On November 13, 2020 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights (Press release, Shattuck Labs, NOV 13, 2020, View Source [SID1234570872]).

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"Shattuck has pioneered the development of bi-functional fusion proteins, and it is a testament to our team to be running multiple clinical trials in just four years from our founding," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. "This has been a transformative year for Shattuck, and our additional clinical trials and support from a base of world-class investors was enabled by the clinical progress we have made to date. Shattuck now has the balance sheet and vast pipeline to support years of continued growth and execution, to aggressively develop SL-172154 as a differentiated asset in the CD47 field and to continue delivering on our partnership with Takeda Pharmaceuticals on SL-279252."

Recent Business Highlights

Initiated Enrollment of Phase 1 Clinical Trial of SL-172154: In August 2020, Shattuck announced the initiation of a Phase 1 clinical trial for its lead wholly owned asset SL-172154, the second clinical program to advance from its proprietary Agonist Redirected Checkpoint (ARC) platform. SL-172154 is a bi-functional fusion protein that simultaneously blocks the CD47/SIRPα checkpoint and activates the tumor necrosis factor (TNF) costimulatory receptor CD40. The Phase 1 trial will initially evaluate the safety, tolerability, and anti-tumor effects of SL-172154 in patients with ovarian cancer. Initial Phase 1 dose escalation data from the trial are expected in the second half of 2021.

Continued Enrollment of Phase 1 Clinical Trial of SL-279252: The Company is continuing to enroll patients in its Phase 1 clinical trial evaluating SL-279252, a bi-functional fusion protein that simultaneously inhibits the PD-1/PD-L1 interaction and stimulates the OX40 receptor pathway in immune cells. The Phase 1 trial is an open label, multi-center, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity, and pharmacodynamics effects of SL-279252 in patients with advanced solid tumors or lymphomas. SL-279252 is currently being developed in collaboration with Takeda Pharmaceuticals. Phase 1 dose escalation data from the trial are expected in the second half of 2021.

Completed Initial Public Offering (IPO): In October 2020, Shattuck completed an upsized IPO of common stock at $17.00 per share, raising gross proceeds of approximately $232.3 million, before deducting underwriting discounts, commissions, and estimated offering costs.

Presented at TIGIT Therapies Summit: In October 2020, Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, presented at the TIGIT Therapies Summit on exploring the novel method of modulating T cell function using TIGIT inhibition and presenting initial preclinical data of SL-9258 (TIGIT-Fc-LIGHT), a bi-functional fusion protein that simultaneously blocks the TIGIT/PVR checkpoint and activates the TNF costimulatory receptor known as LIGHT.

Advanced GADLEN Platform: The Company continues to advance its deep preclinical pipeline, including a second proprietary platform, the Gamma Delta T Cell Engager (GADLEN) platform. In November 2020, Shattuck presented an update on the progress of the GADLEN platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting.

Appointed New Director: In July 2020, Helen M. Boudreau was appointed to Shattuck’s Board of Directors and currently serves as the Audit Committee chair and a member of the Compensation Committee. Ms. Boudreau brings over 30 years of corporate and financial expertise in the life sciences and healthcare industries.
Third Quarter 2020 Financial Results

Cash and Investments: As of September 30, 2020, cash, cash equivalents, and short-term investments were $134.9 million, which does not include total net proceeds of approximately $213.5 million from the Company’s IPO completed in October 2020.

Research and Development (R&D) Expenses: R&D expenses were $11.8 million for the third quarter of 2020, as compared to $7.9 million for the third quarter of 2019.

General and Administrative (G&A) Expenses: G&A expenses were $2.5 million for the third quarter of 2020, as compared to $1.4 million for the third quarter of 2019.

Net Loss: Net loss was $11.8 million for the third quarter of 2020, or $1.54 per basic and diluted share, as compared to a net loss of $7.3 million for the third quarter of 2019, or $0.96 per basic and diluted share.
Financial Guidance

The Company believes its cash, cash equivalents, and short-term investments, together with the net proceeds of its successful IPO on The Nasdaq Global Select Market will be sufficient to fund its anticipated operations through 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

On November 13, 2020 Aileron Therapeutics (NASDAQ:ALRN) reported business highlights and financial results for the third quarter ended September 30, 2020 (Press release, Aileron Therapeutics, NOV 13, 2020, View Source [SID1234570818]).

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"We recently achieved the critical milestone of clinical proof of concept of ALRN-6924, demonstrating a protective effect against severe anemia, thrombocytopenia and neutropenia in our ongoing Phase 1b trial of patients with p53-mutated small cell lung cancer undergoing treatment with topotecan," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "These positive findings help inform our future clinical development strategy, which involves advancing randomized, controlled studies of ALRN-6924 in large cancer indications, including, non-small cell lung cancer, gastrointestinal cancers such as colorectal cancer, and other cancers."

Dr. Aivado continued, "We are laying the foundation to advance our broad vision to bring chemoprotection to patients with p53-mutated cancers, which represent approximately 50% of cancer patients, regardless of cancer type or chemotherapy. We believe our approach, grounded on the principle of chemoprotection without the potential to interfere with chemotherapy’s anticancer activity, may establish ALRN-6924 as standard of care for chemoprotection among patients with p53-mutated cancers who are undergoing chemotherapy."

Key Third Quarter and Recent Highlights

Announced proof-of-concept data from ongoing Phase 1b trial of ALRN-6924. In October 2020, Aileron announced new positive clinical data from its ongoing Phase 1b trial demonstrating clinical proof of concept that treatment with ALRN-6924 given 24 hours prior to second-line topotecan administration resulted in a protective effect against severe chemotherapy-induced bone marrow toxicities – anemia, thrombocytopenia and neutropenia – in patients with p53-mutated small cell lung cancer (SCLC). Robust and clinically meaningful protection against toxicities were observed with the 0.3 mg/kg dose of ALRN-6924. The findings were featured in a late-breaking poster presentation at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual (ENA 2020) Symposium on Molecular Targets and Cancer Therapeutics. The poster presentation and associated data press release can be viewed here and here, respectively. An archived webcast with company management and the study’s principal investor, Bojan Zaric, M.D., Ph.D., discussing the findings, can be found on Aileron’s website here.

Chemotherapy is unselective, meaning it cannot distinguish between cancer cells and healthy cells. As a result, chemotherapy destroys both cancer cells and rapidly dividing healthy cells, such as bone marrow cells, hair follicle cells and skin cells, among others. ALRN-6924 is a cell-permeating peptide drug designed to work intracellularly, activating wild-type p53 to arrest cell cycling in normal, healthy cells and thereby selectively shield these cells from chemotherapy in patients who harbor p53-mutant tumors, without interrupting chemotherapy’s targeting of cancer cells.
"Chemotherapy-induced toxicities are a long-overlooked and unaddressed area of significant unmet need among the millions of cancer patients undergoing chemotherapy," said Dr. Aivado. "For our ongoing Phase 1b trial we have focused on chemotherapy-induced bone marrow toxicities because of their severe, often life-threatening consequences for patients and also because they are the most objectively quantifiable to evaluate chemoprotection. Biologically, we believe that ALRN-6924’s ability to arrest cell cycling in normal, healthy cells has the potential to protect patients undergoing chemotherapy against a spectrum of side effects beyond bone marrow toxicities, such as hair loss, nausea, vomiting, diarrhea and fatigue."

Upcoming Milestones

Following the achievement of clinical proof-of-concept for ALRN-6924, Aileron anticipates undertaking the following next steps to progress and expand clinical development of ALRN-6924.

Initiate Phase 1b randomized, controlled chemoprotection trial in patients with advanced non-small cell lung cancer. Aileron is planning to start a Phase 1b randomized, controlled trial of ALRN-6924 in patients with p53-mutated advanced non-small cell lung cancer who are receiving first-line platinum-based chemotherapy in the second quarter of 2021, subject to additional funding.

Complete schedule optimization part of the Phase 1b trial in small cell lung cancer to inform potential alternative dosing schedule for additional flexibility. Aileron continues to enroll patients in the schedule optimization part of the Phase 1b trial in small cell lung cancer, which is intended to determine whether ALRN-6924 given six hours prior to topotecan ("6h-schedule part") could be an alternative dosing schedule that could provide patients and healthcare providers with additional flexibility of when to administer ALRN-6924 before topotecan. Aileron expects to report final data from the Phase 1b trial, including data from the 6h-schedule part, in the first quarter of 2021.

Undertake healthy volunteer study to support long-term clinical development strategy for ALRN-6924. In the fourth quarter of 2020, Aileron plans to initiate a study of ALRN-6924 in healthy volunteers to gather data to support the company’s long-term strategy to bring chemoprotection to all patients with p53-mutated cancer regardless of cancer type or chemotherapy. Specifically, the study is being conducted to characterize the time to onset, and the magnitude and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. This study is designed to further support Aileron’s design of future randomized, controlled studies of ALRN-6924 when given prior to various chemotherapies.
Third Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and investments as of September 30, 2020 were $14.1 million, compared to $18.3 million as of December 31, 2019. We expect, based on our current operating plan, that our cash, cash equivalents and investments will fund operations into the fourth quarter of 2021.

Research and Development Expenses: Research and development expenses for the quarter ended September 30, 2020 were $2.7 million, compared to $4.5 million for the quarter ended September 30, 2019.

General and Administrative Expenses: General and administrative expenses were $2.3 million for the quarter ended September 30, 2020, compared to $3.4 million for quarter ended September 30, 2019.

Net Loss: Net loss was $5.0 million for the quarter ended September 30, 2020, compared to $7.7 million for the corresponding period in 2019.

On November 13, 2020 AskAt Inc. (AskAt) reported that it received a Notice of Allowance dated November 3, 2020 from the United States Patent and Trademark Office (USPTO) in connection with Application No.16/803,163, a use patent for AskAt’s EP4 antagonist (grapiprant, AAT-007) in the treatment of melanoma, leukemia, lymphoma, and liver cancer (Press release, AskAt, NOV 13, 2020, View Source [SID1234570816]). AskAt has previously received an allowance for the use of grapiprant in the treatment of epithelial cancer and several cancer types.

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Ikena Oncology, Inc (formally Kyn Therapeutics, Inc. which licensed worldwide rights to AskAt’s EP4 antagonists except in China) and Ningbo NewBay Pharmaceutical Co. Ltd. (a subsidiary of Ningbo Tai Kang Medical Technology Co. Ltd., which licensed AskAt’s EP4 antagonists for cancer use in China) are currently conducting clinical studies of grapiprant (IK-007/RMX-1002) in the U.S. and China, respectively.

On November 12, 2020, Eli Lilly and Company and Seed Therapeutics, Inc. (a subsidiary of BeyondSpring, hereinafter referred to as " BeyondSpring Seed"), partner of StoneWise reported the company has reached a US $790 million cooperative development agreement for jointly using its new protein degradation technology platform to develop new drugs, and StoneWise AIDD platform promoted the agreement as an underlying technical support party with computational biology, virtual screening and rational design (Press release, Stonewise, NOV 12, 2020, View Source [SID1234654560]). Therefore, from the deal, it well demonstrates that StoneWise and BeyondSpring Seed are leading and innovating the technology in the field of protein degradation drug research and development.

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StoneWise and BeyondSpring Seed reached a cooperation in early 2020, making use of artificial intelligence + computational chemistry platform to provide compound screening and design in the drug development for BeyondSpring Seed. BeyondSpring Seed focuses on using "molecular glue" technology with independent IP and better drug-forming properties to identify and degrade pathogenic proteins that are not usually used as drug targets.

Applying in the new drug research and development practice supported by the world’s most cutting-edge technology platform, StoneWise has further showed its technology and team strength in the field of small molecule drug discovery that it has been focusing on. StoneWise has invested in the research of Molecular glue and PROTAC platform since the establishment of the company, accumulated abundant know-how and molecular generation and optimization related AI based methodology, and reached similar cooperative development agreements with several companies.

Small molecules induce protein degradation through E3, which can solve drug development problems with pathogenic proteins as targets that cannot be realized by active pocket "occupying" mode (It is known at present that 80% of human proteins cannot be developed as drugs through this way). Protein degradation targeting chimerism (PROTAC) technology has preliminarily proved the safety and effectiveness of drugs based on this pathway in clinical practice. It is known that there are more than 600 kinds of E3 ubiquitination systems existing in human body, but only CRBN、VHL、MDM2 and so on are the most commonly used E3 systems. In addition, in order to achieve the bidirectional chimerism of target protein and E3 ubiquitin ligase protein, the molecular weight of the active compounds obtained by rational design is large, and the subsequent development difficulty caused by drug formation problem is improving comparing with traditional small molecules. Therefore, the discovery and validation of novel effective E3 ubiquitination system and the discovery of small molecules with better drug-forming that can mediate protein degradation have attracted great attention in this newly emerging field.

On November 12, 2020 Trobix Innovation Ltd. (Trobix Bio), an Israeli-based biotechnology company developing therapies to remove the threat of antimicrobial resistance, reported that the Israel Innovation Authority (IIA), the lead R&D supporting arm of the Israeli government, recently approved a non-dilutive grant under its "R&D fund Program", in the aggregate amount of approximately NIS 5.3M (Press release, Trobix Bio, NOV 12, 2020, View Source [SID1234644365]). This grant, alongside the recently completed funding, will be used to advance the company’s antimicrobial resistance platform technology and to further the pre-clinical development of its lead product, TBX101.

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"The promising achievements in our development plan have paved the way to further financial support from the IIA, which we are grateful for", said Dr. Adi Elkeles, Founder & CEO of Trobix Bio. "The Covid-19 pandemic stresses the urgent need to tackle the global challenges of infectious diseases, and Trobix Bio is committed to developing products that can effectively tackle the imminent threat of antimicrobial resistance", he added.