On September 14, 2021 Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with Roche (SIX: RO. ROG; OTCQX: RHHBY), to develop Tumor Treating Fields (TTFields) together with Roche’s anti-PD-L1 therapy, atezolizumab, in metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, NovoCure, SEP 14, 2021, View Source [SID1234587679]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and accounts for 85%–95% of all solid pancreatic tumors. As a highly lethal malignancy, it is the seventh leading cause of cancer death worldwide and is responsible for more than 300,000 deaths per year. PDAC is highly resistant to current therapies, affording patients a 5-year overall survival rate of only 7.2%.

"We are pleased to collaborate with Roche, a global leader in oncology, to explore the efficacy of TTFields together with atezolizumab immunotherapy in pancreatic cancer," said William Doyle, Novocure’s Executive Chairman. "The immune-shielded environment of the pancreas has proved challenging for immunotherapies alone to provide benefit. Our phase 2 pilot trial with Roche will study the ability of TTFields together with atezolizumab to improve clinical outcomes for patients with this deadly disease."

The phase 2 study was designed to test the safety and efficacy of TTFields together with atezolizumab, gemcitabine and nab-paclitaxel as a first-line treatment for mPDAC. The study is designed to enroll approximately 75 patients in the EU and United States. The primary endpoint of the study is disease control rate by RECIST 1.1. The secondary endpoints include overall survival, progression free survival, one year survival, objective response rate, PFS at six months, duration of response, and toxicity profile. Novocure is the study sponsor and Roche is providing atezolizumab for the trial.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

On September 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that its Decipher Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer (Press release, Veracyte, SEP 14, 2021, View Source [SID1234587678]). The new guidelines specifically recommend Decipher Prostate RP after radical prostatectomy and that men with high-risk scores (>0.6) should be strongly considered for salvage radiotherapy with the addition of concurrent hormone therapy, when early radiation therapy is missed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled that Decipher Prostate RP is now recommended by the NCCN to guide specific treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, scientific and clinical operations, urologic cancers. "The NCCN’s designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy."

The new NCCN recommendations are based on results of the NRG Oncology Phase 3 randomized controlled trial, RTOG 96-01. This study, which followed patients for a median of 12 years, demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men receiving greater absolute benefit from hormone therapy compared to Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On September 14, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS, will present at the 2021 Cantor Global Healthcare Conference to be held virtually on Tuesday, September 28, 2021, at 4:00 p.m. ET (Press release, Sellas Life Sciences, SEP 14, 2021, View Source [SID1234587676]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For more information about the conference, or to schedule a one-on-one meeting with SELLAS management, please contact your Cantor representative directly, or send an email to Cantor at [email protected] or KCSA Strategic Communications at [email protected].

On September 14, 2021 Sanofi reported the completion of its acquisition of Translate Bio, further accelerating the company’s efforts to develop transformative vaccines and therapies using mRNA technology (Press release, Sanofi, SEP 14, 2021, View Source [SID1234587675]). The acquisition adds a critical pillar to the company’s mRNA Center of Excellence which aims to unlock the potential of next-generation mRNA vaccines and other strategic areas such as immunology, oncology, and rare diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The tender offer for all of the outstanding shares of Translate Bio common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, September 13, 2021. The minimum tender condition and all of the other conditions to the offer have been satisfied and on September 14, 2021, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, Sanofi completed its acquisition of Translate Bio through the merger of a wholly owned subsidiary of Sanofi with and into Translate Bio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Translate Bio continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

In connection with the merger, all Translate Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $38 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of September 14, 2021, Translate Bio common stock will cease to be traded on the NASDAQ Global Select Stock Market.

Morgan Stanley & Co. International plc acted as exclusive financial advisor to Sanofi while Weil, Gotshal & Manges LLP acted as legal counsel. Centerview Partners acted as lead financial advisor to Translate Bio in the transaction, while Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal counsel. Evercore also acted as a financial advisor in this transaction to Translate Bio. MTS Health Partners, LP also gave financial advice to Translate Bio.

On September 14, 2021 LeaderMed Health Group Limited, a pharmaceutical development company with operations based in Asia, and OPKO Health, Inc. (NASDAQ: OPK), a diversified healthcare company focused on diagnostics and pharmaceuticals, reported the formation of a joint venture to develop, manufacture and commercialize two of OPKO’s clinical stage, long-acting drug products in Greater China and eight other Asian territories (Press release, Opko Health, SEP 14, 2021, View Source [SID1234587674]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreements, OPKO will grant the joint venture exclusive rights to develop, manufacture and commercialize (a) OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and (b) Factor VIIa-CTP, a novel long-acting coagulation factor being developed to treat hemophilia, in exchange for a 47% ownership interest in the joint venture. In addition, OPKO will receive an upfront payment of $1 million and will be reimbursed for clinical trial material and technical support it provides the joint venture.

LeaderMed will be responsible for funding the joint venture’s operations, development and commercialization efforts and will, with its syndicate partners, initially invest $11 million in exchange for a 53% ownership interest. OPKO retains full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies.

"Through this joint venture, we have an opportunity to extend the global availability of two of our novel long-acting development products and to establish a presence in China in partnership with collaborators who have significant experience and deep knowledge of the Asian biopharmaceutical opportunity," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.

"LeaderMed Group is an innovative pharmaceutical development company with its own pipeline of licensed products. Our capabilities include an experienced management team with demonstrated success in bringing biopharmaceutical and pharmaceutical products to market in China and globally, cGMP facilities to manufacture clinical-grade products, and a corporate charter that acknowledges and protects client IP. We are excited about the opportunity to expeditiously deliver a novel and superior treatment for obesity and diabetes to hundreds of millions of patients in China and Asia, as well as a treatment for hemophilia, an orphan indication," added Dr. Joanne Jiang, Chief Executive Officer of LeaderMed Group and architect of the joint venture.

About Oxyntomodulin
Oxyntomodulin is a naturally occurring hormone produced in the colon that binds the GLP-1 and glucagon receptors, regulating both blood glucose appetite and lipid metabolism. OPKO Health is developing OPK88003, a long-acting, once-weekly oxyntomodulin analog for the treatment of type 2 diabetes and obesity. OPK88003 has been successfully studied in two Phase 2 clinical trials enrolling type 2 diabetes patients, studying weight loss and reduction in glycosylated hemoglobin (HbA1c or A1c), a marker of sugar metabolism. Driven by the LeaderMed-OPKO joint venture, it is positioned to be the first dual-targeted drug approved for diabetes and obesity in the Chinese and Asia markets.

About Factor VIIa-CTP
Factor VIIa-CTP is a novel, long-acting recombinant Factor VIIa utilizing OPKO’s proprietary technology to extend its circulatory half-life without the use of polymers, encapsulation techniques or nanoparticles. The technology is based on a naturally occurring peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin. The CTP technology is also used in OPKO’s hGH-CTP (somatrogon), a long-acting recombinant human growth hormone product that successfully completed Phase 3 clinical trials in children with growth hormone deficiency. hGH-CTP has been submitted for approval in the United States, Europe and Japan and is partnered with Pfizer for global commercialization. Factor VIIa-CTP has been granted orphan drug designation in the U.S. and Europe.

In China, hemophilia was designated as a rare disease in 2018. LeaderMed expects to seek fast regulatory approval for Factor VIIa-CTP through a special national rare disease channel.