On July 29, 2020 Novartis reported the European Commission (EC) reportedhas approved Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (Press release, Novartis, JUL 29, 2020, View Source [SID1234562481]). Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumors harbor a PIK3CA mutation, which stimulates tumor growth and is associated with poor response to therapy13.

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"Piqray is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumors have a PIK3CA mutation, and we look forward to making it available in countries across Europe," said Kees Roks, Head Region Europe, Novartis Oncology. "Knowledge of PIK3CA status can better equip doctors as they develop a personalized upfront treatment plan for patients. Piqray offers new hope for advanced breast cancer patients with a PIK3CA mutation, who typically face a worse overall prognosis."

This approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on the Phase III SOLAR-1 trial showing that Piqray nearly doubled median progression-free survival (PFS) compared to fulvestrant alone1,2. Overall response rate, an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to fulvestrant compared to fulvestrant alone1,2. Read more about the positive CHMP opinion and the SOLAR-1 clinical trial results here.

Patients with HR+/HER2- advanced breast cancer should be selected for treatment with Piqray based on the presence of a PIK3CA mutation in tumor or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, tumor tissue should be tested if available.

About Piqray (alpelisib)
Piqray is a kinase inhibitor developed for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen. Piqray is approved in 48 countries, including the US and European member states.

Important Safety Information from the PIQRAY EU SmPC
The most common ADRs and the most common grade 3 / 4 ADRs (reported at a frequency >20% and ≥2%, respectively) were plasma glucose increased, creatinine increased, gamma-glutamyltransferase increased, rash, lymphocyte count decreased, nausea, alanine aminotransferase increased, anaemia, fatigue, lipase increased, decreased appetite*, stomatitis, vomiting*, weight decreased, hypocalcaemia, plasma glucose decreased*, activated partial thromboplastin time prolonged*, alopecia**, diarrhoea, hypokalaemia, hypertension, nausea, creatinine increased, and mucosal inflammation (*<2% grade 3/4 ADRs reported, ** no grade 3/4 ADRs reported).

Piqray can cause serious side effects such as severe hypersensitivity, severe cutaneous reactions, hyperglycaemia, pneumonitis, diarrhoea, and osteonecrosis of the jaw.

The following should be taken into consideration prior to or during treatment with Piqray:

Piqray should be permanently discontinued in patients with serious hypersensitivity reactions.

Piqray should not be initiated in patients with a history of severe cutaneous reactions, should be interrupted if signs or symptoms of severe cutaneous reactions are present, and permanently discontinued if a severe cutaneous reaction is confirmed.

Fasting glucose and HbA1c levels should be monitored frequently in the first 4 weeks of treatment, and patients should be advised of the signs and symptoms of hyperglycaemia.

In case of new or worsening respiratory symptoms, the patient should be evaluated for pneumonitis.

Patients should be advised to notify their physician if diarrhoea occurs.

Caution should be exercised when Piqray and bisphosphonates or denosumab are used together or sequentially. Piqray should not be initiated in patients with ongoing osteonecrosis of the jaw.

The efficacy and safety of Piqray has not been studied in patients with symptomatic visceral disease.

Animal studies suggest that Piqray may cause fetal harm in pregnant women. Therefore, as a precaution, women of childbearing potential should use effective contraception while receiving Piqray during treatment and at least 1 week after stopping treatment. Women should not breast feed for at least 1 week after the last dose of Piqray. Piqray may affect fertility in males and females.

On July 29, 2020 Alentis Therapeutics, the Swiss biotech developing breakthrough treatments for fibrotic diseases, reported that Dr. Roberto Iacone, has been named Chief Executive Officer (Press release, Alentis Therapeutics, JUL 29, 2020, View Source [SID1234562480]).

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Dr. Iacone is a physician-scientist, a serial entrepreneur and brings more than 15 years life science industry experience to Alentis. Most recently while at Versant Ventures, he co-founded Bright Peak Therapeutics and Ridgeline Therapeutics, and was part of the leadership team that built the precision oncology company Black Diamond Therapeutics from inception through to its NASDAQ IPO in three years. Prior to Versant, Roberto was Roche’s Global Head of Rare Diseases Research, where he established numerous collaborations with academic and biotech partners, which included large and small molecule as well as gene therapy programs.

Welcoming Dr Iacone to the company, Neil Goldsmith, Chairman of the Board of Alentis Therapeutics, said: "Alentis has developed significantly in our first year, with excellent progress in our understanding of the role of Claudin-1 as a novel therapeutic target in fibrosis and hepatobiliary cancers. We have taken major strides in Chemistry and Manufacturing Control (CMC) for our first product, and its safety profile appears very encouraging from the pilot studies conducted to date. We are delighted that Roberto has decided to join our cause, and look forward to further great strides from him and the team. We also would like to thank former CEO Markus Ewert for his fantastic work building the company, portfolio and team."

"We’re very excited that Roberto has joined us to lead the team as the company moves to the next level in its development," said Thomas F. Baumert MD, founder and board member of Alentis Therapeutics, Professor of Medicine and Head of the Inserm Research Institute for Viral and Liver Diseases at the University of Strasbourg. "His entrepreneurial thinking and leadership experience will rapidly advance the Alentis portfolio into the clinic addressing key unmet medical needs to improve patients’ lives and outcomes."

"The recent advances in science enable novel therapies to treat and reverse fibrosis, which is central to multiple diseases as well as several life-threatening cancers such as hepatocellular carcinoma and cholangiocarcinoma," said Dr. Iacone. "Alentis has developed a tremendous portfolio and platform to develop breakthrough treatments for fibrotic diseases."

He added that following the foundation of the company one year ago, the development of Alentis’ lead compound has markedly advanced with completed preclinical in vivo proof-of-concept studies for liver and kidney fibrosis, fibrosis-driven hepatobiliary cancer and extensive safety studies.

"As we now transition towards a clinical-stage company, I look forward to working with the team and board, our collaborators, and the investors, to realise the potential benefit for patients," said Dr. Iacone.

"Roberto’s expertise in developing drugs in biotech, pharma and VC will be most valuable in effectively translating Alentis Therapeutics’ most promising research and its assets into clinical benefit for patients as well as commercial value," said Dr. A. Wallnöfer, General Partner at BioMed Partners VC and former Head of Clinical Research & Exploratory Development at F. Hoffmann-La Roche.

Roberto holds an M.D. from the University of Naples, and a PhD from the Max Planck Research School for Molecular Cell Biology and Genetics.

On July 29, 2020 AskAt Inc. (AskAt) received a notice of allowance dated July 21, 2020 from the Brazilian National Institute of Industrial Property (NIIP) in connection with Application No. PI1014174-0, a use patent for AskAt’s EP4 antagonists in the treatment of epithelial cancers (Press release, AskAt, JUL 29, 2020, View Source [SID1234562479]).

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Clinical Development of Grapiprant for Cancer Immunotherapy Ikena Oncology (formally Kyn Therapeutics, a parent company of Arrys Therapeutics, which licensed worldwide rights to AskAt’s EP4 antagonists except in China) and Ningbo NewBay Pharmaceutical Co. Ltd. (a subsidiary of Ningbo Tai Kang Medical Technology Co. Ltd., which licensed AskAt’s EP4 antagonists for cancer use in China), are currently conducting clinical studies of grapiprant (IK-007/RMX1002) in the U.S. and China, respectively.

On July 29, 2020 Cancer Research UK, the University of Southampton(link is external) and Touchlight Genetics(link is external), a London based biotechnology company reported a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC) (Press release, Cancer Research UK, JUL 29, 2020, View Source [SID1234562478]).

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"We expect that this trial will deliver fundamental insights into how we can use cancer vaccines in the most optimal way so we can boost survival for people with head and neck cancer." – Professor Christian Ottensmeier, Chief Clinical Investigator at the University of Southampton

HNSCC is the UK’s eighth most common cancer, but treatment options are limited and around 4,000 of those affected in the UK die each year. Whilst existing immunotherapies have a huge impact for a small number of cancer patients, it is hoped that targeted cancer vaccines could extend this benefit to many more people.

DNA cancer vaccines encode antigens from cancer cells that prime the immune system, waking up immune cells that can tackle cancer. These therapies have shown significant promise in clinical studies. However, to date, they have been based on circular plasmid DNA, which means their use is limited by slow and expensive manufacturing.*

The newly designed DNA vaccine combines potent cancer antigens with Touchlight Genetics’ novel DNA vector – Doggybone DNA (dbDNA). Unlike plasmid DNA vectors, dbDNA is a double-stranded, linear, covalently closed molecule, which is an optimal vector for advanced therapies.**

TGL-100 encodes two antigens overexpressed in HNSCC to induce an antigen-specific anti-tumour immune response in the body. This preclinical development was led by Dr Natalia Savelyeva at the Centre for Cancer Immunology(link is external) at the University of Southampton in partnership with Dr Kue Peng Lim at Cancer Research Malaysia(link is external), and the clinical trial will be led by Professor Christian Ottensmeier.

Jonny Ohlson, CEO of Touchlight Genetics said: "TGL-100 emerged from a collaboration with the brilliant Christian Ottensmeier and his talented team at the University of Southampton. Partnering with Cancer Research UK will provide the regulatory know-how, clinical expertise and operational capability to help translate this potentially transformative class of personalised therapies into patient benefit."

Under the terms of the agreement, Cancer Research UK’s Centre for Drug Development will sponsor and manage the Phase I/II trial to test TGL-100 in HNSCC patients with recurrent metastatic disease.***

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "We’re delighted to be working with Touchlight Genetics and the University of Southampton at the forefront of oncology innovation. Through our collaboration we’ve been able to accelerate the development of this promising experimental vaccine and hope to see benefit for patients with HNSCC, a cancer that is hard to treat."

The proposed clinical trial will test a new combination strategy of vaccination alongside a currently available PD-1 checkpoint inhibitor. This combination could markedly improve a HNSCC patient’s response to the checkpoint inhibitor and could lead to patients living longer.

Professor Christian Ottensmeier, Chief Clinical Investigator at the University of Southampton, said: "We hope this new DNA cancer vaccine will wake up immune cells already present at the tumour site and train new T cells to travel to the cancer tissue so they can fight the cancer.

"We expect that this trial will deliver fundamental insights into how we can use cancer vaccines in the most optimal way so we can boost survival for people with head and neck cancer."

On July 29, 2020 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported that it is commencing an underwritten public offering of $325,000,000 of common shares (Press release, CRISPR Therapeutics, JUL 29, 2020, View Source [SID1234561579]). In addition, the underwriters will have a 30-day option to purchase up to an additional $48,750,000 of common shares at the public offering price less the underwriting discount.

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Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

The common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. A copy of the prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].