EpiAxis heads to Venture & Capital Sydney investor conference

On July 28, 2023 EpiAxis Therapeutics reported its participation in the Venture & Capital Sydney investor conference, scheduled for Thursday, 3 August 2023 (Press release, EpiAxis Therapeutics, JUL 28, 2023, View Source;utm_medium=rss&utm_campaign=epiaxis-heads-to-venture-and-capital-sydney-investor-conference [SID1234633481]).

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The event will be held at Hilton Sydney, located at 488 George St, Sydney NSW, from 9am to 6pm. This conference provides a fantastic opportunity to connect with investors and our CEO Dr Jeremy Chrisp would be delighted to speak with attendees at the event.

Venture and Capital 2023 is an exclusive conference designed to empower high-net-worth VCs, Family Offices and professional investors lwith unparalleled access to investment opportunities and exclusive networking.

EpiAxis will be highlighting its disruptive epigenetic approach to overcome treatment resistance and prevent cancer recurrence at the conference.

CYTEA

On July 28, 2023 CYTEA BIO reported that it has taken a significant step towards addressing the urgent medical need for effective glioblastoma multiforme (GBM) treatments (Press release, CYTEA BIO, JUL 28, 2023, View Source [SID1234633480]). The company has submitted Briefing Documents to both European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) regulatory bodies seeking advice for the completion of pre-clinical and manufacturing development of the company’s first oncology treatment for glioblastoma multiforme, based on the proprietary PinTM platform, utilizing monoclonal antibody-armed Natural Killer (NK) effector cells.

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This advice will enable completion of pre-clinical studies and chemistry, manufacturing and control (CMC) development to position CYTEA|BIO to enroll first patients in a clinical study in 2025.

GBM, the most aggressive form of brain cancer, remains a devastating pathology with alarmingly poor patient prognosis. With the average age at diagnosis being less than 60 years and average survival rates extending for barely one year from diagnosis, there is an urgent and pressing need for novel and innovative therapies to help manage this life-threatening disease.

Curium receives marketing authorization in the EU for Pylclari™, an innovative 18F-PSMA PET tracer indicated in adults with prostate cancer

On July 28, 2023 Curium, a world leader in nuclear medicine, reported that the European Commission has granted marketing authorization for PYLCLARI (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings (Press release, Curium, JUL 28, 2023, View Source [SID1234633479]):

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Primary staging of patients with high-risk PCa prior to initial curative therapy
To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Today’s decision follows the positive recommendation for marketing authorization approval by The Committee for Medicinal Products for Human Use of the European Medicines Agency in May 2023.

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, "We are very pleased to receive marketing authorization in the EU for PYLCLARI. The successful clinical development and granted marketing authorization of PYLCLARI in the EU confirms our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine. We are looking forward to bringing PYLCLARI to prostate cancer patients as well as to working together with health care professionals across the EU."

Benoit Woessmer, PET Europe CEO at Curium added, "The decision by the European Commission means that PYLCLARI will soon be available across Europe for the benefit of prostate cancer patients. With the leading PET radiopharmaceutical network in Europe, we are pleased to be improving the set of diagnostic tools available to better diagnose and monitor prostate cancer – ultimately for the benefit of prostate cancer patients."

Curium currently has the widest European network of PET products production sites – 32 sites with the capability to supply in 18 countries. When in full production, PYLCLARI will be the most widely available 18F-PSMA tracer in Europe.

Prostate cancer is one of the most frequently diagnosed cancers in men in Europe, accounting for around 23 percent of all new cancer cases in 2020 and nearly 10 percent of all deaths due to cancer in men.

In the U.S., Lantheus received approval for [18F]-DCFPyL, now PYLARIFY (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 PSMA PET Imaging Agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.

Biogen to Acquire Reata Pharmaceuticals

On July 28, 2023 Biogen Inc. (Nasdaq: BIIB) ("Biogen") and Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata") reported that the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3 billion (Filing, 8-K, Biogen, JUL 28, 2023, View Source [SID1234633478]).

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Reata has made significant advancements developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases. Reata’s FDA-approved SKYCLARYS (omaveloxolone) is the first and only approved treatment for Friedreich’s ataxia (FA) in the United States, with a commercial launch underway, and European regulatory review ongoing. In addition, Reata is developing a portfolio of innovative products for a range of neurological diseases.

"With extensive expertise in rare disease product development and global commercialization, as demonstrated by SPINRAZA and the recent launch of QALSODY, we believe Biogen has the foundation in place to accelerate the delivery of SKYCLARYS to patients around the world," said Christopher Viehbacher, Biogen’s President and Chief Executive Officer. "This is a unique opportunity for Biogen to bolster our near-term growth trajectory, and SKYCLARYS is an excellent complement to our global portfolio of treatments for neuromuscular and rare disease."

"Biogen’s expertise and commercial footprint make it the optimal choice to help SKYCLARYS realize its full potential," said Warren Huff, Chairman and Chief Executive Officer of Reata. "With its clear understanding of the rare disease patient journey and existing commercial infrastructure, we believe Biogen will establish SKYCLARYS as the standard of care in the treatment of this devastating genetic disease."

Financial Details and Terms of the Transaction

The transaction, which was approved by the boards of directors of both companies, is currently anticipated to close in the fourth quarter of 2023. Biogen expects this acquisition to be accounted for as a business combination. The acquisition of Reata is expected to be slightly dilutive to Biogen’s Non-GAAP diluted Earnings Per Share (EPS) in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs. Biogen plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release.

Biogen expects to finance the acquisition with cash on hand, supplemented by the issuance of term debt. The transaction is subject to customary closing conditions, including approval by Reata stockholders and the receipt of necessary regulatory approvals. Biogen has entered into voting and support agreements with certain stockholders of Reata representing approximately 36% of the voting power of Reata’s common stock.

Conference Call Details

Biogen will host an investor call on July 28, 2023, at 9:00 a.m. ET. The conference call will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

Advisors

Lazard acted as financial advisor to Biogen in this transaction and Cravath, Swaine & Moore acted as its legal advisor. Goldman Sachs acted as financial advisor to Reata and Vinson & Elkins acted as its legal advisor.

Aravive to Present Updated Clinical Data from Batiraxcept Trials in Renal and Pancreatic Cancer at ESMO Congress 2023

On July 28, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the acceptance of two abstracts for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, being held October 20-24, 2023 in Madrid, Spain (Press release, Aravive, JUL 28, 2023, View Source [SID1234633477]). Posters will feature clinical data from the Company’s ongoing Phase 1b/2 trials of batiraxcept in clear cell renal cell carcinoma (ccRCC) and pancreatic adenocarcinoma (PDAC).

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Presentation Details:

Title: Phase 1b/2 Study of Batiraxcept (BT, AVB-S6-500, an AXL pathway inhibitor) in Combination with Cabozantinib (Cabo) in Patients with Advanced Clear Cell Renal Cell Carcinoma (ccRCC) who Failed First Line (1L) Therapy
Presenter: Neil Shah, MBBS
Abstract Number: 2294

Title: Phase 1b/2 Study of Batiraxcept (AVB-S6-500, BT) plus Nab-paclitaxel (NP) and Gemcitabine (G) as first-line treatment (1L) for metastatic pancreatic adenocarcinoma (PDAC)
Presenter: Vaibhav Sahai, MBBS, MS
Abstract Number: 3218
Posters will be available on the "Publications" section of the Aravive website at the start of the meeting.