On January 5, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported a prospective study (NCT05257551), in collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN), that aims to identify biomarkers of response in patients with small cell lung cancer (SCLC) (Press release, Tempus, JAN 5, 2023, View Source [SID1234625940]). The study, titled Sculptor, is co-sponsored by Tempus and AstraZeneca’s Personalize SCLC Initiative and is currently open for enrollment.

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"This type of early-stage, prospective study is only possible when combining Tempus’ comprehensive sequencing capabilities, multimodal database, and just-in-time clinical trial network."

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In the United States, lung cancer is the second most common cancer, and approximately 13% of people diagnosed with lung cancer have SCLC, according to the American Cancer Society. SCLC is an aggressive disease characterized by rapid growth, early metastasis, and acquired therapeutic resistance in which there is a high unmet need for therapeutic targets. To date, there are limited ways to stratify this specific patient population and limited defined therapeutic targets or associated treatments.

The Sculptor study is leveraging Tempus’ comprehensive portfolio of molecular profiling offerings to gather the insights necessary to support this kind of early research, with the goal of identifying distinct segments that may benefit from emerging therapies, or a treatable target from which to develop an associated therapy to treat patients with SCLC. This study is currently active at five TIME Trial Network sites, with plans to expand to additional providers across the country to ensure the study’s dataset is representative of the overall SCLC patient population in the United States.

"This collaborative study will facilitate the investigation of SCLC patient populations to provide us with key insights in hopes of enabling pharmaceutical solutions that increase the overall survival of this disease," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "This type of early-stage, prospective study is only possible when combining Tempus’ comprehensive sequencing capabilities, multimodal database, and just-in-time clinical trial network."

"We are excited to announce commencement of the first clinical trial stemming from our strategic collaboration with Tempus," said Cristian Massacesi, Chief Medical Officer & Oncology Chief Development Officer, AstraZeneca. "AstraZeneca’s investigation of novel therapies for SCLC sub-populations is another example of our precision medicine approach and mission to put patients first and follow the science."

On January 5, 2023 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints reported the close of an additional $25 million through a Series B extension, for a total of $131 million in Series B financing (Press release, Immune-Onc Therapeutics, JAN 5, 2023, View Source [SID1234625939]). This extension was led by existing investor Triwise Capital and with participation from new investors including Proxima Ventures, among others. In addition, the company has received continued strategic capital investments from The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP) and Wuxi Biologics HealthCare Venture.

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Proceeds from the financing will be used to accelerate development of Immune-Onc’s lead clinical candidates, IO-108 and IO-202, and advance the selection of additional novel myeloid checkpoint inhibitor programs. Immune-Onc will provide additional corporate and clinical progress updates during 1:1 investor and prospective partner meetings at the upcoming J.P. Morgan 41st Annual Healthcare Conference.

"Immune-Onc had an incredible year of growth and development with two myeloid-checkpoint inhibitor programs progressing in the clinic in the U.S. and China for multiple types of cancer where great unmet needs remain," said Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc. "We are confident in the long-term growth prospects for Immune-Onc and believe that our progress this past year provides a compelling foundation for continued success in 2023. We are on track to deliver on several key milestones for our lead clinical candidates, including obtaining proof-of-concept results in leukemia and solid tumor expansion cohorts for IO-202 and IO-108, respectively, completing dose escalation for IO-202 in solid tumors, and further characterizing clinical biomarkers and/or mechanisms of actions for our checkpoint inhibitors that may ultimately lead to new clinical programs."

2022 Clinical & Corporate Highlights:

Clinical:

Dosed the first patient in the expansion cohorts of the company’s ongoing Phase 1 study for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors
Dosed the first patient with IO-108 in a Phase 1 clinical trial in China for patients with advanced solid tumors following the Center for Drug Evaluation of the China National Medical Products Administration approving the company’s Investigational New Drug application
Dosed the first solid tumor patient in the company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3)
Granted Fast Track designation by the U.S. Food and Drug Administration for IO-202 for the treatment of patients with relapsed or refractory acute myeloid leukemia

Corporate:

Entered a clinical supply agreement with Regeneron Pharmaceuticals, Inc. ("Regeneron") to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), as part of its ongoing clinical development program in the U.S.
Entered into a clinical trial collaboration and supply agreement to evaluate IO-108 and IO-202 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China
Appointed Austin L. Gurney, Ph.D., and Barbara J. Klencke, M.D., to the company’s Board of Directors and Christopher Whitmore as chief financial officer
Won the 2022 BayHelix "R&D Achievement of the Year" award
Named the top 5 woman-led life science companies in the San Francisco Bay Area
Participation at upcoming industry panel:

The Future of Checkpoint Inhibitors and Immuno-Oncology at Fierce JPM Week on Jan 10.

On January 5, 2023 Adcendo ApS ("Adcendo"), a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of underserved cancers, reported a license agreement with Duality Biologics ("Duality"), a clinical-stage biotech company focused on discovering and developing a pipeline of ADCs targeting cancers and autoimmune diseases (Press release, ADCendo, JAN 5, 2023, View Source [SID1234625937]).

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Under the terms of the agreement, Adcendo will license Duality’s proprietary DITAC (Duality Immune Toxin Antibody Conjugates) linker/payload platform for its lead uPARAP-ADC program in mesenchymal cancers. The DITAC platform is designed to generate ADCs with superior safety profiles, sustainable payload delivery and release in tumors, and efficient bystander killing of antigen low and negative cells. Both parties are in discussions to expand the license agreement to cover additional targets selected by Adcendo.

uPARAP is a novel cancer target overexpressed on the cell surface of mesenchymal cancers. The expression profile and unique internalization properties of uPARAP make it a highly attractive ADC target.

Michael Pehl, Chief Executive Officer of Adcendo, said: "We are very pleased to announce this agreement to leverage Duality’s DITAC platform for our first-in-class uPARAP ADC program. We believe that Duality, through its DITAC platform, has clearly brought linker-payload technologies to the next level and we are very much looking forward to collaborating closely and developing ADCs with a superior safety and efficacy profile for cancer patients in need."

John Zhu, Chief Executive Officer of Duality, said: "Duality is dedicated to becoming a leading next-generation ADC company. The clinical assets built upon our DITAC platform have started to show encouraging efficacy and safety results in patients. We are very glad to work with Adcendo on breakthrough ADC medicines and apply our platform to its novel and unique uPARAP program. We believe the collaboration reflects the mutual recognition of each party’s unique strengths in ADC discovery and development and look forward to supporting the development of innovative ADC drugs."

On January 5, 2023 Akamis Bio (formerly PsiOxus Therapeutics), a clinical-stage oncology company leveraging its Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform to positively impact the lives of people living with cancer, reported a $30 million convertible note financing co-led by a group of leading US life science investors (Press release, PsiOxus Therapeutics, JAN 5, 2023, View Source [SID1234625938]). In addition, the company provided a progress update on its clinical pipeline programs, NG-350A and NG-641, while announcing a relaunch of the company as Akamis Bio building upon its ongoing corporate transformation. In conjunction with the corporate name change, the company has launched a new website at www.akamisbio.com.

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The $30 million convertible note financing was co-led by new US investors ARCH Venture Partners, the Parker Institute for Cancer Immunotherapy, and Westlake Village BioPartners. It will further fund development activities for the clinical stage NG-350A and NG-641 programs, as well as general corporate purposes.

"Over the last several years, we have undergone an incredible transformation as a company, and our new name reinforces this evolution and our focused commitment to oncology drug development. The $30 million financing will enable the continued advancement of our clinical pipeline of T-SIGn therapeutics and further establishes our US footprint," said Howard Davis, Ph.D., Chief Executive Officer of Akamis Bio. "As we relaunch the company today, we thank our existing and new investors for their support and shared commitment to leveraging our groundbreaking solid-tumor targeted T-SIGn therapeutics to turn the tide in the battle against cancer."

Akamis Bio, formerly PsiOxus Therapeutics, was founded and has grown with the support of leading global and European investors including SROne, IP Group, Hambro Perks, Lundbeckfonden, Sedgwick Yard, Mercia Asset Management, and Rosetta Capital Limited.

"We are excited to support the talented team at Akamis Bio in their efforts to bring a set of powerful new immuno-oncology therapeutics to people living with cancer," said Robert Nelsen, Co-founder and Managing Director of ARCH Venture Partners. "We are delighted to partner with Akamis Bio’s existing investors as the company advances its current clinical programs and continues to expand its pipeline of T-SIGn therapeutics."

Clinical Progress Update – NG-350A & NG-641

Akamis Bio’s T-SIGn therapeutics are viral vector-based, tumor gene therapies which have demonstrated the ability to specifically home to and replicate within primary and metastatic solid tumor tissue following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive intratumoral expression of multiple immunologically active biomolecules and therapeutic proteins to remodel the tumor microenvironment and trigger robust antitumor immune responses. Akamis Bio’s clinical pipeline of T-SIGn therapeutics is anchored by two Phase 1 programs: NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody; and NG-641, a stromal-targeted tumor gene therapy driving intratumoral expression of a FAP-CD3 bispecific antibody, CXCL-9, CXCL-10, and interferon alpha.

Across more than 200 patients with epithelial-derived solid tumors who have been treated in Akamis Bio’s clinical trials to date, T-SIGn therapeutics have been well-tolerated and demonstrated a consistent safety profile. In clinical studies, NG-350A and NG-641 have shown promising preliminary evidence of clinical activity including dose-dependent elevation of systemic immune response cytokines and dose-dependent increases in CD8+ immune cell infiltrates within the targeted solid tumor tissue.

As the ongoing clinical studies for NG-350A (FORTITUDE and FORTIFY) and NG-641 (STAR, NEBULA, and MOAT) advance in 2023, Akamis Bio will continue to assess safety, tolerability, and preliminary efficacy in both monotherapy and combination (with checkpoint inhibitors) settings, as well as the potential benefits of multiple cycles of T-SIGn therapeutic dosing. Akamis Bio anticipates the initiation of a set of expansion cohort studies for NG-350A and NG-641 in early 2024 to demonstrate clinical proof-of-concept in patient populations with a single type of epithelial-derived solid tumor.

Akamis Bio Corporate Relaunch

The company’s new name is derived from "Akamas," one of the warriors who was inside of the mythical Trojan Horse which facilitated the successful Greek attack on Troy from inside the city’s otherwise impenetrable walls. The name is a nod toward the "Trojan Horse" mechanism of action of its T-SIGn therapeutics which enter solid tumor cells and turn them into "drug factories" to facilitate the immune system’s attack on the tumor from the inside.

The company’s relaunch builds on the ongoing corporate transformation which has included the Q3 2022 hiring of a new US-based CEO in Howard Davis, Ph.D., as well as the company’s Q4 2022 establishment of its hub of US operations in Kendall Square in Cambridge, Massachusetts. In conjunction with the corporate name change, the company has launched a new website (www.akamisbio.com).

About T-SIGn

Akamis Bio’s Tumor-Specific Immuno-Gene (T-SIGn) therapeutics are chimeric group B adenoviral vector-based, tumor gene therapies which are capable of homing specifically to primary and metastatic solid tumors following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive intratumoral expression of multiple immunologically active biomolecules and therapeutic proteins encoded by the vector to remodel the tumor microenvironment and trigger robust antitumor immune responses. T-SIGn therapeutics have potential for use in the treatment of solid tumors as monotherapy, as well as in combination with other immuno-oncology agents (e.g., checkpoint inhibitors, antibody drug conjugates, bispecific T-cell engagers, and cell therapies) to enable and/or enhance the efficacy of those modalities in the solid tumor setting. Akamis Bio has an extensive and growing body of clinical experience with T-SIGn therapeutics with more than 200 patients treated across both the monotherapy setting, as well as in combination with checkpoint inhibitors. Across clinical studies, T-SIGn therapeutics have demonstrated a consistent safety and tolerability profile, as well as promising preliminary evidence of clinical activity.

On January 5, 2023 iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, reported an update on IOA-244, its lead cancer drug, which is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer arising within the uveal tract of the eye (Press release, iOnctura, JAN 5, 2023, View Source [SID1234625936]).

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After assessing the novel chemical and biological properties of IOA-244, and the promising signals of clinical activity seen to date in patients with uveal melanoma, the US FDA granted Orphan Drug Status for IOA-244. This grants certain benefits during development and commercialization. Uveal melanoma is a disease in which cancer originates in the tissues of the eye, causing symptoms such as blurred vision or a dark spot on the iris. When the cancer metastases, which it does in approximately 50% of patients, there are limited treatment options and projected overall survival is only a year.

A PI3Kδ inhibitor, IOA-244 recently received the proposed name roginolisib and is being investigated in the DIONE-01 trial, a two-part, first-in-human Phase I study (ClinicalTrials.gov, identifier NCT04328844). Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. Part B is an ongoing cohort-expansion of the biologically-effective dose (BED) of 80mg in solid and hematologic malignancies including a recently opened non-Hodgkin´s lymphoma cohort.

As of December 2022, 38 patients (including 23 with metastatic uveal melanoma and eight patients with follicular lymphoma) have been treated with IOA-244. Across all patients treated to date, roginolisib given at the BED showed less than 5% Grade 3 or Grade 4 toxicities, with these toxicities being transient in nature. There have been no dose-limiting drug reductions or interruptions and long-term (over six months) administration of IOA-244 is well tolerated.

Clinical activity, including partial and complete responses, are being seen in patients with both solid and hematologic malignancies. Further details on clinical responses will be released at a future international clinical conference in 2023. Fourteen of 38 patients (including 11 of 23 uveal melanoma patients) are still on treatment, with two patients having been on treatment for more than two years. The one-year OS rate is currently 70%; median OS has not been reached.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "We are delighted to provide these positive updates on IOA-244, our lead clinical program. These important new data, taken together with previous findings, show a drug with a game-changing clinical safety and activity profile. These data demonstrate for the first time that a semi-allosteric inhibitor of PI3Kδ can be given to patients safely for long durations with no serious adverse events. We are excited to take IOA-244 forwards into a monotherapy registration study in uveal melanoma and to further explore its potential both in lymphoma and solid tumors such as NSCLC."