On February 14, 2020 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated commercial-stage biopharmaceutical company developing novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for the accelerated approval of TAZVERIK (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy (Press release, Epizyme, FEB 14, 2020, View Source [SID1234554364]). The FDA granted Priority Review and has designated the company’s application as a supplemental NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020. Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

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"Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "If approved, we believe TAZVERIK could become an important new option for these patients and their physicians. We are thrilled with FDA’s acceptance of our application as an sNDA with Priority Review, for TAZVERIK for patients with relapsed or refractory FL. We look forward to working with the Agency during their review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable in bringing us to this point."

"On the heels of our first approval for TAZVERIK for epithelioid sarcoma last month and a successful launch into the market, this sNDA filing acceptance brings us one step closer to providing TAZVERIK to a larger patient population," said Robert Bazemore, chief executive officer of Epizyme. "The June 2020 PDUFA date positions TAZVERIK for two FDA approvals within six months of each other, which would be a remarkable achievement for Epizyme. We are actively building off our experience with our ES commercial launch, in order to seamlessly expand to an FL launch where we anticipate rapid market adoption, if approved."

Epizyme’s sNDA submission is based primarily on updated Phase 2 efficacy and safety data for TAZVERIK in this patient population, which were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data demonstrated that treatment with TAZVERIK resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).

To support a full approval of TAZVERIK for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of TAZVERIK with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. The safety run-in portion of the trial is underway, and the company expects to advance into the efficacy portion of the Phase 1b/3 trial in 2020.

About TAZVERIK
TAZVERIK (tazemetostat) is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For the full prescribing information, please visit www.TAZVERIK.com.

On February 14, 2020 Noxopharm (ASX: NOX) is reported positive interim results from its LuPIN Phase 1/2 clinical trial (Press release, Noxopharm, FEB 14, 2020, View Source [SID1234554365]). The data was presented during a poster presentation at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers (GU) Symposium 2020 in San Francisco by St. Vincent’s Hospital Sydney.

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The LuPIN study is being conducted by St. Vincent’s Hospital Sydney and is evaluating Noxopharm’s lead drug candidate, Veyonda, in combination with 177Lu-PSMA-617, in 56 patients with late-stage metastatic castration-resistant prostate cancer (mCRPC).

"Today’s results are highly encouraging for patients, for Noxopharm shareholders, and for the St. Vincent’s Hospital Sydney team," said Dr. Gisela Mautner, Noxopharm chief medical officer. "The study reported an unprecedented median overall survival of 17.1 months. In a patient group that normally would have a survival expectation of much less than this, such a result is astoundingly good. The combination treatment of Veyonda and 177Lu-PSMA-617 has delivered a clinically meaningful and strong anti-cancer effect in a high proportion of men and, importantly, continues to have an excellent safety profile."

All patients had received and failed two prior lines of therapy (chemotherapy and androgen-signaling inhibitors), and most patients (29 of 32) had failed a third line of therapy (another chemotherapy) prior to entering the trial.

"The study investigators at St. Vincent’s Hospital Sydney continue to do excellent work through the LuPIN trial and we are pleased to support them," Dr. Mautner added.

"Being able to deliver a meaningful anti-cancer response for at least 50% of patients with Stage 4 for any form of cancer would be a remarkable outcome," said Noxopharm CEO Dr. Graham Kelly. "But it is even more remarkable to do so in late-stage prostate cancer, where the disease typically involves a substantial number of secondaries in the skeleton, which are a significant and poorly accessible tumor load. A median overall survival of 17.1 months is remarkable for this novel radiosensitizing and immuno-oncology drug."

On February 14, 2020 OncoDNA ("OncoDNA or "the Company"), the healthcare technology company making precision medicine a reality, reported that it has completed a €19 million ($20 million) Series B equity financing (Press release, OncoDNA, FEB 14, 2020, View Source [SID1234554366]). The new funding will support rapid international growth, accelerate software development and hiring initiatives.

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The round was led by Vesalius Biocapital III and Swisscanto Invest by Zürcher Kantonalbank with the significant support of SFPI-FPIM. Historical shareholders together with CPH Bank, Inventures, Sambrinvest, Sofinim (Ackermans & Van Haaren) and SRIW have also participated. This represents another landmark achievement after the €8 million Series A fundraising closed in September 2016.

OncoDNA is now maximizing the fast and proper rollout of its oncology clinical decision support software OncoKDM with the objective of becoming the European leader in oncogenomic data interpretation and reporting to further support molecular laboratories, healthcare professionals and the pharma industry in their daily research and clinical practice.

Jean-Pol Detiffe, Founder & Chief Executive Officer at OncoDNA: "We are delighted to have successfully raised sufficient new capital from such quality investors who will enable us to grow and increase our support to oncologists and cancer patients with our data driven solutions. OncoDNA is already positioned as the European champion for cancer precision medicine as we built a worldwide network of more than several thousand oncologists. Our next move is to connect molecular laboratories to our advanced data interpretation tools, which we pride ourselves on now being possible thanks to the support of our new investors."

Guy Geldhof, Partner at Vesalius Biocapital III S.C.A. SICAR said: "We are excited about co-leading the Series B investment in OncoDNA. It is thrilling to work with a team that has both world class experience in genomic molecular profiling and a strong desire to serve patients by offering best-in-class support to oncology professionals. We are confident OncoDNA will accelerate the development and commercialization of its valuable new solutions, especially through closer collaborations with the biopharma industry, with the final objective of contributing to better healthcare."

Robert Schier, Partner at Swisscanto (CH) Private Equity Switzerland Growth I KmGK added: "OncoDNA has grown significantly over the past years and are continuing to add the necessary clinical expertise and know-how to act upon its mission. Its disruptive vision and highly integrated market approach make it to be the perfect candidate to rapidly become the European leader in oncology big data. We are delighted to partner with OncoDNA as we firmly believe the company contributes to both a more sustainable healthcare system and improved patient health outcomes."

"Considering our important investment in OncoDNA, alongside players like Vesalius Biocapital III and Swisscanto, we are convinced that the company has all the necessary means at a key moment of its development to successfully carry out appropriate projects to assist and support oncologists in prescribing the most optimal therapeutic treatments to patients. We are happy to count on the support of our colleagues from SRIW and Sambrinvest as historical stakeholders" concluded François Fontaine, at SFPI-FPIM.

On February 13, 2020 Replimune Group Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a corporate update, highlighting the progress of its key programs (Press release, Replimune, FEB 13, 2020, View Source [SID1234554262]).

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"Based on the early data in our lead indication of CSCC, we believe there is a high probability of success in our ongoing randomized registration-directed clinical trial of RP1 in combination with Libtayo compared to Libtayo alone, and we are also looking forward to starting an additional trial to test RP1 as a monotherapy in solid organ transplant recipients with CSCC. This is a patient population for whom immune checkpoint blockade is contraindicated due to the substantial risk of rejection of the transplanted organ and for whom the incidence of CSCC is particularly high," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "Deaths from CSCC in the US approach the levels of those from melanoma, suggesting a significant initial commercial opportunity. In addition to reporting further data from our lead indications and initial clinical data with RP2 during 2020, we look forward to announcing the expansion of the clinical development plan for RP1 into additional indications as we continue to execute upon our mission to make our oncolytic immuno-gene therapies a cornerstone of cancer treatment."

Program Highlights

Replimune is currently developing three oncolytic immuno-gene therapies derived from its Immulytic platform. RP1 is Replimune’s first clinical product candidate and is based on a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R), intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. RP2 is a version of RP1 that in addition to expressing GALV-GP-R and GM-CSF also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands – CD40L and 4-1BBL – together with anti-CTLA-4 and GALV-GP-R-. CD40L activates CD40, with the goal of achieving broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), intended to promote the expansion of cellular and memory immune responses.

RP1 in combination with Libtayo in CSCC: Enrollment in the 240-patient registration-directed Phase 2, randomized, controlled clinical trial is ongoing and is expected to take approximately 18 to 24 months with enrollment intended in the US, Australia, Canada, United Kingdom and European Union.
RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, metastatic bladder cancer, and MSI-H/dMMR tumors: The Phase 2 part of the Phase 1/2 clinical trial of RP1 in combination with Opdivo remains on track with initial data from completely enrolled or ongoing skin cancer cohorts expected in mid-2020 with further data from all four cohorts expected to be available by year-end.
RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients: The Company has initiated recruitment in a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients.
RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company remains on track to initiate a 30 patient Phase 1/2 clinical trial to assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC in the first half of 2020.
RP2 alone and in combination with Opdivo: The ongoing Phase 1 clinical trial evaluating the safety, tolerability, and optimal dose for further development of RP2 alone and in combination with Opdivo remains on track with initial data from this all-comers clinical trial expected by the end of 2020.
RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial of RP3 alone and in combination with anti-PD-1 therapy remains on track to initiate in 2020.
Corporate Highlights

Organization transitioning into a late-stage clinical development company and preparing for commercialization. Replimune continues to grow and evolve its leadership team as it transitions into a late-stage clinical development company with the recent appointment of Jean Franchi as Chief Financial Officer and the transition of Robert Coffin, Ph.D. from Chief Executive Officer into the newly created role of President and Chief Research & Development Officer. As previously announced, Philip Astley-Sparke has moved from part-time Executive Chairman to now full-time Chief Executive Officer, and together with Robert Coffin will co-lead the company going forward.
Completed building manufacturing facility to support late-stage development and commercialization. The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s product candidates with sufficient capacity to support full commercialization. The facility is now fully operational and technology transfer activities are underway.
Financial Highlights

Replimune strengthened the balance sheet in the quarter closing with $180.9 million in cash, cash equivalents and short-term investments, compared with $134.8 million as of March 31, 2019, an increase of $46.1 million. Our increased cash operating expenses were offset by $99.7 million of net proceeds from financing activities.

Based on our current operating plan, we expect our current cash, cash equivalents, and short-term investments will be sufficient to fund operating expenses and capital expenditure requirements into the second half of calendar year 2022.

Research and development expenses for the quarter ended December 31, 2019 were $11.9 million compared with $7.9 million for the same period in the prior year. The increase was driven by increased headcount and services supporting advancement of our lead program RP1 into phase II trials, additional trials, and initiating work in RP2 and RP3.

General and administrative expenses were $4.7 million for the quarter ended December 31, 2019 compared with $2.3 million for the same period in the prior year. The increase was primarily driven by increased headcount and related expense, professional fees, and facility expansion.

Replimune reported a net loss of $16.2 million for the quarter ended December 31, 2019 compared with $7.7 million for the same period in the prior year.

On February 13, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020 (Press release, Corcept Therapeutics, FEB 13, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-audited-financial-results-0 [SID1234554286]). The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information

To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.