On November 29, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that management will be participating in the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 30 through December 2, 2021 (Press release, Opko Health, NOV 29, 2021, View Source [SID1234596185]). A pre-recorded company fireside chat is available for registered attendees via the Piper Sandler conference site and at this link.

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Management will be available for one-on-one virtual meetings with investors on Wednesday, December 1st, which can be requested through Piper Sandler.

On November 29, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company has initiated a Phase 2, single arm, open-label study of trilaciclib administered prior to the antibody-drug conjugate (ADC), Trodelvy (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (Press release, G1 Therapeutics, NOV 29, 2021, View Source [SID1234596203]). Antitumor efficacy and myeloprotective endpoints are being assessed in this trial. Initial results of this study are expected in the second half of 2022.

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"All of our clinical programs are designed to maximize the utility of trilaciclib and evaluate its ability to transform treatments for patients living with cancer, including potential synergies with newer promising agents, such as ADCs," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "We are excited to develop this combination in TNBC, an area where trilaciclib in our Phase 2 trial and Trodelvy have both shown clinically meaningful and substantial improvements in overall survival and could act synergistically to improve patient outcomes with fewer myelosuppressive side effects. We believe strongly in the clinical rationale underlying this combination and that the data generated from this study will be instructive as we contemplate combinations of trilaciclib and ADCs in other treatment settings and tumor types."

Patient recruitment in this trial is now underway. Approximately 40 patients will be enrolled in this exploratory Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic TNBC who received at least 2 prior treatments, at least 1 in the metastatic setting. Trilaciclib will be administered as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy treatment on day 1 and day 8 of each 21-day cycle.

Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first.

The primary objective is to evaluate the anti-tumor efficacy of trilaciclib when administered prior to sacituzumab govitecan-hziy as measured by progression-free survival (PFS). Key secondary endpoints include evaluation of the anti-tumor efficacy as measured by the objective response rate (ORR), duration of objective response (DOR), clinical benefit rate (CBR), and overall survival (OS); and evaluation of the myeloprotective effects of trilaciclib.

About Triple Negative Breast Cancer (TNBC)

According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15-20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because mTNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating mTNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with mTNBC compared to other forms of breast cancer, and mTNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.

On November 29, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in combination with the anti-PD-1 antibody, pembrolizumab (Press release, Adagene, NOV 29, 2021, View Source [SID1234596225]). The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

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ADG116 utilizes Adagene’s proprietary NEObody platform technology and is designed to target a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor microenvironment (TME). ADG116 is designed with a soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.

"The FDA clearance of this trial represents a significant milestone for our anti-CTLA-4 program as we advance our evaluation of ADG116 in combination with anti-PD-1 therapy," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "By applying NEObody technology, ADG116 can overcome existing safety limitations of anti-CTLA-4 therapies to achieve improved clinical benefit. Our exploration of ADG116 with pembrolizumab aims to unleash the dual CTLA-4/PD-1 blockade and realize the full potential of this combination therapy approach as a cornerstone of cancer treatment – balancing safety and efficacy."

The ADG116-P001 trial is expected to dose the first patient in early 2022, and is designed to evaluate the safety and tolerability, determine the maximum tolerated dose, and assess preliminary efficacy of the combination of ADG116 and pembrolizumab.

Additionally, the ongoing ADG116-1003 trial is on track to expand with two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors.

On November 29, 2021 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the use of CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients with first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (Press release, Celularity, NOV 29, 2021, View Source [SID1234596186]). CYNK-101 is an investigational genetically engineered natural killer (NK) cell therapy designed to enhance antibody-dependent cellular cytotoxicity (ADCC) with approved and novel antibody therapeutics.

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"Gastric cancer represents the fifth most common cancer worldwide, and in advanced stages of the disease, continues to be associated with less than desirable survival outcomes despite recent advances," said Robert Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity. "By enhancing the innate ADCC activity of our placental-derived NK cells, we have developed a cellular therapy platform that holds promise to complement and synergize with a range of antibody treatment strategies across a variety of tumor types. Our goal is to combine the potential advantages of placental-derived cellular therapies, including enhanced persistence, proliferation and resistance to cell exhaustion, with approved treatment strategies," Hariri said.

Andrew Pecora, M.D., President of Celularity, said, "Among patients with locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction adenocarcinoma, advances in patient outcomes have been achieved with the addition of trastuzumab, and more recently, pembrolizumab, to standard chemotherapy, leading to regulatory approval of this combination. We are now excited to begin assessing if our off-the-shelf allogeneic placental-derived NK cells that have been genetically modified to enhance ADCC and resist cleavage of CD16 can improve clinical outcomes when added to the current combination in this patient population."

The Phase 1/2a open-label, non-randomized clinical trial is designed to evaluate the safety and preliminary efficacy of the combination treatment strategy.

About CYNK-101

Celularity’s lead therapeutic candidate based on its placental-derived genetically modified NK cell type is CYNK-101, an allogeneic, off-the-shelf human placental CD34+-derived NK cell product genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. Currently CYNK-101 is being developed as a treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab for HER2+ overexpressing gastric or gastroesophageal junction adenocarcinoma. The safety and efficacy of CYNK-101 have not been established, and CYNK-101 has not been approved for any use by the U.S. Food and Drug Administration or any other analogous regulatory authority.

On November 29, 2021 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that the company management team will provide a corporate update on Monday, December 13, 2021 at 5:30 PM ET, in conjunction with participation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting (Press release, Aptose Biosciences, NOV 29, 2021, View Source [SID1234596204]). The event will include a review of HM43239 data highlighted in an oral presentation at ASH (Free ASH Whitepaper), as well as the up-to-date clinical status of luxeptinib. HM43239 is an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML). Luxeptinib is an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory B cell malignancies who have failed or are intolerant to standard therapies, and in a separate Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS)

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Aptose Corporate Update Details

Date & Time: Monday, December 13, 2021, 5:30 PM ET

Participant Webcast Link: Link

Participant Dial-in:

Toll Free: 1-877-407-9039

Toll/International: 1-201-689-8470

Conference ID: 13725358
The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

As announced previously, the abstracts accepted for presentation at ASH (Free ASH Whitepaper) are listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website. Note that the poster presentations will include additional data not found in the abstracts.

Oral Presentation Details

Publication #702: First in Human FLT3 and SYK Inhibitor HM43239 Shows Single Agent Activity in Patients with Relapsed or Refractory FLT3 Mutated and Wild-Type Acute Myeloid Leukemia (AML)
Oral Presentation Session Date & Time: Monday, December 13, 2021, 4:00 PM ET
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Targeted Therapies and Novel Therapies
Location: Georgia World Congress Center, Georgia Ballroom 1-3

Poster Presentation Details

Publication #1355: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic BTK/FLT3 Inhibitor Luxeptinib (CG-806) in Patients with Relapsed or Refractory B-Cell Malignancies
Poster Session Date & Time: Saturday, December 11, 2021, 5:30 – 7:30 PM ET
Session Name: 623. Mantle Cell, Follicular, and other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Location: Georgia World Congress Center, Hall B5

Publication #1272: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic FLT3/BTK Inhibitor Luxeptinib (CG-806) in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Poster Session Date & Time: Saturday, December 11, 2021, 5:30 – 7:30 PM ET
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Location: Georgia World Congress Center, Hall B5

Publication #3411: A Phase 1 a/b Dose Escalation Study of the MYC Repressor Apto-253 in Patients with Relapsed or Refractory AML or High-Risk MDS
Poster Session Date & Time: Monday, December 13, 2021, 6:00 – 8:00 PM ET
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Location: Georgia World Congress Center, Hall B5

The poster abstracts also are published in the November supplemental issue of Blood, an ASH (Free ASH Whitepaper) journal, available online.