On July 7, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported the e-publication of results from a Phase 1 company-sponsored study of oral rigosertib in combination with standard dose azacitidine in the treatment of patients diagnosed with either higher-risk myelodysplastic syndrome (HR-MDS) or acute myeloid leukemia (AML) in the international hematological malignancy journal Leukemia Research (Press release, Onconova, JUL 7, 2020, View Source [SID1234561724]).

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"A key strategy emerging in the treatment of MDS is the identification of safe and effective combinations, particularly those involving oral agents. The results from this Phase 1 study represent Onconova’s first efforts to explore oral rigosertib in combination with azacitidine to address the unmet medical need in patients with MDS and AML. We anticipate meeting with the FDA, in conjunction with the pivotal data readout from the INSPIRE Trial, for alignment with the agency on a registration trial for the combination of oral rigosertib plus azacitidine in HMA-naïve HR-MDS," said Steven M. Fruchtman, M.D., President and CEO of Onconova.

"These results coupled with preliminary data from the phase II studies, support further clinical development of this novel combination with a manageable safety profile and efficacy in patients with MDS both those HMA naïve and after HMA failure," said study principal investigator Lewis R. Silverman, M.D., Director, Translational Research Center for the Myelodysplastic Syndrome, Associate Professor, Medicine, Hematology, and Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. "The oral administration of rigosertib is not just more convenient for patients, but may improve treatment compliance, leading to improved clinical outcomes."

This publication reports the results of an open-label, dose-escalating Phase 1 study with the combination oral of rigosertib and standard dose azacitidine administered sequentially to patients diagnosed with HR-MDS following HMA-failure, or relapsed/refractory AML. The study objectives were to assess safety and determine the recommended Phase 2 dose (RP2D) for future studies. The study evaluated three dose cohorts of oral rigosertib with no dose-limiting toxicities reported. In addition, the oral rigosertib/azacitidine combination demonstrated an overall response rate of 7/9 (78%) in patients with HR-MDS and 2/7 (29%) in patients with AML. The Phase 2 part of the study is ongoing. Additional details are available on www.clinicaltrials.gov (NCT01926587).

"We believe this combination could eventually prove very beneficial for patients with higher-risk MDS. In addition to its oral formulation and thus ease of administration, rigosertib is potentially an attractive partner for a variety of combination approaches due to its novel mechanism of action as a RAS mimetic that differentiates it from other MDS therapies," said Richard C. Woodman, M.D., Chief Medical Officer of Onconova.

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model reported rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in HMA naive and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

On July 7, 2020 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin therapeutics, reported that it has successfully placed 5,528,089 registered shares (the New Shares), corresponding to approximately 25% of the company’s currently registered share capital, by way of an accelerated bookbuilding process (the Offering), at an offering price of CHF 14.50 per share (Press release, Molecular Partners, JUL 7, 2020, View Source(SIX%3A%20MOLN,25%25%20of%20the%20company’s%20currently [SID1234561723]). The gross proceeds of the Offering, before deducting commissions and offering expenses, amount to approximately CHF 80.2 million (~USD 85.1 million). The offering included participation by new and existing institutional investors in Switzerland, the United States and the European Union, including Suvretta Capital Management, LLC, Camber Capital Management LP, BVF Partners L.P., Federated Hermes Kaufmann Funds and Monashee Investment Management LLC.

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The New Shares will be issued from existing authorized share capital of the company under exclusion of the existing shareholders’ pre-emptive rights.

SVB Leerink LLC, Cowen and Company, LLC, Credit Suisse AG and Van Lanschot Kempen Wealth Management N.V. acted as Joint Bookrunners. HC Wainwright & Co. and Octavian AG served as Financial Advisors.

The New Shares are expected to be listed and admitted to trading on SIX Swiss Exchange as of July 9, 2020. Payment and settlement is expected to take place on the same date. Molecular Partners AG intends to use the net proceeds from the Offering to fund R&D activities, in particular to accelerate
its early stage pipeline, as well as for general corporate purposes.

The company, members of the board of directors and members of the management board have agreed to a 90-day lock-up period after settlement of the New Shares, subject to certain customary exceptions.

The New Shares were offered exclusively to (a) professional investors in Switzerland on the basis of applicable exemptions from the prospectus requirements under the Swiss Financial Services Act and outside of the United States in compliance with Regulation S under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act), (b) certain qualifying investors outside of Switzerland and outside of the United States by way of private offerings in reliance on Regulation S under the U.S. Securities Act and exemptions from prospectus, registration and/or filing requirements available under local securities laws and (c) a limited number of persons within the United States who are reasonably believed to be qualified institutional buyers in a private placement pursuant to Section 4(a)(2) of the U.S. Securities Act or pursuant to another exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act.

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.