On August 17, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported it will host a conference call and webcast to provide a business update on Monday, August 31, 2020 at 4:30 p.m. EDT (Press release, Cue Biopharma, AUG 17, 2020, View Source [SID1234608299]). Live and archived versions of the event can be accessed via the Company’s website.

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Members of the Cue Biopharma executive management team will provide an update on the Company’s ongoing Phase 1 clinical trial of CUE-101 for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), technology platforms and pipeline progress, as well as updates on its strategic objectives and anticipated milestones.

On August 17, 2020 Astellas reported that The National Institute for Health and Care Excellence has now published final guidance backing NHS use of Xospata as monotherapy for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML) (Press release, Astellas, AUG 17, 2020, View Source [SID1234563838]).

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The endorsement remains contingent on the confidential commercial agreement agreed with the company, and does not include its use as a maintenance therapy after haematopoietic stem cell transplant.

Each year around 3,100 people in the UK are diagnosed with AML, a rare and aggressive cancer of the blood and bone marrow that, if untreated, can be fatal within a few months.

Around one-third will test positive for the FLT3 gene mutation, which can result in higher relapse rates and lower rates of survival than other forms of the disease.

Data from the Phase III ADMIRAL trial showed that relapsed or refractory FLT3 mutation-positive AML patients who received the drug experienced significantly longer overall survival than those who received salvage chemotherapy.

Median overall survival for patients who received Xospata was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy, while rates of one-year survival were 37% and 17%, respectively.

On August 17, 2020 JW Therapeutics reported that it has filed the paperwork (PDF) for a Hong Kong IPO (Press release, JW Therapeutics, AUG 17, 2020, View Source [SID1234563831]). The Juno Therapeutics-WuXi AppTech joint venture is seeking money to advance a cell therapy pipeline led by anti-CD19 CAR-T JWCAR029.

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In 2016, Juno and WuXi teamed up to found JW. The biotech went on to raise $190 million over the course of its series A and B rounds, giving it the financial firepower to take JWCAR029 to a filing for approval in third-line diffuse large B-cell lymphoma in China while exploring the effect of the anti-CD19 CAR-T and other cell therapies on a range of different hematological and solid cancers.

Now, with the commercial launch of JWCAR029 in sight, JW has filed to raise money in a Hong Kong IPO. The financing target is redacted from the paperwork, but earlier media reports suggest JW plans to raise $200 million to $300 million.

JW is seeking the money to continue developing JWCAR029, which is in development in five blood cancers, and build out an in-house sales and marketing team to support the launch of the CAR-T in China. The rest of the money will support development of JWCAR129, an anti-BCMA therapy that is in IND-enabling studies, and a solid tumor pipeline led by anti-AFP cell therapy JWATM203.

JWATM203 is yet to enter the clinic, but JW’s partner, Eureka Therapeutics, has taken its AFP T-cell therapy into phase 1/2 in the U.S. JW and Eureka are developing the AFP cell therapies as treatments for liver cancer.

JW has another anti-AFP asset, JWATM213, in development that uses technology accessed through a collaboration with Lyell to enhance T-cell function and improve efficacy. Lyell and JW disclosed their solid tumor collaboration, which also includes an anti-GPC3 program, last week. The IPO paperwork fleshes out the details, revealing Lyell has granted JW a license to T-cell anti-exhaustion functionality.

The partnership brings together biotechs with strong links to Juno. Lyell’s founder and CEO is Rick Klausner, the co-founder of Juno. JW was set up by pioneering Seattle-based CAR-T biotech Juno.

On August 17, 2020 JW Therapeutics, the JV formed by Seattle’s CAR-T specialist Juno Therapeutics and China’s WuXi AppTec, reported that it has posted its prospectus for a Hong Kong IPO (Press release, JW Therapeutics, AUG 17, 2020, View Source [SID1234563828]). The company will bring Juno’s CAR-T cell therapies to China, but it has expanded to include immunotherapy in-licensings from other companies as well. Last month, JW acquired Syracuse Biopharma, a Hong Kong cell therapy company. And the prospectus reveals JW will also acquire China rights to off-the-shelf natural killer cell therapy candidates from Taiwan’s Acepodia. JW is expected to raise between $200 million and $300 million in the offering.

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On August 17, 2020 Agile Therapeutics, Inc. (Nasdaq: AGRX), a forward-thinking women’s healthcare company, reported the appointment of Paul Korner, MD, MBA, to the position of Chief Medical Officer (Press release, Agile Therapeutics, AUG 17, 2020, View Source [SID1234563773]). Dr. Korner is a board-certified obstetrician and gynecologist with more than 20 years of pharmaceutical and biotech industry experience, including significant experience within women’s healthcare. He will be responsible for supporting the commercial launch of Twirla, advancing the Company’s internal pipeline and evaluating external growth opportunities. Dr. Korner will report to Al Altomari, Agile’s Chairman and Chief Executive Officer.

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"We are excited to welcome Dr. Korner to Agile as we continue to strengthen and expand our senior leadership team," said Al Altomari. "Dr. Korner’s private practice work and his deep pharmaceutical experience, particularly in leading multiple women’s health product approvals and launches, makes him a natural fit as we continue to advance Twirla towards commercial launch and broaden our women’s health portfolio for areas of unmet need."

Dr. Korner has served in various leadership positions of increasing responsibility at several global companies focused on female reproductive health, including Solvay Pharmaceuticals, Wyeth Research, Bayer, and Ferring Pharmaceuticals. Dr. Korner has led more than 50 clinical trials that include multiple engagements with the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency in Japan, and Health Canada. Most recently Dr. Korner brought his clinical and development acumen to the gene therapy space as a Senior Vice President of Clinical Development & Medical Affairs at Axovant Gene Therapies, Ltd.

"Agile is at the forefront of expanding healthcare options for women, and I am thrilled to join the Company at this important time. I look forward to supporting Agile’s continued product development and the launch of Twirla, an innovative and important new contraceptive option for women," said Dr. Korner.

Dr. Korner received his MD from the Stritch School of Medicine at Loyola University. He also holds an MBA from the Michael J. Coles College of Business at Kennesaw State University. He currently serves on the Laidlaw Venture Partners Scientific Advisory Board and the Board of Directors of Voltron Therapeutics as an Independent Director.