On January 7, 2020 Avidity Biosciences (Avidity) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference being held January 13-16, 2020 in San Francisco, CA (Press release, Avidity Biosciences, JAN 7, 2020, View Source [SID1234552781]).

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Sarah Boyce, President and CEO of Avidity, will present an overview of the company’s novel approach to treating rare muscle disorders and other serious diseases using Avidity’s proprietary Antibody-Oligonucleotide Conjugates (AOCs). Avidity’s AOCs combine the tissue selectivity of monoclonal antibodies with the specificity of oligonucleotide-based therapeutics to modulate disease-related RNAs in many cell types and tissues. This presentation follows the close of a successful $100 million Series C in 2019 that will fund development activities and expansion of the Avidity platform to other tissues and organs.

Presentation details are below:

Date: Wednesday, January 15th, 2020
Time: 10:30 am PT
Location: The Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA

On January 7, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT candidate for prostate cancer (Press release, Advaxis, JAN 7, 2020, View Source [SID1234552779]). ADXS-HOT is the Company’s off-the-shelf neoantigen clinical program targeting hotspot mutations that currently includes over ten cancer-type specific drug constructs in various stages of development.

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"With encouraging proof-of-concept data within our neoantigen program, we believe the ADXS-HOT program has potential to provide off-the-shelf, neoantigen targeted immunotherapies to a broad patient population," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We are proud of the progress we have made to date with our HOT program, which includes advancing the clinical development of ADXS-503, our candidate for non-small cell lung cancer, while also seeking to launch our next clinical program, ADXS-504, in prostate cancer. We look forward to presenting immunogenicity and safety data from the first cohort from our lung program later this quarter."

On January 7, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited revenues for the fourth quarter and full year ended December 31, 2019 (Press release, Clovis Oncology, JAN 7, 2020, View Source [SID1234552778]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$38.3-$39.3M in Rubraca product revenues for the fourth quarter of 2019 compared to $37.6M for Q3 2019 and $30.4M for Q4 2018

$142.0-$143.0M in Rubraca product revenues for the FY2019 compared to $95.4M for FY2018

Clovis plans to discuss these results with investors this week at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

"We are very pleased with our sales performance in the fourth quarter and the momentum it provides us going into this year," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "In mid-November 2019, we submitted the supplemental New Drug Application (sNDA) for Rubraca in BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and also during the quarter announced the first reported human experience of FAP-2286 and launched Rubraca in England and Italy. With this progress, we are looking forward to an eventful 2020. Key milestones include additional EU country ovarian cancer launches for Rubraca, a potential U.S. Rubraca launch in prostate cancer, initial data for lucitanib combination studies, and a planned IND filing for FAP-2286 in the second half of the year."

Clovis Oncology to Present at 38th Annual J.P. Morgan Healthcare Conference on January 13, 2019

Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 38th Annual J.P. Morgan Healthcare Conference to be held at the Westin St. Francis hotel in San Francisco on Monday, January 13 at 10:00 a.m. PT. A live webcast of the presentation and Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Following the live presentations, replays of the webcasts will be available on the Company’s website for 30 days.

Fourth Quarter and Full Year 2019 Financial Results Release Planned for February 24, 2020

The Company plans to report financial results for the fourth quarter and full year ended December 31, 2019 on Monday, February 24, 2020, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the Company’s results in greater detail.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

In the EU, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. This expands rucaparib’s indication beyond its initial marketing authorization in the EU granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Rubraca is also approved in the EU for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and the EU.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/b) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

FAP-2286 is an unlicensed medical product.

On January 7, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 10:00 a.m. PT at the Westin St. Francis in San Francisco, followed by a question and answer breakout session at 10:30 a.m. PT (Press release, Karyopharm, JAN 7, 2020, View Source [SID1234552777]).

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A live webcast of the presentation and breakout session will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 30 days following the presentation.

On January 7, 2020 Tyme Technologies, Inc. (Nasdaq: TYME) ("TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), and Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle"), reported the formation of a U.S. strategic collaboration focused on the co-promotion of TYME’s lead CMBT candidate oral SM-88 in advanced cancers (Press release, Eagle Pharmaceuticals, JAN 7, 2020, View Source [SID1234552776]). CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, oral SM-88 has demonstrated complete or partial responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and blood cancers with minimal serious grade 3 or higher adverse events.

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"TYME’s approach is unique and transformational. Targeting cancer’s metabolism by disrupting protein synthesis has advantages over existing treatment approaches in terms of both efficacy and safety," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals. "This collaboration provides an excellent opportunity to continue expanding our presence in the oncology space, as well as to evaluate potential combination opportunities with SM-88 in our existing pipeline. We look forward to leveraging our oncology sales infrastructure to maximize the commercialization of SM-88 in the U.S., if approved. As always, our goal remains to deliver innovative, next-generation therapeutics to address patient needs and to create value for our shareholders," concluded Tarriff.

Terms of the Agreements

Under the terms of the securities purchase agreements, TYME will receive a $20 million upfront cash payment for 10 million restricted shares of TYME common stock at $2.00 per share. In addition, TYME will receive a $20 million milestone payment upon the successful completion of the first to occur of the following three events: (1) achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial; or (2) achievement of the primary endpoint of overall survival in the PanCAN Precision PromiseSM SM-88 registration arm; or (3) U.S. Food and Drug Administration (FDA) approval of SM-88 in any cancer. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.

Under the terms of the co-promotion agreement, Eagle Pharmaceuticals will undertake 25% of the promotional sales effort for SM-88 in the U.S. oncology market and receive 15% of the net U.S. revenues of SM-88, and TYME will be responsible for the remaining promotional effort. TYME will also be responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. TYME retains the remaining 85% of net U.S. revenues and reserves the right to repurchase Eagle’s co-promotion right for $200 million.

As part of this partnership between TYME and Eagle, there is also the potential to evaluate oral SM-88 in combination therapy or as monotherapy through leveraging Eagle’s oncology pipeline and expertise in oncology settings, which may include trials in breast or lung cancers and other tumor types.

"We are extremely pleased to establish this collaboration with Eagle Pharmaceuticals who shares our passion and commitment to improving the lives of patients with advanced cancers. After a thorough due diligence process by both parties, each came away with great respect for each organization’s capabilities and potential," said Steve Hoffman, Chairman and Chief Executive Officer of TYME. "This alliance provides TYME with the commercial and capital resources to advance our leadership position in the field of cancer metabolism and the potential to expand our capabilities and accelerate clinical programs that will create value for all of our stakeholders, most importantly for the patients we serve."

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

Clinical results of SM-88, based on data as of April 25, 2019, from the Phase II portion of the TYME-88-Panc study, were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain on Wednesday, July 4, 2019 (TYME-88-Panc poster). The study demonstrated a median overall survival in evaluable patients (38 of 49) of 6.4 months. These survival results compare very favorably to the analysis of 19 prospective pancreatic cancer trials where the median reported survival after progressing on second-line therapy was 2.0 – 2.5 months1 based on reported historical trials. In the Phase II portion of the TYME-88-Panc study, a RECIST CBR of stable disease or better was achieved by 44% of patients (11 of 25) with available imaging. Patients achieving stable disease or better demonstrated a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death (hazard ratio=0.08). The CBR was durable with a majority of patients remaining in stable disease or better for more than 7 months after receiving treatment with SM-88. The study showed a median reduction of 63% in CTC burden in evaluable patients. Patients (10 of 24) with available results reaching an 80% reduction or greater in CTCs demonstrated a 60% decrease in risk of death (hazard ratio=0.40).

The Phase II portion of the TYME-88 Panc study reported that SM-88 was well tolerated with only 4.0% of patients (2 of 49) who experienced serious adverse events (SAEs) deemed at least possibly related to SM-88 (abdominal pain, arthralgia, and hypotension). One patient with reported SAEs continued on treatment.

About Advanced Pancreatic Cancer

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.2 The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer – adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers.

However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.

About Precision PromiseSM

Precision PromiseSM is an adaptive randomized Phase III registration-ready clinical trial. The objective of Precision PromiseSM is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities. The primary goal of SM-88’s inclusion is to study SM-88 as a monotherapy treatment arm for patients who have failed one prior line of chemotherapy. Additionally, it is planned that SM-88 will be evaluated in combination with gemcitabine (Gemzar ) and nab-paclitaxel (Abraxane ) for first-line patients. The primary end point of these randomized trials is overall survival.