On March 28, 2019 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Dr. Cornelis Melief will give an oral presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, on March 31, 2019 (Press release, ISA Pharmaceuticals, MAR 28, 2019, View Source [SID1234534689]).

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The presentation titled "A strong HPV-specific T-cell response after chemo-immunotherapy for advanced cervical cancer is associated with prolonged survival"is scheduled for Sunday, March 31, 2019, as part of the session "Predictive Biomarkers for Immunotherapy" (12:45-2:45pm, Marcus Auditorium- Bldg A-GWCC).

The data will outline the effects of vaccination with ISA Pharmaceuticals´ therapeutic vaccine ISA101 during chemotherapy in 77 patients with advanced, recurrent or metastatic cervical cancer in a dose assessment study.

ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer. Clinical efficacy of ISA101 in combination with Regeneron’s PD-1 inhibitor cemiplimab is currently being tested in a randomized controlled Phase 2 trial in platinum refractory, HPV16-positive oropharyngeal cancer patients (NCT03669718). The results to be presented at AACR (Free AACR Whitepaper) form the basis for a planned Phase 3 trial, in which the clinical benefit of the combination of ISA101 plus cemiplimab on top of standard-of-care chemotherapy will be studied in patients with advanced HPV16-positive cervical cancer.

On March 28, 2019 ESSA Pharma Inc. (TSX-V: EPI;Nasdaq: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the nomination of EPI-7386 as the lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC"). EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor (Press release, ESSA, MAR 28, 2019, View Source [SID1234534727]). Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogens are inactive. Compared to ESSA’s first generation compound, ralaniten acetate, EPI-7386 is significantly more potent, metabolically stable and more effective in preclinical studies. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date. IND-enabling studies are currently underway, and ESSA expects to enter clinical studies with EPI-7386 in the first quarter of 2020.

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As recently presented at the 2019 Genitourinary Cancers Symposium, EPI-7386 demonstrates in vitro cellular potency against the androgen receptor in a similar range to the leading antiandrogens, bicalutamide and enzalutamide. Importantly, EPI-7386 shows activity in numerous in vitro models of antiandrogen resistance driven by the AR-V7 splice variant of the androgen receptor while enzalutamide is inactive. In addition, EPI-7386 is metabolically stable in liver microsome and hepatocyte preparations and shows a favorable pharmacokinetic profile in mice, exhibiting significant exposure and a long half-life. Lastly, EPI-7386 (60 mg/kg) displayed comparable activity to enzalutamide (30 mg/kg) in a prostate cancer LNCaP xenograft mouse model in which enzalutamide mouse exposure was estimated to be twice the clinical exposure of enzalutamide in humans.

"We are excited to announce the nomination of EPI-7386 as our lead clinical candidate for the treatment of mCRPC," said David Parkinson, President and Chief Executive Officer of ESSA. "EPI-7386 represents a novel approach to targeting the androgen receptor, one of the most validated targets in oncology. We look forward to bringing this novel drug candidate to patients with mCRPC who have no other treatment options."

On March 28, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T therapies, reported the appointment of Filippo Petti as Chief Executive Officer (CEO) of Celyad effective April 1, 2019 (Press release, Celyad, MAR 28, 2019, View Source [SID1234534758]). Mr. Petti is currently Celyad’s Chief Financial Officer (CFO), and will serve as interim CFO until the Company appoints a permanent successor for the role. Dr. Homsy will continue to serve as a member of Celyad’s Board of Directors and chair the Strategy Committee of the Board of Directors. Dr. Homsy will support Mr. Petti in his new function on an as needed basis.

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Michel Lussier, Celyad’s Chairman commented:"The Board is delighted to appoint Filippo to the role given his intimate knowledge and appreciation for Celyad’s pipeline, team and shareholders as the Company advances its CAR-T therapies to the next stage of development. Since he joined the Company, Filippo has demonstrated that his experience combined with the vision of the Company should maximize value for all of our stakeholders including patients and shareholders."

"I am honored to succeed Christian as Celyad’s next CEO and together with the Board, the senior leadership team, and all of our employees, look forward to advancing our promising CAR-T programs to deliver novel therapies to cancer patients," said Mr. Petti."The momentum we are building across our pipeline is truly exciting and should provide the Company with a tremendous opportunity as we enter our next phase of growth."

Mr Lussier added: "Christian’s vision and drive, combined with his commitment to serving the long-term interests of the Company, has helped Celyad develop a growing pipeline of CAR-T candidates. Christian will continue to support an agile organization well-positioned for success. I’d like to thank him personally, and on behalf of the Board, for his tireless contribution to Celyad as CEO."

Dr. Homsy added: "I congratulate Filippo on his appointment and look forward to working with him in my new role. It has been an honor to lead the organization over the past 12 years making it a leader in cell therapy development and manufacturing. I am humbled by the talented people I have had the pleasure of working with since the inception of the Company. Today Celyad is an incredibly talented organization with exceptional vision and operational excellence. Together with the portfolio of groundbreaking technologies, this will undoubtedly make Celyad a forefront player of the CAR-T field. I am very grateful to Celyad employees and to all the other stakeholders for making this journey possible."

Mr. Petti has nearly 20 years of work experience related to the biopharmaceutical industry. Prior to joining Celyad as CFO, Mr. Petti served as a healthcare investment banker at Wells Fargo Securities and William Blair & Company. Prior to his roles in investment banking, he worked in equity research, with a focus in oncology, both at William Blair & Company and Wedbush Securities. Mr. Petti began his career as a research scientist at OSI Pharmaceuticals, Inc., where he was involved in translational research studies focused on the EGFR inhibitor Tarceva (erlotinib) before transitioning into corporate development with the company. Mr. Petti holds a Master of Business Administration from Cornell University, a Master of Science from St. John’s University and a Bachelor of Science from Syracuse University.

On March 28, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the year ended December 31, 2018 (Press release, Can-Fite BioPharma, MAR 28, 2019, View Source [SID1234534712]).

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Clinical Development and Corporate Highlights During 2018 Include:

In a deal worth up to $74.5 million, Can-Fite signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Limited for the commercialization of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis, and Namodenoson in the treatment of advanced liver cancer and NAFLD/NASH, in China.
In another multi-million dollar deal, Can-Fite signed a distribution deal with Gebro Holding GmBH in Spain, Switzerland, and Austria, to distribute Piclidenoson in the treatment of rheumatoid arthritis and psoriasis upon receipt of regulatory approval.
Can-Fite raised $5 million through a registered direct offering.
Can-Fite recently reported top line result from its Phase II trial of Namodenoson in the treatment of advanced liver cancer. While the study did not achieve its primary end point of median overall survival in the whole population of 78 patients, it did achieve superiority in median overall survival in the largest study subpopulation of 56 patients and in secondary end points for the whole population. These data support progression into a Phase III study.
Phase III clinical studies of Piclidenoson in the treatment of psoriasis and rheumatoid arthritis continue to enroll patients.
Top-line Data from Phase II NASH Study with Namodenoson expected in H2 2019
"2018 marked significant achievements for Can-Fite including our largest distribution deal to date valued at up to $74.5 million. We continued to build our intellectual property assets, presented new data at scientific conferences and saw our findings published in peer reviewed journals. We are particularly pleased to move much closer to commercialization with both Piclidenoson, now in two Phase III studies, and Namodenoson, now completing a Phase II study," stated Can-Fite CEO Pnina Fishman. "We just announced top line results from our Phase II Namodenoson study in advanced liver cancer which produced encouraging results to move into a Phase III, even though the primary end point was not met. We believe our drugs’ strong safety profile, combined with efficacy in a specific sub-population within each target disease indication will improve patient health and longevity."

Financial Results

Revenues for the year ended December 31, 2018 were $3.8 million, an increase of $3.0 million, or 384%, compared to $0.8 million for the year ended December 31, 2017. The increase in revenue was mainly due to the recognition of a $2 million advance payment received in August 2018 under the License, Collaboration and Distribution Agreement with CMS Medical and from the recognition of a portion of the $2.2 million advance payment received in January 2018 under the Distribution and Supply Agreement with Gebro.

Research and development expenses for the year ended December 31, 2018 were $6.0 million, an increase of $0.9 million, or 19%, compared to $5.1 million for the year ended December 31, 2017. Research and developments expenses for the year ended 2018 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2019 and beyond.

General and administrative expenses were $3.1 million for the year ended December 31, 2018 an increase of $0.3 million, or 10%, compared to $2.8 million for the year ended December 31, 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2019.

Financial expenses, net for the year ended December 31, 2018 aggregated $1.1 million compared to immaterial financial income, net for the same period in 2017. The increase in financial expense, net was mainly due to a loss from long-term investment revaluation and from recognition of interest expenses related to implementation of revenue recognition accounting standard IFRS 15, while in the same period in 2017, financial income was mainly due to fair value revaluation of warrants which were offset by financial expenses from exchange rate differences.

Net loss for the year ended December 31, 2018 was $6.6 million compared with a net loss of $6.4 million for the year ended December 31, 2017. The increase in net loss for the year ended December 31, 2018 was primarily attributable to increase in revenues in 2018 which were offset by an increase in research and development expenses and increase in finance expenses, net.

As of December 31, 2018, Can-Fite had cash and cash equivalents of $3.6 million as compared to $3.5 million at December 31, 2017. The increase in cash during the year ended December 31, 2018 is due to increase in net cash provided by financing activity which was offset by a decrease in net cash used in operating activity. In January 2019, Can-Fite raised $2.35 million in a registered direct offering.

On March 28, 2019 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular" or "Molecular Templates"), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the fourth quarter of 2018 (Press release, Molecular Templates, MAR 28, 2019, View Source [SID1234534730]). As of December 31, 2018, Molecular’s cash and investments totaled $98 million, and is expected to fund operations into the first half of 2021.

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"2018 was a year of important progress for Molecular Templates, marked by new clinical data for MT-3724, advancement of our preclinical pipeline, the CD38 partnership with Takeda, and a successful equity financing," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "In 2019, we are excited to generate more clinical data from multiple Phase II studies with MT-3724, advance MT-5111 and TAK-169 into the clinic, and file an IND for MT-6035, our PD-L1 ETB with antigen seeding. We are also focused on business development activity to generate additional non-dilutive capital."

Company Highlights and Upcoming Milestones

Corporate

Molecular will present new data on its pipeline programs and technology platform in four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, to be held March 29 – Apr 3, 2019 in Atlanta, Georgia. Presentations will feature data on 1) CD38-targeted ETB TAK-169, 2) CD20-targeted ETB MT-3724 in combination with chemotherapy or IMiDs, 3) PD-L1-targeted ETB for direct cell kill approach to PD-L1 expressing cancers, 4) Bispecific ETBs for targeted cancer treatment.
On February 19, 2019, Molecular strengthened its senior management team with the appointment of Roger J. Waltzman, M.D., as Chief Medical Officer. Dr. Waltzman is a board-certified medical oncologist with over 20 years of experience in the pharmaceutical and biotechnology industries, and in medical practice/academia. His career highlights include 9 years in senior drug development roles at Novartis Pharmaceuticals Corporation, including 6 years in positions of increasing responsibility at Novartis Oncology (2007–2013). He played a leading role in the development of highly successful Novartis branded oncology drugs, Glivec (imatinib) and Jakafi (ruxolitinib).
On November 9, 2018, Molecular presented a poster on its PD-L1 ETB with Antigen Seeding Technology (AST) program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington D.C. The poster, titled "Identification and Functional Profiling of PD-L1 Targeted Engineered Toxin Bodies for Antigen Seeding Technology (AST) and Redirection of T cell Response to Tumors" summarized a series of preclinical experiments conducted by Molecular to create PD-L1 targeted ETBs that have antigen seeding properties and to analyze the mechanisms by which they can kill cancer cells.

TAK-169

Takeda and Molecular expect to file an IND and start a Phase I multiple myeloma trial in 2019 for TAK-169 (CD38 targeted ETB).

MT-3724

Molecular recently announced the initiation of a Phase II monotherapy study of MT-3724 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This study has the potential to be pivotal. Molecular expects to provide an update on this study in 2H19, with final data expected in 2020.
Molecular is also conducting a Phase II combination study with MT-3724 and chemotherapy in earlier lines of DLBCL.
Molecular expects to initiate a second Phase II combination study with MT-3724 and Revlimid in earlier lines of DLBCL in 2Q19.
Molecular expects to report an update on both MT-3724 combination studies with MT-3724 in 2H19.

Research

Molecular expects to initiate a Phase I study in cancer patients for MT-5111, its ETB targeting HER2, in 2Q19.
Molecular expects to report an update on this study in 2H19.
Molecular expects to file an IND application for MT-6035, its ETB targeting PD-L1 (with antigen seeding), in 2H19.
Several other ETB candidates are in preclinical development, targeting both solid and hematological cancers.

Takeda Multi-Target Collaboration

Takeda and Molecular are conducting lead optimization for ETBs against two undisclosed targets selected by Takeda under the collaboration. Should Takeda exercise its option to license ETBs for both targets, Molecular would receive $25 million and would be eligible to receive up to $547 million in milestone payments and tiered royalties on sales.
Financial Results

The net loss attributable to common shareholders for the fourth quarter of 2018 was $6.6 million, or $0.18 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.9 million, or $0.26 per basic and diluted share, for the same period in 2017.

Revenues for the fourth quarter of 2018 were $4.7 million, compared to $0.8 million for the same period in 2017. Revenues for the fourth quarter of 2018 were comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the fourth quarter of 2018 were $7.6 million, compared with $4.7 million for the same period in 2017. Total general and administrative expenses for the fourth quarter of 2018 were $3.9 million, compared with $3.5 million for the same period in 2017.

The net loss attributable to common shareholders for the year ended December 31, 2018 was $30.3 million, or $1.02 per basic and diluted share. This compares with a net loss attributable to common shareholders of $24.1 million, or $2.11 per basic and diluted share, for 2017.

Revenues for the year ended December 31, 2018 were $13.3 million, compared to $3.4 million for 2017. These revenues were mainly comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the year ended December 31, 2018 were $30.2 million, compared with $9.5 million for 2017. Total general and administrative expenses for the year ended December 31, 2018 were $14.1 million, compared with $11.8 million for 2017.