On February 20, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported interim data from its ongoing Phase II TACTI-002 study (Press release, Immutep, FEB 20, 2020, View Source [SID1234554592]). The results are being presented today at the 34th German Cancer Congress in Berlin by Principal Investigator, Dr. Bernhard Doger of START Madrid, Spain. The Company will also present this interim data and provide a further update on its clinical programs in a global webcast, details below.

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The data relates to use of the Company’s lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 protein, as part of a combination treatment with pembrolizumab. The activation of antigen-presenting cells (APC) and subsequent T cell recruitment with efti may lead to stronger anti-tumour responses than observed with pembrolizumab alone.

Immutep CSO and CMO, Dr Frederic Triebel said: "The results we are seeing from our TACTI-002 trial are highly encouraging, with 47% of first line non-small cell lung cancer patients responding. These results are remarkable given that usually only 20% of patients respond to pembrolizumab monotherapy, if not pre-selected for high PD-L1 expression. Interestingly, patient responses are being seen in all three PD-L1 expression level groups, meaning the combination treatment seems to work even in patients not expected to respond to pembrolizumab monotherapy.

The initial overall response rate of 33% of second line head and neck squamous cell carcinoma patients is also very exciting, albeit from a smaller patient group. It compares well to an expected pembrolizumab monotherapy response rate of 15-18%, especially taking into account that three patients could not yet be assessed."

Immutep CEO, Marc Voigt stated: "We are very excited by the results from TACTI-002 as pembrolizumab monotherapy is approved only for PD-L1 subgroups in first line NSCLC. Seeing substantial response rates also in low PD-L1 expression groups from the combination therapy is very encouraging, particularly in light of the good safety profile to date for efti."

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

Overview of the Trial

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients. All patients receive 200 mg of pembrolizumab every three weeks, along with 30 mg of efti every two weeks for the first eight cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9).

The trial is a Simon’s two-stage, open-label, single-arm study, with patients participating in three Parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

Key Findings

Stage 1 Part A (1st line NSCLC):

Overall Response Rate (ORR) of 47% and no patient with a response had progressive disease thus far

Distribution of the PD-L1 subgroups is as expected (see table) ~30% with ³ 50% PD-L1

Tumour responses are reported across all three PD-L1 expression level groups (< 1%, 1-49% and ³50%) for NSCLC. 5 out of the 8 responders had a PD-L1 expression <50%

Majority (10/17; 59%) of NSCLC patients are still under treatment and median PFS is not yet reached with all patients having passed the 7+ months mark already

PD-L1 status of stage 1 of Part A (n=17) are detailed below:

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

Interim ORR of 33% with 6 out of 18 patients reporting a response according to iRECIST (3 patients are not yet re-staged after initiation of therapy and PD-L1 results are currently being evaluated)

More detailed data will be provided as patient treatment duration advances.

Safety:

No new safety signals for this combination therapy reported thus far.

Recruitment Update

Recruitment is ongoing for stage 1 of Part B, along with stage 2 of Parts A and C. The table below summarises the number of patients recruited to date for the TACTI-002 cohorts.

The presentation entitled, ‘Initial results from a Phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab’ will be made available on the Company’s website at View Source

Webcast Details

The Company will also present this interim TACTI-002 data and provide a further update on its clinical programs in a global webcast. The details for the webcast are as follows:

Date & Time:
Wednesday, February 26, 2020, 8:00 am Australian Eastern Daylight Time /

Tuesday, February 25, 2020, 4:00 pm US Eastern Daylight Time

Register:
Interested parties can register via a link to the webcast on the Company’s website or via the following link:

View Source

Questions: Investors are invited to submit questions in advance via [email protected].
A replay of the webcast will also be available at www.immutep.com from the day after the event.

About the TACT-002 trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.

On February 20, 2020 Biocare Medical, a leading provider of innovative, automated immunohistochemistry (IHC) reagents and instrumentation, reported the launch of seven novel IVD IHC antibody markers for clinical diagnostics and research applications (Press release, Biocare Medical, FEB 20, 2020, View Source [SID1234554588]). The most recent launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.

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Biocare re-developed a major antibody marker (S100 Protein), which is expressed in Schwannomas, ependymomas, astrogliomas, and nearly all melanomas (benign and malignant) and their metastases. Biocare’s new marker, S100 [4C4.9], lends a stronger and more robust staining signal for IHC applications vs. previous offerings.

Biocare also releases one mouse monoclonal and five novel rabbit monoclonal antibodies in the immuno-oncology space. Recombinant rabbit monoclonal antibodies are ideal for research applications for use with Multiplex IHC technologies and are not reliant upon hybridomas that may expire. CTLA-4 [CAL49], GITR [CAL8], LAG3 [CAL26], PD-1 [CAL20], CD22 (M) [BLCAM/1796], and E-Cadherin [CDH1/2208R] are now commercially available.

CTLA-4 – Ipilimumab, the first immunotherapeutic drug directed toward CTLA-4 inhibition, has demonstrated overall survival benefit in metastatic melanoma. Another CTLA-4 inhibitor, tremelimumab (IgG2 isotype), has also proven successful in metastatic melanoma and other malignancies1,2.

GITR – GITR modulation in preclinical models has shown promising antitumor activity via significant increase in effector T cells and decrease in Tregs3. Several human monoclonal antibodies that agonize GITR are currently undergoing phase I clinical studies in various solid malignancies. Preliminary results demonstrate an acceptable safety profile without dose limiting toxicities4-5.

LAG3 – Recent studies in a metastatic ovarian cancer mouse model showed that LAG-3 blockade leads to upregulation of other immune checkpoints (PD-1, CTLA4, and TIM-3), and combination therapy targeting LAG-3, PD-1, and CTLA-4 increases functional cytotoxic T cell levels while reducing Tregs and myeloid-derived suppressor cells6,7.

PD-1 – Treatments targeting PD-1 and its ligand, PD-L1, have also shown encouraging results in melanoma, non-small-cell lung cancer, and renal cell carcinoma8-10. This antibody can also be used in multiplex stains with other antibodies such as CD4, CD8, FOXP3, cytokeratin, and melanoma markers11.

CD22 (M) – May be a useful marker for phenotyping mature leukemias, as CD22 membrane expression has been shown to be limited to the late differentiation stages between mature B cells (CD22+) and plasma cells (CD22-)12, 13. CD22 is also strongly expressed in hairy cell leukemia14.

E-cadherin – A decreased expression of E-cadherin is associated with metastatic potential and poor prognosis in breast cancer, prostate, and esophageal cancer.

"We are proud to be able to launch novel, IVD IHC markers that meet the highest standards in cancer diagnostics. This commitment to quality ensures Biocare is providing the best diagnostic and research utility possible," said Dr. Jason Ramos, Vice President – Reagent Research and Development at Biocare Medical.

The new product launches continue Biocare Medical’s long-standing history of providing novel, high-quality reagents to customers looking to advance their research and diagnostic efficiency in the laboratory.

On February 20, 2020 InDex Pharmaceuticals Holding AB (publ) reported that Year-end Report 2019 (Press release, InDex Pharmaceuticals, FEB 20, 2020, View Source [SID1234554587])

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"The robustness and consistency of the CONDUCT results support our strategy to move cobitolimod forward in development and our phase III preparations are continuing according to plan," says Peter Zerhouni, CEO of InDex Pharmaceuticals.

Period October – December 2019

Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK -25.6 (-22.3) million
Result after tax amounted to SEK -25.6 (-22.3) million, corresponding to SEK -0.29 per share (-0.33) before and after dilution
Cash flow from operating activities amounted to SEK -34.2 (-20.6) million
Period January – December 2019

Net sales amounted to SEK 0.1 (0.1) million
Operating result amounted to SEK -87.7 (-82.0) million
Result after tax amounted to SEK -87.8 (-82.1) million, corresponding to SEK -1.19 per share (-1.29) before and after dilution
Cash flow from operating activities amounted to SEK -85.1 (-78.6) million
Cash and cash equivalents at the end of the period amounted to SEK 126.8 (83.0) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 88,781,275
All comparative amounts in brackets refer to the outcome during the corresponding period 2018.

Significant events during October – December 2019

InDex held an extraordinary general meeting, which resolved to approve the Board’s resolution on a new issue of shares with deviation from the shareholders’ preferential rights.
InDex updated the list of shareholders on the homepage with information as of October 18, 2019.
Significant events after the reporting period

InDex in-depth analysis of the CONDUCT study confirmed the successful top line results and supports the strategy going forward.
CEO statement

We have now concluded in-depth analysis of the complete data set from the CONDUCT study with the help of several key opinion leaders in the field of inflammatory bowel diseases. The analysis confirms that the highest dose tested, which met the primary endpoint of the study, demonstrates an outstanding combination of efficacy and safety. Also results in secondary endpoints ranging across clinical, biochemical and quality of life measures provide supportive evidence for the efficacy of this dose in patients with moderate to severe ulcerative colitis. The analysis also confirms cobitolimod’s excellent safety profile. Our intention is to present the complete study results in a scientific journal as well as at upcoming international medical conferences.

This patient population is hard to treat, and many do not respond to or cannot tolerate available medical therapies, resulting in a high unmet medical need. This, in combination with the robustness and consistency of the CONDUCT results support our strategy to move cobitolimod forward in development and our phase III preparations are continuing according to plan. Our plan is to be ready to enrol patients in the second half of this year.

The next step in the preparations is to complete the ongoing discussions with the European and American regulatory authorities, EMA and FDA, regarding our proposed design of the phase III program. We should have received all formal feedback from them by the end of the first quarter of this year. In parallel, we are conducting market research as well as consulting with our medical advisors and clinical research organisations (CROs), and this input will also be considered in the study design. We expect to have sufficient information to be able to finalise the design of the phase III program during the second quarter of this year. Then we can also determine the costs and associated capital requirements.

In January, I was in San Francisco during the annual JP Morgan conference that kicks off the biotech year. I presented the positive top line results and the development plans to both pharmaceutical companies and specialist investors who have shown interest in cobitolimod and InDex. That work will intensify now that we have the in-depth conclusions from CONDUCT and soon also the feedback from the regulatory authorities, so that we can provide a complete picture of the continued development towards commercialisation of cobitolimod.

To meet a growing international interest, we have decided to adopt IFRS for our external financial reporting as of this report. I look forward to an eventful spring and hope to see you at the annual general meeting, which this year is held already on April 20.

Conference call for investors, analysts and media
A conference call on the company’s year-end report for 2019 and the conclusions from the CONDUCT study will be held with CEO Peter Zerhouni on Thursday, February 20, 2020 at 11:00 (CET). During the conference call, which will be held in Swedish, it will be possible to ask questions to the company.

The conference call can be followed at View Source

Phone numbers for participants:
SE: +46850558355
UK: +443333009032
US: +16467224957

The full report is attached as a PDF and is available on the company’s website View Source

Publication

This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on February 20, 2020.

InDex Pharmaceuticals in brief

InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s foremost asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in treatment of various immunological diseases.

InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB with email address [email protected] och phone number +46 8 121 576 90 is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.

On February 20, 2020 Hummingbird Bioscience, an innovative biotherapeutics company pioneering the discovery of new breakthrough antibody therapeutics for difficult-to-treat conditions, reported it has signed an agreement with Mycenax Biotech for the production of material for the Phase 1 clinical trial of its HMBD-002 program which is anticipated to commence in the second half of 2020 (Press release, Hummingbird Bioscience, FEB 20, 2020, View Source [SID1234554586]).

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HMBD-002 is an anti-VISTA antibody developed for solid tumors that are unresponsive to existing treatments. VISTA is a new and important target for cancer as it strongly suppresses the activation of the body’s anti-tumor immune response. The presence of VISTA cells is frequently associated with the emergence of tumors and resistance to current cancer immunotherapies.

HMBD-002 uniquely blocks VISTA’s activation, turning off the signal that keeps immune cells dormant. Critically, unlike other investigational anti-VISTA agents, HMBD-002 does not remove VISTA expressing cells from the body, thus allowing many of these cells to become active tumor-killing cells. Pre-clinical studies have shown that HMBD-002 can strongly inhibit tumor growth, both as a monotherapy and even more potently when combined with anti-PD(L)1 treatment.[1],[2]

"We are very pleased to be working with Mycenax, a pioneering provider of high-quality biologics, for the production of our anti-VISTA antibody, HMBD-002. This contract takes us one step closer to realizing the goal of more effective immunotherapies for a broader population of individuals with cancer," said Dr Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder, Hummingbird Bioscience.

"We think HMBD-002 has great therapeutic potential and we are honored and excited to work with Hummingbird Bioscience on this project. We are committed to providing professional and customized service to facilitate the progress of the project. We are optimistic that, with our expertise and capability in CMC and production, HMBD-002 will be able to enter clinical trials and show therapeutic benefits soon," said Dr Pei-Jiun Chen, CEO and President of Mycenax.

Further terms of the agreement were not disclosed. Following completion of manufacturing in Texas, an Investigational New Drug application will be submitted to the FDA to commence clinical trial. The development of HMBD-002 into the clinic is supported by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

[1]Boyd-Kirkup J, et al. HMBD-002-V4: A novel anti-VISTA antibody that uniquely binds murine and human VISTA and potently inhibits tumor growth by remodeling the immunosuppressive tumor microenvironment. Journal for ImmunoTherapy of Cancer 2018, 6(Suppl 1):P477.

[2]Boyd-Kirkup J, et al. Integrative immune profiling of syngeneic tumor models provides predictive immune signatures for treatment response with HMBD002, a novel anti-VISTA neutralizing antibody. In: Proceedings of the AACR (Free AACR Whitepaper) Annual Meeting 2018; AACR (Free AACR Whitepaper); Cancer Res 2018, 78(Suppl): Abstract 1729.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralising antibody. VISTA is a co-inhibitory immune checkpoint receptor of the B7 family that suppresses T-cell activity and has been shown to play a critical role in the formation of tumors and resistance to immunotherapy in cancer.

HMBD-002 binds to VISTA at a specific site predicted to be essential for ligand-binding and function thus blocking VISTA activation.

Preclinical models have shown that a HMBD-002 as a monotherapy significantly reduces tumor growth and prolongs progression-free survival with no observed toxicity. In combination with antibodies against PD(L)-1 efficacy more than doubled.

The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded Hummingbird Bioscience a US$13.1 million product development grant to advance this first-in-class anti-VISTA therapeutic antibody into clinical trials for the treatment of solid tumours that are unresponsive to existing therapies and have their anti-tumour immunity suppressed by VISTA-mediated activity. The clinical trial of this investigational candidate is expected to commence following regulatory submission approvals in the second half of 2020.

On February 20, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported its plan to initiate a Phase 1/2 study evaluating a triple combination of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo (nivolumab) and BMS-986207, Bristol-Myers Squibb’s investigational anti-TIGIT antibody (Press release, Compugen, FEB 20, 2020, View Source [SID1234554585]).

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The triple combination study is designed to evaluate the blockade of the three immune checkpoint pathways – PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s science-driven DNAM axis hypothesis in various advanced solid tumors. The study is expected to commence in the second half of 2020, following the clearance of a new Investigational New Drug Application by the U.S. Food and Drug Administration. Compugen will be the study sponsor with Opdivo and BMS-986207 supplied by Bristol-Myers Squibb.

"We are excited to expand our collaboration with Bristol-Myers Squib with this biomarker-informed triple combination study to accelerate the clinical evaluation of COM701," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The triple combination regimen allows us to ultimately test our science-driven hypothesis that the dual inhibition of the DNAM axis with PVRIG and TIGIT blockers, together with the inhibition of the PD-1 pathway, will enable robust activation of T cells leading to anti-tumor immune responses in cancer patients who are non-responsive or refractory to PD-1 blockers."

"The initial encouraging signals of anti-tumor activity observed in heavily pretreated patients in the monotherapy dose escalation arm of our ongoing Phase 1 study, paired with our strong scientific rationale and preclinical data, support to our decision to evaluate whether the combination of these three immune checkpoint inhibitors improve patient outcomes and broaden the patient population that will respond to immunotherapies," added Dr. Cohen-Dayag.

Under the existing collaboration with Bristol-Myers Squibb, COM701 is being investigated as a monotherapy and in combination with Opdivo in an ongoing Phase 1 study. Following the Companies’ joint decision to move forward with a triple combination study, Compugen will complete the dose escalation arm of the dual combination of COM701 with Opdivo under its ongoing Phase 1 study. Future studies evaluating COM701 in combination with a PD-1 inhibitor in specific tumor types will be assessed at a later date. As previously indicated, Compugen plans to present initial data from the combination dose escalation study of COM701 with Opdivo in the second half of 2020. Compugen will continue to advance the biomarker informed monotherapy expansion arm of the ongoing COM701 Phase 1 study, as planned.

The planned open-label Phase 1/2 trial is designed to evaluate the safety, tolerability and antitumor activity of COM701 in combination with Opdivo and BMS-986207. The study will evaluate a safe and tolerable dose of the combination during dose escalation and antitumor activity in selected tumor types in the expansion cohorts (ovarian cancer, endometrial cancer and a biomarker-driven arm of tumor types with high expression of PVRL2). Dose levels for Opdivo and BMS-986207 combinations have already been determined through prior testing by Bristol-Myers Squibb, allowing for dose escalation of COM701 with fixed doses of Opdivo and BMS‑986207.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. PVRIG and TIGIT, also discovered by Compugen’s computational discovery platform in 2009, constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. As such, preclinical data suggest that the inhibition of PVRIG together with TIGIT and/or PD-1 has the potential to further enhance anti-tumor immune response and improve patient outcomes in a broad variety of tumor types.

COM701 is being evaluated as a monotherapy and in combination with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 inhibitor in a Phase 1 open-label clinical trial in patients with advanced solid tumors. Primary end points of the trial are safety and tolerability; secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics in patients with selected tumor types. Data from the monotherapy dose escalation study (n=13) presented at SITC (Free SITC Whitepaper) 2019 showed that COM701 is well-tolerated and demonstrated preliminary signs of anti-tumor activity in heavily pretreated patient population Additional information is available at www.clinicaltrials.gov (NCT03667716).

Conference Call and Webcast Information

Compugen management will hold a conference call today, February 20, 2020, at 8:30 AM ET. To access the conference call by telephone, please dial 1-888-407-2553 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.