On March 16, 2020 Varian (NYSE: VAR) reported it was selected to equip the new Ethos Personalized Adaptive Therapy Center in Phoenix, Arizona, and help launch a new era in cancer treatment for patients in the region (Press release, Varian Medical Systems, MAR 16, 2020, View Source [SID1234555613]). Ethos therapy provides the ability to personalize the patient’s radiation treatments based on their anatomy and the tumor’s shape and position on a daily basis at the time of treatment. The goal is to better target the tumor, reduce dose to healthy tissue, and potentially improve overall patient outcomes.

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This new center will be equipped with Varian’s Ethos therapy. This artificial intelligence (AI)-driven holistic adaptive therapy solution is designed to deliver an entire adapted treatment for daily personalized radiation therapy in a typical 15-minute timeslot.

"We are excited to be opening this new center to bring a new level of personalized care to all cancer patients in Arizona and proud to be among the first clinics to offer Ethos therapy in the United States," said John Kresl MD PhD, senior partner and medical director at Palo Verde Cancer Specialists and Phoenix CyberKnife Center. "Ethos therapy will continue to enable our physicians to be the leaders in providing the latest state-of-the-art tumor focused radiation therapy by better visualizing the daily changes in a patient’s anatomy and quickly adapt their therapy right on the spot, thereby potentially providing better treatments to our patients. We initially plan to use Ethos therapy for pancreas, prostate, breast, head & neck, and lung cancer treatments."

"Every patient deserves personalized cancer care," said Chris Toth, president Varian Oncology Systems. "The launch of Ethos therapy was a transformational moment for cancer care, and we are honored to be working with this new center to bring these adaptive treatments to patients in Arizona and help us move closer to creating a world without fear of cancer."

On March 16, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported the closing of its previously announced underwritten public offering of 7,500,000 shares of its common stock, at a price to the public of $0.60 per share (Press release, Apricus Biosciences, MAR 16, 2020, View Source [SID1234555593]). The net proceeds to Seelos from this offering are expected to be approximately $3.9 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by Seelos. Seelos intends to use the net proceeds from the offering for general corporate purposes and to advance the development of its product candidates.

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Benchmark Company acted as sole book-running manager for the offering.

The securities described above were offered by Seelos pursuant to a "shelf" registration statement on Form S-3 (File No. 333-221285) previously filed with the Securities and Exchange Commission (the "SEC") on November 2, 2017, amended on December 1, 2017 and declared effective by the SEC on December 7, 2017. A final prospectus supplement and the accompanying prospectus relating to and describing the offering was filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained by visiting the SEC’s website at www.sec.gov or by contacting The Benchmark Company, LLC, Attn: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On March 16, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and utilizing a product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it has submitted a request for a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss the trial design for a potential pivotal study of envafolimab in sarcoma (ENVASARC) (Press release, Tracon Pharmaceuticals, MAR 16, 2020, View Source [SID1234555614]).

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TRACON plans to propose a pivotal trial with two cohorts of approximately 80 patients each to assess the objective response rate in sarcoma subtypes known to be responsive to checkpoint inhibition, with one cohort receiving single-agent envafolimab and the second cohort receiving envafolimab and Yervoy (ipilimumab).

"We have taken the first step towards beginning the ENVASARC study of envafolimab in sarcoma subtypes known to respond to checkpoint inhibitors. This initiates a series of expected events that we anticipate will culminate in dosing the first patient in a potential pivotal trial in the second half of the year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We believe the proposed study design that utilizes two cohorts provides for greater treatment options for patients and lowers envafolimab’s clinical risk by providing two potential pathways for approval."

Expected Upcoming Envafolimab Milestones Over the Next 6 Months

Type B meeting with the FDA to discuss the potential pivotal trial design of ENVASARC for envafolimab
File IND for envafolimab to conduct the planned ENVASARC study
Apply for orphan drug designation for envafolimab in soft tissue sarcoma
Submission of regulatory approval for envafolimab in China by our partners, 3D Medicine and Alphamab Oncology
Presentation of envafolimab clinical data at ASCO (Free ASCO Whitepaper) by our partners 3D Medicine and Alphamab Oncology
Enroll the first patient in ENVASARC, a potential pivotal trial of envafolimab
About Envafolimab

Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently being dosed in Phase 1 trials in the U.S., China and Japan, a Phase 2 registration trial as a single agent in MSI-H tumor patients in China, and in a Phase 3 registration trial in biliary tract cancer in combination with gemcitabine and oxaliplatin in China. Subject to positive data from the MSI-H registrational trial, 3D Medicines has stated that it plans to file a BLA in China for envafolimab in 2020 based on overall response rate in MSI-H patients. The filing is predicated on the principle that the response rate required for approval in China is similar to the response rate for Keytruda and Opdivo in MSI-H patients from separate clinical trials per the product package inserts.

On March 16, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial and operational highlights for the fourth quarter and year-ended Dec. 31, 2019 (Press release, Turning Point Therapeutics, MAR 16, 2020, View Source [SID1234564377]).

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"I am very pleased with all we accomplished in 2019, and in 2020 we are focused on clinical trial and pipeline advancement," said Athena Countouriotis, M.D., president and chief executive officer. "As we advance our clinical programs with site activations and patient enrollment across our three clinical stage assets, we remain pleased with our progress but are in close contact with our CROs and sites as we navigate and assess the impact of COVID-19 on our studies and current timelines."

Fourth quarter 2019 and recent highlights include:

Ongoing site activations and enrollment in the Phase 2 registrational portion of the TRIDENT-1 study of repotrectinib. The study is planned at approximately 100 global sites with enrollment of approximately 320 ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive advanced solid tumor patients. Approximately 40 percent of planned sites are now active.

Fast Track designation granted by the U.S. Food and Drug Administration for the treatment of ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 tyrosine kinase inhibitor (TKI). There are currently no approved targeted therapies for TKI-pretreated ROS1-positive NSCLC patients.

Ongoing progress in the Phase 1 study of TPX-0022, Turning Point’s MET/CSF1R/SRC inhibitor; and Phase 1/2 study of TPX-0046, Turning Point’s RET/SRC inhibitor trial. Both studies have now enrolled both TKI-naïve and pretreated patients. For TPX-0046, the company previously announced that enrollment had also included RET-positive patients with solvent-front mutations previously treated with other investigational RET inhibitors.

Nomination of TPX-0131, a next-generation ALK inhibitor candidate. TPX-0131 has been designed with a compact macrocyclic structure and in preclinical studies has been shown to potently inhibit wildtype ALK and numerous ALK mutations, in particular the clinically observed G1202R solvent-front mutation and G1202R/L1196M compound mutation.

Acceptance of three abstracts for presentation at the AACR (Free AACR Whitepaper) Annual Meeting, including preclinical repotrectinib combination data and preclinical data for TPX-0131. In light of the postponement of AACR (Free AACR Whitepaper)’s Annual Meeting, these data are planned for presentation by the company in the second quarter.

Naming Siegfried Reich, Ph.D. as executive vice president and chief scientific officer. Dr. Reich has over 25 years of pharmaceutical and biotech experience developing more than 20 drug candidates, including the approved drugs Viracept for HIV and the tyrosine kinase inhibitor Inlyta for the treatment of kidney cancer.
Fourth Quarter Financial Update
Operating expenses for the fourth quarter were $23.1 million compared to $9.5 million for the fourth quarter of 2018 and $22.1 million for the third quarter of 2019. The $13.6 million year-over-year increase was primarily due to increased development spend for repotrectinib, TPX-0022 and TPX-0046 as well as personnel expenses that included $4.2 million in non-cash stock-based compensation. Fourth-quarter net cash used in operating activities totaled $14.1 million.

For the year, operating expenses totaled $77.7 million compared to $25.6 million during 2018. The $52.1 million increase was driven by development expenses for repotrectinib, TPX-0022 and TPX-0046 and personnel expenses that included $12.7 million in non-cash stock-based compensation. Net cash used in operating activities was $57.8 million.

Cash, cash equivalents and marketable securities at Dec. 31, 2019 totaled $409.2 million, a decrease of $14.4 million from Sept. 30, 2019. The company continues to project its cash position funds current operations beyond 2021.

Upcoming Milestones
Key milestones anticipated through 2020 include:

Presenting preclinical repotrectinib combination data and preclinical data for TPX-0131 in the second quarter.

Early interim data from initial patients in some of the registrational cohorts of the repotrectinib TRIDENT-1 Phase 2 study during the second half of the year.

Early interim data from initial patients treated with TPX-0022 during the second half of the year.

Submitting the IND for TPX-0131 by early 2021.
Webcast and Conference Call
Turning Point Therapeutics will not host a Quarterly Update conference call this quarter. The company has posted an updated investor presentation on the "Investors" section of tptherapeutics.com.

On March 16, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided a corporate update (Press release, Arvinas, MAR 16, 2020, View Source [SID1234555594]).

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"2019 was an exciting year for Arvinas, marked by tremendous clinical and corporate progress. We were delighted to present the first human clinical data from targeted protein degraders along with preclinical data demonstrating the brain-penetrating potential of our PROTAC protein degraders. These data underscore the potential of our platform to create safe and well-tolerated drugs for the treatment of a variety of life-threatening diseases," said John Houston, Ph.D., Chief Executive Officer of Arvinas.

Business Highlights and Recent Developments

Presented initial clinical safety and pharmacokinetic data for ARV-110 (as a treatment for men with metastatic castration-resistant prostate cancer) and ARV-471 (as a therapy for patients with locally advanced or metastatic ER+/HER2- breast cancer). These data showed that ARV-110 and ARV-471 were well-tolerated and safe for further development at the doses disclosed in October 2019. Further, both PROTAC protein degraders reached exposure levels in human patients that were correlated with tumor inhibition oral regression in preclinical models.

Closed an underwritten public offering of 5,227,273 shares of common stock at a public offering price of $22.00 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Arvinas received net proceeds of approximately $107.6 million, after deducting underwriting discounts and commissions and offering expenses.

Presented preclinical data demonstrating that oligomer-specific PROTAC molecules degraded aggregates of human alpha-synuclein in primary rat neurons.

Announced the appointment of Laurie Smaldone Alsup, M.D., to Arvinas’ board of directors. Dr. Smaldone Alsup currently serves as Chief Scientific Officer and Chief Medical Officer for NDA Group. She brings experience leading commercially successful product approvals and global regulatory strategies that have successfully advanced programs through all stages of clinical development.

Anticipated Milestones and Expectations

For the ARV-110 program, Arvinas expects to share Phase 1 dose escalation clinical data in the second quarter of 2020.

For the ARV-471 program, Arvinas expects to share Phase 1 dose escalation clinical data in the second half of 2020.

In the second half of 2020, Arvinas expects to provide information about the advancement of additional programs in its robust preclinical pipeline.

Financial Guidance

Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2022.

Full Year and Fourth Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities Position: As of December 31, 2019, cash, cash equivalents and marketable securities were $280.9 million as compared with $187.8 million as of December 31, 2018. The increase primarily related to net proceeds from a public offering of common stock of $107.6 million, aggregate proceeds of $51.5 million from a collaboration and license agreement with Bayer and the issuance of common stock to Bayer and collaborator milestone and other payments of $7.8 million, partially offset by cash used to fund operations of approximately $67.6 million and cash used to purchase fixed assets and leasehold improvements of $6.2 million. Cash, cash equivalents, and marketable securities increased by $90.4 million in the fourth quarter of 2019. This increase primarily related to net proceeds from a public offering of common stock of $107.6 million and collaborator milestone and other payments of $2.2 million, partially offset by cash used to fund operations of approximately $17.6 million and cash used to purchase fixed assets and leasehold improvements of $1.8 million.

Research and Development Expenses: Research and development expenses were $67.2 million and $20.4 million for the year and quarter ended December 31, 2019, respectively as compared with $45.2 million and $14.6 million for the year and quarter ended December 31, 2018, respectively. The increase in research and development expenses for the year and quarter primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs and its estrogen receptor (ER) and androgen receptor (AR) clinical development programs.

General and Administrative Expenses: General and administrative expenses were $27.3 million and $7.3 million for the year and quarter ended December 31, 2019, respectively, as compared with $12.9 million and $5.8 million for the year and quarter ended December 31, 2018, respectively. The increase in general and administrative expenses for the year and quarter primarily related to increasing infrastructure costs and being a public company for a full year in 2019.

Revenues: Revenue was $43.0 million and $4.9 million for the year and quarter ended December 31, 2019, respectively, as compared with $14.3 million and $3.4 million for the year and quarter ended December 31, 2018, respectively. Revenue for the year ended December 31, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the PROTAC technology in agricultural applications (the Joint Venture). The remaining revenue of $18.3 million and revenue of $4.9 million for the year and quarter ended December 31, 2019, respectively, was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.

Loss from Equity Method Investment: Loss from equity method investment for the year ended December 31, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint Venture’s expensing the values associated with the contributed intellectual property from the Joint Venture partners.

Net Loss: Net loss was $70.3 million and $21.0 million for the year and quarter ended December 31, 2019, respectively, as compared with $41.5 million and $16.1 million for the year and quarter ended December 31, 2018, respectively. The increase in net loss for the year and quarter primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs, its ER program, its AR program and increase in general and administrative infrastructure costs related to the first full year as a public company offset by an increase in revenue primarily related to the Bayer collaboration that was initiated in July 2019.

About ARV-110

ARV-110 is an orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas’ Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About ARV-471

ARV-471 is an orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic ER+/HER2- breast cancer. Arvinas’ Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints. In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.