On May 25, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported it has entered into a multi-program research collaboration and license agreement with Genentech, a member of the Roche Group, to discover, develop and commercialize locally delivered respiratory and ophthalmology therapies that leverage Pieris’ proprietary Anticalin technology (Press release, Pieris Pharmaceuticals, MAY 25, 2021, View Source [SID1234580556]).

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The research collaboration will enable Pieris to combine its robust discovery engine with Genentech’s targets, as well as its preclinical and clinical development expertise, to create novel therapies for the treatment of respiratory and ophthalmological diseases. These two focus areas of the collaboration are uniquely suited to the advantages offered by the small size of Anticalin proteins when delivered locally.

"We look forward to working closely with Genentech on the development of new inhaled and ophthalmological treatments based on the Anticalin platform. This collaboration further expands our partnered efforts in respiratory diseases and opens a new avenue for our Anticalin technology to potentially provide patient benefit through local biological effects. This is our second respiratory alliance with a major biopharma company, and we remain deeply committed to inhaled biologics, which have already shown benefit in the clinic. We also look forward to pursuing another local application of our technology in ophthalmology, where Genentech has extensive capabilities," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

"Genentech has a longstanding commitment to understanding the underlying biology of respiratory and ocular diseases and translating this expertise into treatments for patients," said James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche. "We are excited to partner with Pieris Pharmaceuticals to advance potential new therapies that we hope could make a significant difference in the lives of people who need them."

Under the terms of the agreement, Pieris will receive $20 million as an upfront payment and may be eligible to receive more than $1.4 billion in additional milestone payments across multiple programs, as well as tiered royalties for commercialized programs. Pieris will be responsible for discovery research and early preclinical development of the programs, and Genentech will be responsible for IND-enabling activities, clinical development, and commercialization of those programs. Genentech will also have the option to select additional targets in return for an option exercise fee. The collaboration does not include any of Pieris’ internal programs.

On May 25, 2021 -Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with GT Medical Technologies, Inc., to develop Tumor Treating Fields (TTFields) together with GT Medical Technologies’ GammaTile Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent glioblastoma (GBM) (Press release, NovoCure, MAY 25, 2021, View Source [SID1234580572]). Novocure’s TTFields are electric fields that disrupt cancer cell division. GammaTile is an FDA-cleared therapy for the treatment of all types of brain tumors.

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"Our collaboration with GT Medical Technologies is an exciting and important opportunity to test the radio-sensitizing effect of Tumor Treating Fields, which will be applied for at least two weeks prior to resection and GammaTile implantation," said William Doyle, Novocure’s Executive Chairman. "This trial is designed to build additional evidence of the effectiveness of Tumor Treating Fields plus radiation therapy and to explore the potential to further extend survival for recurrent GBM patients."

Novocure and GT Medical Technologies plan to conduct a phase 2 pilot study to test the effectiveness and safety of neo-adjuvant TTFields followed by resection, GammaTile Therapy, and adjuvant TTFields for recurrent GBM. The study is designed to enroll approximately 55 patients in the United States. Progression free survival (PFS) for the intent-to-treat population is the primary endpoint of the study. Secondary endpoints include overall survival, PFS for per protocol patients, time to progression, six-month survival rate, one-year survival rate, PFS at six months, and safety.

"GT Medical Technologies is enthusiastic about the potential of these combined therapies," said Matthew E. Likens, President and CEO of GT Medical Technologies. "This trial is a great opportunity to expand care and therapeutic options for recurrent GBM patients. GammaTile delivers 50 percent of the radiation within 10 days of resection, which we believe maximizes patient outcomes while improving local tumor control and access to care. We are pleased to partner with Novocure in this pursuit."

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 is 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 broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.

On May 25, 2021 Ascletis Pharma Inc. (HKEX code: 1672) reported that following the consultation with China National Medical Products Administration (NMPA), the clinical trial application of ASC40 combined with bevacizumab to treat patients with recurrent glioblastoma (rGBM) has been accepted for review by China NMPA (Press release, Ascletis, MAY 25, 2021, View Source [SID1234580504]).

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Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including rGBM, non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.

ASC40 (known as TVB-2640 outside China) is a potent, selective and safe oral small molecule inhibitor of FASN. The positive results were demonstrated from the investigator sponsored Phase II trial of ASC40 (TVB-2640) in combination with bevacizumab in patients with first relapse of high-grade astrocytoma i.e. rGBM, which was completed in the United States (ClinicalTrials.gov Identifier: NCT03032484). The data from this Phase II trial have shown that the overall response rate (ORR) for ASC40(TVB-2640) plus bevacizumab was 65% including the complete response (CR) of 20% and partial response (PR) of 45%. Furthermore, the data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus bevacizumab was 47%, representing a statistically significant improvement in PFS6 over historical bevacizumab monotherapy (BELOB16%, P=0.01). ASC40 (TVB-2640) in combination with bevacizumab was safe and well tolerated in such patient population.

"Since the announcement on March 30 this year for investment escalation in R&D of cancer lipid metabolism and oral checkpoint inhibitors, this is a key step forward for the Company’s oncology pipeline." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

On May 25, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will host a virtual Investor Event on Tuesday, June 8, 2021 at 1 p.m. ET to discuss data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Bristol-Myers Squibb, MAY 25, 2021, View Source [SID1234580523]).

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Company executives will provide an overview of data presented from the company’s oncology portfolio and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at View Source Materials related to the webcast will be available at the same website prior to the event. An archived edition of the Investor Event will be available later that day.

On May 25, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron") reported that it has sold $150 million of senior unsecured convertible promissory notes (the "Notes") in a private placement transaction (Press release, Heron Therapeutics, MAY 25, 2021, View Source [SID1234580541]). The Notes are convertible into shares of Heron common stock at a conversion price of $15.276 per share, which represents a 13% premium over the most recent closing price of Heron’s common stock. Proceeds from the sale of the Notes will be used for the commercial launch of ZYNRELEFTM (bupivacaine and meloxicam) extended-release solution, as well as for general working capital.

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The Notes will be senior, unsecured obligations of Heron and will accrue interest at a rate of 1.5% per annum, payable semi-annually in arrears. The Notes will mature on June 1, 2026, unless earlier redeemed, converted or repurchased. Holders will have the right to convert their Notes at any time. Heron will settle conversions solely in shares of its common stock, except for payments of cash in lieu of fractional shares.

"Based on sales projections for our three commercial products, these funds allow the company to not only fully implement its launch plans for ZYNRELEF, but should also be sufficient to reach profitability," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In the first 24 hours after announcing FDA approval, ZYNRELEF received its first formulary approval for unrestricted use. We are confident that this is the first of many formulary approvals."

The offer and sale of the Notes and any shares of common stock issuable upon conversion of the Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any other securities laws, and the Notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the Notes or any shares of common stock issuable upon conversion of the Notes, nor will there be any sale of the Notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

J. Wood Capital Advisors LLC acted as financial advisor and Gibson, Dunn & Crutcher LLP acted as legal advisor to Heron on the transaction.