On September 17, 2026 Altis Labs, Inc. ("Altis"), the AI endpoint company, reported the closing of its US$25 million Series A financing. The round was co-led by OrbiMed and Qiming Venture Partners USA, with participation from Innovation Endeavors, Benchstrength, Fusion Fund, Lumira Ventures via the Cancer Breakthrough Fund, and others.

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The financing will be used to expand Altis’ AI models across additional cancer types, scale commercial deployment with global biopharmaceutical partners, and establish AI endpoints as a new standard for oncology trials.

Oncology trials have long relied on imaging endpoints like objective response rate (ORR), yet these measures provide an incomplete picture of whether patients ultimately live longer. Drug developers must nonetheless rely on early endpoints for critical go/no-go, trial-design, and portfolio decisions, each representing hundreds of millions of dollars in R&D investment and billions of dollars in commercial value. When conventional imaging endpoints fail to predict efficacy, drug developers risk discontinuing promising treatments prematurely or advancing therapies that ultimately fail in later stage trials.

"Every clinical trial is fundamentally a learning process, and right now it is a slow one. The faster and more accurately we can determine whether a treatment is truly delivering benefit to patients, the faster our biopharma partners can bring new effective medicines to those who need them," said Felix Baldauf-Lenschen, Founder and CEO of Altis Labs. "We’re thrilled to have the support of Qiming US, OrbiMed, and our other investors for the critical work ahead."

Altis was founded on the premise that AI models trained on real-world survival outcomes can more accurately predict true, long-term clinical benefit missed by conventional imaging endpoints. Altis’ flagship AI model, IPRO, automatically generates survival predictions from routinely acquired radiology scans, enabling drug developers to detect treatment effects earlier and more reliably. In Johnson & Johnson’s independent post-hoc analysis of the Phase 3 MARIPOSA trial presented at the 2026 World Conference on Lung Cancer, Altis’ AI endpoint, IPRO Response Rate, detected a statistically significant treatment effect 11 months before the primary PFS readout and 26 months before the final overall survival readout, whereas ORR failed to predict the significant survival benefit.

"Having spent the majority of my career developing cancer therapies, I know how much rides on early efficacy signals that can often fail to predict whether a drug will truly improve patient outcomes," said Tal Zaks, Partner at OrbiMed. "Altis has assembled the industry’s most comprehensive longitudinal oncology dataset linking imaging and outcomes to train AI models and has now translated that into a compelling novel outcome measure with strong Phase 3 validation results. We believe this approach can meaningfully de-risk and accelerate clinical development, and we are thrilled to support the team as they scale."

"Earlier, accurate measurement of efficacy is the most impactful application of AI in drug development. Altis is a leader in AI endpoints, a new category that directly addresses the high late-stage failure rates, costs, and timelines bottlenecking therapeutic R&D," said Anna French, DPhil, Managing Partner at Qiming Venture Partners USA. "Altis has shown its AI endpoint can outperform existing standards, and we’re excited to support their mission."

(Press release, Altis Labs, SEP 17, 2026, View Source [SID1234670937])

On September 17, 2026 Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the publication of data from a retrospective analysis which suggests a three-year overall survival (OS) benefit with TREGZITM, in patients with hematologic malignancies. This retrospective analysis evaluated data from the Precision-T phase 1b multicenter study comparing TREGZI + tacrolimus (Tac) to a CIBMTR-NMDP registry cohort of patients receiving conventional allo-HSCT + PTCy based GVHD prophylaxis. The findings, featured in the journal Transplantation and Cellular Therapy, showed improved survival outcomes for patients treated with TREGZI compared to similar patients treated with PTCy in the myeloablative setting. The data published in Transplantation and Cellular Therapy reinforce the potential role of high-precision graft engineering platforms and therapeutic interventions like TREGZI, in improving long-term outcomes in patients with blood cancer.

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"Allogeneic stem cell transplant has long been considered the only curative option for advanced hematologic malignancies, but the risks associated with them – including graft versus host disease (GVHD) – are potentially life threatening," said Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center. "While there are treatment options available to help prevent GVHD, data on the impact of them on overall survival have been limited. The findings from this retrospective analysis on the recently approved therapy, TREGZI, point to the value of cell therapy in potentially improving transplant outcomes for patients without sacrificing long-term survival."

The TREGZI arm was associated with higher OS over a three-year follow-up period compared to PTCy arm (HR=0.41; log-rank p=0.003). Overall survival at one, two, and three years for patients receiving TREGZI (n=76) was 96% (95% CI: 88%-99%), 86% (76%-92%), and 83% (73%-90%), respectively.

For patients included in the PTCy cohort (n=360), OS at one, two, and three years was 81% (95% CI:77%-85%), 72% (67%-77%), and 66% (60%-71%), respectively.

Historically, a drug cocktail of Tacrolimus/methotrexate (tac/MTX) was the predominant standard of care to prevent GVHD for patients following alloHSCT. However, there has been increased adoption of different approaches to GVHD prevention such as, PTCy-based regimens and the recently approved high-precision cell therapy, TREGZI.

In clinical studies, both TREGZI + Tac and allo-HSCT + PTCy have demonstrated the reduced cumulative incidence of GVHD relative to Tac/MTX.

"We welcome the publication of these data in Transplantation and Cellular Therapy as it contributes to the body of evidence that supports the therapeutic value of graft engineering approaches in GVHD," said Nate Fernhoff, co-founder and CEO, Orca Bio. "We are a company committed to redefining what’s possible for patients in allogeneic cell therapy, and these data reinforce the value of Orca Bio’s technology in the durable restoration of a healthy immune system and reducing treatment-related toxicities in patients with blood cancer."

About the Phase 1b Study and Comparative Analysis

The data published in Transplantation and Cellular Therapy, were based on a retrospective analysis of long-term survival follow up from a Phase 1b multicenter trial evaluating TREGZI for the treatment of hematologic malignancies, data from which have been presented at multiple scientific congresses including the American Society of Hematology (ASH) (Free ASH Whitepaper) and the Tandem meetings of ASTCTTM and CIBMTRTM. The three-year OS outcomes observed with TREGZI were compared to a historical cohort of patients receiving an allogeneic stem cell transplant with PTCy-based GVHD prophylaxis. The cohort included was from registry data collected by CIBMTR-NMDP.

The inclusion criteria for this comparative analysis were similar to those of the TREGZI Precision-T Phase 3 trial including: patients who were ≤65 years of age with confirmed diagnoses of either intermediate- or high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) in complete remission or myelodysplastic syndrome (MDS), who were treated with a myeloablative conditioning (MAC) regimen, and an 8/8 HLA-matched donor.

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

Graft Failure: Graft failure has occurred after TREGZI administration. Screen TREGZI recipients for antidonor antibodies that may prevent engraftment. Monitor patients closely for laboratory evidence of hematopoietic recovery.

Graft-Versus-Host Disease: Acute and chronic Graft-Versus-Host disease (GVHD), including life-threatening and fatal cases, occurred following treatment with TREGZI. Acute GVHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GVHD may include skin rash, mouth sores, dry eyes, liver inflammation, and development of scar tissue in the skin and joints and damage to the lungs. Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD, and treat if GVHD develops.

Infusion Reactions: Infusion reactions (IRs) may occur during or following treatment with TREGZI. Serious hypersensitivity reactions including anaphylaxis may occur to DMSO, human serum albumin (HSA), Dextran or murine protein present in TREGZI. IRs may begin within minutes of the start of TREGZI infusion, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of IRs during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Premedicate patients with antipyretics and histamine antagonists prior to infusion to reduce the incidence and intensity of infusion reactions.

Secondary Malignancies and Malignancies of Donor Origin: Secondary malignancies and malignancies of donor origin may occur following treatment with TREGZI. Development of secondary malignancies, including posttransplantation lymphoproliferative disorder (PTLD) may occur many years after transplantation. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. No patient treated with TREGZI has developed PTLD. Monitor for malignancies of donor origin and secondary malignancies. Contact Orca Bio at 1-877-411-6722 if any patient is diagnosed with a secondary malignancy or a malignancy of donor origin.

Transmission of Infectious Agents: Transmission of serious infectious or communicable disease or agents may occur with TREGZI treatment as it is derived from human donor blood and manufactured using animal-derived reagents. Risks of transmission of infectious agents may occur despite screening or testing of donors. Risks of transmission of serious infections include, but are not limited to, human immunodeficiency virus, human T cell lymphotropic virus (HTLV)-1 and -2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, Trypanosoma cruzi, West Nile virus (WNV), cytomegalovirus, transmissible spongiform encephalopathy agents and vaccinia. Monitor patients for signs and symptoms of infections, perform tests for infectious agents and treat as clinically indicated.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) were mucositis, diarrhea, rash, viral infections, infections pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections.

The most common Grade 3-4 laboratory abnormalities (≥ 20%) are lymphocyte count decreased, platelet count decreased, leukocyte count decreased, neutrophil count decreased and hemoglobin decreased.

INDICATIONS AND USAGE

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies.

Please see accompanying full Prescribing Information.

About TREGZI

TREGZI is the first-and-only FDA approved precision-cell therapy for allogeneic transplant in adults with hematologic malignancies to improve survival free of cGVHD. It is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-disease-free survival, in the treatment of adults with hematological malignancies.

TREGZI is a personalized treatment manufactured for each individual patient using living cells from a matched donor. TREGZI uses hematopoietic stem and progenitor cells (HSPCs) to reconstitute the immune system, highly purified regulatory T cells (Tregs) to suppress GVHD and conventional T cells (Tcons) to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity.

The FDA approval of TREGZI was based on the results of Precision-T, a randomized, open-label, multi-center study that evaluated the safety, efficacy and tolerability of TREGZI compared with conventional allogeneic hematopoietic stem cell transplant (alloHSCT).

(Press release, Orca Bio, SEP 17, 2026, View Source [SID1234670936])

On September 17, 2026 Altis Labs, Inc. ("Altis"), the AI endpoint company accelerating clinical trials, reported findings from an independent post-hoc analysis evaluating its AI-powered imaging endpoint, IPRO, in the MARIPOSA Phase 3 trial.1 The findings, which were presented at the World Conference on Lung Cancer (WCLC) 2026 in Seoul, Republic of Korea, show that Altis’ IPRO Response Rate detected an early, notable treatment effect, while RECIST-based objective response rate (ORR) failed to anticipate the investigational treatment’s 12+ month median overall survival (OS) benefit.

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IPRO Response Rate provides early efficacy signal in EGFR-mutated NSCLC

In a post-hoc analysis performed by the trial sponsor, IPRO demonstrated its value as an early endpoint in the trial, which compared treatments in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). The IPRO AI model automatically analyzed approximately 10,000 radiology scans, generating prognostic outcome measures for each patient at baseline and on-treatment assessments. IPRO Response was defined as a ≥50% improvement in the IPRO-α score relative to baseline, and the treatment effect was estimated as the IPRO Response Rate ratio for the investigational treatment versus control arm treatment at landmark early imaging assessments.

Key findings include:

IPRO Response Rate favored the investigational treatment beginning at Week 16 (IPRO Response Rate Ratio, 1.33; 95% CI, 1.03-1.71) and throughout subsequent time points, while ORR failed to anticipate the significant OS benefit throughout.
When evaluating pooled, patient-level IPRO trajectories over time, IPRO deterioration was consistently associated with OS detriment, while IPRO improvement was consistently associated with OS benefit.
IPRO scores for the entire trial were generated automatically from routinely acquired CT imaging, providing an objective, reproducible measure of efficacy.
"This readout proves that AI can anticipate meaningful clinical benefit that traditional imaging endpoints like ORR may fail to detect," said Felix Baldauf-Lenschen, Founder and CEO of Altis Labs. "We’re focused on supporting our biopharma partners and ultimately patients by bringing this level of precision into clinical trials so that efficacy can be detected earlier."

The results were presented on September 13th, 2026, at WCLC, Abstract/Poster: P1.046: IPRO-a Response Rate as a Potential Early Endpoint for Overall Survival in MARIPOSA, a Phase 3 Trial in EGFR-Mutated NSCLC. Abstract can be viewed at: View Source

(Press release, Altis Labs, SEP 17, 2026, View Source [SID1234670935])

On September 17, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the initiation of its ALISertib in CAncer (ALISCA-Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757) of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The ALISCA-Lung2 trial is a sequential dose escalation study that will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy.

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The primary endpoint of the trial is the safety and tolerability of alisertib when administered with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival. Puma will also evaluate clinical biomarkers to help identify which patients have the greatest benefit to guide the future development of alisertib.

Taofeek K. Owonikoko, MD, PhD and Chair of the trial’s Steering Committee, said, "Treatment options for patients with small cell lung cancer that has progressed following platinum-based chemotherapy and immunotherapy remain limited, and there is an urgent need for new treatment approaches for these patients. I am pleased to see further evaluation of alisertib in these patients." Dr. Owonikoko is the Executive Director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, and the Kevin J. Cullen, MD Distinguished Professor of Oncology at the University of Maryland School of Medicine. He added, "The results from previous clinical trials of alisertib in small cell lung cancer, including those in combination with paclitaxel, suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib."

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, "We are pleased to initiate this Phase II trial, and we hope that the study will provide important insight into the safety and clinical activity of alisertib in combination with paclitaxel in patients with small cell lung cancer. We are continuing to advance alisertib monotherapy in the ALISCA-Lung1 trial as well, and we view the ALISCA-Lung2 trial as additive to the clinical development of alisertib in small cell lung cancer. We look forward to the progress of both the ALISCA-Lung1 and ALISCA-Lung2 trials, as well as our other ongoing clinical programs, in the months ahead."

(Press release, Puma Biotechnology, SEP 17, 2026, View Source [SID1234670934])

On September 17, 2026 WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, reported an out-licensing collaboration with Ona Therapeutics on WuXi XDC’s proprietary WuXiTecan-2 payload-linker technology platform. Ona Therapeutics is a global biotechnology company pioneering first-in-class ADCs to address treatment-resistant cancers.

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Under the terms of the agreement, WuXi XDC will grant Ona Therapeutics an exclusive global license to its proprietary WuXiTecan-2 payload-linker technology for the development of an ADC candidate against a single target. Ona Therapeutics will combine its first-in-class target discovery capabilities with the WuXiTecan-2 platform. The total potential deal value includes an upfront payment, and certain development, regulatory, and sales milestone payments. Additionally, WuXi XDC will be eligible to receive tiered royalties on net sales upon commercialization of the resulting ADC product. WuXi XDC will provide comprehensive chemistry, manufacturing and controls (CMC) development and manufacturing support through its integrated ADC CRDMO platform.

This collaboration marks the second partnership between Ona Therapeutics and WuXi XDC in the ADC field. Building on their 2024 collaboration, in which Ona Therapeutics licensed technologies to support its ADC pipeline, the agreement reflects the continued strategic relationship between the two companies and Ona Therapeutics’ confidence in the commercial value and global competitiveness of WuXi XDC’s proprietary technology platforms.

Jimmy Li, Ph.D., CEO of WuXi XDC, stated: "We are truly honored to join forces once again with Ona Therapeutics. As an innovative biotech company focused on first-in-class targets, Ona’s deep insights into novel targets are highly complementary to WuXi XDC’s leading ADC technology platforms. With its hydrophilic linker delivering significantly enhanced ADC stability, the WuXiTecan‑2 platform has completed two out-licensing deals within just six months. This collaboration not only further validates the value of our WuXiTecan‑2 platform but also reaffirms WuXi XDC’s commitment to empowering innovative biotech companies worldwide. Through our integrated, end-to-end CRDMO platform, we look forward to fully supporting Ona Therapeutics in accelerating this first-in-class ADC candidate into the clinic, bringing new treatment options to patients."

Valerie Vanhooren, Ph.D., Co-founder and CEO of Ona Therapeutics, commented: "Partnering again with WuXi XDC and applying its WuXiTecan-2 payload-linker technology to our first-in-class ADC candidate represents an important step in advancing our pipeline. Our previous collaboration established a strong foundation, and we are pleased to build on that relationship as we work to accelerate this promising program toward the clinic with the aim of making a meaningful difference for patients with cancer."

(Press release, Ona Therapeutics, SEP 17, 2026, View Source [SID1234670933])