On June 15, 2021 Phigenix, Inc. Pharmaceutical and Biomedical Research Company, a molecular oncologist-led, biopharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated therapies to address significant unmet needs in diagnosing and precision treatment in oncology, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,033,628, which is directed to methods related to the use and administration of certain PAX2 inhibitors for treating drug-resistant breast cancer(Press release, Phigenix, JUN 15, 2021, View Source [SID1234584036]). Drug resistance of metastatic breast cancers to first-line chemotherapies, either single or a combination of drugs, occurs in 30-70% of cases.

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U.S. Patent No. 11,033,628 also covers the use of a diagnostic test that assesses the expression status of PAX2 and Human Beta Defensin-1 (DEFB1) in addition to the current standard of care molecular markers to determine the best course of treatment of breast cancer. Additional issued claims pertain to methods of using anti-PAX2 compositions to treat particular resistant breast cancers. This newly issued patent is owned by Phigenix, Inc and is the latest U.S. patent issued in connection with Phigenix’s PAX2 robust drug and diagnostics development program for cancer detection and treatment.

"We are extremely pleased with the addition of this new patent to our portfolio to extend our cutting-edge, next-generation medical innovations. This new issuance continues to expand the breadth and depth of our PAX2 intellectual property portfolio covering methods of use for certain PAX2 inhibitors and diagnostic tests for effective breast cancer disease treatment and management. The technology covered in this patent has the potential to revolutionize how physicians determine the most effective course of treatment for breast cancer patients. Ultimately, this new technology may make treatment more affordable and save thousands of lives," said Dr. Carlton D. Donald, Founder, President and Chief Executive Officer of Phigenix, Inc.

On June 15, 2021 Autolus Therapeutics, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO1 (obecabtagene autoleucel, obe-cel), the company’s CAR T cell therapy being investigated in the ongoing FELIX Phase 1b/2 study in relapsed / refractory (r/r) adult B-cell Acute Lymphocytic Leukemia (ALL) in patients 18 years and older (Press release, Autolus, JUN 15, 2021, View Source [SID1234584088]).

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"The ILAP designation for obe-cel, alongside the recent PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA), is another step forward in accelerating the review process of this promising therapy," said Dr. Christian Itin, chief executive officer of Autolus. "Obe-cel continues to show the potential to be differentiated on efficacy, durability and safety from other CAR T cell products and could change standard of care by offering a potentially curative therapy for r/r ALL."

About ILAP
ILAP was announced in December 2020 and launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).

The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to chart a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.

On June 15, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Chief Executive Officer, Bill Newell, will participate in two virtual investor conferences in June (Press release, Sutro Biopharma, JUN 15, 2021, View Source [SID1234584017]).

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Presentation Details
JMP Securities Life Sciences Conference

Format: Fireside Chat

Date: Thursday, June 17, 2021

Time: 3:30 p.m. ET / 12:30 p.m. PT

Raymond James Human Health Innovations Conference

Format: Panel Session

Panel Title: Targeted Oncology 2: Antibody Drug Conjugates

Date: Wednesday, June 23, 2021

Time: 10:40 a.m. ET / 7:40 a.m. PT

Live webcasts of each presentation can be accessed through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.

On June 15, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that on June 11, 2021 it approved non-statutory stock options to purchase an aggregate of 118,350 shares of its common stock and 30,835 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to 66 new employees(Press release, PTC Therapeutics, JUN 15, 2021, View Source [SID1234584037]). The awards were made pursuant to the NASDAQ inducement grant exception as a component of the new hires’ employment compensation.

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The inducement grants were approved by PTC’s Compensation Committee on June 11, 2021 and are being made as an inducement material to each employee’s acceptance of employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

All stock option awards have an exercise price of $42.95 per share, the closing price of PTC’s common stock on June 11, 2021, the date of the grant. The stock options each have a 10-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee’s new hire date and 6.25% of the original number of shares vesting at the end of each subsequent three-month period thereafter until fully vested, subject to the employee’s continued service with the Company through the applicable vesting dates. The RSUs each will vest over four years with 25% of the original number of shares vesting on each annual anniversary of the applicable employee’s new hire date until fully vested, subject to the employee’s continued service with the Company through the applicable vesting dates.

On June 14, 2021 CEBINA GmbH, Central European Biotech Incubator and Accelerator, reported the launch of Danube Labs, a partnership with Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) to fast-track early-stage academic research to drug discovery and development (Press release, Evotec, JUN 14, 2021, View Source;announcements/press-releases/p/evotec-partners-with-cebina-to-launch-danube-labs-a-partnership-to-develop-cutting-edge-biotechnology-projects-sourced-from-central-and-eastern-european-universities-and-research-institutions-6070 [SID1234583941]). The joint project, financed by a dedicated group of private investors, will identify, and develop academic projects into mature therapeutic product development opportunities, primed for biotech company formation or partnering. Danube Labs aims to create up to 8 new biotech companies over 4 years, and is supported by CEBINA Bridge Capital Limited, a private fund established in Gibraltar and committed to providing a minimum investment of € 10 m.

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"We are excited to join forces with Evotec to expand our mission to transform promising research and early-stage drug discovery projects from Central and Eastern Europe into mature projects attractive for forming new companies that will be embedded in the biotech ecosystem CEBINA has created. This partnership brings together great entrepreneurial expertise and experience in drug development that, we believe, will enable us to generate breakthrough therapeutics," commented Eszter Nagy, MD PhD, founder and CEO&CSO of CEBINA.

"Danube Labs represents the latest of Evotec’s BRIDGE partnerships, where we explore exciting academic science with the aim to accelerate the translation of early-stage drug discovery from academia to patients," commented Mark Slack, PhD, VP Academic Partnerships at Evotec. "Through our partnership with CEBINA, we see the opportunity to seek out and validate promising innovative research in Central and Eastern Europe".