On May 19, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported financial results for the fiscal fourth quarter and year ended March 31, 2022 and provided a business update (Press release, Replimune, MAY 19, 2022, View Source [SID1234614852]).

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"We have ended the fiscal year in a very strong position from which to execute on our vision to establish our products as a cornerstone of immuno-oncology regimens and we look forward with these firm foundations in place to a potentially transformative 12-month period ahead," said Philip Astley-Sparke CEO of Replimune. "Updated data in anti-PD1 naïve cutaneous squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma continue to support our two registration-directed clinical trials in these settings. We are maintaining guidance that we expect to complete enrollment into our registration directed CERPASS clinical trial in CSCC mid-year and to release top line data in early 2023. Further, we expect to release initial directional data from our registration directed IGNYTE clinical trial in anti-PD1 failed melanoma in late 2022. Launch scale manufacturing has been established and commercial planning to establish a major skin cancer franchise is advancing. With RP2/3 we have announced an exciting mid stage program in colorectal cancer (CRC), hepatocellular carcinoma (HCC) and head and neck cancer (SCCHN) where an expedited path to potential approval in some settings may be feasible. Finally, we have a strong cash position to drive value through multiple major data catalysts."

Corporate Updates

Provided data update for RP1 in its skin cancer programs at a virtual investor event in March 2022.
IGNYTE anti-PD1 naïve NMSC cohort of patients treated with RP1 combined with Opdivo (nivolumab) (n=32; recruitment complete): The overall response rate (ORR) in CSCC increased to 65%, compared to 60% at the June 2021 update with the complete response rate (CRR) unchanged at 47%. Updated response rates in BCC, MCC and angiosarcoma were 25%, 75% and 67% respectively with multiple complete responses documented, indicating the potential utility of RP1 in additional NMSCs beyond CSCC.
IGNYTE anti-PD1 failed and anti-PD1 naïve melanoma cohort of patients treated with RP1 combined with Opdivo (n=36; recruitment complete): The ORR in anti-PD1 naïve cutaneous melanoma remained at 62.5%. The ORR in cutaneous melanoma patients who had previously failed anti-PD1 or both anti-PD1 and anti-CTLA-4 (n=16) was reported to have risen to 37.5%, an improvement from the 31% ORR reported in the June 2021 update, including two complete responses.
IGNYTE anti-PD(L)-1 failed NMSC cohort of patients treated with RP1 combined with Opdivo (n=12; recruitment ongoing): The initial early ORR data in this group was 33.3% with responses having been observed in anti-PD(L)-1 failed CSCC, MCC and angiosarcoma, including one complete response as of the cutoff date. Other patients who remain on study with a shorter follow up also showed tumor shrinkage. The Company believes the clear activity of RP1 combined with Opdivo in anti-PD(L)-1 failed NMSC represents a new potential therapeutic option for these patients and supports the broader potential for RP1 in skin cancers, including those with anti-PD(L)-1 failed disease.
Phase 1b/2 ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancer (n=6; recruitment ongoing): Initial data with RP1 monotherapy in solid organ transplant patients demonstrated a similar safety profile to that observed in patients who are not immune suppressed, with initial clinical activity having been seen. Two of the first six patients enrolled (33%) had so far achieved a response, with one complete response and one partial response.
Provided detailed strategy and clinical development plan for RP2/3 at a virtual investor event in March 2022.
The Phase 2 development plan for RP2/3 is intended to target tumor types in large underserved markets, including where liver metastases are common, as well as patients with primary liver cancer, and patients with early disease where the objective of treatment would be to increase the rate of cure. This includes the development of RP2/3 in combination with current standards of care (SOC), including immunotherapy, chemotherapy and radiation, and in settings following the current SOC.
The following indications for signal finding single arm Phase 2 clinical trials were identified which meet these criteria:
Locally advanced (LA) and 1L recurrent SCCHN in combination with chemoradiation, or SOC chemotherapy and anti-PD1 therapy, respectively. The Company’s objective is to also expedite the initiation of a randomized controlled registration directed program in LA SCCHN.
1L and 2L hepatocellular carcinoma (HCC) in combination with SOC immunotherapy and anti-PD1/L1 therapy respectively.
3L micro-satellite stable colorectal cancer (CRC) in combination with anti-PD1 therapy.
Additional signal finding work is also intended in other indications.
The RP2/3 Phase 2 program is expected to initiate around the calendar year end.
The decision as to whether RP2 or RP3 will be used in these clinical trials will be made later in the calendar year, following generation and analysis of further clinical data with RP2 and RP3 in their respective ongoing Phase 1 clinical trials.
Upcoming Milestones

CERPASS – Registration-directed Phase 2 clinical trial in CSCC

RP1 in combination with Libtayo (cemiplimab-rwlc) in CSCC: The Company is actively enrolling patients in a registration-directed, global, randomized, controlled, 180-patient Phase 2 clinical trial (CERPASS) evaluating RP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment in mid-year 2022 with top line data expected to be available in Q1 2023.
IGNYTE – Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo

Anti-PD1 failed melanoma cohort: The Company continues to enroll patients in the 125-patient cohort of the IGNYTE Phase 2 clinical trial in patients with anti-PD1 failed melanoma. The Company continues to expect to report initial directional data from the first 75 patient with six months follow up in late 2022.
RP2 and RP3

RP2 alone and in combination with Opdivo in difficult-to-treat cancers: After fully enrolling patients in the RP2 monotherapy (n=9) and combination with Opdivo (n=30) cohorts in the Phase 1 clinical trial with RP2 (data presented in Nov 2020 and Nov 2021), a further cohort of Phase 1 patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer and uveal melanoma) was opened, with the first patients having been enrolled and from which initial data is expected towards the end of the year.
RP3 alone and in combination with Opdivo in difficult-to-treat cancers: The Company completed enrollment in the initial part of its Phase 1 clinical trial with RP3 alone. Following determination of the recommended Phase 2 dose (RP2D), enrollment into the cohort of patients dosed with RP3 combined with Opdivo has recently commenced. This cohort will focus on enrolling patients with GI cancers, breast cancer, lung cancer and head and neck cancer. Initial data for this combination cohort is expected towards the end of the year. Additional patients will also be dosed as monotherapy.
Financial Highlights

Cash Position: As of March 31, 2022, cash, cash equivalents and short-term investments were $395.7 million, as compared to $476.3 million as of March 31, 2021. The decrease was primarily related to cash utilized in operating activities in advancing the Company’s expanded clinical development plan.

Based on the current operating plan, Replimune believes that existing cash and cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body.

R&D Expenses: Research and development expenses were $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022, as compared to $16.2 million for the fourth quarter and $56.8 million for the fiscal year ended March 31, 2021. This increase was primarily due to clinical expenses driven by the Company’s lead programs, expansion into additional studies, operating our dedicated manufacturing facility and related increased personnel costs. Research and development expenses included $2.1 million in stock-based compensation expenses for the fourth quarter and $8.6 million in stock-based compensation expenses for the fiscal year ended March 31, 2022.

S,G&A Expenses: Selling, general and administrative expenses were $10.3 million for the fourth quarter and $38.8 million for the fiscal year ended March 31, 2022, as compared to $6.0 million for the fourth quarter and $23.2 million for the year ended March 31, 2021. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and the initial build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $3.7 million in stock-based compensation expenses for the fourth quarter and $15.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2022.

Net Loss: Net loss was $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022, as compared to a net loss of $21.5 million for the fourth quarter and $80.9 million for the fiscal year ended March 31, 2021.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo. alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.
Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On May 19, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that it will present preclinical research supporting its planned second clinical indication, bile duct cancer, also known as cholangiocarcinoma, at the Global Embolization Oncology Symposium Technologies (GEST) 2022, in New York City (Press release, Renovorx, MAY 19, 2022, View Source [SID1234614885]). The study demonstrates the potential utility of RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform for the treatment of cholangiocarcinoma.

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Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts — thin tubes that carry a digestive fluid, called bile, from the liver to other digestive organs. Most people with cholangiocarcinoma do not have symptoms until the disease becomes more advanced, making early diagnoses difficult. Like pancreatic cancer, which the Company is evaluating in a Phase 3 study, bile duct tumors that grow outside of the liver lack tumor feeder blood vessels, which provide a pathway between the blood stream and the tumor. Tumor feeders are critical to the effectiveness of systemic chemotherapy. Published research supports that without direct access to the tumor, systemic chemotherapy circulates through the body, without a significant amount of chemotherapy reaching the tumor.

RenovoRx plans to launch a Phase 2/3 study in cholangiocarcinoma in the second half of 2022. The Company also received Orphan Drug Designation for this clinical indication in April 2021.

"We are pleased to present our preclinical research data studying RenovoTAMP’s utility in cholangiocarcinoma at this peer-reviewed, scientific meeting – GEST 2022," said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder at RenovoRx. "To be effective, chemotherapy must be able to reach the tumor. RenovoTAMP was designed to bring the chemotherapy to the tumor when there is no other pathway available. Through localized delivery of chemotherapy, we are hoping to provide a more effective treatment option for cancer patients, reduce the debilitating side effects typical of standard of care systemic chemotherapy and improve patient survival for cancers like cholangiocarcinoma."

The purpose of the preclinical study was to compare the effectiveness of delivery of a chemotherapeutic agent inside the bile duct via the gall bladder versus intra-arterially, into the tissue surrounding the bile duct (RenovoTAMP). This study determined that delivery via the gallbladder resulted in zero tissue penetration. In comparison, intra-arterial delivery resulted in extensive tissue penetration, confirming the Company’s plan to utilize RenovoTAMP in its planned Phase 2 study.

The abstract and poster for the study, "Localized Delivery of Chemotherapy Through the Bile Duct Using a Double Balloon Catheter in A Porcine Model," are available on RenovoRx’s website: View Source

RenovoTAMP is currently being investigated in the Phase 3 TIGeR-PaC clinical trial as a potential treatment option for patients with unresectable locally advanced pancreatic cancer. RenovoRx received Orphan Drug Designation for pancreatic cancer in 2018.

On May 19, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported that it will present for the first time proof-of-concept data from clinical trials with EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Enterome, MAY 19, 2022, View Source [SID1234614902]).

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OncoMimics peptides – generating strong CD8+ T-cell responses derived from pre-existing memory cells

OncoMimics peptides are gut microbiome-derived peptides that closely mimic antigens expressed by tumor cells. In contrast to tumor antigens, however, OncoMimics peptides are recognized by the immune system as "non-self" and can generate a strong human cytotoxic CD8+ response steming from memory T cells, offering enormous potential to create a new class of cancer vaccines targeting solid and liquid tumors.

Enterome’s pioneering work on its OncoMimics pipeline leverages the fundamental understanding that the gut is the largest lymphoid organ in the body and is home to most of its memory T-cells. As a result, there is constant interaction and presentation of peptides and proteins secreted by gut bacteria to the body’s immune system, resulting in the formation of a pool of effector memory T cells protecting the human body against bacterial invasion. In the event that the bacterial antigens are mimics of tumor antigens, this process leads to the generation of circulating effector memory T cells with a preserved ability to recognize tumor antigens.

To-date, Enterome has generated a repertoire of OncoMimics peptides correlating to tumor antigens across a wide range of solid and liquid tumor types. From this, the Company is creating a pipeline of off-the-shelf cancer immunotherapies designed to act via the same novel mode of action. The first candidates include EO2401 (in clinical trials for glioblastoma and adrenal malignancies), EO2463 (in clinical development for liquid tumors) and EO4010 (in development for colorectal cancer, and targeted to enter clinical trials in 2023).

Enterome’s lead candidate EO2401 combines three OncoMimics peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, all of which are known driver antigens present on aggressive solid tumors and generate strong human CD8+ responses. In addition, EO2401 contains a CD4 helper peptide UCP4.

At ASCO (Free ASCO Whitepaper), in the first two abstracts, Enterome will present, for the first time, clinical proof-of-concept data from Phase 1/2 clinical trials of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo), for the treatment of patients with first progression/recurrence of glioblastoma (the ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (the SPENCER trial, EOADR1-19).

In a third abstract, the Company will present the use of its second therapeutic vaccine program, EO2463 as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma (the SIDNEY trial, EONHL1-20). EO2463 combines four OncoMimics peptides that exhibit molecular mimicry with the B cell markers CD20, CD22, CD37, and CD268 (BAFF-receptor), respectively.

Jan Fagerberg, Chief Medical Officer of Enterome said, "As a proof-of-concept for the entire Mimicry platform, we have put in action a clinical development strategy for EO2401 that is designed to identify a clinical efficacy signal in various tumor types that have in common the same tumor antigens (IL13Ra2, BIRC5 and FOXM1). In both the ROSALIE and SPENCER trials, EO2401 in combination with checkpoint blockade generated strong systemic immune responses directed against human tumor antigens. We look forward to sharing these very promising clinical data at ASCO (Free ASCO Whitepaper) while continuing to progress these trials, with the aim of providing a more mature set of data at ESMO (Free ESMO Whitepaper), Europe’s leading medical oncology conference, later in the year."

Enterome’s Mimicry Platform

Enterome’s Mimicry drug discovery platform is based on its unique ability to decode the interaction between the gut microbiome and the immune system. The Mimicry platform uses best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 21 million full-length gut microbiome peptides and proteins.

The Mimicry platform is highly productive and has already generated first-in-class small protein and peptide drug candidates targeting multiple therapeutic areas that modulate the immune system by closely mimicking the structure, effect or actions of specific human antigens, hormones or cytokines.

"We are thrilled to be able to present the first clinical data demonstrating the potential of our unique OncoMimics pipeline at ASCO (Free ASCO Whitepaper) this year. We are using our Mimicry platform to generate multiple pipelines of transformative drug candidates, targeting a broad range of therapeutic areas. Presently we are advancing two pipelines of distinct drug candidates – OncoMimics and EndoMimics – which have the potential to address cancer, inflammatory and autoimmune diseases," said Pierre Belichard, CEO of Enterome. "We believe that our unique platform has the potential to create effective new medicines that make a real difference to patients. Our corporate strategy is designed to advance the development of these new therapies as quickly and robustly as possible while generating significant value for our shareholders. Enterome’s future has never looked so exciting."

On May 19, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported the nomination of its second product candidate, BMF-500, a highly selective and potent covalent investigational third-generation FLT3 inhibitor (Press release, Biomea Fusion, MAY 19, 2022, View Source [SID1234614853]).

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Approximately 30% of AML patients present with a FLT3 mutation and remain poorly controlled with currently available therapies. First and second-generation FLT3 inhibitors frequently have a narrow therapeutic window and patients often acquire rapid resistance to treatment, limiting the clinical efficacy of these agents. As a third-generation FLT3 inhibitor, BMF-500 is designed to overcome some of the characteristics that are believed to limit the duration of response and utility of these earlier generation FLT3 inhibitors.

BMF-500 was discovered and developed in-house at Biomea using the company’s proprietary FUSION System. BMF-500, like BMF-219, was designed to be clinically effective at relatively low drug concentrations in order to deliver an optimal therapeutic profile. Specifically, BMF-500 was observed in preclinical studies to be a highly active inhibitor of FLT3 with picomolar affinity for key isoforms of FLT3 while avoiding other key kinases tested, including structurally related KIT.

Because patients often acquire rapid resistance to treatment with first and second-generation FLT3 inhibitors, BMF-500 is designed to strongly inhibit FLT3 variants that are key drivers of resistance. Additionally, BMF-500 is designed to potentially have a therapeutic profile that may allow for combination with standard of care and/or targeted agents like BMF-219. Many patients with AML are older and unfit candidates for intensive chemotherapy but could benefit from BMF-500 and BMF-219 either as monotherapy or in combination.

AML is often described as the result of two broad complementary classes of mutations: Type I – those that confer a proliferative/survival advantage to hematopoietic progenitors including activating FLT3 mutations or their downstream effectors such as RAS, and Type II – those that impair hematopoietic differentiation and drive cell cycle progression, including NPM1, MLL-r, RUNX1, and DNMT3A mutations. With BMF-500 and BMF-219, Biomea plans to interrogate multiple molecular mechanisms that drive AML in the pursuit of establishing long-term disease management or a potential cure for these patients.

"FLT3 has been a challenge for companies to effectively target with either non-covalent or covalent approaches due to the homology of various kinases and other receptors, leading to off-target toxicities at potentially clinically relevant drug concentrations. Leveraging our FUSION System, we have quickly developed BMF-500, which we believe is among the most promising investigational FLT3 inhibitors to date," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "With picomolar activity against key isoforms of FLT3, high specificity to FLT3 observed in preclinical studies, and the potential benefits of covalent engagement, we believe that BMF-500 is poised to become a leading targeted therapy for AML patients with FLT3 mutations, if approved. We look forward to leveraging the existing clinical infrastructure and know-how that we have developed through the planning and execution of our ongoing trial with BMF-219, COVALENT-101, and plan to explore the potential synergy between BMF-500 and BMF-219."

About FLT3 (fms-like tyrosine kinase 3)

FLT3 is a tyrosine kinase receptor that plays a central role in the survival, proliferation, and differentiation of immature blood cells. Notably, FLT3 gene mutations are common in patients with AML and are associated with a poor prognosis. Nearly 30% of AML patients have a FLT3 mutation, representing more than 6,000 incident patients in the United States each year. While FLT3-specific and pan-tyrosine kinase inhibitors are FDA approved across various lines of therapy in AML, these agents have produced relatively low rates of durable responses and overall survival remains an unmet need.

On May 19, 2022 CANbridge Pharmaceuticals Inc. (HKEX:1228), a China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, reported that it will participate in the Morgan Stanley Virtual China Summit 2022 to be held on May 24-26, 2022 (Press release, CANbridge Life Sciences, MAY 19, 2022, View Source [SID1234614886]).

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