On July 7, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX) reported that it intends to offer, subject to market and other conditions, $300.0 million aggregate principal amount of convertible senior notes due 2025 (the "notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Pacira Pharmaceuticals, JUL 7, 2020, View Source [SID1234561722]). Pacira also intends to grant the initial purchasers of the notes a 30-day option to purchase up to an additional $45.0 million aggregate principal amount of notes.

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The terms of the notes, including the interest rate, initial conversion rate and other terms, will be determined by negotiations between Pacira and the initial purchasers of the notes.

Pacira intends to use a portion of the net proceeds from the offering to repurchase a portion of its outstanding 2.375% Convertible Senior Notes due 2022 (the "2022 Notes") concurrently with the pricing of the offering in privately negotiated transactions effected through one of the initial purchasers of the notes or its affiliate, as Pacira’s agent. Pacira intends to use the remainder of the net proceeds from the offering for general corporate purposes, including working capital, research and development expenditures and the license or acquisition of complementary products and/or technologies. Holders of the 2022 Notes that are repurchased in the concurrent repurchases described above may purchase shares of Pacira’s common stock in the open market to unwind any hedge positions they may have with respect to the 2022 Notes. These activities may affect the trading price of Pacira common stock and, if conducted concurrently with this offering, may result in a higher initial conversion price for the notes Pacira is offering.

This offering is being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of Pacira common stock, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or any state securities laws, and, unless so registered, the notes and such shares may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

On July 7, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported a reduction in workforce of approximately 30% of its head count to focus on development of its first-in-class PDK1 inhibitor SNS-510 (Press release, Sunesis, JUL 7, 2020, View Source [SID1234561720]).

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The reduction in workforce is to right size the Company to achieve its objectives and preserve cash resources. The reduction in workforce is expected to be completed during the current quarter and will provide the Company sufficient cash to fund its operations into the second quarter of 2021.

"The changes we are undertaking will extend our cash runway and provide us with the necessary resources to execute on our PDK1 program, while also allowing the flexibility to explore opportunities for additional value creation," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "We thank our affected employees for their contributions and wish them success in their future endeavors."

The Company also plans to review strategic alternatives to maximize shareholder value that can include asset in-licensing, partnering, acquisitions and mergers. There can be no assurance that the strategic review will result in any transaction or other outcome. The Company does not currently intend to publicly discuss or disclose further developments of the strategic review unless and until its Board of Directors has approved a transaction or otherwise determined that further disclosure is appropriate.

"We are committed to evaluating strategic alternatives that enhance value for shareholders as the development organization is focused on advancing SNS-510 to an IND. We are also continuing to explore a path forward for vecabrutinib," said Mr. Misfeldt.

About SNS-510

SNS-510 is a PDK1 inhibitor licensed from Millennium Pharmaceuticals, Inc. ("Takeda Oncology"), a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited. SNS-510 interaction with PDK1 inhibits both PI3K signaling and PIP3-independent pathways integral to many malignancies, and PDK1 can also be overexpressed in breast, lung, prostate, hematologic and other cancers. Evaluation of SNS-510 in the Eurofins Oncopanel, a panel of >300 genomically profiled cancer cell lines from diverse tissue origins, indicated that CDKN2A-mutated tumors are particularly sensitive to SNS-510. CDKN2A alterations are common in human cancers and may prove to be useful biomarkers for broad investigation of SNS-510 as a monotherapy and in combination with other anticancer agents. Sunesis is conducting an Investigational New Drug ("IND")-enabling program for SNS-510.

On July 7, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported they have entered a multi-year deal with Merck KGaA, Darmstadt, Germany under which Merck KGaA, Darmstadt, Germany will provide cetuximab to Rakuten Medical for its ASP-1929 program (Press release, Rakuten Medical, JUL 7, 2020, View Source [SID1234561719]). Rakuten Medical uses cetuximab in an intermediate form as the antibody component in its product candidate ASP-1929, an investigational antibody-dye conjugate being studied for the treatment of recurrent, locoregional head and neck cancers. Under this agreement, Rakuten Medical may use cetuximab to produce ASP-1929 for clinical trials and commercial sales.

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Earlier this year at the World Economic Forum in Davos, Rakuten Medical and Merck KGaA, Darmstadt, Germany memorialized their intent to join forces to explore ways to help patients conquer cancer. "Rakuten Medical is excited to partner with Merck KGaA, Darmstadt, Germany, a leading science and technology company," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "Rakuten Medical is committed to partnering with world class companies such as Merck KGaA, Darmstadt, Germany in order to carry forward its mission to conquer cancer."

Rakuten Medical’s ASP-1929 combines cetuximab and a light activatable dye, IRDye 700DX. Cetuximab, a monoclonal antibody, targets and binds specifically to the epidermal growth factor receptors (EGFR), which are overexpressed in several cancers. After binding to EGFR-expressing cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by an investigational laser device system. Pre-clinical data indicate that illumination of ASP-1929 induces a biophysical process that compromises cell membrane integrity, leading to cancer cell death and tumor necrosis.

On July 7, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the first patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) with spliceosome mutations, such as SF3B1 and U2AF1, that drive expression of the long isoform of IRAK4 (IRAK4-L) (Press release, Curis, JUL 7, 2020, View Source [SID1234561717]). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, and these pathways are frequently dysregulated in patients with AML and MDS.

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"When Drs. Daniel Starczynowski, Professor, Cincinnati Children’s Hospital and Amit Verma, Director of the Division of Hematologic Malignancies at the Albert Einstein College of Medicine, demonstrated the important pathogenic role of IRAK4 in MDS/AML in their seminal publication in Nature Cell Biology and presentation at ASH (Free ASH Whitepaper) last December, everyone in the AML/MDS community paid attention, including our team at Curis," said James Dentzer, President and Chief Executive Officer of Curis. "Dr. Starczynowski, Dr. Verma, and their colleagues showed that IRAK4-L, the oncogenic long isoform of IRAK-4, is expressed as a result of specific spliceosome mutations common in AML and MDS. Further, they demonstrated that it potentially impacts over 50% of the AML/MDS population. We quickly worked with our clinical investigators and the U.S. Food and Drug Administration (FDA) to design a study of CA-4948, our first-in-class IRAK4 inhibitor, in this population. We are pleased to announce today, just six months later, that we have initiated this new study and successfully dosed our first patient. The initial dose in this study is 200mg twice-daily (BID) which, based on our preclinical models, we believe may be a therapeutic dose level. As a result, we expect to report initial efficacy data by the end of the year."

"Historically, no single oncogenic driver of AML and MDS has been known to impact the majority of patients," said Dr. Guillermo Garcia-Manero, Chief, Section of Myelodysplastic Syndromes at the University of Texas MD Anderson Cancer Center. "Recent studies have changed this understanding. The long isoform of IRAK4, itself the result of specific genetic mutations, was recently discovered to be a driver of disease in over half the population of patients with AML and MDS. With CA-4948, we may now have a single drug that can directly target a key driver of disease in these patients. We are delighted to be a lead clinical site in the study of this novel new drug."

About the CA-4948 Phase 1 Clinical Trial

The Phase 1 trial is an open-label, dose escalation study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of CA-4948 in patients with AML and high-risk MDS. The primary objective of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of CA-4948 based on safety and tolerability, dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic findings. A minimum of three patients will be enrolled at each dose level, starting with 200 mg BID, which was determined to be safe, capable of achieving relevant levels of drug exposure, and demonstrated signs of biologic activity and clinical efficacy in a separate, ongoing Phase 1 study. Each treatment cycle will be 28 days in length and repeated in the absence of toxicity. Initial data from the study is expected in the fourth quarter of 2020.

On July 7, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ: ZLAB), an innovative commercial-stage biopharmaceutical company, reported an exclusive license agreement for the development and commercialization of Turning Point’s lead drug candidate, repotrectinib, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan (Press release, Zai Laboratory, JUL 7, 2020, View Source [SID1234561716]).

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Under the terms of the agreement, Zai Lab will obtain exclusive rights to develop and commercialize repotrectinib in Greater China and Turning Point Therapeutics will receive a $25 million upfront payment, with potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in Greater China.

"With more than 700,000 newly diagnosed lung cancer patients every year in Greater China, and the development and commercialization capabilities Zai Lab have shown over time in the region, we view Zai Lab as the ideal partner to help expand the potential reach of repotrectinib," said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point Therapeutics. "Our collaboration with Zai Lab is a strategic step to potentially accelerate the development of repotrectinib in Greater China."

Zai Lab anticipates opening additional sites for the TRIDENT-1 Phase 2 registrational clinical study of repotrectinib. The ongoing study is currently active in 11 countries globally and enrolling patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive solid tumors.

"We are very pleased to enter into this agreement with Turning Point Therapeutics. Repotrectinib is highly synergistic with Zai’s existing pipeline and further strengthens our disease area strongholds across most common tumor types in China, particularly in lung cancer. We are looking forward to bringing this potential best-in-class agent in the front-line setting and for patients previously treated with an tyrosine kinase inhibitor (TKI) where there are no approved targeted therapies," said Samantha Du, Ph.D., Founder, Chairwoman and Chief Executive Officer of Zai Lab.

"In China, there is only one approved targeted therapy for patients with advanced ROS1-positive lung cancer and despite its efficacy, most patients eventually acquire resistance," said Dr. Lu Shun, Director of Chinese Lung Cancer Association. "The unmet need in the ROS1-positive lung cancer patient population is significant. The preliminary clinical activity and safety data generated to date for repotrectinib represent a promising clinical profile. If approved, repotrectinib has the potential to be the standard of care for ROS1-positive patients with advanced non-small cell lung cancer in China."

About Repotrectinib

Repotrectinib is an investigational next-generation TKI designed to effectively target ROS1 and TRK A/B/C with potential to treat TKI-naïve or -pretreated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC in China, and NTRK is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors in China.

Utilizing a 22 July 2019 data cut-off, data from the Phase 1 portion of TRIDENT-1 demonstrated the potential for repotrectinib to be best-in-class for the treatment of ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI, with a 91 percent overall response rate by blinded independent central review, a median duration of response of 23.1 months, a median progression-free survival of 24.6 months, and a generally well-tolerated adverse-event profile.