified transformative technologies that can enable us to rapidly expand the emerging portfolio of next generation novel antibody assets to sustain our innovative immuno-oncology pipeline," said Dr. Taylor Guo, Chief Scientific Officer of I-Mab. "The immense success of COVID-19 mRNA vaccines exemplifies that mRNA-based drugs have finally established themselves as transformative medicines. And channeling the power of AI into drug discovery holds great promise from unlocking novel targets and modalities to accelerating all aspects of R&D. By embracing these technologies, we have again demonstrated our commitment in executing against our long-term innovation strategy."

"We are delighted to establish this collaboration with I-Mab. By unlocking the potential of in vivo synthesized therapeutic antibody modality built on messenger RNA technology, we strive to realize our common mission of bringing the world’s first self-replicating mRNA therapeutics to cancer patients," said Dr. Zihao Wang, CEO of Immorna.

"We look forward to working with I-Mab to generate novel oncology assets, leveraging our proprietary cutting-edge AI technology and unique capabilities to overcome the challenges of drug discovery and create new drugs better and faster," said Dr. Hang Chen, CEO of neoX Biotech.

Both partner companies will receive undisclosed upfront and/or milestone payments stipulated in the collaboration agreements.