On January 8, 2026 Alessa Therapeutics ("Alessa"), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Enolen, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer.

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Fast Track designation is granted by the FDA to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

"Receiving Fast Track designation for Enolen is further evidence of the urgent need for new treatment options for early-stage prostate cancer. Patients living with prostate cancer deserve an alternative to active surveillance or being faced with the considerable negative side effects common with the more aggressive treatment options available today," said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. "We will continue to collaborate closely with the FDA to advance a new treatment option for men suffering not only from the disease itself, but who often face a heavy burden in deciding between not treating their cancer or pursuing therapies with significant health and lifestyle consequences."

Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the potential side effects of systemic anti-androgen and testosterone-lowering drugs, including sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events.

Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the potential negative side effects which can result from systemic exposure.

Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to present initial findings from the study in 2026.

(Press release, Alessa Therapeutics, JAN 8, 2026, View Source [SID1234661881])

On January 8, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported a corporate update and shared anticipated business highlights for 2026.

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"We have built strong momentum with CLN-978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Our CLN-049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH (Free ASH Whitepaper) 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of 2026. In summary, we are focused on generating multiple catalysts for our two high-priority T cell engager programs, CLN-978 and CLN-049, positioning us for a transformative year ahead."

Portfolio Highlights and Anticipated 2026 Milestones

Immunology

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CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
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OUTRACE RA
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Dose escalation is ongoing, and patients are currently being enrolled to the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
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In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
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In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
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OUTRACE SLE
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Dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
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In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, additional biomarker data, and preliminary clinical activity data.
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OUTRACE SjD
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The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
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In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.

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Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
o
In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

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CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study in H2 2026.
o
In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
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In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
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Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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In November 2025, Taiho initiated a rolling submission of an NDA seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in Q1 2026.
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Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
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Cullinan is eligible to receive up to $130 million in payments for U.S. regulatory milestones and a 50/50 profit share in the U.S.

Cash Position and Cash Runway

Unaudited preliminary cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Consistent with prior guidance, Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

The Company expects to report its fourth quarter and full-year 2025 financial results in late February 2026 which will contain additional information required for a more complete understanding of the Company’s financial position and results of operations as of and for the year ended December 31, 2025.

(Press release, Cullinan Oncology, JAN 8, 2026, View Source [SID1234661850])

On January 8, 2026 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported following approval at its 2025 Extraordinary General Shareholders’ Meeting, that Foresee Pharmaceuticals USA Inc., the Company’s fully-owned US subsidiary, has officially signed an exclusive global licensing agreement with Primevera Therapeutics, LLC (hereinafter referred to as "Primevera") for its MMP-12 inhibitor programs. The agreement includes FP-025, FP-020 and third-generation MMP-12 inhibitors currently in the drug discovery stage.

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In return, Foresee USA will receive an upfront payment of 10 million USD, future potential milestones of up to 574.5 million USD and tiered single-digit percentage royalties. [Should Primevera sublicense its rights under the Agreement, Foresee will be entitled to a tiered percentage of all proceeds received by Primevera as part of its sublicense agreements, in lieu of the milestones and royalties]. Furthermore, Foresee USA will hold a 19% equity interest in Primevera. This transaction will have a positive and material impact on boosting Foresee’s working capital and shareholder equity, while reducing R&D expenses and reinforcing financial stability, with a focus on near to mid-term profitability.

This strategic move marks a transformative milestone for Foresee, enabling the company to streamline operations and prioritizes its SIF (Stabilized Injectable Formulation) portfolio. Foresee is at a pivotal junction in its growth trajectory, and intends on building its revenue stream by concentrating resources on CAMCEVI, and its FP-001, 6-month long-acting injectable which has recently completed a successful pivotal P3 study in central precocious puberty patients (CPP), with an NDA submission targeted in 2026. The CAMCEVI six-month formulation has demonstrated stable sales in the U.S. and the three-month formulation, which holds broader commercial potential is expected to launch in Q4 2026. Foresee is also exploring its strategic options related to the future commercialization of FP-001 in CPP. Simultaneously, the agreement with Primevera allows Foresee to maintain significant upside in its NCE (New Chemical Entity) pipeline, while maximizing capital efficiency and working towards profitability.

Going forward, Primevera will assume all subsequent costs for the MMP-12 inhibitors. The development will focus on the following key programs:

FP-020: Preparing an Investigational New Drug (IND) application for a Phase II clinical trial in asthma, with submission to the U.S. FDA expected in early 2026.

FP-025: Preparing for future Phase II clinical trials in rare disease indications.

"Over the past decade Foresee has shown unwavering commitment to the discovery and development of MMP-12 inhibitors, which has allowed us to become recognized globally as a leader in this space. Our partnership with Primevera allows us to continue this mission in a more focused and streamlined way while we foster Foresee’s path to profitability and continue to build the SIF business-" Stated Dr. Ben Chien, PhD. Foresee’s Chairman and CEO.

(Press release, Foresee Pharmaceuticals, JAN 8, 2026, View Source [SID1234661866])

On January 8, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for A2B543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors. A2B543 contains a membrane-tethered IL-12 booster, designed to enhance potency and persistence of Tmod cells and address the immunosuppressive tumor microenvironment. It will be evaluated as a second arm of the EVEREST-2 master protocol (NCT06051695) in patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express mesothelin (MSLN) and have lost HLA-A*02 expression.

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"FDA clearance of our IND for A2B543 is an important milestone for A2 Bio. Our ability to launch four clinical programs in just four years highlights the adaptability and robustness of the Tmod platform and the promising clinical pipeline of Tmod-based cell therapies. We are committed to speeding the clinical development of our therapies to help patients with solid tumors who need new treatment options," said Jim Robinson, chief executive officer of A2 Bio.

A2 Bio continues to advance its clinical development of A2B694, A2B395, the BASECAMP-1 prescreening study, and other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod technology platform. The Tmod platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and beyond.

Enabling Efficient Patient Identification for A2 Bio Precision Medicine Studies

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.1,2

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

About A2B543

A2B543 is designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. A2B543 is comprised of autologous Tmod cells transduced with two lentiviral vectors: one expressing both the HLA-A*02-targeted blocker and the MSLN-targeted CAR activator; and a second expressing a membrane-tethered IL-12 (memIL-12) booster. The inducible memIL-12 booster, which activates only upon engagement with tumor antigens, is designed to reduce toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of Tmod.3

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added memIL-12 booster. The EVEREST-2 study is recruiting participants with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

(Press release, A2 Biotherapeutics, JAN 8, 2026, View Source [SID1234661882])

On January 8, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported a business update and anticipated milestones for 2026.

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"We are excited to build on our transformational progress at CytomX with Varseta-M and will be focused on advancing this novel, potential first-in-class ADC towards a registrational study in late-line CRC. Varseta-M was specifically designed to address a broad, unselected CRC patient population based on the universally high and uniform expression of EpCAM. The promising initial clinical activity we have presented to date in Phase 1 dose escalation underscore this potential. We look forward to providing CRC Phase 1 expansion data later this quarter," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Dr. McCarthy continued, "Given our highly encouraging start in late line CRC we aim to move rapidly towards a potentially registrational trial and advance Varseta-M into earlier lines of CRC treatment to maximize impact in this area of high unmet medical need. We also plan to capitalize on our platform leadership by progressing our broader pipeline of PROBODY Therapeutics, including our masked interferon-alpha-2b program, CX-801, in combination with KEYTRUDA in advanced melanoma."

Clinical Program Updates and 2026 Milestones:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

Varseta-M Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing with a focus on selecting a dose or doses for a potential registrational study in advanced CRC.
Total Phase 1 study enrollment is projected to reach approximately 100 patients by the planned Varseta-M Phase 1 update in Q1 2026.
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
A Phase 1 Varseta-M combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC.
Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026.
CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma. CX-801 monotherapy dose escalation has reached the fourth dose level.
CX-801 monotherapy has been well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.1
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
CX-801 monotherapy biomarker data in advanced melanoma patients were presented at the 2025 Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting that support CX-801’s mechanism of action and the ongoing combination study with KEYTRUDA (pembrolizumab).
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is anticipated by the end of 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

CytomX JP Morgan Healthcare Conference Presentation
Dr. Sean McCarthy will present at the JP Morgan Healthcare Conference on January 14, 2026, at 9 a.m. PST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source

(Press release, CytomX Therapeutics, JAN 8, 2026, View Source [SID1234661851])