On November 12, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its financial results for the third quarter of 2021 (Press release, NexImmune, NOV 12, 2021, View Source [SID1234595401]).

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"We had another strong quarter as characterized by our continued progress developing the AIM technology platform," said Scott Carmer, Chief Executive Officer. "Our primary focus remains on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002. We plan to provide clinical updates for the NEXI-001 trial in AML during the first half of 2022 and will update the NEXI-002 trial in relapsed / refractory multiple myeloma at the upcoming ASH (Free ASH Whitepaper) conference. Additionally, we are presenting the antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies at the SITC (Free SITC Whitepaper) Annual Meeting. Finally, we’re very excited with the progress of our research collaboration with the lab of Professor Kevan Herold at Yale University, which explores the effects of our AIM injectable nanoparticle as a therapeutic for Type 1 Diabetes. Our team looks forward to providing future updates on these and other important projects as we continue to progress the development of our AIM technology across a range of therapy areas and with multiple modalities."

Select 3Q 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses across all dose levels with signs of increased clinical activity associated with higher doses
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Ongoing enrollment in the Phase I/II trial has been affected by higher than anticipated patient replacements between the enrollment and 28-day DLT clearance period due to non-treatment-related events; updated clinical results expected to be announced in the first half of 2022
NEXI-002

Safety cohort completed and expansion phase continues to enroll and dose
NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Further clinical data from the Phase I/II trial is expected to be announced at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors is being presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Investigational New Drug (IND) submission planned for mid-year 2022
Other R&D

First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic in Type 1 diabetes
Business Updates

Announced the appointments of Dr. Jack Ragheb as SVP, Translational Medicine, and Matthew Schiller as Head of Business Development
Select 3Q 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of September 30, 2021 were $93.2M compared to $102.8M for quarter ending June 30, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements through 4Q22.

Research and development expenses were $11.3M in the third quarter of 2021, compared to $4.9M for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.2M, compared to $2.8M for the same period the prior year. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $14.6M for the quarter, or a basic and diluted GAAP loss per share of $0.65. This compared to a net loss of $8.6M, or a basic and diluted GAAP loss per share of $7.52, for the same period the prior year.

On November 12, 2021 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported third quarter 2021 financial results and provided business highlights (Press release, Lyell Immunopharma, NOV 12, 2021, View Source [SID1234595400]).

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"We continue to advance our multi-modality pipeline and remain on track to submit four INDs by the end of 2022 and are expanding our organizational capabilities across research, development and manufacturing to support our pipeline." said Liz Homans, Chief Executive Officer of Lyell. "Our team is preparing to initiate multiple clinical trials incorporating our two platforms that enable T cells to overcome exhaustion and maintain durable stemness in the solid tumor microenvironment, and we look forward to elucidating the potential clinical benefits of these technologies."

Third Quarter 2021 Financial Results

GAAP and Non-GAAP Operating Results

Research and Development (R&D) Expenses were $31.4 million for the three months ended September 30, 2021, compared to $24.5 million for the same period in 2020. The increase in R&D expense on a GAAP basis was primarily due to increases in facilities and technology costs and personnel-related expenses, partially offset by a decrease in success payments expenses. Non-GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, for the third quarter ended September 30, 2021 were $28.7 million, compared to $21.3 million for the same period in 2020.
General and Administrative (G&A) Expenses were $21.2 million for the three months ended September 30, 2021, compared to $13.6 million for the same period in 2020. The increase in G&A expense on a GAAP basis was primarily due to an increase in personnel-related expenses, including stock-based compensation expense. Non-GAAP G&A expenses, which exclude non-cash stock-based compensation, for the third quarter ended September 30, 2021 were $10.9 million, compared to $5.8 million for the same period in 2020.
Net loss was $48.9 million for the three months ended September 30, 2021, compared to $35.7 million for the same period in 2020. Non-GAAP net loss, which excludes non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, was $35.7 million for the third quarter ended September 2021, compared to $24.7 million for the same period in 2020.
A discussion of these non-GAAP financial measures, including reconciliations of GAAP to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2021 were $936.4 million, compared to $692.6 million as of December 31, 2020, an increase of $243.8 million. Lyell successfully completed its initial public offering in June 2021 in which it issued 25 million shares of common stock, at a price of $17.00 per share, for net proceeds of $391.8 million, after deducting underwriting discounts and commissions and offering expenses.

On November 12, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it will host a virtual Key Opinion Leader (KOL) event regarding the potential treatment of pancreatic cancer utilizing Lantern Pharma’s drug candidate LP-184, on World Pancreatic Cancer Day, Thursday, November 18th at 12:00 pm EST (Press release, Lantern Pharma, NOV 12, 2021, View Source [SID1234595399]).

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The event will be cohosted by:

Dr. Igor Astsaturov, an established, NCI-funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center
Dr. Ira Sharp, retired internal medicine specialist, as well as a pancreatic cancer survivor and cancer patient advocate
Dr. Kishor G. Bhatia, Chief Scientific Officer of Lantern Pharma
The event will feature discussions on the recent advances of LP-184, a PTGR1-activated small molecule that leverages DNA repair deficiency to selectively eradicate pancreatic cancers, and potential clinical uses of LP-184 in an upcoming Phase I clinical trial.

Lantern Pharma’s Virtual KOL Event details are as follows:

Thursday, November 18, 2021, 12:00 pm EST- 1:00 pm EST
To register for the webinar, please sign up here: View Source
A replay of the webinar will be available on the investor relations section of the Company’s website: ir.lanternpharma.com
Pancreatic cancer is the fourth leading cause of cancer deaths in the United States with a five-year survival rate of 7.9% and a 10-year survival rate of just 1%. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 new cases of pancreatic cancer globally on an annual basis, with over 62,000 of those cases occurring in North America. Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease. LP-184 is designed to target a specific subset of pancreatic cancer patients that are genetically defined, which has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.

LP-184 is in pre-clinical development for several targeted indications in cancer, including pancreatic cancer and glioblastoma. LP-184 preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer, and also for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas.

On November 12, 2021 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the Jefferies Virtual London Healthcare Conference (Press release, Keros Therapeutics, NOV 12, 2021, View Source [SID1234595398]).

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The presentation will be available on Thursday, November 18 starting at 3:00 a.m. ET at View Source and archived in the Investors section of the Keros website at View Source A replay will be available for 90 days following the conclusion of the event.

On November 12, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that pre-clinical data from its proprietary, multi-specific NK cell engager platform, ANKETTM, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in collaboration with partner, Sanofi (poster #852) (Press release, Innate Pharma, NOV 12, 2021, View Source [SID1234595397]).

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Specifically, the companies will share new data on IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using Innate’s proprietary multi-specific antibody format1 that targets CD123 on acute myeloid leukemia (AML) cells and now co-engages NKp46 and CD16a on NK cells.

CD123 is an attractive target as it is expressed at high levels in the majority of AML patients2. However, overcoming resistance to antibody-dependent cellular cytotoxicity (ADCC) has been a challenge.

In pre-clinical studies, IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells.

In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.

"There is a strong need to develop effective therapies to treat acute myeloid leukemia, the most common acute leukemia in adults," said Pr. Eric Vivier, Ph.D., DVM, Chief Scientific Officer at Innate Pharma. "We’re pleased to present pre-clinical data on IPH6101/SAR443579 that shows antitumor activity against AML, and more specifically, the potential of engaging NK cells through NKp46 and CD16 via our ANKETTM technology. We look forward to seeing Sanofi dose the first patient in the clinic with this molecule soon."

Innate will also present a second ANKETTM poster (poster #851) at SITC (Free SITC Whitepaper) entitled, "Harnessing Innate Immunity in Cancer Therapies: the Example of Natural Killer Cell Engagers." The data will highlight the induction of a unique NK cell activation pathway by its tetra-specific ANKETTM molecule. The abstract can be accessed here.

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 activating receptors (NKp46 and CD16), a tumor antigen and an interleukin-2 receptor (via an IL-2 variant, IL-2v) via a single molecule. This 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-1 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.

About IPH6101/SAR443579:

In the first research program of the Sanofi collaboration, IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using Innate’s proprietary multi-specific antibody format1, has shown antitumor activity in pre-clinical models, including supportive pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies leading to its selection as a drug candidate for development.

About the Innate-Sanofi agreement:

The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the license agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.