On August 7, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the second quarter ended June 30, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, AUG 7, 2020, View Source [SID1234563160]).

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"I am impressed by the execution of the team, and momentum is rapidly building for our lead clinical programs, SRK-015 in SMA and SRK-181 in immuno-oncology, towards several potential value-creation opportunities in late 2020 and throughout 2021," said Tony Kingsley, President and CEO of Scholar Rock. "Scholar Rock has an exceptional proprietary platform that has yielded multiple clinical candidates that have the potential to transform the lives of patients living with serious diseases, and I look forward to seeing the company continue to drive additional product candidates forward."

Company Updates and Upcoming Milestones

SRK-015 Program for Spinal Muscular Atrophy:

SRK-015 is a highly selective inhibitor of latent myostatin being developed as the potential first muscle-directed therapy for the treatment of SMA.

On Track to Report Interim Efficacy and Safety Data from the TOPAZ Phase 2 Trial in the Fourth Quarter of 2020. The interim efficacy, safety, pharmacokinetic (PK), and pharmacodynamic (PD) analysis will include data from 54 patients who have progressed through at least six months of treatment in the TOPAZ Phase 2 trial. The remaining three patients (one in Cohort 2 and two in Cohort 3) missed three doses of SRK-015 due to COVID-19-related restrictions at their trial site, and their 6-month assessments will be excluded from the interim analysis. These patients have resumed dosing and the Company is working closely with the trial site to schedule their next assessments.
To date, one patient (Cohort 1) has discontinued from the trial for reasons unrelated to the study drug and which occurred prior to the COVID-19 pandemic. All remaining 57 patients are continuing in the study.
As of August 1, 2020:
56 of 57 patients have completed the 5-month visit.
54 of 57 patients have completed the 6-month visit for the interim efficacy and safety analysis.
Eight of eight patients who have completed the 12-month treatment period have opted into the 12-month extension study

With the progress to date for the completion of patient visits towards the interim analysis, Scholar Rock is working closely with the clinical trial sites through the ongoing COVID-19 pandemic to enable access to routine data monitoring activities to prepare for the interim analysis. The Company remains on track to report interim efficacy and safety data in the fourth quarter of 2020. Top-line data for the 12-month treatment period are expected in the first half of 2021. There may be further impacts on the timing of future doses and assessments for patients in the trial as the effects of the COVID-19 pandemic continue to evolve.

SRK-181 Program for Immuno-Oncology:

SRK-181 is a potent and highly selective inhibitor of latent TGFβ1 activation being developed towards an aim of overcoming resistance and meaningfully increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Enrollment Advancing in DRAGON Phase 1 Proof-of-Concept Trial with Update on Dose Escalation Expected in the Fourth Quarter of 2020. The DRAGON Phase 1 dose escalation and dose expansion trial is evaluating SRK-181 in patients with locally advanced or metastatic solid tumors. Dose escalation in Part A1 of the trial continues to progress, and the Company expects to advance to Part A2 of the trial to evaluate SRK-181 in combination with an approved anti-PD-(L)1 therapy in the third quarter of 2020 and to Part B of the trial in the first quarter of 2021. An update on dose escalation of SRK-181 as a single agent as well as in combination with anti-PD-(L)1 therapy is on track for the fourth quarter of 2020. Clinical response and safety data are anticipated in 2021.

The two-part DRAGON trial consists of a dose escalation portion (Part A) for SRK-181 as both a single-agent (Part A1) and in combination with an approved anti-PD-(L)1 therapy (Part A2), followed by a dose expansion portion (Part B) evaluating SRK-181 in combination with an approved anti-PD-(L)1 therapy in patients with solid tumors exhibiting primary resistance to that anti-PD-(L)1 therapy. Part B will encompass multiple cohorts that are expected to include urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors. Patients will be administered SRK-181 IV every 3 weeks (Q3W), and additional dosing regimens may be explored in the future. Key objectives of the study include evaluating the efficacy, PK, and safety of SRK-181.
"We are encouraged by the high level of engagement of our trial investigators and patients. Patients in our SRK-015 TOPAZ trial are continuing their visits and thus far, we’ve seen a high rate of enrollment into the 12-month extension study," said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock. "We are also pleased with the progress to date enrolling patients in our SRK-181 DRAGON trial, particularly given the backdrop of the ongoing COVID-19 pandemic. Important readouts from these trials will provide meaningful insights into the therapeutic potential of our product candidates as well as the power of our drug discovery platform."

Executive Leadership Updates:

Appointment of Tony Kingsley as President and Chief Executive Officer. In July 2020, Scholar Rock announced that Tony Kingsley was being appointed President and Chief Executive Officer, effective August 1, 2020. Mr. Kingsley replaces Nagesh K. Mahanthappa, Ph.D., MBA, who chose to step down after serving in this role since 2012. Mr. Kingsley is a proven leader with a successful track record of driving growth, strategy and all facets of corporate operation. Dr. Mahanthappa continues to serve as a scientific advisor to the Company.
Appointment of Ted Myles as Chief Financial Officer and Head of Business Operations. In July 2020, Scholar Rock announced the appointment of Ted Myles as Chief Financial Officer and Head of Business Operations, bringing more than 20 years of experience as a senior finance and operations executive with development and commercial stage biopharmaceutical companies. He had previously served on Scholar Rock’s Board of Directors, including as chair of the audit committee and a member of the compensation committee.
Second Quarter 2020 Financial Results

For the quarter ended June 30, 2020, net loss was $19.3 million or $0.65 per share compared to a net loss of $12.5 million or $0.48 per share for the quarter ended June 30, 2019.

Revenue was $3.9 million for the quarter ended June 30, 2020 compared to $5.0 million for the quarter ended June 30, 2019. Revenue was related to the Gilead fibrosis-focused collaboration that was executed in December 2018.
Research and development expense was $17.0 million for the quarter ended June 30, 2020 compared to $13.7 million for the quarter ended June 30, 2019. The increase year-over-year is attributable to the acceptance of a customized antibody display library from Specifica, Inc., costs associated with the TOPAZ Phase 2 clinical trial for SRK-015, and higher personnel-related costs.
General and administrative expense was $6.4 million for the quarter ended June 30, 2020 compared to $4.7 million for the quarter ended June 30, 2019. The increase year-over-year was primarily attributable to increased headcount and professional services.
As of June 30, 2020, Scholar Rock had cash, cash equivalents, and marketable securities of $141.2 million, which compares to cash, cash equivalents, and marketable securities of $157.4 million as of December 31, 2019.

Conference Call/Webcast:

Scholar Rock will host a conference call and audio webcast to discuss the second quarter 2020 financial results today at 8:00 a.m. Eastern Time. To participate in the call, please dial 833-519-1308 (domestic) or 914-800-3874 (international) and refer to conference ID: 5627485. A webcast of the call will also be available on the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on Scholar Rock’s website at: View Source for approximately 90 days following the presentation.

On August 7, 2020 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Crinetics Pharmaceuticals, AUG 7, 2020, View Source [SID1234563159]).

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"Crinetics has made significant progress in the second quarter of the year, which began with our positive interim data from the Phase 2 ACROBAT Edge trial, and Orphan Drug Designation for paltusotine for the treatment of acromegaly, both solidifying the confidence we have in our lead product to be an effective, orally available treatment for patients with this rare disease," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Looking ahead to the rest of the year, we see additional clinical milestones for the company with topline data from our ongoing Phase 2 trials expected to be presented in the fourth quarter of 2020. Additionally, with the capital from our April financing, we are well positioned to execute on our planned Phase 3 trial in acromegaly, a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors, as well as the planned Phase 1 trials for our ACTH antagonist and SST5 agonist programs."

Second Quarter and Subsequent Highlights

Received Orphan Drug Designation for paltusotine for the treatment of acromegaly. In July 2020, the U.S. Food and Drug Administration (FDA) granted paltusotine Orphan Drug Designation for the treatment of acromegaly. Orphan Drug Designation qualifies Crinetics for certain development incentives, that may include exemption from FDA prescription drug user fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

Confirmed completion for half of the enrolled patients in the ongoing Phase 2 ACROBAT Edge clinical trial for paltusotine. In June 2020, Crinetics announced that over 50% (28/47) of the patients enrolled in the ACROBAT Edge Phase 2 clinical trial have completed the study, which is investigating the effects of once daily oral paltusotine on IGF-1

levels after switching patients from injectable depot therapy. Recruitment for the Edge and Evolve trials has been completed with 47 and 13 patients, respectively, and topline data is planned for the fourth quarter of 2020.

Reported positive interim results for the ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients. In April 2020, Crinetics reported interim results from its ongoing ACROBAT Edge Phase 2 trial. Results as of the February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands.

Successful public offering strengthens cash position. In April 2020, Crinetics completed a public offering in which the company sold an aggregate of 8,222,500 shares of common stock at a price to the public of $14.00 per share. Net proceeds from the public offering after deducting underwriting discounts, commissions and offering expenses, were approximately $107.9 million.

Second Quarter 2020 Financial Results

Research and development expenses were $12.6 million for the three months ended June 30, 2020, compared to $10.3 million for the same period in 2019. The increase was primarily attributable to development and manufacturing activities for paltusotine as well as the advancement of the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $4.3 million for the three months ended June 30, 2020, compared to $3.1 million for the same period in 2019. The increase was primarily due to personnel costs to support the company’s growth.

Net loss for the three months ended June 30, 2020 was $16.5 million, compared to a net loss of $12.4 million for the three months ended June 30, 2019.

Cash, cash equivalents and investments totaled $205.2 million as of June 30, 2020, compared to $118.4 million as of December 31, 2019. The cash balance includes the $107.9 million of net proceeds from the public equity offering completed in April.

As of July 31, 2020, the company had 32,883,582 common shares outstanding.

On August 7, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), reported a business update for the second quarter ended June 30, 2020 (Press release, Orgenesis, AUG 7, 2020, View Source [SID1234563158]).

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Vered Caplan, CEO of Orgenesis, stated, "We continue to implement our Point of Care (POCare) cell and gene therapy strategy, including the expansion of our network, as evidenced by the expected revenue growth. Revenue for the second quarter of 2020 increased 55% to $1.7 million compared to $1.1 million for the second quarter of 2019. We have also maintained a solid balance sheet with over $97.5 million of cash and cash equivalents as of June 30, 2020. Our true progress can be seen in the advancement of our POCare Therapeutics pipeline, including immuno-oncology, metabolic, and anti-viral therapies. Our mission is to make these therapies available to large numbers of patients at reduced costs using the point-of-care model. Our POCare Network also continues to grow via new partnerships with leading hospitals and research institutes around the world."

"We have made progress towards our goal of adapting our cell-based and antiviral technologies to address the COVID-19 pandemic. First, we are focused on advancing our cell-based vaccine platform in order to target COVID-19, as well as other potential existing and emerging viral diseases. Second, we recently launched our BioShield Program, which is designed to potentially accelerate discovery and set up a first line of defense against the spread of viral pathogens, such as COVID-19. And finally, we are engaging with industry partners for the development of Ranpirnase for the potential treatment of COVID-19, as well as other viruses."

The Company remained active through the second quarter and into the third quarter of 2020, reporting the following recent advances:

Entered into a Collaboration Agreement with Educell Ltd., a premier European cell therapy company, to conduct clinical validation of the POCare Technologies for the expansion of T-cells in a whole cell-based vaccine platform for use in cancer immunotherapies.
Entered into a Clinical Study Agreement with The Edith Wolfson Medical Center, a leading public hospital in Israel, to conduct a joint clinical study to validate the partnered POCare Technologies.
Advanced development of a novel cell-based vaccine platform targeting COVID-19 and other existing and emerging viral diseases; plans to commence animal testing trials with human testing expected to follow pending clearance from the FDA and/or other non-US regulatory bodies.
Launched the BioShield Program to accelerate the potential discovery and validation of neutralizing human antibodies as an affordable solution to contain the spread of a viral pathogen or new emerging outbreaks.
Signed a preliminary agreement with Leidos, a FORTUNE 500 science and technology leader, to develop, and potentially obtain, FDA marketing approval of Ranpirnase for the systemic treatment of patients suffering from SARS-CoV-2, the virus that causes COVID-19.
The Company’s complete financial results are available in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2020, which is available at www.sec.gov and on the Company’s website.

On August 7, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the 2020 Wedbush PacGrow Virtual Healthcare Conference on Tuesday, August 11 at 10:20 a.m. ET (Press release, Arvinas, AUG 7, 2020, View Source [SID1234563157]).

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A live audio webcast of the presentation will be available here and on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation

On August 7, 2020 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for the fiscal first quarter ended June 30, 2020 and provided a business update (Press release, Replimune, AUG 7, 2020, View Source [SID1234563156]).

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"In the past few months, we have made important progress in demonstrating the power of our Immulytic platform to deliver meaningful new treatment options for a range of cancers," said Philip Astley-Sparke, CEO of Replimune. "In June, we provided an interim update from the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with Opdivo, establishing clinical proof of principle for RP1 in immune-responsive tumor types, including in patients with anti-PD1 refractory disease. In particular, we believe the data generated bode well for our registration directed programs already underway with RP1 in CSCC and anti-PD1 refractory melanoma. Following a successful follow-on offering, Replimune is now well-financed to advance and expand our pipeline with many exciting milestones ahead of us. We look forward to providing an initial data readout from RP2 later this year, as well as initiating clinical development with RP3 as we seek to establish our products more broadly, beyond immune-responsive tumor types, as a cornerstone of immuno-oncology."

Recent Events and Corporate Updates

Presented interim clinical data from the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with Opdivo in non-melanoma and melanoma skin cancers that continue to support the clinical programs in both cutaneous squamous cell carcinoma (CSCC) and anti-PD1 refractory melanoma.

In CSCC, six of seven evaluable patients demonstrated ongoing response, with four of these six patients having ongoing complete responses (CRs).

Provided interim data evaluating treatment with RP1 in combination with Opdivo in 16 patients with anti-PD1 refractory cutaneous melanoma. Five of the 16 patients at the data cut-off had met the formal criteria for response, including four who had previously failed both anti-PD1 and anti-CTLA4 therapies, providing for a final response rate from this cohort of at least 31%.

Announced promising data of RP1 in combination with Opdivo in patients with anti-PD1 naïve cutaneous melanoma, mucosal melanoma and uveal melanoma.

Announced plans to enroll a new 30 patient cohort of anti-PD1 refractory NSCLC patients into the Phase 2 portion of the clinical trial of RP1 combined with Opdivo.

A link to the data presented can be found here.

Strengthened management team with the appointment of Andrea Pirzkall, M.D. as Chief Medical Officer. Dr. Pirzkall brings to Replimune a track record of drug development success in the biotechnology and pharmaceutical industry, particularly in immuno-oncology, together with multi-disciplinary clinical experience at the intersection of radiology and oncology. Dr. Pirzkall previously served as Executive Director of Clinical Development at BeiGene, Ltd., a publicly traded commercial-stage biotechnology company with responsibility for the development of tislelizumab (anti-PD1) and led successful pivotal trials in squamous and non-squamous cell lung cancer, prior to which Dr. Pirzkall spent 10 years at Genentech in roles of increasing responsibility.

Extended anticipated cash runway to mid-2023. In June 2020, the Company raised gross proceeds of $115 million through a public offering of common stock and pre-funded warrants. The Company believes that the existing cash and cash equivalents and short-term investments, along with a limited use of debt, will enable the Company to fund additional studies and the overall operating plan to mid-2023.

COVID-19 potential impact on milestones: Enrollment into our clinical trials, such as the Company’s clinical trial of RP1 in solid organ transplant patients with CSCC, representing a highly immunocompromised patient population, has been slower than expected, which the Company attributes to the global pandemic. As the clinical sites continue to evaluate their capacity to treat patients, the Company could see additional impact in the second half of 2020 across its programs. The Company has not yet experienced delays that would require an update to previous guidance.
Program Highlights

Replimune is currently developing three oncolytic immuno-gene therapies derived from its Immulytic platform. The Company’s first clinical product candidate, RP1, is 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 a gene encoding the cytokine GM-CSF. In addition to expressing GALV-GP-R and GM-CSF, the Company’s second clinical candidate, RP2, also expresses a genetically encoded anti-CTLA-4 antibody-like molecule 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 additionally 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 cutaneous squamous cell carcinoma (CSCC): The Company is actively enrolling patients into the 240-patient registration-directed Phase 2, randomized, controlled clinical trial in the US and Australia, with clinical trial sites in Canada and Europe expected to open later in the year.

RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors: The clinical trial remains on track with enrollment and accrual of the initial melanoma cohort completing in the first half of 2020 and patients expected to be fully accrued from the non-melanoma skin cancer (NMSC) cohort by the end of 2020. The Company is accumulating data from the MSI-H/dMMR cohort to inform a decision as to whether to pursue MSI-H/dMMR tumors into registration-directed development in 2021.

RP1 in combination with Opdivo in anti-PD-1 refractory melanoma: The Company initiated recruitment into a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo in February 2020 and is currently enrolling patients.

RP1 in anti-PD1 refractory patients with non-small cell lung cancer (NSCLC): In June 2020, the Company announced its plans to add a 30 patient cohort of anti-PD1 refractory patients with NSCLC to the RP1 combined with Opdivo clinical trial. The Company plans to initiate enrollment into this cohort later this year.

RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company initiated enrollment into a 30 patient Phase 1b clinical trial to assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC in May 2020.

RP2 alone and in combination with Opdivo: The Company plans to present initial safety and efficacy data from the ongoing Phase 1 clinical trial evaluating RP2 alone and in combination with Opdivo 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.
Financial Highlights

Cash Position: As of June 30, 2020, cash, cash equivalents and short-term investments were $261.8 million, as compared to $168.6 million as of March 31, 2020. This increase was primarily related to $109.5 million in net proceeds from financing activities offset by cash utilized in fiscal quarter one operating activities largely associated with advancing our expanded clinical development plan.

The Company believes that the existing cash and cash equivalents and short-term investments, along with a limited use of debt, will enable the Company to fund additional studies and the overall operating plan to mid-2023.
R&D Expenses: Research and development expenses were $12.2 million for the first quarter ended June 30, 2020, as compared to $7.5 million for the first quarter ended June 30, 2019. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $1.0 million in stock-based compensation expenses for the first quarter ended June 30, 2020.

G&A Expenses: General and administrative expenses were $5.7 million for the first quarter ended June 30, 2020, as compared to $3.5 million for the first quarter ended June 30, 2019. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $1.5 million in stock-based compensation expenses for the first quarter ended June 30, 2020.

Net Loss: Net loss was $17.5 million for the first quarter ended June 30, 2020, as compared to a net loss of $9.5 million for the first quarter ended June 30, 2019.
About RP1

RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered 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 proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses a pair of optimized immune co-stimulatory pathway ligands. These therapeutics are intended to provide targeted and potent delivery 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.