UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 4, 2019
UNUM THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38443 | 46-5308248 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 200 Cambridge Park Drive, Suite 3100 Cambridge, Massachusetts |
02140 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code (617) 945-5576
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 7.01 | Regulation FD Disclosure. |
Unum Therapeutics Inc. (the “Company”) is furnishing a corporate presentation, attached as Exhibit 99.1 to this Current Report on Form 8-K, which the Company intends to use from time to time in meetings with investors and others beginning on January 7, 2019. The corporate presentation will also be available in the investor relations section of the Company’s website at http://unumrx.com.
The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Events. |
On January 3, 2018, the Company issued a press release announcing 2019 goals and anticipated milestones for 2019.
On January 4, 2018, the Company issued a revised press release, which corrected the anticipated 2019 milestone for BOXR1030 from “initiating clinical development” to “initiating preclinical development”. A copy of the revised press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Unum Therapeutics Inc. corporate presentation. | |
| 99.2 | Press release issued by Unum Therapeutics on January 4, 2018. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: January 7, 2019 | UNUM THERAPEUTICS INC. | |||||
| By: | /s/ Charles Wilson | |||||
| Charles Wilson, Ph.D. | ||||||
| Chief Executive Officer | ||||||
Unum Therapeutics Inc. January 2019 Exhibit 99.1
Forward-Looking Statements and Risk Factors This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, any statements of the plans, strategies, and objectives of management for future operations, including our clinical development and commercialization plans; any projections of financial information; any statement about historical results that may suggest trends for our business; any statement of expectation or belief regarding future events; potential markets or market size, technology developments, our clinical product pipeline, clinical data or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; any statements regarding the anticipated benefits of our collaborations or other strategic transactions; and any statements of assumptions underlying any of the items mentioned. These statement are based on estimates and information available to us at the time of this presentation and are not guarantees of future performance. Actual results could differ materially from our current expectations as a result of many risks and uncertainties, including but not limited to, risks associated with: the success, cost and timing of our product development activities and clinical trials; our ability to obtain regulatory approval for and to commercialize our product candidates; our ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; the effects of competition and technological advances; our dependence on third-party collaborators and other contractors in our research and development activities, including for the conduct of clinical trials and the manufacture of our product candidates; our ability to obtain, maintain, or protect intellectual property rights related to our product candidates; among others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our periodic filings filed from time to time with the Securities and Exchange Commission. Unless as required by law, we assume no obligation and do not intend to update these forward looking statements or to conform these statements to actual results or to changes in our expectations. All of Unum Therapeutics (“Unum”) product candidates are investigational product candidates and their safety and efficacy have not yet been established. Unum has not obtained marketing approval for any product, and there is no certainty that any marketing approvals will be obtained or as to the timelines on which they will be obtained. Any data pertaining to Unum product candidates is interim data, and may include investigator-reported interim data for which Unum has not yet independently reviewed the source data. The interim data may not be representative of the final results that may be obtained in the corresponding trials and results from earlier trials may not be representative of results obtained in later trial or pivotal trials.
Key Company Highlights NOVEL T CELL THERAPY platforms for cancer Promising ANTI-TUMOR ACTIVITY + FAVORABLE TOLERABILITY PROFILE BROAD PIPELINE with three clinical-stage programs, continuing to grow
ACTR Addressing the Challenges for T Cell Therapies Overcoming immunosuppression improving engineered T cell functionality in the solid tumor environment Expanding the universe of T cell therapy targets universal antibody-targeted T cells for hematologic and solid tumor applications BOXR
Product Pipeline Product Candidate Indication Pre-Clinical Phase I Phase II Hematologic Cancers ACTR707 + rituximab r/r B cell NHL ACTR087 + rituximab r/r B cell NHL ACTR087 + SEA-BCMA r/r Multiple Myeloma Solid Tumor Cancers ACTR707 + trastuzumab HER2+ cancers BOXR1030 GPC3+ cancers ATTCK-20-03 ATTCK-17-01 ATTCK-20-2 ATTCK-34-01
ACTR
ACTR: Antibody-Targeted T-Cells ACTR components Costimulatory + TCR domains: provide signals driving T cell response to tumor cell recognition CD16: naturally occurring Fc receptor responsible for antibody-dependent cellular cytotoxicity (ADCC) Tumor-specific antibodies enable ACTR T-cells to target cancer cells Fab: binds tumor antigen Fc: binds ACTR receptor ACTR = Antibody-Coupled T cell Receptor
A Universal Approach A single engineered T-cell product used across many different targets and cancer types Opportunity to leverage a broad set of previously manufactured and clinically tested antibodies Control and Tunability Potential to optimize therapeutic index by adjusting antibody dosing Potential in Solid Tumor Cancers ACTR can discriminate attack between tumor and normal cells based on antigen expression Minimal signaling in the absence of tumor antigen preserves ACTR T cells for sustained attack Key Differentiating Characteristics of ACTR
A Universal Approach for Tumor Cell Killing Preclinical data show that the same ACTR T cell has the potential to kill different types of cancer cells in the presence of the right targeting antibody Kudo et al., “T lymphocytes expressing a CD16 signaling receptor exert antibody-dependent cancer cell killing,” Cancer Res. 74:93-103 (2014) In vitro: cancer cell lines In vivo: mice treated (+/-) rituximab, (+/-) ACTR T cells Lymphoma Breast cancer Neuroblastoma Targeting Antibody (anti-CD20) (anti-HER2) (anti-GD2) ACTR + rituximab ACTR rituximab
ACTR construct only needs to be engineered, manufactured, and pre-clinically validated once, allowing accelerated development Ability to leverage prior investment in antibody discovery and development, and available safety data Potential for strategic collaborations with antibody innovators Ability to target T cell antigens not readily amenable to CAR-T approaches 5T4 BCMA CanAg CAIX CD138 CD27L CD56 CD6 CD79b cG250 cytokeratin EGP ETBR FAP fibronectin FOLR1 GPNMB AFP GCC LIV melanin MUC16 NaPi2b nectin PEM STEAP1 SLC44A4 SLITRK6 tenascin TF HLA a5b1 a5b3 CA125 CD200 CD40 CD55 CD80 CTLA4 CXCR4 EGFL7 (and many more…) CEA CEACAM5 EGFr EpCAM HER2 Lewis Y mesothelin MUC1 PSMA TAG 72 CD20 CD22 CD30 CD33 CD38 CD44 CD70 CD74 naked antibodies antibody-drug conjugates Breadth of Targeting Tumor-targeting antibodies provide opportunities to target a broad range of cancers rapidly and cost effectively
ACTR Control and Tunability Preclinical data indicate ACTR T cell killing may be adjusted by modulating antibody dose. No similar control exists for current T-cell therapies. In vivo (xenograft) In vitro (tumor cell-line killing) rituximab dose (��g/ml) % cytotoxicity
ACTR Clinical Pipeline Rapidly expanding pipeline spanning three clinical programs Product Candidate Indication Pre-Clinical Phase I Phase II Hematologic Cancers ACTR707 + rituximab r/r B cell NHL ACTR087 + rituximab r/r B cell NHL ACTR087 + SEA-BCMA r/r Multiple Myeloma Solid Tumor Cancers ACTR707 + trastuzumab HER2+ cancers ATTCK-20-03 ATTCK-17-01 ATTCK-20-2 ATTCK-34-01
Clinical Validation: ACTR in Lymphoma Potent activity demonstrated in two multi-center trials with r/r NHL patients ATTCK-20-03: ACTR707 (CD28) + rituximab ATTCK-20-2: ACTR087 (41BB) + rituximab Clear dose-dependent ACTR cell expansion observed Persistence of ACTR cells in all patients while on study Compelling activity and safety profile Anti-tumor activity comparable to NHL CAR-T therapies Favorable safety demonstrated at the correct dose level ACTR707 selected for further development in NHL CD16 CD28 CD3ζ CD16 4-1BB CD3ζ ACTR087 ACTR707 ACTR technology proof-of-concept established with potential best-in-class product profile
ACTR + Rituximab Trial Design Cycles 4+ Rituximab q21 days Response Assessments q42 days Cycle 3 Rituximab 1st Response Assessment DLT Assessment Cycle 2 Rituximab Infuse ACTR Cycle 1 Rituximab Lymphodepleting Chemotherapy Leukapheresis Screening/Eligibility ACTR Manufacturing Optional bridging therapy Phase I, dose escalation Open-label, single-arm Rituximab-treated CD20+ NHL: primary refractory, >2 prior lines of therapy, or post auto-HSCT Lymphodepleting therapy Rituximab (375 mg/m2) administered on a 3-week cycle
ATTCK-20-03 Patient Characteristics Characteristic Dose Level 1 (n=6) Dose Level 2 (n=3) Diagnosis: DLBCL, n (%) 5 (83) 3 (100) Diagnosis: Gr3b FL, n (%) 1 (17) 0 Median age, years (range) 61 (57-76) 58 (47-77) Age ≥ 65 years, n (%) 2 (33) 1 (33) Men, n (%) 5 (83) 2 (67) ≥ 3 prior therapies, n (%) 3 (50) 2 (67) Refractory to prior therapy*, n (%) 5 (83) 3 (100) Received autologous stem cell transplant, n (%) 2 (33) 3 (100) Received optional bridging therapy, n (%) 5 (83) 1 (33) Mean baseline SPD of target lesion, cm2 (range) 24 (6-112) 14 (12-134) *Refractory defined as PD as best response to any line of chemotherapy or relapse ≤ 12 months post ASCT SPD = sum of product diameters Database snapshot: 01November18
Expansion and Persistence The median peak expansion in Dose Level 2 > 6x Dose Level 1, suggesting dose-dependent ACTR expansion Persistence observed through 233 days (C12D1) post ACTR administration ACTR T cells demonstrate expansion post-infusion and durable persistence Data snapshot: 02 November 2018 Peak ACTR expansion ACTR expansion and persistence by qPCR
ATTCK-20-03 Adverse Events Adverse Events of Special Interest (AESI) Subjects with AESI, n Dose Level 1 (n=6) Dose Level 2 (n=3) New malignancy 0 0 Cytokine release syndrome 0 0 Use of therapeutic plasma exchange for any non-disease related AE 0 0 Clinically significant neurologic disorder 0 0 Clinically significant rheumatologic/autoimmune disorder 0 0 Clinically significant hematologic disorder (excluding cytopenias related to LD chemo) 0 0 Clinically significant = in the opinion of the investigator, clinically meaningful Database snapshot: 01November18 Preferred Term, n (%) Subjects with Serious Adverse Events (SAEs) Related to ACTR707 Dose Level 1 (n=6) Dose Level 2 (n=3) Febrile neutropenia 1 (17) 1 (33) Pancytopenia 0 (0) 1 (33)
ATTCK-20-03 Anti-Tumor Activity Dose Level Response Duration of Response (days) Optional Bridging therapy # prior therapies^ ASCT Refractory* to prior therapy Diagnosis Baseline SPD (cm2) 1 Complete 207+ No 2 no no Gr3b FL 24 1 Complete 180+ Yes 5 yes yes DLBCL 23.4 1 Complete 85 Yes 3 no yes DLBCL 11.9 2 Complete 71+ Yes 3 yes yes DLBCL 14 *Refractory defined as PD as best response to any line of chemotherapy or relapse ≤ 12 months post ASCT ^All subjects received rituximab as prior therapy Database snapshot: 01November18 Dose Level 1 Six enrolled and treated subjects Three subjects with complete responses; three subjects with disease progression Dose Level 2 Three enrolled and treated subjects One subject with complete response; two subjects with disease progression Summary of complete responses
Lymphoma Summary & Next Steps Summary Clinical testing in two independent trials demonstrates anti-tumor activity with a favorable dose-dependent safety profile in relapsed/refractory aggressive NHL patients ACTR707 selected for further development based on best-in-class potential Next Steps ACTR707 + rituximab (ATTCK-20-03, Phase 1) Complete Dose Level 3 safety evaluation and assessment Cohort expansion at recommended phase 2 dose (RP2D) ACTR087 + rituximab (ATTCK-20-2, Phase 1) Complete ATTCK-20-2 dose confirmation of ACTR087 at RP2D
ACTR + SEA-BCMA (ATTCK-17-01) Collaborating with Seattle Genetics to co-develop and co-commercialize novel ACTR + SGI mAb Potential differentiating characteristics Despite high response rates, durability remains a question for many BCMA targeting assets in development Multiple mechanisms of action exerted by ACTR+SEA-BCMA combination may deepen responses and enhance durability Improved ACTR T cell persistence may translate into enhanced response duration compared to CAR-T Study Design & Objectives Open label Phase I adaptive dose-escalating study (exploring both ACTR cell dose and antibody dose) Define safety and tolerability of ACTR087 in combination with SEA-BCMA Determine recommended Phase II dose of the combination
ATTCK-17-01 Status Completed first three cohorts in dose escalation, starting at very low antibody doses SEA-BCMA: 0.03 mg/kg (n=1) à 0.1 mg/kg (n=1) à 0.3 mg/kg (n=5) ACTR087: target = 30 x 106 ACTR+ T cells SEA-BCMA well-tolerated with expected pharmacological profile ACTR087 expansion observed in the peripheral blood of all subjects Safety profile supports further dose escalation Enrollment in cohort 4 (2 mg/kg SEA-BCMA; 30 x 106 ACTR+ T cells) is ongoing
ACTR expansion and persistence ATTCK-17-01 Safety and T Cell Expansion AESI n (%) (Cohorts 1-3; n=7) New malignancy 0 Cytokine release syndrome 1 (14)* Use of therapeutic plasma exchange for any non-disease related AE 0 Clinically significant neurologic disorder 1(14)^ Clinically significant rheumatologic/ autoimmune disorder 0 Clinically significant hematologic disorder (excluding cytopenias related to LD chemo) 0 Clinically significant = in the opinion of the Investigator, clinically meaningful, requires medical intervention, and medically important within the context of study treatment * Serious event of grade 1 CRS (cohort 2) that resolved without therapeutic intervention ^ Non-serious, grade 1 event of preferred term neurotoxicity (cohort 3) that resolved without therapeutic intervention. Data cutoff: 01 November 2018 Adverse Events of Special Interest (AESIs) No DLTs and no severe CRS or neurological events reported ACTR087 demonstrates expansion and persistence in Cohorts 1-3 ongoing at up to 12 weeks
ACTR + Trastuzumab (ATTCK-34-01) vehicle ACTR alone ACTR + trastuzumab trastuzumab HER2 CAR Potent xenograft activity First ACTR Solid Tumor Program Combination for the treatment of adult patients with relapsed/refractory HER2+ cancers Intending to enroll patients with HER2+ breast cancer, gastric cancers, and other HER2+ malignancies >10,000 patients (U.S.) with HER2+ breast or gastric cancers have exhausted current standard of care Antibody-based treatment options have failed to achieve durable complete responses for metastatic disease Current Status IND in effect Enrolling patients
ATTCK-34-01: Study Design Schema Example dose escalation schema (n = 12-24 subjects) Design Adaptive Bayesian design Exploring multiple dose levels of ACTR707 and trastuzumab Dose escalation followed by cohort expansion Objectives Assess safety and tolerability of ACTR707 and trastuzumab Assess anti-tumor activity Secondary measures: ACTR707 T cell expansion and persistence trastuzumab PK inflammatory markers cytokines and chemokines Patient population Histologically confirmed, HER2-positive, advanced solid tumor malignancy (including breast cancer, gastric or gastroesophageal junction adenocarcinoma, or other locally advanced, recurrent or metastatic malignancy) Disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer ACTR707 dose trastuzumab dose cohort 1 cohort 2b cohort 3 cohort 2a
ACTR Selectivity in Solid Tumors Many solid tumor antigens (e.g., HER2) exhibit low level expression on some normal tissues On-target, off-tumor toxicity can result from inappropriate attack by CAR-T ACTR demonstrates a threshold effect for cytotoxic killing – minimal activity when antigen is below a target threshold tumor cell lines (HER2 high) normal tissue cells (HER2 low) tumor CAR T cell tumor ACTR T cell normal ACTR T cell normal CAR T cell ACTR can differentiate between tumor cell lines and normal tissue cells while HER2 CAR cannot ACTR + trastuzumab HER2 CAR
BOXR
Overcoming Solid Tumor Immunosuppression BOXR components (1) Chimeric Receptor: universal ACTR or antigen-specific CAR drives cancer cell targeting and attack + (2) Bolt-On: independent transgene that re-programs T cell biology to improve functionality in the tumor microenvironment (TME) BOXR = Bolt-On Chimeric Receptor Tumor microenvironment (TME) inhibits immune function, limiting efficacy of engineered T cells Unum’s BOXR technology is designed to target the TME, yielding more effective T cell therapies “bolt-on” genetic element BOXR cassette chimeric targeting receptor (ACTR or CAR)
BOXR Discovery Engine Focus on overcoming three primary mechanisms of immunoregulation in solid tumors: nutrient limitations, T-cell exhaustion, and immunosuppressive cell types Biologic Hypothesis Unique insights into immunoregulation within tumors High Throughput Screening Novel, multi-stage screening strategy to simulate TME In Vivo Validation Stringent xenograft models to test BOXR activity in hostile environments Translational Medicine Identify patients whose tumors are most susceptible to each BOXR Anderson et al., Cancer Cell, 31:311-325 (2017)
BOXR High Throughput Screening > 100 genes testing literature-based hypotheses Cytotoxicity Cytokines Proliferation Assess basic T cell function Co-express ACTR / CAR + bolt-on transgene Assess function in simulated solid TME Regulatory T cells Suppressive myeloid cells Nutrient shortages Chronic stimulation Secreted T cell inhibitors ACTR parent 4-1BB BOXR constructs Score IL-2 Prolif IL-2 Prolif IL-2 Prolif Prolif Prolif PGE2 Adenosine Kynurenine TGF-b Assess activity in stringent xenograft models
BOXR1030: First BOXR Candidate Engineered to improve T cell metabolism in solid TME Lung and liver tumors deplete glucose in the tumor Low glucose compromises T cell function, correlates with poor patient outcomes Aviel-Ronen, et al. Modern Pathology. 2008. Tumor targeting: GPC3 (oncofetal antigen) is well expressed in SqCC tumors “bolt-on” BOXR1030 GPC3 CAR BOXR Strategy: Screen a library of GPC3 CAR + bolt-on cassettes Goodwin, et al. Nature Communications. 2017. Lung squamous cell carcinoma (SqCC) TME: Increased metabolism driven by increased glucose transporter expression SqCC ADC
BOXR1030: In Vivo Models Show Improved Activity CAR-T lose activity in low glucose 2 intratumoral glucose (mM) Cancer cells deplete TME glucose 1 CAR-T active in high glucose xenografts 3 CAR-T fails in more stringent xenografts; BOXRs retain functionality 4 untreated GPC3 CAR untreated GPC3 CAR BOXR1030 BOXR #1
BOXR Pipeline Initiating preclinical development for BOXR1030 Additional discovery-stage BOXR programs consist of multiple leads targeting alternative mechanisms BOXR TME Mechanism Indications Target BOXR1030 Metabolic Competition Lung (SqCC) Liver (HCC) GPC3 BOXR637 BOXR889 BOXR1011 Immune cell suppression (Treg / MDSC) Ovarian (high grade serous) Endometrial FOLRA BOXR947 BOXR1012 BOXR1045 BOXR1108 Exhaustion due to chronic stimulation (multiple) (multiple)
Business Considerations
Building for Commercialization Unum uses the CliniMACS Prodigy in GMP manufacturing with centralized manufacture at a commercial CMO to support current early phase trials Enables an automated operation and closed processing of all manufacturing steps ACTR successfully manufactured for all subjects to date Continuing to invest resources to optimize process development Future plans to build pilot GMP capacity to support our growing pipeline GMP Manufacturing Intellectual Property Unum has exclusively licensed worldwide rights to issued and pending patents to core ACTR technology Additional Unum patent applications encompass new ACTR- and BOXR-related innovations and products
Strong Financial Position, Capital Efficient Business Model In April 2018, completed an IPO and concurrent private placement, raising $77M in gross proceeds $154M raised since inception Strategic collaboration with Seattle Genetics has provided an additional ∼$37MM to date in non-dilutive funding Current cash balance of $87M (as of 09/30) provides runway through at least Q2 2020 9-months ended 09/30/2018 operating cash flow: ($23.5M)
SGEN Collaboration Exemplifies Partnering Strategy Partnership to co-develop and co-commercialize novel ACTR + SGEN mAb combination therapies Structured to leverage each partner’s expertise Collaboration provides Unum with: Access to SGEN proprietary mAbs targeting hematologic and solid tumor indications Significant funding Retained value and rights in programs Unum - Seattle Genetics (SGEN) Strategic Collaboration June 2015 August 2017
2019 Milestones NHL ACTR707 + rituximab ATTCK-20-03: dose escalation completed ATTCK-20-03: preliminary data from cohort expansion ACTR087 + rituximab ATTCK-20-2: confirm recommended Ph2 dose (study completion) Multiple Myeloma ACTR087 + SEA-BCMA ATTCK-17-01: multiple readouts from dose escalation Solid tumors ACTR707 + trastuzumab ATTCK-34-01: patient dosing initiated ATTCK-34-01: dose escalation initial readouts BOXR1030 Initiate preclinical development
Experienced Leadership Geoff Hodge Chief Technical Officer Xcellerex, VP Process Development & Manufacturing GE Healthcare, Millennium Seth Ettenberg, PhD Chief Scientific Officer Novartis, Head of Oncology Biologics CuraGen, NCI Michael Vasconcelles, MD Chief Medical Officer Takeda/Millennium, Global Head of Oncology Genzyme Novartis, Global Head of Strategic Alliances Archemix, Chief Technology Officer Chuck Wilson, PhD Chief Executive Officer
Key Company Highlights NOVEL, UNIVERSAL ACTR platform for cancer cell therapy 1 Promising ANTI-TUMOR ACTIVITY and FAVORABLE TOLERABILITY PROFILE 2 BROAD PIPELINE with three current clinical stage programs growing to four by 2019 3 Ability to expand pipeline RAPIDLY and COST EFFECTIVELY 4 EXPERIENCED LEADERSHIP TEAM 5
Exhibit 99.2
CORRECTING and REPLACING — Unum Therapeutics Announces 2019 Goals and Expected Milestones
In a release issued yesterday under the same headline by Unum Therapeutics Inc. (NASDAQ: UMRX), please note the anticipated 2019 milestone for BOXR1030 has been changed from initiating clinical development to initiating preclinical development in the last paragraph. The corrected release follows:
- Multiple Data Readouts from ATTCK-20-03 and ATTCK-17-01 Expected in 2019 -
- Initial Data on ATTCK-34-01, Unum’s First Program in Solid Tumors, Expected in Second Half of 2019 -
- First Development Candidate from BOXR Platform Advancing Toward Clinical Development -
CAMBRIDGE, Mass., Jan. 04, 2019 (GLOBE NEWSWIRE) — Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, today announced its anticipated milestones for 2019.
“Unum made substantial progress in 2018 as we reported early data from our programs in non-Hodgkin lymphoma and multiple myeloma, while simultaneously expanding applications of our ACTR platform into solid tumors and introducing a second novel technology platform, BOXR, designed to improve the functionality of engineered T cells,” said Chuck Wilson, CEO of Unum. “We expect 2019 also to be a year of significant momentum, with data expected from all four of our ongoing clinical programs, including readouts from the ATTCK-20-03 and ATTCK-17-01 trials, as well as an initial data readout from our first study in solid tumors. Additionally, we continue to innovate in the field of cell therapy and have recently nominated our first development candidate from our BOXR technology platform to advance toward clinical development.”
Anticipated 2019 Milestones
ACTR707 + rituximab in r/r NHL
| • | Complete the dose escalation phase of ATTCK-20-03, the ongoing, multicenter Phase 1 study testing ACTR707 in combination with rituximab to treat patients with relapsed/refractory B cell non-Hodgkin lymphoma. Advance into cohort expansion to confirm the preliminary recommended Phase 2 dose. |
| • | Report results from the dose escalation phase and preliminary data from the cohort expansion phase of the ATTCK-20-03 study. |
ACTR087 + SEA-BCMA in r/r multiple myeloma
| • | Progress dose escalation of ACTR087 and SEA-BCMA in ATTCK-17-01, a Phase 1, multi-center, open-label trial designed to test the safety, tolerability and anti-myeloma activity of the combination in patients with r/r multiple myeloma. |
| • | Report clinical data from multiple cohorts of the dose escalation phase. |
ACTR707 + trastuzumab in HER2+ advanced cancers
| • | Enroll and dose patients in Unum’s first ACTR T cell study in solid tumors, ATTCK-34-01, a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab in patients with HER2+ advanced cancers. |
| • | Report initial clinical data from ongoing dose escalation. |
ACTR087 + rituximab in r/r NHL
| • | Complete enrollment in ATTCK-20-2, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with relapsed or refractory B cell NHL, and report data from the trial. |
BOXR Platform
| • | Continued progress with new Bolt-On Chimeric Receptor technology platform (“BOXR”) that improves T cell functionality by countering immunosuppression in solid tumor cancers. Initiate preclinical development of BOXR1030, which has been nominated as the first product candidate from this platform. |
About Unum Therapeutics
Unum Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products designed to harness the power of a patient’s immune system to cure cancer. Unum’s novel proprietary technologies include Antibody-Coupled T cell Receptor (ACTR), a universal, engineered cell therapy intended to be used in combination with a wide range of tumor-specific antibodies to target different tumor types, and Bolt-On Chimeric Receptor (BOXR), an approach for improving T cell functionality to enable solid tumor cancer applications. Unum has four product candidates currently in Phase I clinical testing, including: ACTR707 used in combination with rituximab, an anti-CD20 antibody, in adult patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL); ACTR087 used in combination with the novel antibody SEA-BCMA in adult patients with relapsed or refractory multiple myeloma; and ACTR707 used in combination with trastuzumab, an anti-human epidermal growth factor receptor 2 (HER2) antibody, in adult patients with HER2+ advanced cancer.
The Company is headquartered in Cambridge, MA.
Forward looking Statements
This press release contains forward-looking statements. Statements in this press release about our future expectations, plans and prospects, including projections regarding future revenues and financial performance, the anticipated timing of our clinical trials and regulatory filings, our long-term growth and our ability to achieve our strategy, the design of our clinical trials, the development of our product candidates, including the three lead ACTR product candidates, the results of our clinical trials, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to the accuracy of our estimates regarding expenses, future revenues, capital requirements, and the need for additional financing, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
Investor Contact:
Stephanie Ascher, 212-362-1200
stephanie@sternir.com
Media Contact:
Paul Kidwell, 617-680-1088
paul.kidwell@unumrx.com