CellFiber and Tidewave Bio Enter Collaboration to Evaluate Scalable 3D Manufacturing for Next-Generation Solid Tumor Immunotherapy

On August 5, 2026 CellFiber Co., Ltd. ("CellFiber"), a Tokyo-based biotechnology company built on its proprietary CellFiber cell encapsulation platform, and Tidewave Bio ("Tidewave"), a Los Angeles-based biotechnology company developing a universal, off-the-shelf immunotherapy platform for solid tumors, reported a collaboration to evaluate CellFiber’s closed, automated 3D cell culture platform in support of the scalable manufacturing of Tidewave’s next-generation cell immunotherapy.

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Under the collaboration, the parties have agreed to undertake a joint proof-of-concept evaluation comparing conventional planar (2D) cell culture against CellFiber’s encapsulation (3D) approach for the expansion and differentiation of immune cells relevant to Tidewave’s allogeneic platform. The work, to be conducted at CellFiber’s facility in Tokyo, is designed to generate process performance data that will drive Tidewave’s manufacturing strategy as the program advances, while demonstrating the applicability of the CellFiber platform to off-the-shelf solid tumor immunotherapy manufacturing. Any further activities beyond the proof-of-concept evaluation will be subject to separate written agreement between the parties.

"Tidewave Bio’s mission is to make next-generation cancer immunotherapy accessible to every solid tumor patient, regardless of tumor type, treatment setting, or geography," said Francois Binette, Chief Executive Officer of Tidewave Bio. "Delivering on that mission requires manufacturing approaches that can scale efficiently, reliably, and cost-effectively. We are pleased to partner with CellFiber to evaluate how their innovative encapsulation platform can support our process development strategy as we advance toward the clinic."

"Tidewave Bio is pursuing a genuinely differentiated approach to solid tumor immunotherapy, and we are excited to support their program," said Dr. Kazuchika Furuishi, Representative Director and Chief Executive Officer of CellFiber. "Our CellFiber platform was designed to remove the manufacturing bottlenecks that have historically constrained cell therapy scale-up. This collaboration is an opportunity to demonstrate the value our closed, automated 3D culture system can bring to the next generation of off-the-shelf cell therapies, and to advance our shared vision of making these therapies more widely accessible to patients."

(Press release, Tidewave Bio, AUG 5, 2026, View Source [SID1234669762])

Kymera Therapeutics Announces Second Quarter 2026 Financial Results and Provides a Business Update

On August 5, 2026 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, reported financial results for the second quarter ended June 30, 2026, and provided business highlights and updates on its pipeline.

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"Kymera is delivering in a pivotal period of execution, with multiple clinical-stage programs advancing, important data catalysts ahead, and growing conviction in the potential of oral degrader medicines to transform the standard of care for chronic, debilitating immunological diseases," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "The rapid completion of enrollment in our KT-621 BROADEN2 Phase 2b trial in atopic dermatitis nearly six months ahead of our original timeline is a powerful example of the immense interest from clinicians and patients in a once-daily oral therapy and excellent execution from the Kymera team. The accelerated timeline enables us to pull forward our expected topline readout to year-end 2026, positions us for an earlier than anticipated start to Phase 3 trials next year, and ultimately allows us to move faster for patients who are waiting for new options."

Dr. Mainolfi continued, "We see the significant gaps that remain across the immunology treatment landscape, and we are hearing directly from clinicians, advocacy groups, patients and their families about the need for effective, safe, and convenient approaches. We remain focused on executing across our differentiated portfolio to address those needs. With KT-621 advancing in both AD and asthma, KT-579 progressing toward Phase 1 data and a planned patient proof-of-concept trial in lupus, and important progress across our partnered programs and early discovery engine, we are translating that urgency into action as we work to deliver a new generation of oral medicines."

Business Highlights, Recent Developments and Upcoming Milestones

STAT6 Degrader Program

KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation. KT-621 is currently in Phase 2 clinical development in atopic dermatitis (AD) and asthma. KT-621 has the potential to transform treatment for more than 140 million patients around the world suffering from Type 2 diseases such as atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), prurigo nodularis (PN), and bullous pemphigoid (BP), among others.

In June 2026, the Company announced the completion of enrollment in the KT-621 BROADEN2 Phase 2b clinical trial in patients with moderate to severe atopic dermatitis nearly six months ahead of its original timeline. The earlier than expected completion of enrollment enabled the Company to accelerate its expected topline data readout by six months to year-end 2026, earlier than prior guidance to share data by mid-2027. Subject to discussions with regulators, the Company expects to initiate Phase 3 trials in AD by mid-2027.

Enrollment is ongoing in the KT-621 BREADTH Phase 2b clinical trial in patients with moderate to severe eosinophilic asthma. The Company expects to report data in late 2027.

In June 2026 at the Japanese Dermatological Association (JDA) Annual Meeting, the Company presented results from the KT-621 Phase 1 study in healthy Japanese adults designed to support the enrollment of patients in Japan in global KT-621 studies. KT-621 demonstrated a favorable PK profile, rapid and sustained STAT6 degradation in blood, with median STAT6 degradation of ≥98% at both dose levels, and a favorable safety and tolerability profile. These results are consistent with those observed in non-Japanese healthy adults and atopic dermatitis patients.

The Company presented data from the KT-621 Phase 1 clinical trials across leading dermatology and respiratory forums, including a late-breaking oral presentation at the Society for Investigative Dermatology (SID) Annual Meeting, an oral presentation at the American Thoracic Society (ATS) Respiratory Innovation Summit, and poster presentations at the Revolutionizing Atopic Dermatitis (RAD) and American Academy of Dermatology (AAD) Innovation Academy meetings.

IRF5 Degrader Program
KT-579 is an investigational, first-in-class, oral degrader of IRF5, a genetically validated transcription factor and master regulator of immunity, that is currently in Phase 1 testing. KT-579 has the potential to be the first novel mechanism with broad utility in diseases where effective and well tolerated oral therapies are needed, such as lupus, Sjögren’s, inflammatory bowel disease (IBD), rheumatoid arthritis (RA) and others.

Enrollment is ongoing in the KT-579 Phase 1 clinical trial in healthy volunteers, with data expected in the fourth quarter of 2026. The Company plans to initiate a Phase 1b patient proof-of-concept trial in lupus soon after the completion of the healthy volunteer trial.

The Company presented new preclinical data for KT-579 at the European Alliance of Associations for Rheumatology (EULAR) and Federation of Clinical Immunology Societies (FOCIS) Annual Meetings that demonstrated consistent disease-modifying activity across multiple preclinical lupus models. The Company also presented IBD data at Digestive Disease Week (DDW), where KT-579 demonstrated activity comparable or superior to clinically relevant comparators in a preclinical IBD model.

Partnered Programs

In June 2026, under its existing collaboration, Sanofi initiated the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral, potent and selective second generation IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa patients. Under the terms of the collaboration, dosing of the first participant resulted in a $20 million milestone payment to Kymera. KT-485 has the potential to offer a novel oral approach for a variety of chronic immuno-inflammatory diseases. Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program.

In April 2026, the Company announced that Gilead Sciences exercised its option to exclusively license KT-200, a first-in-class, oral CDK2 molecular glue degrader development candidate discovered and characterized by Kymera. As a result, Kymera achieved a $45 million milestone payment. KT-200 has the potential to deliver meaningful improvements in the standard of care for patients with breast cancer and other solid tumors. Gilead intends to progress the program into IND-enabling studies to support an IND filing in 2027.

Research

Leveraging its unique target selection strategy, proven small molecule discovery capabilities, and deep development expertise, the Company continues to advance an early pipeline of novel oral programs with a goal to deliver at least one new development candidate per year.

Corporate

In June 2026, the Company announced the appointment of Felix J. Baker, PhD, as Chairman of the Board of Directors. Dr. Baker succeeds Bruce Booth, DPhil, who has served as Chairman since co-founding Kymera in 2016 and will remain an Independent Director.

In July 2026, the Company appointed Terence Rooney, MD, as Chief Medical Officer. Dr. Rooney is an accomplished drug development leader with extensive experience advancing immunology therapies across the full development lifecycle, from early clinical stage through commercialization and franchise expansion. Dr. Rooney will lead Kymera’s global clinical development strategy and guide the advancement of the Company’s oral immunology portfolio. He succeeds Jared Gollob, MD, who retired from his role after eight years of leadership at the Company and will remain as an advisor through the end of the year.

The Company further strengthened its leadership team with the two important appointments further positioning Kymera to advance its clinical-stage pipeline through its next phase of development and growth. Penny Carlson joined as Senior Vice President, Development Operations, to oversee global clinical development operations. Elizabeth Laws, PhD, joined as Senior Vice President, Development Program Leader, to lead the strategy and global development of KT-621 and the STAT6 franchise.

Financial Results

Collaboration Revenues: Collaboration revenues were $65.0 million for the second quarter of 2026 compared to $11.5 million for the second quarter of 2025. Collaboration revenues recognized in the second quarter of 2026 consisted of a $45 million option exercise fee related to the Company’s collaboration with Gilead Sciences and a $20 million milestone payment related to the Company’s collaboration with Sanofi. Both payments were earned and fully recognized as revenue in the second quarter of 2026. The Company received the $45 million option exercise fee during the second quarter and received the $20 million milestone payment during the third quarter. Collaboration revenues recognized in the second quarter of 2025 were all attributable to the Company’s collaboration with Sanofi.

Research and Development Expenses: Research and development expenses were $119.5 million for the second quarter of 2026 compared to $78.4 million for the second quarter of 2025. This increase was primarily due to increased expenses related to the investment in the Company’s STAT6 program, platform and discovery programs, as well as costs related to continued growth in the research and development organization. Stock based compensation expenses included in R&D were $10.4 million and $8.0 million for the second quarters of 2026 and 2025, respectively.

General and Administrative Expenses: General and administrative expenses were $21.1 million for the second quarter of 2026 compared to $17.6 million for the second quarter of 2025. The increase was primarily due to an increase in legal and professional service fees in support of the Company’s growth and an increase in personnel, facility, occupancy, and other expenses to support growth as a public company. Stock based compensation expenses included in G&A were $8.6 million and $7.4 million for the second quarters of 2026 and 2025, respectively.

Net Loss: Net loss was $61.2 million for the second quarter of 2026 compared to $76.6 million for the second quarter of 2025.

Cash and Cash Equivalents: As of June 30, 2026, Kymera had $1.5 billion in cash, cash equivalents and investments. Kymera expects that its cash balance will provide the Company with a cash runway into 2029 beyond multiple clinical inflection points in its pipeline.

Event Details

Kymera will host a video conference call today, August 5, 2026, at 8:30 a.m. ET. To join the call please use this link to register. A live webcast of the event will be available under News and Events in the Investors section of the Company’s website at www.kymeratx.com. A replay of the webcast will be archived and available following the event.

(Press release, Kymera Therapeutics, AUG 5, 2026, View Source [SID1234669761])

Telix to Host R&D Day in New York City on September 22, 2026

On August 5, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that it will host a Research and Development (R&D) Day on Tuesday, September 22, 2026, from 8:30 a.m. to 12:30 p.m. EDT in New York City.

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Institutional investors and analysts are invited to register to attend the in-person session, which will feature a comprehensive overview of Telix’s therapeutic and precision medicine pipeline, as well as key scientific, clinical and strategic developments across the portfolio.

Members of the Telix leadership team will present at the event, including Managing Director and Group CEO, Dr. Christian Behrenbruch; Group Chief Medical Officer, Dr. David N. Cade; CEO Therapeutics, Richard Valeix; CEO Precision Medicine, Kevin Richardson and Vice President Discovery Sciences, Dr. Michael Wheatcroft. The program will also feature presentations from key opinion leaders who will provide their perspectives on the clinical and scientific opportunities.

Advance registration is required for in-person attendance. Additional event details, including the venue, agenda and presentation materials, will be provided to registered attendees.

To RSVP or inquire about the R&D Day, please contact [email protected] or [email protected].

Capital Markets Day to be hosted in Melbourne on November 4, 2026 – Save the Date

Telix will also host a Capital Markets Day in Melbourne on Wednesday, November 4, 2026. Telix management will provide updates on the Company’s strategy, growth outlook, financial targets and key business priorities. Further details will be provided in a separate announcement.

(Press release, Telix Pharmaceuticals, AUG 5, 2026, View Source [SID1234669760])

Acrivon Advances ACR-2316, a Potential First-in-Class WEE1/PKMYT1 Inhibitor, into Randomized Dose Expansion in its Ongoing Phase 1/2 Study

On August 5, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported that ACR-2316 has advanced into the randomized dose expansion portion of its ongoing Phase 1/2 study. The advancement is supported by the differentiated favorable safety profile and clinical activity observed during dose escalation, including tumor shrinkage and partial responses (PRs) with durable clinical benefit in multiple subjects. Acrivon has selected 120 mg and 160 mg administered orally once daily (QD) on a 3d on/4d off weekly schedule for further dose optimization and final dose selection.

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"Advancing ACR-2316 into dose expansion is an important milestone for Acrivon, and the exciting initial clinical activity observed represents further clinical validation of our AP3 platform," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "We rationally designed ACR-2316 using AP3 to overcome the resistance mechanisms that limit efficacy of single-target WEE1 and PKMYT1 inhibition, hence enabling potent tumor cell death. We are highly encouraged by the durable single-agent activity, including tumor shrinkage and PRs, and clinical benefit observed for more than a year in multiple heavily pretreated subjects with lung cancer. These data support our belief that ACR-2316 has the potential to become an important therapy across multiple high unmet need patient populations."

"ACR-2316 has demonstrated a favorable safety profile in dose escalation, with adverse events limited primarily to transient, mechanism-based hematological events, mainly neutropenia, and a notable absence of non-hematological adverse events," said Mansoor Raza Mirza, M.D., chief medical officer of Acrivon. "This promising differentiated safety profile and initial clinical activity support its rapid advancement into a randomized expansion phase, to establish the dose with the optimal benefit-risk profile to carry into subsequent development."

ACR-2316 Dose Escalation Data and Observations To Date

Two weekly (3d on / 4d off QD and 2d on / 5d off QD) oral dosing regimens have been established, while a bi-weekly (3d on / 11d off QD) oral dosing regimen was evaluated, but deprioritized.
A total of 35 subjects received ACR-2316 across 6 dose levels ranging from 30 to 240 mg QD in the two weekly oral dosing schedules.
Amongst the subjects treated with ACR-2316 at ≥120 mg QD in the weekly schedules, tumor shrinkage with long-lasting clinical benefit were observed across multiple tumor types, including PRs in lung cancer and endometrial cancer.
In the 7 efficacy-evaluable subjects (median 3 prior lines of systemic therapy) with SCLC, sqNSCLC, and adNSCLC, AP3-predicted tumor types not previously shown to be sensitive to clinical single agent WEE1 or PKMYT1 inhibitors, a disease control rate of 86% (2 PRs, 4 SD, and 1 PD) was observed.
Ongoing durable clinical benefit observed in 3 heavily pretreated lung cancer subjects remaining on treatment for over one year.
In the selected 3d on / 4d off dosing regimen, the 120 mg QD and 160 mg QD doses were well tolerated, with a favorable, differentiated safety profile; no grade ≥4 treatment-related adverse events (TRAEs) were reported, and grade 3 TRAEs were limited to primarily transient, mechanism-based hematologic events, predominantly neutropenia.
These observations support further evaluation of ACR-2316 in the selected 3d on / 4d off QD regimen in a randomized dose expansion study of AP3-informed tumor types.

The dose expansion will evaluate ACR-2316 in subjects with SCLC, sqNSCLC and adNSCLC, as well as endometrial cancer, cervical cancer, and esophago-gastric junction carcinoma, all with AP3-identified biomarker signatures associated with pathway vulnerability, including loss or mutation of TP53 or FBXW7, or overexpression or amplification of CCNE1 or CCNB1, or HPV+ in the case of cervical cancer. The expansion utilizes a 3d on / 4d off weekly administration schedule and will include stratification by lung cancer versus non-lung cancer tumor types, with 1:1 randomization within each group to the 120 mg QD or 160 mg QD dose level. The two selected doses are candidate doses for final recommended phase 2 dose selection.

The ACR-2316 dose escalation and expansion study adheres to the principles of the FDA’s Project Optimus, which emphasize dose selection based on the totality of efficacy, safety, tolerability, pharmacokinetic and pharmacodynamic data, and specifically stipulate randomized evaluation of multiple doses rather than routine selection of the maximum tolerated dose. Acrivon expects to provide further updates as the study progresses.

(Press release, Acrivon Therapeutics, AUG 5, 2026, View Source [SID1234669759])

Context Therapeutics Reports Second Quarter 2026 Operating and Pipeline Progress

On August 5, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported its financial results for the second quarter ended June 30, 2026, and reported on recent and upcoming business highlights.

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"During the second quarter, we advanced our pipeline and reported interim Phase 1a data from CTIM-76 in a limited number of heavily pretreated patients with platinum-resistant ovarian cancer ("PROC") receiving weekly dosing," said Martin Lehr, Chief Executive Officer of Context. "These data demonstrated encouraging interim efficacy and safety findings. We intend to evaluate CTIM-76 with every-three-week ("Q3W") dosing in less heavily pretreated PROC patients in the second half of 2026, aiming to further characterize its clinical profile in a larger and more commercially relevant dataset."

Mr. Lehr added, "We also expect to dose the first patient in our Phase 1 clinical trial evaluating CT-202 in patients with Nectin-4-positive urothelial, colorectal, and triple-negative breast cancers in the third quarter of 2026, marking an important step in the clinical advancement of our Nectin-4 x CD3 TCE program."

Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs:

CTIM-76: CLDN6 x CD3 TCE

Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with PROC.

Recent Progress:

April 2026: The U.S. Food and Drug Administration granted Fast Track Designation for the treatment of PROC in patients that have received all standard of care therapies
June 2026: Presented interim Phase 1a safety, tolerability and efficacy data with weekly dosing in PROC patients
Upcoming Expected Milestones:

Q1 2027: Initiation of Phase 1b dose expansion trial
Q2 2027: Phase 1a initial safety, tolerability and efficacy data with Q3W dosing in PROC patients
CT-202: Nectin-4 x CD3 TCE

Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal, and triple-negative breast cancers.

Recent Progress:

April 2026: Human Research Ethics Committee approval and Clinical Trial Notification acknowledgement by the Australian Therapeutic Goods Administration to initiate a first-in-human Phase 1 clinical trial
May 2026: Entered into a License Agreement Amendment with BioAtla, Inc. removing all future milestones and royalty obligations owed
Upcoming Expected Milestones:

3Q 2026: First patient dosed in Phase 1 trial
2H 2027: Phase 1a initial topline safety, tolerability and early efficacy data
CT-95: MSLN x CD3 TCE

As part of a portfolio prioritization and capital allocation strategy, Context is discontinuing the development of CT-95 and will focus its development efforts on CTIM-76 and CT-202.

Second Quarter 2026 Financial Results

Cash and cash equivalents were $43.0 million at June 30, 2026, compared to $66.0 million at December 31, 2025. The Company expects its cash and cash equivalents will be sufficient to fund its operations into the fourth quarter of 2027.
Research and development ("R&D") expenses were $12.5 million for the second quarter of 2026, as compared to $7.8 million for the second quarter of 2025. The increase in R&D expenses compared to the second quarter was primarily driven by higher CT-202 expense of $4.4 million and higher CTIM-76 expense of $0.8 million. The increase in CT-202 expense was primarily a result of a higher in-process research and development charge of $6.5 million related to consideration paid to amend the BioAtla license agreement for CT-202, offset by lower contract manufacturing and preclinical expenses. These increases were partially offset by lower personnel-related costs of $0.5 million.
General and administrative expenses were $2.4 million for the second quarter of 2026, as compared to $1.9 million for the second quarter of 2025. The increase was primarily driven by higher professional fees of $0.3 million and an increase of $0.2 million in salaries and personnel-related costs, including share-based compensation as compared to the same period in 2025.
Other income was $0.4 million for the second quarter of 2026, as compared to $0.9 million for the second quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances.
Context reported a net loss of $14.6 million for the second quarter of 2026, as compared to $8.8 million for the second quarter of 2025.

(Press release, Context Therapeutics, AUG 5, 2026, View Source [SID1234669758])