On January 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, JAN 13, 2020, View Source [SID1234553149]).

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"Replimune had a very productive 2019 where a key highlight included the presentation of initial clinical data with RP1 as monotherapy and combined with Opdivo at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "We believe the data provides strong support for our ongoing registration-directed trial in our lead indication of CSCC as well as the decision to initiate a new clinical trial in organ transplant recipients who have developed the disease. Similarly, the data in melanoma led to the decision to expand the clinical trial to include a registration-directed cohort of melanoma patients who are refractory to prior treatment with anti-PD1 therapy. We also initiated our first clinical trial of RP2, the next therapy in our pipeline. Overall we are thrilled with our progress and are excited for the year ahead as we release further data sets, bring our third product into the clinic to address less immune-responsive tumors and as we continue to execute upon our mission to make our oncolytic immuno-gene therapies a cornerstone of cancer treatment."

Program Updates

RP1: 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. The Company presented initial data from the Phase 1/2 clinical trial of RP1 alone and in combination with Opdivo in November 2019 at SITC (Free SITC Whitepaper) 2019. The Company believes the data demonstrates that RP1 used alone and in combination with Opdivo is well tolerated and showed preliminary anti-tumor efficacy in target tumor types providing strong support for its ongoing and planned development programs in melanoma and CSCC. This clinical trial is being conducted under a clinical trial collaboration and agreement with Bristol-Myers Squibb (BMS) for the supply of Opdivo.

Recent RP1-specific program progress is summarized below:

The registration-directed Phase 2 clinical trial of RP1 in combination with Libtayo in CSCC is underway. This multi-center, randomized, controlled clinical trial is intended to enroll approximately 240 patients with CSCC. The clinical trial’s primary objective is to compare the response rate following treatment with RP1 in combination with Libtayo to the response rate achieved with Libtayo alone. Libtayo is an FDA-approved anti-PD-1 therapy developed by Regeneron and Sanofi for the treatment of patients with metastatic or locally-advanced CSCC who are not candidates for curative surgery or radiation. This clinical trial is being conducted under the Company’s collaboration agreement with Regeneron, whereby the Company and Regeneron split development and supply costs equally. Recruitment for this clinical trial is expected to take approximately 18 to 24 months and enroll patients in the United States, Australia, Canada, United Kingdom and European Union.

Recruitment is currently ongoing in the Phase 2 part of the Phase 1/2 clinical trial of RP1 in combination with Opdivo. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts with melanoma, non-melanoma skin cancers, metastatic bladder cancer, and MSI-H tumors. Data from completely enrolled or ongoing skin cancer cohorts is expected to be presented during the second half of 2020 with further data from all four cohorts expected to be available by year-end.

On track to initiate 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 in the first quarter of 2020, based on the initial clinical efficacy data with RP1 in melanoma. The additional cohort will be enrolled under an expansion of the clinical trial collaboration and Opdivo supply agreement with BMS.

On track to initiate a clinical trial of RP1 as monotherapy in solid organ transplant recipients with CSCC in the first half of 2020. The U.S. Food and Drug Administration (FDA) has accepted the protocol for this clinical trial under its previously-accepted Investigational New Drug application for RP1. The clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC and is expected to provide initial data by the end of 2020.
RP2: 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. Similar to RP1, RP2 is intended to be used primarily in combination with anti-PD-1 therapy.

The Phase 1 clinical trial of RP2 alone and in combination with Opdivo is underway. The clinical trial is designed to assess the safety and tolerability, and to determine the optimal dose, of RP2 alone and in combination with Opdivo and is being conducted under a clinical trial collaboration and agreement with BMS for the supply of Opdivo. Initial data from this all-comers trial is expected by the end of 2020.
RP3: 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, which is intended to result in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), which is intended to promote the expansion of cellular and memory immune responses.

The Phase 1 clinical trial of RP3 alone and in combination with an anti-PD-1 therapy is expected to initiate in 2020.
Corporate Updates

Manufacturing: Completed the build-out of Replimune’s state of the art 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 Immulytic product candidates. The Company believes that the capacity of this facility is sufficient to support full commercialization of its product candidates. An occupancy certificate for the facility has been obtained and the first technology transfer manufacturing run has been successfully completed. Full GMP manufacturing is expected to commence in the first half of 2020.

Cash Position: Based on its current operating plan, Replimune expects that its cash, cash equivalents and short-term investments, of approximately $183 million as of December 31, 2019, will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2022.
J.P. Morgan Conference Presentation and Webcast.

As previously announced, the Company will be presenting at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 5:00 p.m. PT at the Westin St. Francis Hotel in San Francisco, CA. A simultaneous webcast of the presentation will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.

On January 13, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer and SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that they have entered into a clinical trial collaboration agreement (Press release, SpringWorks Therapeutics, JAN 13, 2020, View Source [SID1234553148]). This agreement will evaluate ALLO-715, Allogene’s investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy in combination with SpringWorks’ investigational gamma secretase inhibitor (GSI), nirogacestat, in patients with relapsed or refractory multiple myeloma.

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 In addition, emerging clinical data suggest that a GSI may increase antitumor efficacy of BCMA-targeted autologous CAR T therapy in patients with relapsed and refractory multiple myeloma.23

"Autologous CAR T therapy has shown the potential for engineered cell therapy to treat multiple myeloma and provide significant benefits to patients. We believe allogeneic CAR T therapy is the next frontier in genetically engineered cell therapy for the treatment of cancer," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene Therapeutics. "The search to find long-lasting and potentially curative therapies for patients with multiple myeloma continues to evolve. We are pleased with the progress of our ALLO-715 Phase 1 UNIVERSAL trial and are excited to explore the combination of ALLO-715 with nirogacestat as a means to further unlock the potential of allogeneic CAR T therapy in this disease."

Under the terms of the agreement, Allogene will sponsor and conduct the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all development costs associated with the study. Allogene and SpringWorks will form a joint development committee to oversee the clinical study, which is expected to commence in the second half of 2020 pending discussions with regulators.

"Gamma secretase inhibition has emerged as a clinically validated mechanism to potentiate BCMA therapies and we believe that nirogacestat has the potential to become a cornerstone of BCMA combination therapy for patients with multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We are delighted to partner with Allogene, a pioneer in the allogenic cell therapy field, to further explore nirogacestat in combination with an ‘off-the-shelf’ CAR T therapy for these patients where the need for treatment options remains great."

SpringWorks is currently enrolling patients in a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat in adults with progressing desmoid tumors.

About ALLO-715
ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is currently in Phase 1 development as a potential novel treatment for multiple myeloma. Multiple myeloma is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow of people with the disease,4 multiple myeloma is incurable for most patients, and most patients relapse despite the treatments available.5 Preclinical study results for ALLO-715 were published in the journal Molecular Therapy validating the potential for an AlloCAR T to treat multiple myeloma and demonstrating the ability for ALLO-715 to sustain potent anti-tumor responses in pre-clinical models. Allogene initiated the UNIVERSAL study in the third quarter of 2019.

ALLO-715 utilizes TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds global development and commercial rights for this investigational candidate.

About Nirogacestat
Nirogacestat is an investigational, oral, selective, small molecule gamma-secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders. To date, SpringWorks has entered into two clinical collaborations to evaluate nirogacestat in combination with GlaxoSmithKline’s BCMA antibody-drug conjugate belantamab mafodotin and with Allogene’s allogeneic BCMA CAR-T cell therapy ALLO-715.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors (June 2018) and from the European Commission for the treatment of soft tissue sarcoma (September 2019). The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (November 2018 and August 2019).

On January 13, 2020 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported its preliminary* fourth quarter and full year 2019 global net product revenues for ONPATTRO and GIVLAARI and provided additional updates on the products’ commercial launches (Press release, Alnylam, JAN 13, 2020, View Source [SID1234553146]).

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For ONPATTRO, the Company reported:

Preliminary global net product revenues for the fourth quarter and full year 2019 were approximately $56 million and $166 million, respectively.

As of year-end 2019, over 750 patients worldwide were receiving commercial ONPATTRO, and over 1,000 total patients worldwide were being treated with patisiran, when also including those patients in clinical studies and in the Company’s global Expanded Access Program (EAP).

In the U.S., 44% of Start Forms submitted in 2019 came from cardiologists, 38% from neurologists, and 18% from other physician specialties.

Significant ONPATTRO new patient growth in the fourth quarter was seen in the U.S. and EU, along with a strong launch in Japan.

In the U.S., Alnylam has now completed definitive value-based agreements (VBAs) with 14 commercial payers, including each of the top 5 commercial payers and 8 of the top 10, with signed VBAs now covering over 130 million U.S. lives in the aggregate.

For the period following approval of GIVLAARI in the U.S. on November 20 through year end, the Company reported:

A total of 13 Start Forms were submitted.

Preliminary global net product revenues were approximately $0.2 million representing initial channel stocking.

The Company has made significant progress toward establishing VBAs, including a Prevalence-Based Adjustment feature, with multiple ongoing discussions with payers.

"In 2019 we achieved continued and steady growth of patients on ONPATTRO and we expect sustained growth in 2020 and beyond. We believe our preliminary results reflect strong patient and physician demand and excellent execution by our commercial teams around the world. With the early U.S. approval of GIVLAARI, we are now a multi-product commercial company, and are pleased with the strong initial interest from patients and physicians in the short period since the drug’s approval by the FDA. We’re also encouraged by the receptivity of U.S. payers to the value that GIVLAARI has the potential to deliver," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "In 2020, we look forward to the continued launches of ONPATTRO and GIVLAARI, bringing the benefits of these innovative therapies to patients around the world. We also look forward to advancing lumasiran – as our third wholly owned RNAi therapeutic – as well as inclisiran – with our partners at Novartis – toward the market in 2020 and achieving additional milestones across our broad late-stage pipeline of investigational RNAi therapeutics, notably in our ATTR amyloidosis clinical programs."

In addition, the Company today reported that at December 31, 2019, it had preliminary cash, cash equivalents, marketable debt and equity securities, and restricted investments of approximately $1.5 billion, as compared to $1.1 billion at December 31, 2018.

Alnylam management will discuss these preliminary selected financial results and commercial updates during a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California tomorrow, Monday, January 13, 2020, at 10:30 a.m. PT (1:30 p.m. ET).

* The preliminary selected financial results are unaudited, subject to adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results in February 2020.

About ONPATTRO (patisiran)

ONPATTRO is an RNAi therapeutic that is approved in the United States and Canada for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved in the European Union and Switzerland for the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and in Japan for the treatment of hATTR amyloidosis with polyneuropathy. Based on Nobel Prize-winning science, ONPATTRO is an intravenously

administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby blocking the production of TTR protein before it is made. ONPATTRO blocks the production of TTR in the liver, reducing its accumulation in the body’s tissues in order to halt or slow down the progression of the polyneuropathy associated with the disease. For more information about ONPATTRO, visit ONPATTRO.com.

ONPATTRO Important Safety Information

Infusion-Related Reactions

Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO. In a controlled clinical study, 19 percent of ONPATTRO-treated patients experienced IRRs, compared to 9 percent of placebo-treated patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache.

To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. Monitor patients during the infusion for signs and symptoms of IRRs. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.

Reduced Serum Vitamin A Levels and Recommended Supplementation

ONPATTRO treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking ONPATTRO. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with ONPATTRO, as serum levels do not reflect the total vitamin A in the body.

Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g. night blindness).

Adverse Reactions

The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory-tract infections (29 percent) and infusion-related reactions (19 percent).

For additional information about ONPATTRO, please see the full Prescribing Information.

About GIVLAARI (givosiran)

GIVLAARI is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) that is approved in the U.S. for the treatment of adults with acute hepatic porphyria (AHP). In the pivotal study, GIVLAARI was shown to significantly reduce the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or IV hemin administration at home compared to placebo. GIVLAARI is Alnylam’s first commercially available therapeutic based on its Enhanced Stabilization Chemistry (ESC) GalNAc conjugate technology to increase potency and durability. GIVLAARI is administered via subcutaneous injection once monthly at a dose based on actual body weight and should be administered by a healthcare professional. GIVLAARI works by specifically reducing elevated levels of ALAS1 messenger RNA (mRNA), leading to reduction of toxins associated with attacks and other disease manifestations of AHP. For more information about GIVLAARI, visit GIVLAARI.com.

GIVLAARI Important Safety Information

Contraindications

GIVLAARI is contraindicated in patients with known severe hypersensitivity to givosiran. Reactions have included anaphylaxis.

Anaphylactic Reaction

Anaphylaxis has occurred with GIVLAARI treatment (<1% of patients in clinical trials). Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI. Monitor for signs and symptoms of anaphylaxis. If anaphylaxis occurs, immediately discontinue administration of GIVLAARI and institute appropriate medical treatment.

Hepatic Toxicity

Transaminase elevations (ALT) of at least 3 times the upper limit of normal (ULN) were observed in 15% of patients receiving GIVLAARI in the placebo-controlled trial. Transaminase elevations primarily occurred between 3 to 5 months following initiation of treatment.

Measure liver function tests prior to initiating treatment with GIVLAARI, repeat every month during the first 6 months of treatment, and as clinically indicated thereafter. Interrupt or discontinue treatment with GIVLAARI for severe or clinically significant transaminase elevations. In patients who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly. The dose may be increased to the recommended dose of 2.5 mg/kg once monthly if there is no recurrence of severe or clinically significant transaminase elevations at the 1.25 mg/kg dose.

Renal Toxicity

Increases in serum creatinine levels and decreases in estimated glomerular filtration rate (eGFR) have been reported during treatment with GIVLAARI. In the placebo-controlled study, 15% of patients receiving GIVLAARI experienced a renally-related adverse reaction. The median increase in creatinine at Month 3 was 0.07 mg/dL. Monitor renal function during treatment with GIVLAARI as clinically indicated.

Injection Site Reactions

Injection site reactions were reported in 25% of patients receiving GIVLAARI in the placebo-controlled trial. Symptoms included erythema, pain, pruritus, rash, discoloration, or swelling around the injection site. One (2%) patient experienced a single, transient, recall reaction of erythema at a prior injection site with a subsequent dose administration.

Drug Interactions

Concomitant use of GIVLAARI increases the concentration of CYP1A2 or CYP2D6 substrates, which may increase adverse reactions of these substrates. Avoid concomitant use of GIVLAARI with CYP1A2 or CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP1A2 or CYP2D6 substrate dosage in accordance with approved product labeling.

Adverse Reactions

The most common adverse reactions that occurred in patients receiving GIVLAARI were nausea (27%) and injection site reactions (25%).

For additional information about GIVLAARI, please see full Prescribing Information.

About LNP Technology

Alnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

On January 13, 2020 LabCorp (NYSE: LH) reported that it will release its fourth quarter and full year 2019 financial results before the market opens on Thursday, Feb. 13, 2020, and then will host a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, JAN 13, 2020, View Source [SID1234553144]). The earnings release and accompanying financial information will be posted on the LabCorp Investor Relations website.

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Interested parties can access the conference call by dialing 1-844-634-1444 within the U.S. and Canada, or 1-615-247-0253 internationally, using the passcode 8663007. In addition, a real-time webcast of the conference call will be available on the LabCorp Investor Relations website.

An audio replay of the conference call will be available from 1:00 p.m. EDT on Feb. 13, 2020, until 11:30 a.m. EDT on Feb. 27, 2020, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 8663007. The webcast of the conference call will be archived and accessible through Jan. 29, 2021, on the LabCorp Investor Relations website.

On January 13, 2020 Aprea Therapeutics presented the corporate presentation (Presentation, Aprea, JAN 13, 2020, View Source [SID1234553143]).

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