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Immutep Reports Dosing of First Patient For
Triple Combination (efti + anti-PD-1 + chemo) in INSIGHT-003

On August 5, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported that the first patient has been enrolled and safely dosed in INSIGHT-003 (Press release, Immutep, AUG 5, 2021, View Source [SID1234585804]). This patient with metastatic non-small cell lung carcinoma received pembrolizumab plus doublet chemotherapy (carboplatin and pemetrexed) combined with Immutep’s lead product candidate eftilagimod alpha (efti or IMP321).

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INSIGHT-003 is evaluating a triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy and anti-PD-1 therapy. The study will continue to recruit up to 20 patients with various solid tumours and first results are expected in calendar year 2022.

CSO and CMO Dr. Frédéric Triebel said: "INSIGHT-003 is the first time a triple combination therapy consisting of efti plus anti-PD-1 plus chemo is administered. We are evaluating how efti might boost an approved chemotherapy and anti-PD-1 combination therapy, looking at safety and initial activity. Dosing the first patient in this trial is a significant milestone and it sets the wheels in motion for reporting first data which are currently anticipated in 2022."

About INSIGHT-003

INSIGHT-003 is an investigator-initiated trial conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being run as the third arm (Stratum C) of the ongoing phase 1 INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator.

Up to 20 patients with solid tumours will be recruited to participate in the trial. Patients will receive 30 mg subcutaneous doses of efti every two weeks in conjunction with standard of care chemotherapy plus anti-PD-1 therapy. The trial will assess the safety, tolerability and initial efficacy of the combination.

Pre-clinical data on HOOKIPA’s arenaviral immunotherapeutic in melanoma published in Nature Communications

On August 5, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that pre-clinical data on its replicating Lymphocytic choriomeningitis (LCMV) arenaviral-based immunotherapeutic has been published in the peer-reviewed journal, Nature Communications (Press release, Hookipa Pharma, AUG 5, 2021, View Source [SID1234585803]). The data demonstrate that HOOKIPA’s LCMV-based vector, designed to target melanoma, modulated the tumor microenvironment and induced potent, tumor antigen-specific T cell responses, resulting in tumor regression and tumor cures in a pre-clinical setting. The publication is available online.

"The pre-clinical data published in Nature Communications add to the growing body of evidence on our arenaviral therapeutics’ ability to induce potent T cell responses and drive tumor regression and, in many cases, tumor cures," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We’re pleased to see parallels in significant T cell responses, even after a single administration, between these data in melanoma and the HPV data we’ve reported in both pre-clinical and clinical settings. We believe our novel, versatile platform has the potential to redefine success in cancer immunotherapy, and we continue to drive our lead HPV program forward while exploring additional indications to address unmet needs."

Pre-clinical data featured in the article showed that replicating LCMV-based arenaviral vector administered as a monotherapy led to melanoma tumor regression in all mice, with tumor cures in about 60 percent of recipients after a single, intra-tumoral administration. Importantly, a single, local injection of the vector into the tumor also led to systemic immune responses, significantly reducing the number of lung metastases.

Other key highlights from the paper include findings that HOOKIPA’s single-vector therapy:

Modulated the tumor micro-environment, producing a shift towards immune-stimulatory cells
Produced a significant increase in tumor antigen-specific CD8+ T cells, known as killer cells, which are critical for effective tumor control
Reduced T cell exhaustion, resulting in better functional CD8+ T cells within the tumor, as well as more immune-stimulatory CD4+ T cells
Induced long-term memory and protection against melanoma tumor re-challenge
Demonstrated the ability of the arenaviral platform to break tolerance in a difficult-to-treat, poorly immunogenic melanoma model, highlighting the potential of this approach more broadly
These data reinforce the promise of HOOKIPA’s arenaviral immunotherapeutic technology to activate and mobilize anti-tumor T cells, as well as overcome some of the challenges of oncolytic virus technology.

HOOKIPA is evaluating its single-vector and alternating 2-vector technologies in cancer in an ongoing Phase 1/2 clinical trial with HB-201 and HB-202. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. Phase 1 data on HB-200 has shown outstanding CD8+ T cell responses, preliminary efficacy as monotherapy in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors, and favorable tolerability. HOOKIPA’s HB-300 program for prostate cancer also uses the LCMV and PICV arenaviral backbones directed against three validated antigens for prostate cancer: PAP, PSA, and PSMA.

GlycoMimetics Reports Highlights and Financial Results for Second Quarter 2021

On August 5, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the quarter ended June 30, 2021 and highlighted recent events (Press release, GlycoMimetics, AUG 5, 2021, View Source [SID1234585802]). Cash and cash equivalents at June 30, 2021 were $118.9 million.

"There are now six trials underway evaluating our lead clinical candidate, uproleselan, including three registration trials and three ISTs, which we anticipate will provide clinical data flow beginning in 2022. Importantly, recruitment rates in both our Company-sponsored Phase 3 trial and the National Cancer Institute’s Phase 2 portion of the Phase 2/3 trial support our expectation that enrollment in both studies can be completed by the end of this year. The support of clinicians who are enrolling patients in our global studies, and now the new ISTs, has made it possible to broaden the scope of our uproleselan clinical research to address unmet needs in AML and beyond," commented Chief Executive Officer Rachel King.

Operational Highlights

Uproleselan

Enrollment of GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Canada, Australia and Europe at a steady pace throughout the second quarter of 2021. The Company continues to project that enrollment will be completed by year-end 2021.
The pace of enrollment in the National Cancer Institute (NCI)-sponsored Phase 2/3 registration trial, designed to evaluate the use of uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, continues to support the Company’s expectation that the Phase 2 portion will complete in 2021, and allow for a subsequent interim Event-Free Survival analysis of 262 patients.
During the quarter and shortly after the quarter close, clinicians initiated three ISTs designed to evaluate uproleselan in AML and in bone marrow transplantation for multiple myeloma. These trials are expected to begin producing clinical data in 2022, which the Company believes will support the potential of uproleselan to be used as a foundational treatment in AML to overcome well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment and reduce adverse effects of chemotherapy.
GMI-1359

In April 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting, Duke University clinicians reported biologic activity, as demonstrated by cell mobilization, redistribution of immune subset profiles and changes in other pharmacodynamic markers, observed in the initial two patients treated in the ongoing Phase 1b study in patients with advanced breast cancer with bone metastases. The initial clinical data support the dual functionality of the compound and the potential of GMI-1359 to enhance responses to chemo and immune therapies.
GMI-1687

The Company continued to advance GMI-1687 towards filing of an investigational new drug application (IND), anticipated in the first half of 2022.
Management Transition

Yesterday, the Company announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed Founding CEO Rachel King. Mrs. King, who has served as CEO since the Company’s founding, has decided to retire for personal reasons and will continue her involvement with the Company through her role on the Board of Directors and serving as an advisor during a transition period. Mr. Semerjian, a seasoned executive with strong commercial oncology experience, will lead the Company as it advances its registration trials for uproleselan in AML, accelerates planning for potential commercialization, and continues to build out the Company’s pipeline.
Second Quarter 2021 Financial Results

Cash position: As of June 30, 2021, GlycoMimetics had cash and cash equivalents of $118.9 million as compared to $137.0 million as of December 31, 2020.
R&D Expenses: Research and development expenses increased to $10.2 million for the quarter ended June 30, 2021 as compared to $9.9 million for the quarter ended June 30, 2020. This increase was primarily due to an increase in clinical trial costs in our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.
G&A Expenses: General and administrative expenses were $4.2 million for the second quarter ended June 30, 2021 and 2020.
Shares Outstanding: Shares of common stock outstanding as of June 30, 2021 were 51,539,010.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 9977599. Participants are encouraged to connect 15 minutes in advance of the call to ensure they are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, with participant code 9977599.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4, which are adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as AML and multiple myeloma, or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor affecting about 900 adolescents a year in the United States. GMI-1359 completed a Phase 1 clinical trial in healthy volunteers, and a Phase 1b clinical study designed to enable investigators to study dose ranging and to generate initial biomarker data around the drug’s activity in breast cancer patients is in progress. In the first two patients evaluated, the study showed evidence of on-target effects, immune-activation and cell mobilization. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist. It has been shown in preclinical studies to be bioavailable via subcutaneous administration. During 2020, data from oral presentations at major scientific conferences pointed to the potential for a self-administered drug to treat VOC of sickle cell disease. Previously, GlycoMimetics demonstrated in preclinical models that GMI-1687 could be a potentially self-administered drug to be used in treatment of AML. The investigational drug also represents a potential life-cycle extension opportunity for uproleselan.

Plus Therapeutics to Present at Canaccord Genuity 41st Annual Growth Conference

On August 5, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will present a Company overview during the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12th at 4:30 p.m. ET (Press release, Cytori Therapeutics, AUG 5, 2021, View Source [SID1234585800]).

Investors interested in arranging a meeting with the Company’s management should contact the Canaccord Genuity conference coordinator.

A webcast of the conference presentation will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com.

CRISPR Therapeutics to Participate in the Canaccord Genuity 41st Annual Growth Conference

On August 5, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021 at 2:30 p.m. ET (Press release, CRISPR Therapeutics, AUG 5, 2021, View Source [SID1234585798]).

A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following each presentation.