On March 8, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported three presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 8-13, 2022 in New Orleans, Louisiana (Press release, Neoleukin Therapeutics, MAR 8, 2022, View Source [SID1234609798]).

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"The upcoming AACR (Free AACR Whitepaper) presentations provide additional preclinical data demonstrating the potential for NL-201 to treat hematologic cancers as well as synergy when NL-201 is combined with radiation therapy," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "These compelling findings suggest that NL-201 could benefit patients broadly across many indications and in combination with a wide variety of standard-of-care agents."

Poster Presentations:

NL-201, a de novo agonist of IL-2 and IL-15 receptors, demonstrates antitumor activity in preclinical B cell lymphoma models

Session Title: Immunomodulatory Agents and Interventions 3
Date and Time: Wednesday, April 13, 2022, 9:00 a.m. to 12:30 p.m CST
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38
Poster Board Number: 7
Abstract Number: 4227

NL-201, a de novo engineered IL2/IL15 mimic, synergizes with radiation to generate potent antitumor immunity

Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions 1
Date and Time: Monday Apr 11, 2022, 1:30 p.m. to 5:00 p.m. CST
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38
Poster Board Number: 4
Abstract Number: 2067

A first-in-human Phase 1 study of NL-201 in patients with relapsed or refractory cancer

Session Title: Phase I Trials in Progress 2
Date and Time: Wednesday, April 13, 2022, 9:00 a.m. to 12:30 p.m. CST
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 35
Poster Board Number: 11
Abstract Number: CT250

On March 7, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the fourth quarter and year ended December 31, 2021 and provided pipeline updates (Press release, AnaptysBio, MAR 7, 2022, View Source [SID1234609583]).

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"We advanced our wholly-owned antibody product pipeline and completed a $250 million royalty monetization transaction during 2021," said Hamza Suria, president and chief executive officer of AnaptysBio. "We look forward to multiple clinical data readouts during 2022 and remain focused on developing first-in-class therapeutic antibodies using a capital-efficient business model."
Imsidolimab (Anti-IL-36 Receptor) Program
•Following an end-of-Phase 2 meeting with the FDA, we initiated our GEMINI-1 Phase 3 trial of imsidolimab in generalized pustular psoriasis (GPP) where the primary endpoint is the proportion of patients achieving a score of clear (0) or almost clear (1) skin on the Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) at week 4 in 45 patients randomized against placebo. These same patients will subsequently be enrolled into GEMINI-2, which will assess 6 months of monthly subcutaneous dosing and safety follow-up.
•We anticipate top-line data from the ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne in H1 2022 and from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022.
Rosnilimab (Anti-PD-1 Agonist) Program
•We announced positive top-line data from a randomized placebo-controlled healthy volunteer single and multiple ascending dose Phase 1 trial of rosnilimab, our investigational wholly-owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030. Top-line data demonstrated favorable safety, pharmacokinetics and pharmacodynamic results, which supported initiation of our Phase 2 AZURE clinical trial of rosnilimab in alopecia areata.
ANB032 (Anti-BTLA Modulator) Program
•We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.

GSK Partnered Programs
•We completed a royalty monetization agreement with Sagard Healthcare Royalty Partners where AnaptysBio received a $250 million payment in exchange for JEMPERLI royalties due to AnaptysBio on annual commercial sales below $1 billion and certain future milestones starting October 2021. The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment.
Fourth Quarter Financial Results
•Cash, cash equivalents and investments totaled $615.2 million as of December 31, 2021, compared to $411.2 million as of December 31, 2020, for an increase of $204.0 million. The increase relates primarily to cash received from the royalty monetization transaction with Sagard Healthcare Partners offset by cash used for operating activities.
•Collaboration revenue was $1.0 million and $63.2 million for the three and twelve months ended December 31, 2021. The $1.0 million earned during the fourth quarter primarily relates to royalty revenue earned for sales of JEMPERLI (dostarlimab) and Zejula by GSK, compared to $60.0 million and $75 million of milestone revenue for the three and twelve months ended December 31, 2020.
•Research and development expenses were $26.8 million and $98.5 million for the three and twelve months ended December 31, 2021, compared to $21.6 million and $80.0 million for the three and twelve months ended December 31, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
•General and administrative expenses were $5.4 million and $21.5 million for the three and twelve months ended December 31, 2021, compared to $5.1 million and $18.9 million for the three and twelve months ended December 31, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
•Net loss was $32.5 million and $57.8 million for the three and twelve months ended December 31, 2021, or a net loss per share of $1.18, and $2.11, compared to net income of $33.6 million for the three months ended December 31, 2020 or net income per share of $1.23 and a net loss of $19.9 million for the twelve months ended December 31, 2020, or net loss per share of $0.73.

On March 7, 2022 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its fourth quarter and year end 2021 financial results and provided a corporate update (Press release, Instil Bio, MAR 7, 2022, View Source [SID1234609601]).

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"I am pleased with our progress in establishing our operational capabilities and initiating a clinical study in our first year as a public company," said Bronson Crouch, Chief Executive Officer of Instil. "With the DELTA-1 Phase 2 trial of ITIL-168 underway and continued expansion of our manufacturing capabilities in both the United Kingdom and the United States, we continue to develop our platform to deliver cell therapies to patients. In 2022, we look forward to the opportunity to expand the targeted patient population for receiving our therapies in multiple indications with ITIL-168 and ITIL-306."

2021 Highlights and Anticipated Milestones:

Enrollment Ongoing in DELTA-1: Instil is enrolling patients in DELTA-1, a global Phase 2 clinical trial of ITIL-168 with registrational intent in patients with advanced melanoma whose disease has progressed following PD-1 inhibitor therapy and, if BRAF-mutated, targeted therapy. Instil expects top-line safety and efficacy data in 2023 which could potentially support BLA submission and a European Medicines Agency marketing authorization application (MAA) filing.

INDa Cleared for DELTA-2: Instil reported that in Q4 2021 the IND amendment was cleared for DELTA-2, a Phase 1 study of ITIL-168 in non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical cancer, and cutaneous squamous cell carcinoma (CSCC).

Readiness to Initiate Phase 1 Study of ITIL-306 in 2022: Instil remains on track to file an IND for a Phase 1 study of its first genetically engineered CoStAR-TIL, ITIL-306, in multiple solid tumor indications in H1 2022.

Presenting Pre-clinical Data on the CoStAR Platform: Instil expects to present further pre-clinical data on the CoStAR platform, including manufacturability and in vivo models of efficacy and safety, at an upcoming scientific conference in 2022. In November 2021, Instil presented posters highlighting pre-clinical data from the CoStAR platform demonstrating how CoStAR expression led to marked enhancement of effector function and proliferation of T cells and TILs in the studies. Further details can be found in the poster publications available on the publication section of the Company’s website.

Developing Novel CoStAR Constructs: Instil is developing novel, proprietary families of CoStAR constructs against new targets for solid tumors beyond the initial indications targeted for ITIL-306. Instil expects to select the next CoStAR candidate for IND-enabling studies in 2022.

Expansion of UK Manufacturing Facility Complete: Regulatory approval of the IMPACT manufacturing facility in Manchester, UK has been granted and clinical product manufacturing is ongoing. The opening of the IMPACT facility expands Instil’s clinical manufacturing capacity in Manchester, UK.

Validation of Tarzana Clinical Manufacturing Facility Ongoing: Validation of Instil’s clinical manufacturing facility in Tarzana, California is ongoing, with availability for clinical manufacturing expected in the first half of 2022. Upon readiness of the Tarzana clinical manufacturing facility, Instil expects to achieve manufacturing capacity of up to approximately 500 patient doses per year.
Fourth Quarter Full Year 2021 Financial and Operating Results:

As of December 31, 2021, we had $37.6 million in cash and cash equivalents and $416.5 million in marketable securities, compared to $241.7 million in cash and cash equivalents and no investments in marketable securities as of December 31, 2020. The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $42.6 million and $107.3 million for the fourth quarter and full year ended December 31, 2021, compared to $10.2 million and $19.4 million for the fourth quarter and full year ended December 31, 2020, respectively.

General and administrative expenses were $11.2 million and $48.3 million for the fourth quarter and full year ended December 31, 2021, compared to $7.2 million and $14.4 million for the fourth quarter and full year ended December 31, 2020, respectively

On March 7, 2022 GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in prostate cancer, NASH liver fibrosis, and type 2 diabetes, reported that has been granted worldwide, exclusive rights to a UMB technology to advance the company’s pipeline of therapeutics for treating drug-resistant metastatic colorectal cancer (mCRC) (Press release, GlycoMantra, MAR 7, 2022, View Source [SID1234614714]).

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According to the American Society of Cancer Oncology, colorectal cancer (CRC) is the second leading cause of cancer death among men and women in the U.S., totaling about 53,000 deaths per year. Drug resistance to CRC is a primary challenge and mCRC remains a lethal disease. Although 5-fluorouracil (5-FU)—one of the current standards of care for patients with mCRC—exerts clinical benefit, all patients have acquired resistance to the drug over time.

To address drug resistance, GlycoMantra is developing a novel combination therapy, using two natural bioingredients that are expected to treat mCRC and 5-FU-resistant mCRC in multiple pathways: inhibition of the neoangiogenesis to reduce cancer stem cells (CSCs) and increasing apoptosis (cell death). Aditi Banerjee, PhD, of the University of Maryland School of Medicine Department of Pediatrics, is the lead inventor of the technology.

"The combination therapy we’re pursuing is anticipated to be a significant advancement in the arsenal against mCRC. By exerting multiple and prolonged attack on tumors, our goal would be to achieve longer survival of mCRC patients with use of this approach," said Hafiz Ahmed, PhD, Founder, President, and CEO of GlycoMantra. "This licensing agreement with the University of Maryland, Baltimore will allow us to advance our very important research and development."

So far, the efficacy of the combination drug has been demonstrated in a preclinical model. IND-enabling experiments such as toxicity and PK/PD are the next steps prior to beginning human clinical trials.

Phil Robilotto, DO, MBA, associate vice president of UMB’s Office of Technology Transfer and director of UM Ventures at Baltimore said, "We are thrilled to collaborate with Dr. Ahmed, an experienced scientist who has successfully implemented both short and long-term strategic R&D programs focused on cancer and metabolic disease. I’m excited to see what the future holds for his team and for patients."

On March 7, 2022 Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive, will participate in an in-person fireside chat at the 34th Annual ROTH Conference on Monday, March 14, 2022, at 8:30 am PT in HEALTHCARE VFC – Suite 2022 at The Ritz Carlton, Dana Point, California (Press release, Aravive, MAR 7, 2022, View Source [SID1234609549]). Dr. McIntyre and Vinay Shah, Chief Financial Officer of Aravive, will be available for one-on-one meetings on Monday, March 14th.

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A live webcast and a replay of the presentation will be available on Events & Presentations page of www.aravive.com.