On August 15, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported a clinical trial supply agreement with Novartis to evaluate tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with HiFiBiO’s HFB200301, an investigational first-in-class monoclonal anti-TNFR2 agonist antibody for the potential treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform (Press release, HiFiBiO Therapeutics, AUG 15, 2022, View Source [SID1234618370]).

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HFB200301 is currently being evaluated as a single agent in the first-in-human dose escalation and expansion clinical trial (NCT05238883), with the intention of following up with a combination of HFB200301 and tislelizumab.

"Immuno-oncology therapies have significantly improved the way we treat cancers. Unfortunately, they are not effective in every patient, and many individuals are still left with few options. Combination immunotherapy approaches have become a promising solution for harder to treat cancers," said Luigi Manenti, M.D., Chief Medical Officer at HiFiBiO Therapeutics. "HFB200301 has the potential to reenergize the immune system to fight against cancers, both as a single agent and in combination. We are excited to explore whether HFB200301 in combination with tislelizumab can further improve patient outcomes in DIS selected cancers."

"HiFiBiO is proud to highlight the potential of our DIS platform to rapidly advance novel therapeutics like HFB200301 from targets to patients. Additionally, this collaboration showcases our continuing commitment to Open Innovation for the benefit of cancer patients with high unmet needs," said Liang Schweizer, Ph.D., Founder, Chairperson and CEO at HiFiBiO Therapeutics.

Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200301.

HFB200301

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications that may benefit the most from HFB200301 treatment. HFB200301 is an investigational agent. Safety and efficacy have not been established. There is no guarantee that HFB200301 will become approved and commercially available anywhere globally.

Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

On August 15, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended June 30, 2022 and provided a corporate update (Press release, Tempest Therapeutics, AUG 15, 2022, View Source [SID1234618369]).

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"In the second quarter, we presented promising trial results from TPST-1120, our novel PPARα antagonist, at the ASCO (Free ASCO Whitepaper) Annual Meeting. This was the first presentation of clinical data from a Tempest program: a significant milestone for the company that was enhanced by its selection for a podium presentation," said Stephen R. Brady, chief executive officer of Tempest. "In addition to progress on our other programs, we closed a financing with support from both a new, top-tier investor and our founding investor that extended Tempest’s runway into the first quarter of 2024, providing additional stability during this turbulent time in the biotech capital markets."

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) presented data from the monotherapy and combination therapy arms of the TPST-1120 Phase 1 study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting; (ii) hosted a well-attended investor event at ASCO (Free ASCO Whitepaper) during which multiple key thought leaders discussed Tempest’s programs; and (iii) continued enrollment in a first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented a "trials in progress" poster for the ongoing TPST-1495 Phase 1 monotherapy and combination therapy clinical trial at ASCO (Free ASCO Whitepaper); and (iii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Financing: closed $15 million private investment in public equity (PIPE) financing with new investor, EcoR1 Capital, and founding investor, Versant Venture Capital.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): early data from the first 40 patients in the first-line randomized global Phase 1b/2 study in patients with HCC under a collaboration with F. Hoffmann La Roche expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023, with planned presentation of the combined data in 2023.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2022 with $51.6 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $15.5 million offset by proceeds from the PIPE financing of $14.5 million (net of issuance costs).
Net loss and net loss per share for the second quarter of 2022 were $9.2 million and $0.79, respectively, compared to $7.1 million and $7.63, respectively, for the second quarter of 2021.
Research and development expenses for the second quarter of 2022 were $5.7 million compared to $4.2 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.
General and administrative expenses for the second quarter of 2022 were $3.1 million compared to $2.6 million for the same period in 2021. The increase of $0.5 million was primarily due to higher professional and consulting fees and insurance expense as a result of operating as a publicly-traded company.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2022 was $15.5 million.
Net loss and net loss per share for the six months ended June 30, 2022 were $17.7 million and $1.88, respectively, compared to $12.4 million and $17.30, respectively, for the same period in 2021.
Research and development expenses for the six months ended June 30, 2022 were $10.8 million compared to $7.8 million for the same period in 2021. The $3.0 million increase was primarily due to expanded research and development efforts and higher personnel-related costs.
For the six months ended June 30, 2022, general and administrative expenses were $6.2 million compared to $4.1 million for the same period in 2021. The increase of $2.1 million was primarily due to an increase in professional and consulting fees and higher insurance expense as a result of operating as a publicly-traded company.

On August 15, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported Brian M. Culley, Lineage’s Chief Executive Officer, will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Director of Research; Managing Director, Equity Research, H. C. Wainwright & Co. LLC (Press release, Lineage Cell Therapeutics, AUG 15, 2022, https://investor.lineagecell.com/news-releases/news-release-details/lineage-present-hc-wainwright-co-2nd-annual-virtual [SID1234618368]). The fireside chat will be available to investors on demand, starting on August 17th, 2022 at 7am ET.

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Interested parties can register to view on-demand replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

On August 15, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide, reported a strategic agreement with Ontada, a McKesson business with leading provider technology and actionable real-world research, education, and evidence in oncology, to improve U.S. community oncology care through the development of real-world evidence (RWE) data, tools, and insights to help increase access to affordable, cutting-edge therapies (Press release, BeiGene, AUG 15, 2022, View Source [SID1234618367]).

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The partnership will be led by Ontada and focus on accelerating the development and implementation of RWE to improve community education on the financial impact and value of oncolytics as well as improve patient access to oncology medicines.

"BeiGene is excited to work with Ontada to advance our shared vision of improving patient access, affordability, and value for community oncology stakeholders and key partners working at the intersection of clinical practice and real-world evidence," said Josh Neiman, Chief Commercial Officer, North America and Europe, at BeiGene. "Working together, BeiGene and Ontada will generate novel oncology insights through real-world data, tools, and technologies that will facilitate the acceleration of precise decision-making in support of community oncology practices whose ultimate mission is to improve patient outcomes."

As part of the collaboration, the companies will optimize the use of RWE to communicate value across key stakeholders including patients, providers, and payers; develop timely education on emerging science and therapeutic differentiation; and collaborate to advance use of RWE in healthcare and regulatory decision making to increase timely and affordable patient access to life-saving oncology therapies.

"BeiGene aims to bring 10 molecules per year to the clinic starting in 2023 and, as this research advances, we’re delighted to form this strategic partnership with McKesson, which shares the same vision as BeiGene for improving the care of cancer patients," said Christiane Langer, M.D., Senior Vice President of Global Medical Affairs, Ex-China, at BeiGene. "This collaboration will leverage Ontada’s technology platform and deep understanding of the experiences of patients treated in community oncology clinics to help accelerate both the development of the BeiGene portfolio and expand access to treatment options."

"As a leader in real-world research, Ontada is uniquely positioned to support complex research that uncovers deeper patient insights and perspectives that advance cancer care," said Susan Shiff, Ph.D., president of Ontada. "We are excited to announce this unique partnership with BeiGene and look forward to developing a stronger understanding of how to better treat oncology patients through the use of real-world data and evidence."

On August 15, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a diversified oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, reported financial results for the second quarter and six months ended June 30, 2022 and provided a corporate update (Press release, Pyxis Oncology, AUG 15, 2022, View Source [SID1234618366]).

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"Our strong balance sheet and cash runway will allow us to fund the Company through the second half of 2024, solidifying our position to potentially capitalize on multiple expected near-term catalysts and advance our programs to clinical development," said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "We have elected to sharpen our near-term focus on the clinical execution of our two most advanced programs, anti-EDB Antibody Drug Conjugate (ADC), PYX-201, and anti-Siglec-15 monoclonal antibody (mAb), PYX-106. We also look forward to leveraging our team’s extensive industry network in identifying and facilitating opportunities where we can forge strategic partnerships to efficiently advance therapies that might change the treatment paradigm for patients with cancer."

Corporate Development Highlights

Focus on advancing lead programs toward the clinic with near-term catalysts: Pyxis Oncology is on track to file Investigational New Drug applications (INDs) for PYX-201 and PYX-106 in 2022. Pyxis Oncology remains confident in the clinical and commercial opportunity for both programs based on the in vivo preclinical data to date and looks forward to working with the FDA to advance both programs into clinical development. PYX-201 is a novel, non-internalized ADC directed against a first-in-class target (EDB), which is selectively expressed in a large population of non-small cell lung cancer (NSCLC), breast cancer, and other solid tumors. PYX-106 is a potentially best-in-class mAb targeting Siglec-15, which has demonstrated over six-fold binding affinity for human Siglec-15 vs. prior attempts against this target.

Pausing development of anti-CD123 ADC, PYX-203, and anti-KLRG1 IO program, PYX-102: The Company will pause the preclinical development of PYX-203 and PYX-102. Pyxis Oncology remains optimistic about the long-term clinical promise of both assets and will consider both strategic collaboration and licensing opportunities and potential future in-house development to maximize value for both programs.

Ceasing development of anti-DLK1 ADC, PYX-202: On March 29, 2022, Pyxis Oncology disclosed it was conducting additional GLP and non-GLP toxicology studies on PYX-202, the ADC in-licensed from LegoChem Biosciences, to determine the clinical viability of the candidate. Upon review and analysis of the data, the Company has elected to stop the continued development of PYX-202. Preclinical data suggests DLK1 has the potential to be a novel therapeutic target in the treatment of small-cell lung cancer and soft tissue sarcoma. As LegoChem continues to work on the development of ADCs targeting DLK1 using its proprietary next generation payloads, Pyxis Oncology looks forward to leveraging its collaboration with LegoChem to evaluate the potential of these new candidate ADCs.
Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, commented, "We believe that our therapeutic candidates have distinct advantages and are ideally suited for targeting difficult-to-treat tumors. PYX-201 represents a potentially first-in-class ADC with a novel mechanism of action, and PYX-106 has a differentiated activity profile with the potential to help patients who don’t respond or have stopped responding to current PD-1 targeted therapies. We look forward to progressing these two most advanced programs towards the clinic and filing INDs in the second half of this year."

Addition to Board of Directors

Pyxis Oncology has appointed Rachel Humphrey, M.D., to its Board of Directors. Dr. Humphrey brings over 20 years of experience in oncology drug development and extensive experience in product development from pre-IND to commercialization of small molecules, cytotoxics and biologics in oncology and immuno-oncology. She currently serves as President and Chief Executive Officer of Normunity, an innovative immuno-oncology company. She was previously Chief Medical Officer at Black Diamond Therapeutics, a precision oncology medicine company, and was a member of the Board of Directors at Xilio Therapeutics. Prior to that, she served as Chief Medical Officer and a member of the Board of Directors of CytomX Therapeutics, a clinical stage oncology company, where she was responsible for the clinical development of Probody Therapeutics for the treatment of cancer. She oversaw the early and late-stage clinical development of two new oncology molecular entities, ipilimumab (Yervoy) while serving as Vice President, Clinical Development at Bristol-Myers Squibb, and sorafenib (Nexavar) at Bayer.

Dr. Sullivan commented, "We are excited to welcome Rachel to our Board of Directors. Her experience and successful track record in oncology drug development spanning across large pharmaceutical and small biotechnology companies will add incredible value to our already deep bench of industry leaders as we near the clinic with two promising oncology therapeutic candidates."

Financial Update for Quarter Ended June 30, 2022

Pyxis Oncology had cash and cash equivalents of $223 million as of June 30, 2022, and approximately $207 million (preliminary, unaudited) as of August 15, 2022, which is expected to fund operations through the second half of 2024.
Research and development expenses were $17.2 million for the three months ended June 30, 2022, compared to $3.2 million for the three months ended June 30, 2021. The increase was primarily due to increased expenses associated with contract manufacturing of drug products and drug substance, preclinical cost related to toxicity studies and an increase in employee headcount to support research and development activities.
General and administrative expenses were $8.6 million for the three months ended June 30, 2022, compared to $2.7 million for the three months ended June 30, 2021. The increase was primarily due to higher personnel-related expenses (including stock-based compensation), increases in legal and professional fees, rent, and directors and officers insurance expense to support our growth and operations.
Net loss was $25.6 million, or $(0.79) per common share, for the three months ended June 30, 2022, compared to $8.1 million, or $(5.54) per common share, for the three months ended June 30, 2021. Net loss for the three months ended June 30, 2022 and 2021 included $4.0 million and $0.6 million, respectively, related to non-cash stock-based compensation expense.
As of August 15, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 32,834,561.