On May 29, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the company today presents additional novel data from the ongoing Phase I clinical trial with the bispecific drug candidate ATOR-1015 developed as tumor-directed therapy for metastatic cancer, which further validates the potential of the drug (Press release, Alligator Bioscience, MAY 29, 2020, View Source [SID1234558672]). The presentation will be held at the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual Meeting, which this year is being held virtually.

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The results from the evaluation of doses up and including 600 mg (about 10 mg/kg) show that ATOR-1015 is well tolerated, and dose-escalation has continued to 750 mg (12.5 mg/kg). In this presentation, 21 patients with varying cancer types (colon cancer, eye melanoma, pancreatic cancer, ovarian cancer, gallbladder cancer, gastric cancer, and melanoma) are included and evaluated in terms of safety. The drug related adverse events in the study have generally been mild and transient. No dose-limiting toxicity or severe immune-related adverse events have been reported.

"The results presented at ASCO (Free ASCO Whitepaper) truly support the fact that ATOR-1015 could be a safer and more efficacious drug than current treatment options for spread cancer disease. We are consequently very much looking forward to moving ATOR-1015 into efficacy studies," said Per Norlén, CEO of Alligator Bioscience.

Due to the positive tolerability profile of ATOR-1015, dose escalation will continue at even higher doses than expected but still allows for a preliminary efficacy readout in melanoma patients already towards the end of 2021.

The ASCO (Free ASCO Whitepaper) poster presentation with the title "A first-in-human phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of ATOR-1015, a CTLA-4 x OX40 bispecific antibody" is available on the company website View Source

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CEST on May 29, 2020.

About the ATOR-1015 Phase I study
The Phase I study with ATOR-1015 is a dose escalation study in patients with metastatic cancer (NCT03782467). The primary endpoint of the study is to investigate the safety and tolerability of ATOR-1015 and to determine the recommended dose for subsequent Phase II studies. The first patient was dosed in March 2019 and following the establishment of the maximum tolerable dose or recommended dose for Phase II, further clinical development of ATOR-1015 is planned, primarily for the treatment of malignant melanoma.

About ATOR-1015
ATOR-1015, wholly owned by Alligator, is a bispecific CTLA-4 antibody developed as tumor targeted immunotherapy with increased capacity for killing regulatory T cells. ATOR-1015 binds to two different immune receptors – the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which can lead to reduced side effects.

On May 29, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported updated data from the ongoing Phase 1 study evaluating single agent vorasidenib in isocitrate dehydrogenase (IDH)-mutant advanced solid tumors, including glioma (Press release, Agios Pharmaceuticals, MAY 29, 2020, View Source [SID1234558671]). Data from the non-enhancing glioma population were featured in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which is being held virtually. Vorasidenib, an investigational, oral, selective, brain-penetrant inhibitor of mutant IDH1 and IDH2 enzymes, is currently being evaluated in the registration-enabling Phase 3 INDIGO study as a potential treatment for patients with residual or recurrent Grade 2 non-enhancing glioma.

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"For patients with IDH-mutant non-enhancing glioma who currently have limited treatment options beyond chemotherapy and radiation, targeted oral options such as vorasidenib are urgently needed," said Ingo Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center, an investigator for the Phase 1 dose-escalation study. "The updated results of this study in non-enhancing glioma patients provide further evidence of the potential benefit of vorasidenib for these patients, with a favorable safety profile and encouraging preliminary activity, including prolonged disease control, objective tumor responses, and clinically meaningful progression-free survival rates."

"These promising efficacy and safety data in patients with IDH-mutant non-enhancing glioma provide further support for our registration-enabling Phase 3 INDIGO study," said Chris Bowden, M.D., chief medical officer at Agios. "With vorasidenib – the first and only brain-penetrant IDH inhibitor in Phase 3 trials for low-grade glioma – we have an opportunity to target a highly prevalent driver mutation early in the disease evolution, providing a therapeutic alternative to ‘watch and wait’ that can potentially delay the need for chemotherapy and radiation."

Vorasidenib Phase 1 Dose-Escalation Study

Vorasidenib is being evaluated as a single agent in an ongoing Phase 1 dose-escalation trial in IDH1/2 mutant advanced solid tumors (n=93), including glioma (n=52). Enrollment was completed in June 2017. As of the March 3, 2020 data cut-off, study design, enrollment and baseline characteristics of the 22 non-enhancing glioma patients are reported below:

Seventy-seven percent of patients (n=17) had World Health Organization (WHO) classified Grade 2 tumors and 23% (n=5) had Grade 3 tumors.
Ninety-one percent of patients (n=20) had an IDH1 mutation and 5% (n=1) had an IDH2 mutation. One patient did not have a biopsy but was confirmed as IDH mutant positive due to 2-HG elevation by magnetic resonance spectroscopy (MRS).
The median age of these patients is 47 years (ranging from 16 to 73).
Sixty-four percent of patients (n=14) had received prior systemic therapy. Patients had received a median of two prior systemic therapies (ranging from 1 to 4).
Fifty-nine percent of patients (n=13) had previously received temozolomide and 36% (n=8) of patients received prior radiation therapy.
Patients received daily doses of vorasidenib ranging from 10 mg to 200 mg.
Thirty-six percent of patients (n=8) remain on treatment.
Safety Data

The safety analysis conducted on the 22 patients with non-enhancing glioma as of the data cut-off demonstrated that vorasidenib has a favorable safety profile at dose levels below 100 mg once daily. Safety data for this population are consistent with the results reported for all patients enrolled in this trial at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting.

The majority of adverse events (AEs) reported by investigators were mild to moderate, with the most common (>40%) across all grades being increased alanine aminotransferase (ALT) (64%), increased aspartate aminotransferase (AST) (59%), nausea (46%) and headache (41%).
Grade 3 or higher AEs were observed in 27% of patients (n=6) with the most common being increased ALT (9%) and AST (9%).
AEs of Grade 2 or higher elevated transaminases occurred in seven non-enhancing glioma patients at the higher dose levels (≥100 mg) and resolved to Grade ≤1 with dose modification or discontinuation.
No AEs of Grade 2 or higher elevated transaminases were observed in patients at the lower dose levels (<100 mg).
Of the 14 (64%) patients who discontinued treatment, 9% (n=2) discontinued due to an AE.
Efficacy Data

Efficacy data from the 22 non-enhancing glioma patients as of the data cut-off showed:

The investigator-reported objective response rate (ORR) was 18% with one patient exhibiting a partial response and three patients exhibiting minor responses using the Response Assessment in Neuro-Oncology for low-grade glioma (RANO-LGG) criteria.
Seventy-three percent of patients (n=16) achieved stable disease according to the investigator as assessed by RANO-LGG.
With 59% of events reported, median progression free survival (PFS) was 31.4 months (95% CI 11.2, 40.8).
Twenty-four month PFS rate was 55.4%.
The median treatment duration was 25.8 months (ranging from 1.0 to 47.9) with 68% (n=15) remaining on treatment for ≥1 year.
Ongoing Phase 3 INDIGO Trials in Progress Poster
A trials in progress poster was presented at the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting to highlight the ongoing global, randomized, placebo-controlled Phase 3 INDIGO study of vorasidenib in approximately 366 patients with residual or recurrent, non-enhancing, Grade 2 low-grade glioma with an IDH1 or IDH2 mutation and who have undergone surgery as their only treatment. The goal of the study is to evaluate the efficacy of vorasidenib compared with placebo based on radiographic PFS and determine whether vorasidenib could provide a therapeutic alternative to "watch and wait" to help control low-grade glioma and potentially delay the need for chemotherapy and/or radiation. The study is currently enrolling. More information can be found on the INDIGO study website.

Vorasidenib is not approved in any country for the treatment of patients with low-grade glioma.

About Glioma
Glioma presents in varying degrees of tumor aggressiveness, ranging from slower growing (low-grade glioma) to rapidly progressing (high-grade glioma-Glioblastoma Multiforme). Tumor enhancement is an imaging characteristic assessed by magnetic resonance imaging (MRI), and enhancing tumors are more likely to be high-grade.

Common symptoms of glioma include seizures, memory disturbance, sensory impairment and neurologic deficits. The long-term prognosis is poor, and regardless of treatment, the majority of patients with low-grade gliomas will have recurrent disease that will progress over time. Approximately 11,000 low-grade glioma patients are diagnosed annually in the U.S. and EU and approximately 80 percent have an IDH mutation.

On May 29, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infections, reported the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO2020) Virtual Scientific Program on AGEN1181 by Dr. Steven J. O’Day, the Executive Director of the John Wayne Cancer Institute and Cancer Clinic and Director of Providence Los Angeles Regional Research (Press release, Agenus, MAY 29, 2020, View Source [SID1234558670]).

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AGEN1181 is a multifunctional Fc-engineered next generation anti-CTLA-4 antibody specifically designed to improve the safety and efficacy of first-generation CTLA-4 antibodies. AGEN1181 is advancing in the clinic both as monotherapy and in combination with balstilimab (Agenus’s anti-PD-1). Patients receiving this multifunctional antibody have progressed on prior treatments including other I-O agents, such as anti-PD-1.

"I am very pleased to report data on AGEN1181 alone and in combination with balstilimab (anti-PD-1). Preliminary efficacy is encouraging with objective responses (both complete and partial) as well as prolonged stable disease in a variety of advanced cancers progressing after standard therapies," said Dr. Steven O’Day, Executive Director of the John Wayne Cancer Institute and Cancer Clinic. "Importantly, unlike first-generation CTLA-4 antibodies, we have seen no evidence of complement mediated toxicities, such as hypophysitis, with AGEN1181. These early data, including responses in patients with CD16 polymorphisms, support the accelerated development of AGEN1181 into multiple tumors, including PD-1 refractory melanoma, NSCLC, and others."

Abstract:

TPS3157

Title:

AGEN1181, A Clinical Stage Fc-engineered anti-CTLA-4 Antibody with Improved Therapeutic Potential for the Treatment of Patients with Advanced Malignancies

Presenter:

Dr. Steven J. O’Day

Session:

Developmental Therapeutics—Immunotherapy

Date/Time:

May 29, 2020; 8:00-11:00AM

Conference call scheduled on June 2, 2020

B.Riley FBR Senior Analyst Mayank Mamtani, will host a conference call for investors on Tuesday, June 2, 2020 with Dr. Steven O’Day and Dr. Charles Drake, Co-Director of the Cancer Immunotherapy Program and Co-Leader of the Tumor Biology & Microenvironment Program at Columbia University, and Jennifer Buell, PhD and President and COO of Agenus, to discuss the data coming out of the ASCO (Free ASCO Whitepaper)2020 Virtual Scientific Program.

Date: Tuesday, June 2, 2020
Time: 5:30 PM ET
Dial-in details: Investor access: 800.267.2845/973.413.6102 (Passcode: 842069)

The presentation will be available for on-demand viewing online at View Source

On May 29, 2020 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, presented updated data from its ADP-A2M4 Phase 1 trial at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Adaptimmune, MAY 29, 2020, View Source [SID1234558669]). The data demonstrate durability and responses in synovial sarcoma, supporting SPEARHEAD-1 as a potential registrational trial. The ASCO (Free ASCO Whitepaper) presentation also describes a new response in a patient with lung cancer, and a response in a patient with head and neck cancer (reported in January).

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The Company also announced new responses in the SURPASS trial, confirming the potential for SPEAR T-cell therapies targeting MAGE-A4 to treat a broad range of cancers in addition to sarcoma. These data further support the rationale for two new Phase 2 trials – SPEARHEAD-2 in head and neck cancer, which will begin later this year, and a second trial in esophagogastric junction (EGJ) cancer planned for 1H 2021. A webcast of Dr. Elliot Norry, Adaptimmune’s Chief Medical Officer, and Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer, summarizing these and other clinical data is available here: https://bit.ly/3enqBBy.

"I am pleased to announce that we have identified a new indication to progress into late stage development. We plan to initiate a Phase 2 trial in esophagogastric junction cancer in the first half of 2021, with our next-generation ADP-A2M4CD8 SPEAR T-cells. In addition, the ASCO (Free ASCO Whitepaper) data demonstrate promising durability for ADP-A2M4 in sarcoma bolstering our ambition to have our first marketed therapy in 2022," said Adrian Rawcliffe, CEO. "I’m thrilled with the responses in a broad range of tumors with our programs targeting MAGE-A4 and AFP. I am confident that we will be able to identify more indications for late stage development as more patients are treated in our trials."

During an oral presentation at ASCO (Free ASCO Whitepaper), Dr. David Hong of the MD Anderson Cancer Center reported positive durability and efficacy data in synovial sarcoma from the ADP-A2M4 Phase 1 trial. Based on these data, the Company believes that SPEARHEAD-1 can support registration for ADP-A2M4. These positive data also supported removal of the futility analysis from SPEARHEAD-1, reducing the sample size from 60 to 45 patients.

Outside of sarcoma, Dr. Hong shared a new RECIST response in a patient with lung cancer, as well as the response in a patient with head and neck cancer reported earlier this year. Further, he reported evidence of anti-tumor activity in ovarian cancer, bladder cancer, and melanoma.

In the SURPASS trial, three patients have responded out of the first four treated with ADP-A2M4CD8. One patient with EGJ cancer treated in the first dose cohort had a confirmed partial response (PR) reported in January, which remains ongoing approximately six months post-infusion. As reported today, a second patient in the first dose cohort, also with EGJ cancer, has an unconfirmed PR. The third response in the trial is an unconfirmed PR in a patient with head and neck cancer. Data from this trial will be updated and presented in the second half of 2020 at a medical conference. Based on these data, the Company plans to initiate a Phase 2 trial in EGJ cancer in the first half of 2021.

In January, the Company reported one confirmed PR in a patient with liver cancer from the ADP-A2AFP Phase 1 trial. Subsequently, this PR has been assessed as a confirmed complete response, which remained ongoing at the last assessment (Week 24). The next two patients with liver cancer (or hepatocellular carcinoma [HCC]) treated in Cohort 3 did not respond. A separate cohort for AFP expressing tumors other than HCC was initiated and the one patient treated to date has not responded. Detailed data will be presented in a poster and an oral presentation at the International Liver Congress (ILC) in August 2020 (rescheduled from April of this year).

RECIST Responses with SPEAR T-cell Monotherapy in Patients with Late Stage Cancers*

a: n=number of patients treated; b: includes one unconfirmed PR; c: patient treated in radiation sub-study of ADP-A2M4 Phase 1 trial; d: previously assessed as PR

CR=complete response; EGJ=esophagogastric junction; HCC=hepatocellular carcinoma; PR=partial response

* As of May 2020

ADP-A2M4 clinical update

·ASCO: Oral presentation by Dr. David Hong titled: "Phase 1 Dose Escalation and Expansion Trial to Assess Safety and Efficacy of ADP-A2M4 in Advanced Solid Tumors"

oSynovial sarcoma data

§50% response rate with inclusion of unconfirmed PR assessed after data cut-off (44% response rate without inclusion of unconfirmed PR)

§Median duration of response ~28 weeks, progression free survival ~20 weeks, median overall survival not reached

§3 out of the 7 responders have continued to benefit as of their one year assessments

§Disease control rate of 90% defined by best overall response (BOR) of PR or stable disease (SD) at time of data cut off (April 6, 2020)

oOther cancer indications

§Confirmed responses in lung cancer (reported today) and head & neck cancer (as reported in January)

§Of note, there was a response in a patient with rectal mucosal melanoma from the radiation sub-study of this trial (still recruiting) reported in January, which remains ongoing at Week 24. This patient was not part of the ASCO (Free ASCO Whitepaper) dataset

oMost adverse events were consistent with those typically experienced by cancer patients undergoing lymphodepletion cytotoxic chemotherapy, and cellular therapy

oTrial closed for enrollment with the exception of ongoing recruitment in the low-radiation sub-study

·SPEARHEAD-1

oIntended to be a registrational trial

oBased on the strength of the ADP-A2M4 Phase 1 data, futility analysis removed reducing the sample size from 60 to 45 patients

oRecruiting patients in 20 centers in Canada, France, Spain, and the US

oScreened more than half the patients likely required to complete the trial

oCurrently, there are more than 30 patients identified who would be eligible based on HLA and MAGE-A4 expression

oAim to complete SPEARHEAD-1 recruitment by 1H 2021 and launch in the US in 2022

Other trials in the MAGE-A4 program

SURPASS

·Out of the first 4 patients treated (2 with EGJ cancer; 1 with ovarian cancer, 1 with head and neck cancer) 3 have been assessed as PRs (1 confirmed)

o2 patients with EGJ cancer (1 confirmed PR announced in January and a second unconfirmed PR announced today)

o1 patient with head and neck cancer with an unconfirmed PR

·Based on the responses in EGJ cancer, the Company plans to initiate a new Phase 2 trial in this indication

oPlanning to present the full trial design in 2H 2020 and to initiate the trial in 1H 2021

·Enrollment in the SURPASS trial will focus on indications for which there have been early signs of efficacy, including responses, with SPEAR T-cells targeting MAGE-A4. These indications include lung, EGJ, head & neck, and bladder cancers

·Cohorts 2 and 3 were merged and 3 patients will be treated in this new group with up to 5 billion SPEAR T-cells, before moving into the expansion phase (subject to safety)

·Data will be presented at an upcoming medical oncology congress in 2H 2020

SPEARHEAD-2

·The trial will enroll 10 patients with head and neck cancer combining ADP-A2M4 with pembrolizumab following initiation of first line pembrolizumab in the relapsed/metastatic setting

·This will be the first time that a SPEAR T-cell will be used in sequence with first line systemic therapy

·All patients will be apheresed and have their cells manufactured with the intent of having their SPEAR T-cells available by the time of their first assessment on pembrolizumab

·Patients who do not respond to pembrolizumab (published response rate ~20%) or who progress after an initial response will receive SPEAR T-cells and continue to receive pembrolizumab

·All clinical sites are in the process of being initiated

ADP-A2AFP clinical trial

·There is one confirmed complete response, reported in January as a PR, in a patient with liver cancer – the first patient treated at target dose in Cohort 3

·The next two patients in this cohort did not respond

·Following requests from investigators, the Company opened a cohort for patients with non-hepatocellular carcinoma tumors that express AFP and the one patient treated in this cohort has also not responded

·Data will be presented at the International Liver Congress in August

On May 29, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX:TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported data from an ongoing phase 1 dose escalation study of TTI-622 in patients with advanced relapsed or refractory lymphoma (Press release, Trillium Therapeutics, MAY 29, 2020, View Source [SID1234558668]). The data are being presented today at a poster session at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. TTI-622 is an innate immune checkpoint inhibitor targeting CD47, a "do not eat me" signal that cancer cells use to evade destruction by the immune system.

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"The data emerging from this dose escalation study suggest that TTI-622 is a promising and highly differentiated CD47 blocker," said Jan Skvarka, President and Chief Executive Officer of Trillium. "We are seeing strong tolerability, consistent with the red blood cell-sparing property associated with this molecule. Both drug exposure and target engagement have shown dose response relationships. Notably, in addition to the previously reported monotherapy complete response, we have observed a partial response in a second DLBCL patient."

The poster (#94, abstract #3030), entitled "Ongoing, First-in-human, Phase 1 Dose Escalation Study of the Investigational CD47-blocker TTI-622 in Patients with Advanced Relapsed or Refractory Lymphoma", will be presented by lead author Krish Patel, MD, Director of the Lymphoma Program at the Swedish Cancer Institute in Seattle. It will be available on the meeting website beginning at 8 a.m. ET on Friday, May 29 in the Developmental Therapeutics – Immunotherapy session. A copy of the poster will also be available on the Events and Presentations page of Trillium’s website.

Highlights from the Phase I Study Update

The presentation reports on data from 19 relapsed/refractory lymphoma patients who were enrolled in the first 5 cohorts, and were treated with TTI-622 monotherapy at a dose of up to 4 mg/kg.
Weekly intravenous infusions of TTI-622 were shown to be well tolerated, with no dose-limiting toxicities or drug-related grade ≥3 anemia or thrombocytopenia.
Preliminary data indicate dose-dependent increases in both drug exposure and target engagement, with receptor occupancy levels above 60% at doses of 2 mg/kg measured immediately after and 24 hours after infusion administration.
Objective responses were observed in two heavily pretreated diffuse large B-cell lymphoma (DLBCL) patients. One patient achieved a partial response (PR) at week 8 and a complete response (CR) at week 36; a second patient achieved a PR at week 8. Both patients have been continuing on study for 340 and 90 days, respectively, as of April 24, 2020.
Further dose escalation is in progress. The study is currently dosing at 8 mg/kg.
About the TTI-622 Phase I Study

This trial (NCT03530683) is a two-part, multicenter, open-label, phase 1a/1b study of TTI-622 in patients with advanced relapsed or refractory lymphoma or multiple myeloma. The objective of the study is to characterize safety, tolerability and pharmacokinetics, and to determine the maximum tolerated dose. In the phase 1b study, patients will be treated with TTI-622 in combination with other agents.

About TTI-622

TTI-622 is Trillium’s second SIRPαFc decoy receptor in clinical trials. It consists of the CD47-binding domain of human SIRPα linked to an IgG4 Fc region. It is designed to enhance phagocytosis and anti-tumor activity by preventing CD47 from delivering its inhibitory signal. Importantly, preclinical data indicate that TTI-622 does not bind appreciably to human red blood cells, providing a key differentiation feature.