Jacobio Announces Strategic Investment in Hebecell to Further Develop iPSC-NK Cell Therapy

On August 31, 2021 Jacobio Pharmaceuticals ("Jacobio", 1167.HK) reported a strategic investment in the US-based biotech company Hebecell on August 31 (Press release, Jacobio Pharmaceuticals, AUG 31, 2021, View Source [SID1234587064]). Jacobio will collaborate with Hebecell to develop the next-generation natural killer cell therapy based on induced pluripotent stem cells (iPSC-NK).

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Once the deal is completed, Jacobio chairman and CEO Dr. Yinxiang Wang will be appointed as Chairman of Hebecell.

"Cell therapy is at the forefront of cancer therapy. We have long focused on revolutionary and innovative therapies," said Dr. Wang. "We have strong ability and know-how on drug R&D of small molecule and antibody, with the partnership with Hebecell in place, we plan to add the allogeneic cell therapy into our pipelines in a move to explore the clinical value of a combination therapy with our existing products."

As part of the therapy’s core advantages, iPSC-NK is based on natural killer ("NK") cells that can be produced indefinitely from induced pluripotent stem ("iPSC") cells, eliminating the need to separate the cells from the patient’s blood. As a result, it supports standardized production and has the potential to become an off-the-shelf product. In addition, the fact that there is no need to wait for preparation helps enhance the solution’s commercial prospects and potential for mass production.

The current CAR-T cell therapy requires the isolation of lymphocytes from the patient’s own blood, and then the separated cells must be injected back to the patient after a complex preparation process in vitro. Consequently, it is hard to achieve standardized production due to limited cell resources, time-consuming preparation, and high production costs.

Founded in Boston in 2016, Hebecell is primarily engaged in developing universal, cost-effective and off-the-shelf NK cell therapeutics based on its proprietary 3D- induced pluripotent stem cell (3D-iPSC) platform, which will be potentially available to all patients worldwide for the treatment of cancer, viral infectious and autoimmune diseases.

Hebecell’s proprietary technology uses its unique feeder-free 3D-iPSC spheroid platform to produce all-purpose NK cells, which is more efficient than the traditional 2D method. Hebecell has established an efficient, scalable and reproducible 3D-iPSC platform, which supports the massive production of iPSC-NK cells for cancer and other diseases. This platform technology will alter the NK cell therapy field by delivering cost effective allogeneic therapies worldwide. Moreover, Hebecell is also exploring the application of its 3D-iPSC platform in the treatment of other diseases, including macular degeneration, Parkinson’s, viral infectious and autoimmune diseases.

Hebecell’s founder, Dr. Shi-Jiang (John) Lu, added, "Our unique 3D-iPSC augmentation platform represents the next-generation of iPSC-NK cell therapy. The establishment of a master iPSC-CAR cell bank targeting multiple specific antigens will provide inexhaustible cell sources for the manufacture of truly off-the-shelf CAR-NK cells. We believe that this collaborative partnership building on the unique complementary strengths and resources between Hebecell and Jacobio will rapidly advance our unique off-the-shelf iPSC-NK products into clinics, realize the clinical application and commercial value of iPSC-NK therapy, and address the health challenges caused by tumors and other diseases ."

Eagle Pharmaceuticals Granted Additional Patent for Bendamustine Franchise

On August 31, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,103,483, entitled "Formulations of Bendamustine (Press release, Eagle Pharmaceuticals, AUG 31, 2021, View Source [SID1234587030])." Eagle is submitting the ‘483 patent for listing in the U.S. Food and Drug Administration’s Orange Book for both BENDEKA and BELRAPZO.

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Eagle had asserted several Orange Book-listed patents against Slayback Pharma LLC, Apotex Inc. et al, Mylan Laboratories Limited, and Fresenius Kabi USA, LLC, related to their respective abbreviated new drug applications referencing BENDEKA. On July 6, 2020, the District Court for the District of Delaware had held these asserted patents both valid and infringed. Apotex, Mylan, and Fresenius appealed this ruling. Previous to the appellate hearing, Eagle settled the Fresenius litigation. On August 13, 2021, the United States Court of Appeals for the Federal Circuit affirmed that the asserted patents were both valid and infringed. Both the asserted patents and the ‘483 patent expire in 2031.

"We are pleased that this appellate decision, as well as the newly issued patent, continue to strengthen Eagle’s intellectual property rights for both BENDEKA and BELRAPZO," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Phio Pharmaceuticals Announces Upcoming Data Presentation at the ESMO Virtual Congress 2021

On August 31, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that new data in support of upcoming clinical studies is scheduled to be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, which is being held from September 16-21, 2021 (Press release, Phio Pharmaceuticals, AUG 31, 2021, View Source [SID1234587047]).

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Details are as follows:

Event:

ESMO Virtual Congress 2021

Title:

Dual targeting PD-1 and BRD4 with INTASYL self-delivering RNAi elicits persistent anti-tumor immunity in-vivo following complete resolution of tumors

Authors:

Benjamin Cuiffo, et al.

Abstract Number:

#4154

Date:

September 16-21, 2021

An archived version of the Phio presentation will be made available on the "Investors – Events and Presentations" section of the Company’s website (click here)

Jacobio Pharmaceuticals Announces 2021 Interim Results

On August 31, 2021 Jacobio Pharmaceuticals ("Jacobio", 1167.HK) reported its results for the first half of 2021. Investment in R&D for the clinical-stage biotech firm reached 175 million yuan (approx. US$27 million) for the half year, up 146 percent year-on-year (Press release, Jacobio Pharmaceuticals, AUG 31, 2021, View Source [SID1234587065]). Driven by revenue generated from its overseas licensing deals, the company recorded revenue of 57.69 million yuan (approx. US$8.9 million) during the reporting period.

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During the six months, Jacobio accelerated the pace of its clinical-stage research projects in both China and the United States.

The company received a US$20 million milestone payment from one of its partners, triggered by the first two patients have been dosed in clinical trial of SHP2 inhibitor JAB-3312 in combination with PD-1 antibody Pembrolizumab and MEK inhibitor Binimetinib respectively.
The KRAS G12C inhibitor JAB-21822 was approved for clinical trials in both China and the United States, and the first patient with advanced solid tumors was dosed in a Phase I/II clinical trial in China.
In addition, the BET inhibitor JAB-8263 completed the first patient administration in China during the period after completing the same in the US in late 2020.
Jacobio’s research projects focus on five major tumor signaling pathways: SHP2/RAS, I/O, RB, tumor metabolism, and c-MYC, with the aim of seeking out undeveloped therapy targets on validated signaling pathways. Besides the clinical phase projects, the company has five programs in IND-enabling stage, three in preclinical stage and others in early pipelines under development.

In addition to small molecules and antibody drugs, Jacobio is also developing revolutionary therapies in the realm of tumor treatment. During the period, the company made a strategic investment in cell therapy company Hebecell for the development of new iPSC-derived natural killer (iPSC-CAR-NK) cells both in global markets.

In the first half of 2021, Jacobio collaborated with many well-known players in the industry, including a number of AI-driven new drug R&D companies, major oncology hospitals and other medical facilities, to enhance its strength in each link of new drug R&D through complementary cooperation.

During the period, Jacobio’s staff expanded from 180 to 213 employees. In order to attract more professionals, the company set up an R&D center in Shanghai in April 2021 to ramp up its R&D footprint alongside facilities in Beijing and Boston. In addition, the 20,000 square meter in Beijing has been roof-sealed and is expected to become the headquarters where R&D, production and administrative offices will be integrated in one space, paving the way for the company to become a full function biopharma with R&D, manufacture and sales.

"As new drug R&D has entered a critical and complex phase, Jacobio is committed to benefiting the patient while seeking project opportunities from the latest scientific research achievements with the aim of developing first-of-its-kind new drugs," said Dr. Wang Yinxiang, Chairman and CEO of Jacobio, "We strive to be among the world’s top three producers when it comes to core projects and grow global market share through project licensing cooperation with internationally renowned pharmaceutical manufacturers."

For more information about Jacobio Pharmaceuticals, please visit here.

Veracyte to Participate in Morgan Stanley 19th Annual Global Healthcare Conference

On August 31, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global diagnostics company, reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, reported that it will participate in a fireside chat at the Morgan Stanley Virtual 19th Annual Global Healthcare Conference on Tuesday, September 14, at 3:30 p.m. Eastern Time (Press release, Veracyte, AUG 31, 2021, View Source [SID1234587048]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source Replays of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.