On March 12, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Leap Therapeutics, MAR 12, 2021, View Source [SID1234576587]).

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2020 Leap Highlights:

Signed agreement with BeiGene, Ltd. for rights to Leap’s anti-DKK1 antibody, DKN-01, in Asia (excluding Japan), Australia and New Zealand
Completed a $51.75 million public offering of common stock and pre-funded warrants to purchase common stock
Presented updated data from study of DKN-01 plus pembrolizumab in esophagogastric (EGC) cancer demonstrating positive outcomes in DKK1-high patients
Data for DKN-01 in endometrial cancer demonstrates single agent activity in biomarker-selected patients
First patient dosed in Phase 2a study of DKN-01 in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, for the treatment of metastatic gastric or gastroesophageal junction (G/GEJ) cancer
Received Orphan Drug Designation and Fast Track Designation for DKN-01 from FDA
"2020 was a transformative year for Leap as we executed our first strategic alliance with BeiGene and advanced our DKN-01 development program, initiating our Phase 2a combination study with BeiGene’s tislelizumab in gastric cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "The data for DKN-01 to date, both as a monotherapy and in combination approaches, provide evidence of the potential utility of DKN-01 as an attractive treatment option for multiple biomarker-focused cancer indications."

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin and PI3K/AKT signaling pathways. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.

Leap and BeiGene Announced First Patient Dosed in Study of DKN-01 in Combination with Tislelizumab for the Treatment of Metastatic Gastric/Gastroesophageal Junction (G/GEJ) Cancer – In September 2020, Leap and BeiGene announced that the first patient was dosed in the DisTinGuish trial (NCT04363801), a Phase 2a, nonrandomized, open-label, multicenter study of Leap’s DKN-01 in combination with BeiGene’s tislelizumab with or without chemotherapy as first-line or second-line therapy in adult patients with inoperable, locally advanced G/GEJ adenocarcinoma. The study, which will be conducted in two parts, is currently evaluating approximately forty patients with second-line G/GEJ cancer whose tumors are DKK1-high per perspective analysis. In addition, the study is evaluating the combination of DKN-01 with tislelizumab and capecitabine and oxaliplatin in approximately twenty patients with first-line G/GEJ cancer. Initial data is expected in the second half of 2021.

Leap Presented Updated Data from DKN-01 in EGC Demonstrating Positive Outcomes in DKK1-high Patients – At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, Leap presented clinical data from the Phase 1b/2a clinical trial of DKN-01 in patients with advanced EGC. In the study, high levels of tumoral DKK1 expression correlated with improved clinical outcomes in heterogeneous EGC patients treated with DKN-01 monotherapy or in combination with paclitaxel or the anti-PD-1 antibody, pembrolizumab.

Leap Presented Updated Data for DKN-01 in Endometrial Cancer Demonstrating Single Agent Activity in Biomarker-selected Patients – At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference on Endometrial Cancer: New Biology Driving Research and Treatment, Leap presented additional clinical data from the epithelial endometrial cancer (EEC) patients treated with DKN-01 monotherapy as part of its ongoing Phase 2 clinical trial for DKN-01, as both a monotherapy and in combination with paclitaxel chemotherapy, in patients with advanced gynecological malignancies. In the study, DKN-01 demonstrated single agent activity in biomarker-selected EEC patients, including an ongoing complete response that is over 2.5 years in duration and prolonged progression-free survival. Additional data from this study will be presented at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer.

Leap Receives Orphan Drug Designation and Fast Track Designation – On June 11, 2020, the FDA granted Orphan Drug Designation to DKN-01 for the treatment of gastroesophageal junction and gastric cancer. On September 24, 2020, the FDA granted Fast Track Designation to DKN-01 in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1, following disease progression on or after prior fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.
Selected Year-End and Fourth Quarter 2020 Financial Results

Net Loss was $27.5 million for the year ended December 31, 2020, compared to $32.9 million for the year ended December 31, 2019. This decrease was primarily due to decreased research and development expenses following the deprioritization of the TRX518 program in 2019.

License revenues were $1.5 million for the full year 2020 and relate to the BeiGene Agreement for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. License revenues were $0.4 million for the fourth quarter 2020. The BeiGene Agreement became effective on January 3, 2020. As the BeiGene Agreement is the first such license agreement, no license revenues were recorded during the year ended December 31, 2019.

Research and development expenses were $20.4 million for full year 2020, compared to $24.4 million for same period in 2019. Research and development expenses were $5.1 million for the fourth quarter of 2020, compared to $5.7 million for the same period in 2019. These decreases were primarily due to decreased clinical trial costs due to deprioritizing the continued development of TRX518 in 2019 and timing of patient enrollment, decreased consulting fees associated with research and development activities, and decreased rent expense due to the closing of our research laboratory in April of 2020. These decreases were partially offset by increases in payroll and other related expenses due to an increase in headcount of our research and development full time employees and increases in stock-based compensation expense due to new stock options granted to employees.

General and administrative expenses were $9.6 million for the full year 2020, compared to $9.1 million for the same period in 2019. The increase was due to an increase in professional fees primarily due to increased legal, recruiting and information technology costs, an increase in payroll and other related expenses due to an increase in compensation expense, and an increase in insurance expense. These increases were partially offset by a decrease in stock-based compensation expense. General and administrative expenses were $2.4 million for the full year 2020 compared to $2.6 million for the same period in 2019. This decrease was due to a decrease in stock-based compensation expense, partially offset by increased recruiting and information technology costs.

Cash and cash equivalents totaled $52.1 million at December 31, 2020. Research and development incentive receivables totaled $0.1 million.

On March 12, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that the Company’s fourth quarter 2020 financial results will be released on Tuesday, March 16, 2021 (Press release, Calithera Biosciences, MAR 12, 2021, View Source [SID1234576586]). Company management will host a conference call on Tuesday, March 16, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 6250035. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On March 12, 2021 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the closing of its previously announced underwritten public offering of 5,750,000 shares of its common stock at a public offering price of $11.25 per share, including 750,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Jounce Therapeutics, MAR 12, 2021, View Source [SID1234576585]). Gross proceeds from the sale of the shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $64.7 million.

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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

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Cowen and Piper Sandler acted as joint book-running managers for the offering.

The shares were offered by Jounce pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 8, 2018 and declared effective by the SEC on May 1, 2018. The offering was made solely by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924.

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 registration or qualification under the securities laws of any such state or jurisdiction.

On March 12, 2021 EVERSANA reported The U.S. Food and Drug Administration (FDA) an official Oncology Drugs Advisory Committee (ODAC) meeting to review six indications across a group of PD-1 and PD-L1 inhibitors that have recently had their indications withdrawn in the U.S. due to an accelerated approvals crackdown (Press release, EVERSANA, MAR 12, 2021, View Source [SID1234576584]).

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The panel will assess a group of inhibitors that were granted under the agency’s accelerated approval pathway with confirmatory trials that have not verified clinical benefit, such as Bristol Myers Squibb’s Opdivo (nivolumab), Merck’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab) across six different indications in breast, urothelial, gastric and hepatocellular cancers.

Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence, noted that the committee is "committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible.

"The program allows the FDA to approve a drug or biologic product intended to treat a serious or life-threatening condition based on an outcome that can be measured earlier than survival that demonstrates a meaningful advantage over available therapies. However, when confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn."

Oncology drugs and indications up for review:

Genentech recently announced that it was voluntarily withdrawing the U.S. indication for Tecentriq in prior-platinum treated metastatic urothelial carcinoma, in a joint decision made in consultation with the FDA.

Merck also voluntarily withdrew its U.S. indication for Keytruda for patients with metastatic small-cell lung cancer (SCLC) who experience disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy earlier in March, and in December 2020, Bristol Myers Squibb also announced its withdrawal from the FDA of an application regarding Opdivo (nivolumab) in SCLC.

BMS issued a note of support for the FDA’s decision, stating that "In HCC, despite evolution of the treatment landscape over the past few years, we believe Opdivo continues to address an unmet medical need for patients in the post-sorafenib setting, and we appreciate the opportunity to discuss this in more depth with the Committee."

The special three-day public hearing on April 27 to 29 will "give oncology experts outside of the FDA and patients with cancer an opportunity to describe their experiences with the drugs," explained Pazdur.

According to the FDA, only 6% of accelerated approvals for oncology drugs have been withdrawn over the whole duration of the pathway’s use, including the four recent withdrawals.

On March 12, 2021 Cancer Genetics, Inc. (the "Company") (Nasdaq: CGIX), an emerging leader in novel drug discovery techniques, reported that Jay Roberts, Chief Executive Officer, will present at the Annual 33rd ROTH Conference (Press release, Cancer Genetics, MAR 12, 2021, View Source [SID1234576583]). The event is being held virtually from March 15-17, 2021.

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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

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Mr. Roberts will highlight the Company’s recent transformational business strategy, including the Company’s proposed merger with StemoniX, Inc., and elaborate on the broader going- forward corporate vision.

If you are an investor and would like to attend the Company’s presentation, please click on the following link (View Source) to register for the Annual 33rd ROTH Conference. Once your registration is confirmed, you will be prompted to log into the conference website and will be able to request a one-on-one meeting with the Company.

Cancer Genetics will also be available for outside virtual 1:1 meetings both during and after the Virtual Annual 33rd ROTH Conference. Please contact Jennifer K. Zimmons, Ph.D. [email protected] 917.214.3514 for scheduling.