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BlueSphere Bio Data to be Presented at the 2022 Joint ASTCT + EBMT Basic and Translational Scientific Retreat

On May 25, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported that Sawa Ito, M.D., Ph.D., was selected to provide an oral presentation during the 2022 Joint ASTCT + EBMT Basic and Translational Scientific retreat (Press release, BlueSphere Bio, MAY 25, 2022, View Source [SID1234616065]). The retreat is a select gathering limited to 100 attendees focused on basic and translation biology in the field.

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The presentation will highlight the capabilities of the company’s TCXpress platform and its ability to rapidly clone TCRs against specific targets from single T cells. This work enabled the discovery of BlueSphere’s first clinical candidate, a TCR T-cell therapy directed against the minor histocompatibility antigen (miHA) HA-1. The company anticipates filing its first IND by the end of 2022. The TCXpress platform has also enabled the discovery of four new TCRs reactive against other relevant miHAs, in addition to HA-1. BlueSphere plans to announce details on these other targets later this year.

Title: High Throughput Cloning Reveals Diverse Properties of anti-HA-1 T Cell Receptors

Presenter: Dr. Sawa Ito, hematologist/oncologist at UPMC Hillman Cancer Center and Assistant Professor, Division of Hematology-Oncology and Department of Immunology at the University of Pittsburgh School of Medicine.

About TCXpress

TCXpress is a proprietary high-throughput and efficient T-cell receptor (TCR) capture, expression and functional screening platform capable of processing thousands of single T cells directly into functionally expressed TCRs within a matter of days, thereby creating extensive libraries without the need for sequencing or TCR gene synthesis.

DiaMedica Therapeutics to Attend the 19th Annual Craig-Hallum Institutional Investor Conference Wednesday, June 1, 2022

On May 25, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that it will be participating in the 19th Annual Craig-Hallum Institutional Investor Conference being held virtually on Wednesday, June 1, 2022 (Press release, DiaMedica, MAY 25, 2022, View Source [SID1234615110]). Management will be available to participate in one-on-one meetings. Investors and attendees that would like to schedule a meeting with DiaMedica’s management can contact their Craig-Hallum representative to arrange a meeting.

ImmunoGen Announces Webcasts of Presentations at Upcoming Conferences

On May 25, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, MAY 25, 2022, View Source [SID1234615058]):

William Blair 42nd Annual Growth Stock Conference
June 8 at 11:20am CT / 12:20pm ET
Jefferies Healthcare Conference
June 9 at 9:30am ET
A webcast of each presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

Oxford BioTherapeutics Announces Collaboration with Agenus to Support the Clinical Development of OBT’s Antibody Drug Conjugate OBT076 in combination with Agenus’ CPI Balstilimab

On May 25, 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, reported that it has entered into a collaboration and supply agreement with Agenus Inc., an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, to support a clinical trial evaluating the combination of OBT076 with the anti-PD1 checkpoint inhibitor (CPI) balstilimab (Press release, Oxford BioTherapeutics, MAY 25, 2022, View Source [SID1234615056]).

OBT has observed near complete responses in two chemotherapy-refractory advanced cancer patients with low to no PD-L1 expression after 2-5 cycles of OBT076 and 1-2 cycles of a CPI, indicating preliminary signs of clinical activity. Immuno-blood profiling during translational work on these patients revealed a potential novel immuno-oncology mechanism for immune system reactivation and tumor shrinkage.

OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus´ proprietary CPI, balstilimab. Balstilimab is an PD-1 blocking antibody currently in clinical development in several solid tumor indications.

"I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "Our preliminary data suggest that depletion of CD205+ immuno-suppressive cells and subsequent T-cell activation after OBT076 treatment followed by a single cycle of a CPI coincides with the rapid resolution of the primary tumor, as well as metastases, and we believe that balstilimab is the ideal combination agent for these studies."

Under the terms of the agreement, OBT will be the sponsor of the combination trial and responsible for operational execution, and Agenus will provide drug supply and scientific support.

"We look forward to collaborating with Oxford BioTherapeutics to bring this novel combination to patients," said Steven O’Day, MD, Chief Medical Officer of Agenus. "The clinical data generated with OBT076 in advanced solid tumors is promising, and we believe will broaden the therapeutic benefit of balstilimab observed across treatment-resistant tumors."

The study will be conducted in the US as well as in several European countries including France, Germany, Belgium and Greece, and will focus on patients with solid tumors including lung, gastric and ovarian cancer.

"Our initial Phase 1 findings suggest that OBT076 may activate the immune response against the tumor through a potentially novel mechanism in some patients; based on these encouraging results, we are advancing OBT076 into the next stage of clinical development in combination with a CPI," said Rahim Fandi, MD, PhD, Chief Medical Officer (CMO) of Oxford BioTherapeutics. "With their deep experience in the field of immune-oncology, Agenus is the ideal partner for us in this next stage of OBT076’s development."

About OBT076

OBT’s lead clinical program, OBT076, an ADC utilizing an ImmunoGen toxin, initiated expansion in a U.S. Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers. OBT076 is advancing into Phase 1b trials assessing the efficacy of OBT076 as a monotherapy as well as in combination with a CPI in both checkpoint-naïve and resistant patients with solid tumors. Subsequent disease-specific Phase 2a trials are planned in non-small cell lung, ovarian and gastric cancer patients. OBT is also planning for later-stage trials of OBT076, including in combination with a CPI.

Harbour BioMed Announces Dosing of First Patient in Phase I Trial of B7H4x4-1BB Bispecific Antibody

On May 25, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that it has successfully completed the dosing of first patient in phase I trial of B7H4x4-1BB bispecific antibody HBM7008 in Australia (Press release, Harbour BioMed, MAY 25, 2022, View Source [SID1234615055]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors.

HBM7008 is generated from our unique and innovative HBICE platform, leveraging the advantages of HBM HCAb and H2L2 platforms. It targets Tumor-Associated Antigen (B7H4), mediated crosslinking T cell activation through 4-1BB. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in the mouse tumor model.

As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutic. Following its global innovation and development strategy, Harbour BioMed will advance the global clinical development project of HBM7008 at full speed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency on TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.