On November 27, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported an exclusive license agreement for Centessa Pharmaceuticals’ (NASDAQ: CNTA) blood dendritic cell antigen 2 (BDCA2) modulator antibody portfolio, including lead asset CBS004 and related family of backup antibodies, for the treatment of autoimmune and inflammatory diseases (Press release, AnaptysBio, NOV 27, 2023, View Source [SID1234637967]). Anaptys anticipates filing an IND application for CBS004, which will be renamed ANB101, in H2 2024.

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"Acquiring the rights to this BDCA2 modulator portfolio, which specifically targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation, complements our portfolio of best-in-class immune cell modulators to drive differentiated clinical outcomes in systemic, heterogeneous autoimmune and inflammatory diseases," said Daniel Faga, president and chief executive officer of Anaptys. "We now plan to file two INDs in 2024: ANB101 in H2 2024 and ANB033, our CD122 antagonist, in H1 2024."

"We are pleased to enter into this agreement with Anaptys, which enables the continued advancement of Centessa’s BDCA2 modulators," said Saurabh Saha, M.D., Ph.D., chief executive officer of Centessa. "With their focus on developing immune cell modulators, Anaptys is well positioned to further the research and development of this program in autoimmune and inflammatory diseases."

Plasmacytoid dendritic cells (pDCs) are a key upstream node in the inflammatory cascade that serve as a bridge between innate and adaptive immunity. They have been shown to be prolific secretors of type I interferons, which drive activation of a variety of downstream cell types including T cells and monocytes. Together with their ability to present antigens to the adaptive immune system, this creates a pro-inflammatory environment for the establishment and perpetuation of autoimmune pathology.

BDCA2 is a molecule specifically expressed on pDCs, a class of immune cells which, while found in relatively small numbers in healthy patients, are enriched in patients with a variety of inflammatory diseases, that is critical to the regulation of toll-like receptor signaling and interferon secretion. BDCA2 has been implicated in the pathophysiology of systemic lupus erythematosus (SLE), where there exists mechanistic clinical proof of concept for pDC modulation. ANB101 is a potentially best-in-class BDCA2 modulator antibody that targets pDCs and potently inhibits interferon secretion and modulates antigen presentation for the treatment of autoimmune and inflammatory diseases.

Under the terms of the agreement, Anaptys will receive from Centessa Pharmaceuticals an exclusive, global license for ANB101. Anaptys will also receive the same rights to ANB102, an extended half-life BDCA2 modulator with the potential to enable quarterly or less frequent dosing. ANB101 has successfully completed IND-enabling studies and manufacturing scale-up. Anaptys will assume responsibility for all future clinical development.

In exchange, Anaptys will pay Centessa a one-time upfront cash payment of $7 million, inclusive of a one-time cash payment of $3 million for manufactured and released GMP supply of ANB101. Centessa is eligible to receive an additional development milestone payment and low single-digit royalties on global net sales.

On November 27, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,813,279 and 11,813,281 for Ampligen titled "Compositions for cancer therapy and methods," and "Methods for improving exercise tolerance in myalgic encephalomyelitis patients," respectively (Press release, AIM ImmunoTech, NOV 27, 2023, View Source [SID1234637966]).

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AIM Chief Executive Officer Thomas K. Equels stated: "Our ongoing effort to expand and solidify AIM’s global intellectual property estate is a foundational component of our development strategy for Ampligen. AIM’s expectation for Ampligen – both as a therapeutic for people suffering from dire diseases and as a valuable asset for our stockholders – is the driving force behind our multiple clinical studies in oncology, ME/CFS and Post-COVID conditions. These two new U.S. patents will serve to further strengthen the potential financial future of our company by extending certain sole rights to Ampligen and for these uses to 2039."

Click here to watch a brief video from the AIM management team discussing the issuance of the U.S. patents and what it means for the pipeline development strategy for Ampligen.

Oncology Patent

The new patented methods involve the administration of a unique combination of two compounds to patients suffering from pancreatic cancer, renal cell carcinoma, colorectal cancer and/or melanoma. The first compound is an anti-PD-L1 antibody and the second compound is Ampligen. The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment.

The company believes this novel approach promises to revolutionize the treatment landscape for cancers that have historically been challenging to treat. As symptoms appear only in advanced stages and these cancers are extremely difficult to diagnose without deliberate screening, these cancers contribute to high mortality rates and are a significant burden on public health. The advancement, as claimed in the issued patent, is expected to significantly improve treatment outcomes for patients suffering from these cancers in ongoing and upcoming clinical trials.

The granting of U.S. Patent No. 11,813,279 is not only a testament to AIM’s dedication to pioneering cancer treatment, but also opens new avenues for future research and therapy development. AIM, as patent holder, will have the sole rights to exclude other companies from using the claimed method for research or for treatment until August 9, 2039. On the other hand, AIM, either independently or with strategic licensed partners, will be able to continue refining and enhancing this patented treatment method.

ME/CFS Patent

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating condition characterized by extreme fatigue, pain, and cognitive issues. The Centers for Disease Control and Prevention (CDC) estimates that between 836,000 and 2.5 million Americans suffer from ME/CFS. Addressing these severe symptoms has been a complex challenge for healthcare professionals. However, the issuance of U.S. Patent No. 11,813,281 represents a major leap forward, bringing new hope to those impacted by the enduring and debilitating symptoms of ME/CFS.

The novel methods outlined in the new patent claims involve, at least, identifying individuals who have experienced ME/CFS symptoms for 2 to 8 years – a feature identified through extensive research – and treating these symptoms by administering Ampligen. This precision in treatment timing reflects a targeted, cutting-edge approach to personalized medicine in ME/CFS care and is expected to lead to significant improvements and effectiveness in ME/CFS symptoms in this population.

U.S. Patent No. 11,813,281 bestows AIM ImmunoTech Inc. with the sole rights to exclude others from practicing the claimed methods of treating ME/CFS symptoms using Ampligen until January 12, 2040. This exclusivity fortifies AIM’s position in the market by enabling development of a distinctive and unparalleled treatment option. Additionally, the patent paves the way for strategic alliances and licensing deals, endowing AIM with the unique opportunity to conduct further research and development of the claimed method, either independently or with licensed partners, to continue refining and enhancing this patented treatment method.

On November 26, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of two abstracts regarding MCLA-129 on the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress website (Press release, Merus, NOV 26, 2023, View Source [SID1234637963]). The abstracts highlight updated interim clinical data from expansion cohorts in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) for presentation at the ESMO (Free ESMO Whitepaper) Asia Congress 2023 taking place in Singapore December 1-3, 2023.

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"MCLA-129 is now the third asset, together with our other clinical assets petosemtamab and zenocutuzumab, developed from the Merus proprietary Biclonics platform to demonstrate strong clinical activity," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "As we continue the development of MCLA-129, we are planning to take a disciplined capital allocation approach, making focused investments in the program to identify areas of potential differentiation. We remain open to potential business development opportunities as a means to leverage added resources, infrastructure and expertise of a potential partner to more fully evaluate and develop MCLA-129."

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Interim data included in the abstracts describe data from three expansion cohorts in the open label trial evaluating MCLA-129 in combination with osimertinib, a third generation EGFR TKI, in treatment-naïve EGFR mutant (m) NSCLC and in EGFRm NSCLC that has progressed on osimertinib, as well as MCLA-129 monotherapy in previously treated HNSCC.

Updated clinical data, with additional patients and a later data cutoff date, will be included in the mini-oral presentation on NSCLC and the poster on HNSCC at ESMO (Free ESMO Whitepaper) Asia next week.

Mini-oral presentation title: Efficacy and safety of MCLA-129, an EGFR x c-MET bispecific antibody, combined with osimertinib, as first-line therapy or after progression on osimertinib in non-small cell lung cancer (NSCLC)
Observations in the abstract include:

As of a May 10, 2023 data cutoff date, 48 patients (pts) with advanced/metastatic EGFRm NSCLC were treated (14/1L, 34/2L+)
In the 1L setting, 14 pts were treated, with 10 pts evaluable for response
2 confirmed partial responses (PRs) and 6 unconfirmed PRs were observed (8/10, 80%; 95% CI 44-98) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment; all responses were ongoing as of the data cutoff date
90% disease control rate (DCR) (95% CI 56-100)
10 weeks (range 2-26) median duration of exposure with 93% continuing treatment
In the 2L+ setting, 34 pts were treated, with 22 pts evaluable for response
All received prior osimertinib in 1L/2L setting, 71% as the most recent therapy; 24% received prior chemotherapy
6 confirmed PRs and 5 unconfirmed PRs were observed (11/22, 50%; 95% CI 28-72) by RECIST v1.1. per investigator assessment; 9 responses were ongoing as of the data cutoff date, including 4 of the unconfirmed PRs
82% DCR (95% CI 60-95)
10 weeks (range 2-38) median duration of exposure with 68% continuing treatment
Early safety assessment in 48 NSCLC pts treated with MCLA-129 plus osimertinib included
Most common adverse events (AEs) regardless of causality were infusion related reactions (IRRs; composite term) in 85% (6% ≥ grade(G) 3)
Skin toxicity (composite term) in 75% (4% G3)
Treatment related interstitial lung disease (ILD)/pneumonitis in five patients (10%), two were G2, two were G3, and one was G5 and one progressed to G5 after the data cutoff date
Venous thromboembolic (VTE) events in 15%; 4% treatment related
Presentation Details:
Session: Thoracic Cancer
Date: Sunday, December 3, 2023
Time: 9:40 -9:45 a.m. SGT
Presentation #: 516MO

Poster presentation title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell cancer (HNSCC)
Observations in the abstract include:

As of a May 10, 2023 data cutoff date, 18 pts with previously treated HNSCC were treated
Pts received median of two lines prior therapy, 89% prior chemotherapy, 78% prior anti-PD-(L)1, 28% prior cetuximab
12 pts were evaluable for response
2 unconfirmed PRs were observed (2/12, 17%) by RECIST v1.1. per investigator assessment; one response was ongoing as of the data cutoff date
67% DCR (95% CI 35-90%)
8 weeks (range 2-17) median duration of exposure with 50% continuing on treatment
Early safety assessment in 18 HNSCC pts treated with MCLA-129 monotherapy included
Most common AEs regardless of causality were IRRs (composite term) in 72% (28% ≥ G3), all on cycle 1 day 1, that led to treatment discontinuation in two pts
Skin toxicity in 61% (11% G3)
No ILD or VTE events were reported
Presentation details:
Session Category: Poster session
Date: Saturday, December 2, 2023
Time: 17:50-18:45 p.m. SGT
Presentation #: 362P

MCLA-129 Development Strategy
In EGFRm NSCLC, with the strong clinical activity for MCLA-129 shown in the interim data presented today, we are encouraged by the potential for MCLA-129 in the treatment of lung cancer and beyond. We have identified focused investment opportunities. We continue to follow patients with EGFRm NSCLC treated with MCLA-129 in combination with osimertinib, to evaluate potential for biomarkers as a means to maximize efficacy, while proactively addressing safety signals seen to date.

We plan to start a cohort of MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC in the first quarter of next year.

Additionally, we remain interested and are continuing investigation of cohort B evaluating MCLA-129 in patients with MET exon14 skipping NSCLC. We also remain interested in exploring partnering MCLA-129 with other companies to sufficiently resource the development of MCLA-129 and potential benefit it may have for patients.

In HNSCC, based on the interim data, we observed clinical activity with MCLA-129. However, we view the clinical activity with MCLA-129 monotherapy as of the cutoff date as modest, with 2 unconfirmed partial responses or 17%. The safety profile was manageable, and there were no reported ILD or VTE events. Our assessment of this cohort is that the clinical activity of MCLA-129 in second line head and neck cancer appears substantially inferior to that of our lead asset petosemtamab, and only on par with other EGFR or cetuximab-based monoclonal or bispecific antibodies as monotherapy in a similar setting. We believe this efficacy is insufficient to warrant further development in head and neck cancer.

Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics): NRG1 fusion (NRG1+) cancer and other solid tumors
An abstract for an encore of a recent ESMO (Free ESMO Whitepaper) Congress 2023 presentation on zenocutuzumab interim clinical data from the eNRGy trial and Early Access Program in patients with NRG1 fusion (NRG1+) NSCLC has also been accepted for presentation at ESMO (Free ESMO Whitepaper) Asia.

Presentation details:
Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Session Category: Poster session
Date: Saturday, December 2, 2023
Time: 17:50-18:45 p.m. SGT
Presentation #: 595P

As full presentations become available at the ESMO (Free ESMO Whitepaper) Asia Congress 2023, they will contemporaneously be available on the Merus website.

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on November 27, 2023 at 8:00 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.

Date and Time: November 27, 2023 at 8:00 a.m. ET
Webcast link: Available on our website
Dial-in: Toll-Free: 1 (800) 715-9871 / International: 1 (646) 307-1963
Conference ID: 2833671

On November 25, 2023 (the "Effective Date"), Personalis, Inc. (the "Company") and Tempus Labs, Inc. ("Tempus") reported to have entered into a Commercialization and Reference Laboratory Agreement (the "Tempus Agreement") pursuant to which Tempus will market the Company’s NeXT Personal Dx assay (the "Assay") in the United States and the Company will conduct development activities to validate the Assay in breast cancer, lung cancer and immuno-oncology monitoring indications (the "Indications") (Filing, 8-K, Personalis, NOV 25, 2023, View Source [SID1234638011]). The term of the Tempus Agreement is five years from the Effective Date, which may be extended for successive one-year renewal terms upon the parties’ mutual agreement (the "Term").

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Tempus will use commercially reasonable efforts to market and promote the Assay in the same or substantially same manner that it markets and promotes its own tests. The Company will use commercially reasonable efforts to validate the Assay in the Indications and to generate evidence to seek reimbursement from payors in each such Indication. The Company will perform tests using the Assay ordered by customers through Tempus and will bill such customers or payors for the performance of such tests. The Company granted to Tempus a license to certain intellectual property of the Company necessary for Tempus to perform the Assay, which license is exercisable by Tempus upon certain failures by the Company to perform tests using the Assay ordered under the Tempus Agreement, subject to certain limitations.

In consideration of the Company performing such development activities, Tempus will pay to the Company fees of up to $12,000,000 in the aggregate (the "Market Development Fee"), consisting of an activation fee of $3,000,000 (the "Activation Fee"), a first milestone fee of $3,000,000 (upon achievement of a specified clinical validation milestone), and a second milestone fee payable in six quarterly installments totaling $6,000,000 (subject to the Company achieving certain specified additional clinical validation milestones (collectively, the "Second Milestone")). If the Company does not achieve the Second Milestone by a specified date, Tempus may withhold such installment payments until the Company achieves such Second Milestone, and Tempus will have the right to terminate the Tempus Agreement or convert it to a non-exclusive arrangement; upon any such termination or conversion, the Company will refund to Tempus any Market Development Fee other than the Activation Fee paid to Tempus as of the date of such termination or conversion, subject to certain reductions. If the Company is unable to offer the Assay for use in any Indication in accordance with a schedule set forth in the Tempus Agreement, the Company will refund to Tempus any Market Development Fee other than the Activation Fee paid to Tempus as of the date of such failure to meet such schedule and subject to certain reductions.

From the Effective Date through a specified period for each Indication, the Company will not allow any third party (other than an acquiror of the Company or any affiliates of such acquiror) to market the Assay in such Indication and Tempus will not market another tumor-informed molecular residual disease assay indicated for use in such Indication (whether its own or that of a third party), in each case subject to certain exceptions. Such exclusivity obligations terminate on December 31, 2027 to the extent they do not expire earlier. In addition, each party has the right to convert the Tempus Agreement to a non-exclusive arrangement upon the occurrence of certain specified events.

The Company will compensate Tempus for the fair market value of order requisition and results delivery services rendered with respect to tests using the Assay ordered under the Tempus Agreement on a per-test basis. In addition, the parties will perform certain co-promotion activities with respect to Personalis’ reference laboratory services and Personalis will compensate Tempus for the fair market value of promotional and commercialization services provided by Tempus in connection therewith in an amount up to $9,600,000.

The Tempus Agreement also grants Tempus access to certain initial and longitudinal genomic data derived from performance of the Assay and Tempus will have the right to use such data in accordance with applicable laws. If Tempus or its affiliate licenses such data to a third party and Tempus recognizes revenue from such license, Tempus will pay to the Company a percentage of its gross revenue received that is attributable to such license in the range of 10 to 20 percent. Such revenue share shall be payable during the Term and for 10 years thereafter.

Additionally, in consideration of Tempus’ obligations to the Company under the Tempus Agreement, on November 28, 2023, the Company issued to Tempus (1) a warrant to purchase up to 4,609,400 shares of the Company’s common stock (the "Common Stock") at an exercise price per share of $1.50, with an expiration date of December 31, 2024 (the "First Warrant"), and (2) a warrant to purchase up to 4,609,400 shares of Common Stock at an exercise price per share of $2.50, with an expiration date of December 31, 2025 (the "Second Warrant" and, together with the First Warrant, the "Warrants"). The Warrants are exercisable for cash at any time prior to the applicable expiration date, may be net exercised in certain circumstances, and will be automatically net exercised in connection with a change of control of the Company if the value ascribed to the consideration to be paid for one share of Common Stock in such change of control is greater than the applicable exercise price. The number of shares issuable upon exercise of the Warrants and the exercise prices of the Warrants are subject to adjustment by reason of stock dividends, splits, recapitalizations, reclassifications and the like. If Tempus acquires any shares of Common Stock directly from the Company other than by exercising the Warrants (any such shares, "Non-Warrant Shares"), then the total number of shares issuable upon exercise of the Warrants will be reduced by the Non-Warrant Shares on a share-for-share basis, proportionally between the First Warrant and the Second Warrant based on how many shares are then underlying the Warrants. The Company agreed to register the resale of the shares underlying the Warrants by filing a registration statement with the U.S. Securities and Exchange Commission (the "SEC") within 30 calendar days of the issuance date of the Warrants.

Under the Tempus Agreement, Tempus agreed to certain customary standstill restrictions that apply (a) whenever Tempus (together with its affiliates) owns at least 9,218,800 shares of Common Stock until the parties’ exclusivity obligations expire or terminate under the Tempus Agreement and (b) from the Effective Date through the first anniversary of the Effective Date, to the extent the parties’ exclusivity obligations expire or terminate under the Tempus Agreement and Tempus (together with its affiliates) owns at least 5% of the outstanding shares of Common Stock. These standstill restrictions are subject to suspension in certain cases set forth in the Tempus Agreement. In addition, the Company has agreed to notify Tempus in certain circumstances if the Company is pursuing a change of control transaction for the Company.

With respect to any shares it acquires from exercising the Warrants, Tempus also agreed to certain voting commitments under the Tempus Agreement. These voting commitments require Tempus to vote any shares it acquires from exercising the Warrants in accordance with the recommendations of the majority of the Company’s board of directors, and generally apply to director nominations for any meeting of the Company’s stockholders occurring on or before December 31, 2025, various compensation-related matters, and ratification of auditors. These voting commitments terminate on the later of (i) when the parties’ exclusivity obligations expire or terminate under the Tempus Agreement and (ii) the first anniversary of the Effective Date.

Either party may terminate the Tempus Agreement upon the other party’s material breach or insolvency, if the other party assigns the agreement to a competitor of the terminating party, if there are certain materially adverse changes to certain of the other party’s licenses, permits or certifications or if the other party or its personnel have any materially adverse personal or professional conflicts of interest, subject to certain notice periods. After the first anniversary of the Effective Date, either party may terminate the Tempus Agreement for convenience upon 18 months’ prior written notice. Tempus may terminate the agreement if the Company does not achieve the Second Milestone by a specified date.

The foregoing summary of the Tempus Agreement is qualified in its entirety by reference to the full text of the Tempus Agreement, a copy of which is attached to this report as Exhibit 10.1, which is incorporated herein by reference.

The foregoing summary of the Warrants is qualified in its entirety by reference to the full text of (i) the First Warrant, a copy of which is attached to this report as Exhibit 4.1, which is incorporated herein by reference, and (ii) the Second Warrant, a copy of which is attached to this report as Exhibit 4.2, which is incorporated herein by reference.

On November 24, 2021 Pyrotech (Beijing) Biotechnology Co., Ltd ("Pyrotech Therapeutics"), a company dedicated to developing revolutionary innovative drugs for inflammation and cancer, reported that their independently developed small molecule innate immune agonist PTT-936, with a completely new mechanism of action, has been approved by the U.S. Food and Drug Administration (FDA) for clinical research (Press release, Pyrotech, NOV 24, 2023, View Source [SID1234643789]). This marks the company’s first innovative drug to enter clinical evaluation in the United States.

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PTT-936 is a novel alpha-protein kinase 1 (ALPK1) small molecule agonist that activates the body’s immune system to attack tumors. ALPK1, as a new innate immune receptor, can recognize the small molecule ADP-heptose derived from bacteria and activate the body’s immune response. In 2018, Dr. Feng Shao, a co-founder of Pyrotech Therapeutics, reported this discovery in the journal "Nature" (Zhou et al., Nature 2018). Preclinical studies have shown that activating ALPK1 can efficiently induce anti-tumor immunity. Based on this insight, Pyrotech Therapeutics developed the novel ALPK1 agonist PTT-936.

Preclinical studies have demonstrated that PTT-936, either as a monotherapy or in combination with immune checkpoint inhibitors, exhibits excellent anti-tumor activity. Compared to other innate immune agonists with different mechanisms, PTT-936 has a potentially larger therapeutic window. As a small molecule agonist based on a completely new target and mechanism, PTT-936 is expected to circumvent the safety and efficacy issues limiting the utility of existing innate immune agonists and thereby offer a new treatment option for cancer patients.