On December 2, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will present new data from the Phase 2 expansion cohort (‘cohort 3’) exploring the triplet combination of monalizumab, cetuximab and durvalumab, in first-line IO and chemo-naïve patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) at the ESMO (Free ESMO Whitepaper) Immuno-oncology Congress 2021, being held virtually from December 8-11 2021 (Press release, Innate Pharma, DEC 2, 2021, View Source [SID1234596396]).

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Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

Additionally, Pr. Eric Vivier, Ph.D., DVM, Chief Scientific Officer at Innate Pharma, will present in the NK cell biology educational session. Details can be found below.

Presentation Details:

Monalizumab: The oral presentation (#123MO) entitled, "Monalizumab, cetuximab and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): a phase 2 trial," will be presented from 12:15-12:20 pm CET on December 9, 2021.
NK cells: Prof. Vivier will discuss Innate’s multi-specific NK cell engager platform, ANKETTM (Antibody-based NK cell Engager Therapeutics), in the educational session entitled, "NK cells biology and therapeutic opportunities, innate immunity, adaptive immunity" from 11:40 – 12 pm CET on December 9, 2021.
About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells and may enhance the cytotoxic potential of other therapeutic antibodies1.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKETTM molecule, is the first NK cell engager technology to engage two NK cell-activating receptors (NKp46 and CD16), a tumor antigen and the interleukin-2 receptor (by an IL-2 variant, IL-2v), via a single molecule. This molecule leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In pre-clinical studies, Innate’s tri-2 and tetra-specific ANKETTM technologies promote potent NK cell activation, cytotoxicity and efficient control of tumor growth in pre-clinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

On December 2, 2021 CTI BioPharma Corp. (NASDAQ: CTIC) reported that management will provide a corporate overview at the JMP Securities Hematology & Oncology Summit at 3:40 p.m. ET (Press release, CTI BioPharma, DEC 2, 2021, View Source [SID1234596395]). The conference will be held in a virtual meeting format.

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Presentation details:
Event: JMP Securities Hematology & Oncology Summit
Date: Monday, December 6, 2021
Time: 3:40 p.m. ET

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

On December 2, 2021, Delcath Systems, Inc. Presented the Corporate Presentation (Presentation, Delcath Systems, DEC 2, 2021, View Source [SID1234596394]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On December 2, 2021 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported recent pipeline and business progress and third quarter 2021 financial results (Press release, Xilio Therapeutics, DEC 2, 2021, View Source [SID1234596393]).

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"Xilio made significant progress in 2021 as we transitioned to a clinical stage organization with XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a tumor-selective IL-2, in clinical development," said René Russo, Pharm. D., president and chief executive officer of Xilio. "With the recent completion of our IPO and a strong and experienced team in place, we are well-positioned to leverage our geographically precise solutions (GPS) platform to advance our pipeline of immuno-oncology therapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects for the benefit of cancer patients."

Recent Pipeline and Business Progress

Cytokine Programs

In October 2021, the U.S. Food and Drug Administration (FDA) cleared Xilio’s investigational new drug application (IND) to evaluate XTX202, a tumor-selective interleukin-2 (IL-2), as a potential treatment for patients with solid tumors. XTX202 is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known toxicity challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.
In November 2021, at the Society for Immunotherapy in Cancer’s 36th Annual Meeting, Xilio reported data from preclinical studies for XTX301, a tumor-selective interleukin-12 (IL-12). Findings demonstrated selective anti-tumor activity and favorable tolerability with minimal systemic effects observed in mouse models evaluating a murine surrogate for XTX301 and non-human primate models evaluating XTX301.
Checkpoint Inhibitor Program

In September 2021, Xilio initiated patient dosing in its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, for the treatment of solid tumors as a monotherapy and in combination with pembrolizumab, an anti-PD-1. XTX101 is designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations, as well as the inability to use existing anti-CTLA-4 therapies at their full dose in combination with other immuno-oncology therapies.
Recent Business Highlights

On October 26, 2021, Xilio closed its initial public offering (IPO). In connection with the IPO, Xilio issued and sold 7,353,000 shares of common stock at a public offering price of $16.00 per share, and on November 1, 2021, Xilio issued and sold an additional 766,106 shares of common stock at a public offering price of $16.00 per share pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Xilio received aggregate gross proceeds of approximately $129.9 million or aggregate net proceeds of approximately $116.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio.
Appointed Tim Hunt as Xilio’s chief culture and corporate affairs officer in October 2021.
Appointed Sara Bonstein, chief financial officer of Insmed, Inc., to Xilio’s board of directors in August 2021.
Anticipated Milestones in 2022

Xilio currently anticipates the following milestones in 2022:

Initiation of a Phase 1/2 clinical trial to evaluate XTX202 in multiple solid tumor types in the first quarter of 2022
Presentation of preliminary data for the monotherapy cohort of the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the middle of 2022
Presentation of preliminary Phase 1 data for XTX202 in patients with multiple solid tumor types in the second half of 2022
Presentation of preliminary data from the combination cohort for the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the second half of 2022
Submission of an IND for XTX301 in the second half of 2022
Third Quarter 2021 Financial Results

Cash Position and Guidance: Cash and cash equivalents were $99.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020. Cash and cash equivalents as of September 30, 2021 do not include $116.3 million in estimated net proceeds from Xilio’s October 2021 IPO. Xilio believes that its existing cash and cash equivalents, together with the net proceeds from its IPO, will enable it to fund its operating expenses and capital expenditure requirements into 2024.
Research & Development (R&D) Expenses: R&D expenses were $10.5 million for the third quarter of 2021, compared to $11.5 million for the third quarter of 2020. This decrease was primarily driven by lower comparable costs associated with manufacturing development activities for the XTX101 and XTX202 programs, partially offset by higher personnel-related costs due to increased headcount and preclinical research and clinical development expenses.
General & Administrative (G&A) Expenses: G&A expenses were $5.5 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020. This increase was primarily driven by higher personnel-related costs due to increased headcount and higher professional fees related to ongoing business activities and preparations related to operating as a public company.
Net Loss: Net loss was $16.3 million for the third quarter of 2021, compared to $14.8 million for the third quarter of 2020.

On December 2, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported positive results from the phase 3 FOCUS study (Press release, Delcath Systems, DEC 2, 2021, View Source [SID1234596392]). The FOCUS study’s intent-to-treat (ITT) population was comprised of a total of 102 subjects, across various lines of therapy. Of the ITT group, 91 evaluable patients were administered at least one study treatment.

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Treatment with HEPZATO in the ITT analysis resulted in an objective-response-rate (ORR) of 31.4% [95% CI: 22.55-41.31], including 6.9% of patients with a complete response (CR). Median duration of response was 14 months [95% CI: 8.54, NC], with over half of responders continuing to be monitored for progression events. Disease control rate (DCR) was 65.7% [95% CI, 55.63, 74.81].

On the primary ORR endpoint, the lower bound 95% Confidence Interval (CI) of 22.55% exceeded the FOCUS trial’s prespecified 8.3% upper bound 95% CI threshold for success. This threshold was derived from a meta-analysis of sixteen checkpoint inhibitor publications documenting the treatment of 476 metastatic ocular melanoma patients.

Supportive, predefined, exploratory analyses were conducted comparing patients in the HEPZATO arm versus a BAC group. The BAC arm was comprised of a total of 42 patients, originally randomized in the FOCUS trial prior to its amendment, in consultation with FDA, to a single-arm pivotal study in 2018. The evaluable BAC subjects were treated predominantly with liver-targeted Transarterial Chemoembolization (TACE).

Among patients who received at least one study treatment, patients in the HEPZATO arm had statistically significant improvements over BAC in the following prespecified endpoints:

ORR of 35.2% versus 12.5% for the BAC arm (p=0.0154).
Disease Control Rate of 73.6% versus 37.5% for patients in the BAC arm (p=0.0002).
Median Progression Free Survival of 9.03 months versus 3.12 months for the BAC arm (HR=0.39; p=0.0002).
Enrollment in the FOCUS trial HEPZATO arm ended in late 2020 with overall survival data continuing to mature. Per the statistical plan, a final predefined exploratory survival analysis, versus BAC, will be conducted at 24-months after last patient last treatment.

As of this analysis, survival at 12-months in the evaluable patients was 75% in the HEPZATO arm versus 47% for BAC [HR=0.37, p=0.01]. Delcath will provide future overall survival analysis updates, as patient follow-up continues, and the Kaplan-Meier analysis matures.

In the HEPZATO safety population, the most commonly reported treatment-emergent serious adverse events were anemia (29.7% of patients), thrombocytopenia (26.4% of patients) and neutropenia (19.8% of patients), which were well-manageable. 5.3% of patients experienced treatment-emergent serious cardiac adverse events. In all cases the events resolved with no ongoing complications. There were no treatment-related deaths in the trial.

"Metastatic ocular melanoma is a disease with a dismal prognosis and new therapies are urgently needed. The FOCUS study results, along with the predefined analyses versus a relevant BAC group, clarify HEPZATO overall clinical benefit in this difficult-to-treat patient population," noted Dr. Jonathan Zager MD FACS, global lead investigator of the FOCUS study, senior member and Director of Regional Therapies at Moffitt Cancer Center. "The overall efficacy, coupled with an improved safety profile versus the first-generation product, suggests that HEPZATO would offer a compelling clinical benefit were it approved by FDA."

"We are thrilled by the HEPZATO response rates and duration of response which far exceed that which has been seen with other agents in this difficult-to-treat patient population. Our data further highlights HEPZATO’s potential superiority to other available liver-targeted therapies, which suggests a broader utility for our platform across multiple liver-metastatic tumor types. In addition to re-filing our NDA by mid-2022, Delcath, along with key opinion leaders, intend to study HEPZATO in additional indications in the near future."

The FOCUS trial results will be presented at a comprehensive Investor Update Meeting taking place today from 10:00am EST – 1:30pm EST. In addition to the FOCUS trial, a distinguished panel of physicians will discuss their personal clinical experience with HEPZATO in both the clinical trial setting and the commercial setting in Europe, as well as the potential for HEPZATO to treat liver metastatic tumor types beyond metastatic ocular melanoma.

Event Details:

Event: Delcath Systems Virtual Investor Update Meeting
Date: Thursday, December 2, 2021
Time: 10:00am – 1:30 p.m. EST

To register for this event, please click here.

The live webcast of the event may be accessed through the Events and Presentation page of Delcath’s website, under the Investors section. The archived webcast and presentation will be available on the Company’s website after the event.