On February 5, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) (TransCode), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers, in collaboration with Quantum Leap Healthcare Collaborative (Quantum Leap), reported the submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application amendment for a planned Phase 2a clinical trial with TransCode’s lead therapeutic candidate, TTX-MC138. The study will be conducted by Quantum Leap within their PRE-I-SPY program, a leading platform for innovative oncology clinical trials, and represents the program’s first expansion into colorectal cancer.

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As part of the PRE-I-SPY platform, the TTX-MC138 Phase 2a dose-expansion portion of the trial will enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have positive markers for circulating tumor DNA (ctDNA). Recent studies have demonstrated that ctDNA is a prognostic marker of cancer recurrence and may be indicative of the presence of minimal residual disease (MRD) that could be amenable to early interventions. The Phase 2a trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center. This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the MRD setting, where we believe the therapeutic intervention may have the greatest opportunity to improve long-term outcomes.

"This IND submission marks a pivotal step in TransCode’s clinical development program, positioning TTX-MC138 where its mechanism of action has the potential to deliver meaningful benefit to patients," said Sue Duggan, TransCode’s Senior VP, Operations. "We are pleased to partner with Quantum Leap’s PRE-I-SPY program to evaluate TTX-MC138 and to support the expansion of this platform into new indications such as colorectal cancer," added Duggan.

The clinical trial will be performed at several clinical sites of the PRE-I-SPY Platform Network, many of which are members of the National Cancer Center Network. Additionally, the program is focused on partnering with the Colorectal Cancer Alliance, a leading advocacy organization. Information on the PRE-I-SPY program and the Phase 2a trial can be found at clinicaltrials.gov (NCT05868226).

(Press release, TransCode Therapeutics, FEB 5, 2026, View Source [SID1234662512])

On February 5, 2026 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that Michael A. Metzger, Chief Executive Officer, will participate in a fireside chat at the 2026 Guggenheim Emerging Outlook: Biotech Summit on Thursday, February 12, 2026, at 12:30 p.m. ET.

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A live webcast of the fireside chat will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

(Press release, Syndax, FEB 5, 2026, View Source [SID1234662511])

On February 5, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will be participating in the following investor conferences in February:

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Guggenheim Emerging Outlook: Biotech Summit – Participating in a fireside chat on Thursday, February 12, 2026, at 10:30 a.m. ET. Management will also be participating in one-on-one meetings.

Citi’s 2026 Virtual Oncology Leadership Summit – Participating in a fireside chat on Wednesday, February 18, 2026, at 2:30 p.m. ET. Management will also be participating in one-on-one meetings.

Oppenheimer 36th Annual Healthcare Life Sciences – Participating in a fireside chat on Wednesday, February 25, 2026, at 12:00 p.m. ET. Management will also be participating in one-on-one meetings.

Webcasts of the fireside chat discussions will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the event.

(Press release, ORIC Pharmaceuticals, FEB 5, 2026, View Source [SID1234662510])

On February 5, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported new clinical data presented at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City.

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Orca-T with Reduced Intensity Conditioning

"Patients undergoing reduced intensity conditioning allogeneic stem cell transplantation often face a tradeoff between tolerability and long-term disease control," said Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center, and primary investigator on the SERENE-T Phase 2 study. "The clinical evidence being generated today, which suggests Orca-T may improve key outcomes by reducing GVHD without increasing infection risk or relapse rate, provides a strong foundation for our ongoing evaluation of Orca-T in this setting. The dosing of the first patients in the Phase 2 SERENE‑T study further strengthens this initial momentum, representing a meaningful step forward in expanding the investigation of Orca‑T for patients undergoing reduced intensity conditioning."

SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA). The first patients were treated this year at Vanderbilt University, UCLA and Oregon Health & Science University (OHSU) – Knight Cancer Institute. The study continues to enroll patients with plans to open at additional transplant centers across the U.S.

A new analysis compared outcomes from the single-center, open-label Phase 1 investigator-sponsored trial evaluating Orca-T versus a historical cohort of patients from the CIBMTR registry who received a conventional allogeneic hematopoietic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy). All patients were aged 60-75 (median 68 years), had a 7/8 or 8/8 human leukocyte antigen (HLA)-matched donor, and were given a RIC for the treatment of AML, acute lymphoblastic leukemia (ALL), MDS or myeloproliferative neoplasm (MPN).

Patients receiving Orca-T (n=53) compared with PTCy (n=587) demonstrated improved:

Overall survival at one year (OS; 88% vs 72%) and two years (84% vs 61%)
Relapse-free survival at one year (RFS; 82% vs 61%) and two years (79% vs 53%)
Graft-versus-host-disease relapse-free survival at one year (GRFS; 72% vs 54%) and two years (72% vs 45%)
Relapse rates at one and two years (9.7% vs 23%, 9.7% vs 30%) and non-relapse mortality at one and two years (NRM; 8% vs 16%, 12% vs 17%).
At one year, rates of Grade 3-4 acute and moderate-to-severe chronic graft versus host disease (aGVHD, cGVHD) were 0% and 10% with Orca-T, respectively, compared to 6% and 10% with PTCy. At two years, rates of cGVHD were 10% with Orca-T and 12% with PTCy.

Orca-T Versus PTCy in Patients with Myelodysplastic Syndromes

A post-hoc analysis of patients aged 18-65 with MDS compared pooled results from the Phase 3 Precision-T study and the Phase 1b study of Orca-T to a historical cohort from the CIBMTR registry of patients who received a conventional alloHSCT and PTCy in the myeloablative conditioning (MAC) HLA-matched setting. Patients with MDS who were treated with Orca-T (n=25) demonstrated higher one-, two- and three-year OS of 100% compared to the PTCy cohort (n=95) with 80%, 70% and 62%, respectively. At one year, the Orca-T arm showed RFS of 95% versus 64% with PTCy and NRM of 0% versus 9.9%, respectively. Notably, these trends were observed across subgroups including age and donor type.

A similar analysis was conducted across multiple hematologic malignancies, including MDS, AML and ALL with consistent results. In this post-hoc analysis, Orca-T (n=164) demonstrated higher OS compared to PTCy (n=380) at one, two and three years (94% vs 82%, 85% vs 73% and 82% vs 65%, respectively). At one year, RFS was 78% with Orca-T compared with 70% with PTCy, while NRM was 2.7% versus 7.7%, respectively. These findings were consistent with the results observed in a subgroup of patients over 50 years of age.

Reliable Manufacturing and Nationwide Distribution of Orca-T

A manufacturing and distribution analysis from the Phase 3 and Phase 1b Orca-T studies conducted between December 2019 and September 2024 reported on the production of 243 clinical cell therapies, including 215 from single-day and 28 from two-day collections. Overall, 100% of products were delivered to transplant centers across the U.S. within 70 hours, with 99% infused within 72 hours. Product quality was consistent across all three Orca-T components: hematopoietic stem cells, regulatory T-cells and conventional T-cells.

These results demonstrate the feasibility of reliably manufacturing and distributing Orca-T at scale while maintaining high product purity within a controlled logistics framework, supporting multicenter clinical studies and potential future commercial application.

"These data continue to reinforce the strength of Orca-T across both clinical outcomes and operational execution," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "The consistency of these results, along with our ability to reliably manufacture and deliver Orca-T across the U.S., highlights the potential of this therapy to make a meaningful difference for patients with hematologic malignancies. As we move toward a potential launch later this year, we remain focused on executing with the same level of commitment and rigor to support patients, clinicians and transplant centers."

Orca-Q for Patients with Haploidentical Donors

New findings from the ongoing Phase 1 study of Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, evaluated 39 patients with AML, ALL or MDS and a haploidentical donor who received MAC with Bu/Flu/Thiotepa (BFT), TBI/Flu/Thio (TFT) or TBI/Flu. All patients engrafted by Day +19 (median 11 days) and demonstrated encouraging rates of OS at one, two and three years (80%, 77% and 77%, respectively). Patients demonstrated RFS of 77% and GRFS of 72%, with low incidences of Grade 3-4 aGVHD at Day +180 and moderate-to-severe cGVHD at one year (8.1% and 0%, respectively). Outcomes were further improved in the TFT subgroup (n=14) across OS (85%), RFS (85%), GRFS (85%), aGVHD (0%) and cGVHD (0%).

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, FEB 5, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-presents-new-data-at-the-2026-tandem-meetings-of-astct-and-cibmtr-reinforcing-orca-t-as-a-durable-high-precision-cell-therapy-for-hematological-malignancies [SID1234662509])

On February 5, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported data demonstrating a best-in-class profile for commercial Amtagvi (lifileucel) with unprecedented response rates in a real-world clinical, retrospective study in patients with advanced (unresectable or metastatic) melanoma. Amtagvi is the first one-time T cell therapy for a solid tumor cancer as well as the only FDA-approved treatment for advanced melanoma patients previously treated with anti-PD-1 and targeted therapy, where applicable.

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The real-world results were highlighted in an oral presentation at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Salt Lake City, UT.

Forty-one evaluable patients with previously treated advanced melanoma received commercial Amtagvi according to the U.S. prescribing information at four authorized treatment centers. The physician-assessed confirmed objective response rate (ORR) was 44% (18/41) and the disease control rate was 73% (30/41). Response rates were higher with earlier Amtagvi treatment. The ORR was 52% (12/23) following two or fewer lines of therapy compared to an ORR of 33% (6/18) after three or more lines of therapy. The unprecedented real-world response rates also improved upon the 31% ORR in the C-144-01 clinical trial that supported the U.S. FDA accelerated approval of Amtagvi.

Lilit Karapetyan, MD, MS of H. Lee Moffitt Cancer Center & Research Institute stated, "The real-world response rate builds on existing clinical data and supports consideration of lifileucel as soon as possible after immune checkpoint inhibitor treatment. An overall response rate of 44% was observed in the full cohort, with a 52% response rate among patients treated in earlier lines of therapy. I am encouraged by the potential for an increasing number of patients to benefit as adoption of TIL therapy continues."

Daniel Kirby, Chief Commercial Officer of Iovance, stated, "The real world Amtagvi data with impressive response rates, paired with unprecedented five-year durability and survival data, demonstrate a best-in-class profile and better outcomes in patients treated earlier."

Previously treated advanced melanoma represents an unmet medical need with more than 8,000 annual U.S. deaths.1 More than half of patients treated with first line standard of care will progress within 12 months.2 The U.S. FDA granted accelerated approval for Amtagvi in February 2024 based on ORR and duration of response (DOR) from the C-144-01 clinical trial. The published final five-year analysis demonstrated unprecedented durability and follow-up in previously treated advanced melanoma patients, with ~31% ORR, median DOR of 36+ months, and a 20% five-year overall survival.3 Iovance is conducting TILVANCE-301, a Phase 3 clinical trial in frontline advanced melanoma, to confirm clinical benefit.

1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates. View Source (accessed February 2026)
2. Larkin J, et al. NEJM; Robert C, et al. Lancet; Tawbi HA, et al. NEJM
3. Medina T, et al. JCO

About Amtagvi

Amtagvi is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

Amtagvi is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of Amtagvi is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Important Safety Information

What is the most important information that I should know about Amtagvi?

You will likely be in a hospital prior to and after receiving Amtagvi.

Before taking Amtagvi, tell your healthcare provider about all of your medical conditions, including if you:

Have any lung, heart, liver or kidney problems
Have low blood pressure
Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
Are pregnant, think you may be pregnant, or plan to become pregnant
Are breastfeeding
Notice the symptoms of your cancer are getting worse
Have had a vaccination in the past 28 days or plan to have one in the next few months
Have been taking a blood thinner
Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Amtagvi?

Amtagvi is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
Your tumor tissue is sent to a manufacturing center to make Amtagvi. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until Amtagvi is available to be shipped back to your healthcare provider, but the time may vary. Your Amtagvi will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
After your Amtagvi arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
Approximately 30 to 60 minutes before you are given Amtagvi, you may be given other medicines including:
Medicines for an allergic reaction (anti-histamines)
Medicines for fever (such as acetaminophen)
Your Amtagvi will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for Amtagvi infusion, your healthcare provider will give Amtagvi to you by intravenous infusion. This usually takes less than 90 minutes.
After getting Amtagvi

Beginning 3 to 24 hours after Amtagvi is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the Amtagvi treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting Amtagvi. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of Amtagvi?

The most common side effects of the Amtagvi treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the Amtagvi treatment. Talk with your healthcare provider for more information about Amtagvi. You can ask your healthcare provider for information about Amtagvi that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-4682, or to the FDA, at 1-800-FDA-1088 or at View Source

Please see Full Prescribing Information and Patient Information, including Boxed Warning, for additional Important Safety Information.

(Press release, Iovance Biotherapeutics, FEB 5, 2026, View Source [SID1234662508])