On March 18, 2025, HCW Biologics Inc. (the "Company") and WY Biotech Co., Ltd. ("WY Biotech") reported to have agreed to amend their License, Research and Co-Development Agreement ("Agreement") dated November 17, 2024, due to a delay in WY Biotech coming to a definitive agreement with their designated contract development and manufacturing organization ("CDMO") (Filing, 8-K, HCW Biologics, MAR 18, 2025, View Source [SID1234651256]). Specifically, in order to accommodate that delay, the parties agreed to restructure the payment schedule for the $7.0 million upfront license fees, including delaying the initial $4.0 million portion thereof that was originally due on or about March 17, 2025, to reduce the performance milestones that the Company must complete in order to earn the full $7.0 million nonrefundable upfront payments in June 2025, and to provide that either party may terminate the Agreement if WY Biotech is not able to definitively engage its CDMO by June 2025. There were no other material changes to the Agreement, which involves the grant to WY Biotech of an exclusive, world-wide license to use and apply HCW11-006 for in vivo applications. In particular, the Company will retain the Opt-In Right thereunder, which gives the Company the option to assume all control and responsibility for the development, manufacture and commercialization of HCW11-006 for in vivo applications in the North America, South America, and Central America. The foregoing summary of certain terms of the Agreement and the referenced amendment does not purport to be complete.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 18, 2025 Sofinnova Partners, a leading European life sciences venture capital firm, in collaboration with Gustave Roussy, Europe’s leading cancer center, reported the creation of their first pioneering biotech company (Press release, Institut Gustave Roussy, MAR 18, 2025, View Source [SID1234651246]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Signadori Bio, developed with scientific founders Dr. Jean-Luc Perfettini and Professor Nathalie Chaput, is a breakthrough cell therapy platform focused on transforming cancer treatment. This milestone marks a significant achievement in their strategic partnership, aimed at accelerating biotech innovation through rigorous evaluation and development of scientific research.

Since the partnership’s inception in 2023, it has rigorously evaluated 50 promising projects. This has culminated in the creation of a groundbreaking biotech venture in the cell and gene space that is set to advance innovative approaches in oncology. More information will be released as the company comes out of stealth later this year. Additionally, several other promising projects are in the pipeline, showcasing the immense potential for future breakthroughs in cancer therapeutics.

"With cancer on the rise, particularly among younger populations, it’s critical that we fast-track the most promising scientific breakthroughs into tomorrow’s treatments. This partnership is a powerful example of how academia and investors can work together to drive innovation through new companies," said Professor Fabrice Barlesi, General Director of Gustave Roussy. "Gustave Roussy is at the forefront of cancer discovery. With Sofinnova’s expertise in company creation, we are now able to quickly translate these innovations into real-world therapies to benefit patients worldwide."

Matthieu Coutet, Partner at Sofinnova Partners and CEO of Signadori Bio, added: "Turning cutting-edge research into biotech success stories requires more than financing or scientific excellence—it demands the right ecosystem. By combining Gustave Roussy’s research power with Sofinnova’s proven ability to build and scale biotech ventures, we’re creating a direct path from lab to the clinic."

As these ventures progress, Sofinnova Partners and its academic collaborators remain committed to fostering the next generation of biotech companies and driving innovation in cancer therapeutics. This groundbreaking initiative, supported by Sofinnova’s Biovelocita II—a €165M biotech acceleration fund dedicated to identifying and developing cutting-edge scientific advancements from top institutes like Gustave Roussy. This effort is undertaken in close collaboration with the institute’s technology transfer office, Gustave Roussy Transfert.

On March 18, 2025 NeoGenomics, Inc. ("NeoGenomics" or the "Company") (NASDAQ:NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported that it has promoted Warren Stone, the Company’s current Chief Commercial Officer (CCO), to President & Chief Operating Officer, effective April 1, 2025 (Press release, NeoGenomics Laboratories, MAR 18, 2025, View Source [SID1234651245]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mr. Stone has over 25 years of general management and cross-functional commercial experience. In his expanded role, he will be responsible for driving the Company’s lab operations, data solutions division and enterprise operations functions, while maintaining his overall existing commercial responsibilities – including clinical, pharma, marketing and product management functions, and customer service initiatives. Melody Harris, the Company’s current Chief Operations Officer, will depart NeoGenomics at the end of May.

"Since joining NeoGenomics in November 2022, Warren has played an integral role in shaping the Company’s long-term growth strategy by instilling rigor and accountability throughout our commercial organization and advanced our critical business initiatives. This has resulted in eight consecutive quarters of double-digit revenue growth for the Clinical division and affirmed a leadership position in the cancer marketplace," said Chris Smith, CEO of NeoGenomics. "We are grateful to Melody for her many contributions to NeoGenomics and wish her the very best in her next endeavor."

"I am excited to continue working closely with Warren in his new role. The alignment of our commercial and operations teams increases agility and enables us to further leverage our portfolio and the selling channel, as we focus on driving innovation through research & development and business development opportunities," said Tony Zook, incoming CEO. "We have a strong leadership team in place with diverse and complementary skills and experience. Together, we look forward to accelerating our strategy to drive growth and profitability in line with our long-range plan while focusing on delivering an exceptional experience for patients and providers."

Beth Eastland, NeoGenomics’ Senior Vice President, Enterprise Sales, will support Mr. Stone in his new role and assume day-to-day responsibility for all enterprise sales functions. Prior to joining NeoGenomics in 2024, Ms. Eastland was employed by a leading oncology diagnostics provider and has over 35 years of commercial experience in healthcare.

On March 18, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), formerly known as Aadi Bioscience, Inc., an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments, reported it changed its name to Whitehawk Therapeutics, reflecting the Company’s evolution and focus on accelerating its portfolio of antibody drug conjugates (ADCs) with speed, agility and precision (Press release, Aadi Bioscience, MAR 18, 2025, View Source [SID1234651244]). The Company’s common stock will begin trading under the ticker "WHWK" effective March 19, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The three assets in the portfolio are in-licensed from WuXi Biologics and utilize HANGZHOU DAC’s advanced ADC technology platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The platform is coupled with clinically validated tumor targets that are upregulated in high-potential cancer indications, including lung and ovarian. These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors.

"Today marks a transformative moment as we reintroduce ourselves as Whitehawk Therapeutics – a focused oncology company combining science, strategy and execution to swiftly advance our portfolio of promising ADC assets," said David Lennon, President and CEO, Whitehawk Therapeutics. "By leveraging the foundation of well-established tumor biology and integrating cutting-edge technologies, our strategy is designed to address the challenges of treating the most difficult cancers efficiently and effectively. Our goal is to bring all three assets to IND in the next 15 months. Importantly, we believe our robust balance sheet will enable us to see these three assets through early clinical inflections. We are invigorated by the opportunity we have to overcome the limitations of first-generation ADCs to make a meaningful impact for patients."

Recent Operational Highlights:

All proposals were approved at the Company’s Special Meeting of Stockholders on February 28, 2025. Subsequently, the $100 million PIPE financing closed. The closing of the divestiture of Aadi Subsidiary, Inc. ("Aadi Sub") to Kaken Pharmaceuticals ("Kaken") is pending.

Aadi Bioscience divided into two organizations. Upon the divestiture of Aadi Sub to Kaken, Kaken will assume ownership of Aadi Sub, including the Aadi name, trademark and the FYARRO business. As of March 18, 2025, the Aadi parent company has become Whitehawk Therapeutics, with a focus on its portfolio of ADC assets.
Fourth Quarter and Full-year 2024 Financial Results:

Cash, cash equivalents and short-term investments as of December 31, 2024, were $47.2 million as compared to $108.8 million as of December 31, 2023.

Following closing of the strategic transactions, we expect to have cash and cash equivalents in the range of $170 million to $180 million, including the payment of the upfront and early milestones under the Wuxi ADC agreement.

Total revenue for the quarter ended December 31, 2024, was $7.2 million, and $26.0 million for the full-year ended December 31, 2024, resulting from sales of FYARRO.

Net loss for the three months ended December 31, 2024, was $18.3 million as compared to $16.3 million for the three months ended December 31, 2023. Net loss for the full-year ended December 31, 2024, was $63.7 million, as compared to $65.8 million for the same period in 2023.
About the ADC Portfolio

HWK-007 represents a differentiated opportunity to potentially be among the first next-wave ADCs in clinical development for high PTK7 expressing cancers. HWK-007 is being evaluated in IND-enabling studies. The Phase 1 trial is planned in non-small cell lung cancer and platinum resistant ovarian cancer, with potential to expand into novel indications (e.g. gastrointestinal, gynecological).

HWK-016 is the first ADC that targets the membrane-bound portion of MUC16, a glycoprotein often overexpressed in cancers of female origin. HWK-016 is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned in ovarian cancer, with potential to expand into additional indications (e.g. endometrial, cervical).

HWK-206 is designed to address the neuronal target, SEZ6, which is often overexpressed in cancers of neuroendocrine origin. HWK-206 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve internalization and effectiveness of the ADC. HWK-206 is currently in candidate selection. The Phase 1 trial is planned in small-cell lung cancer and neuroendocrine neoplasms, where there are limited treatment options.
Conference Call Information

The Whitehawk management team is hosting a conference call and webcast tomorrow at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the fourth quarter and full-year 2024.

Participants may access a live webcast of the call and the associated slide presentation on the "Investors & News" page of the Whitehawk Therapeutics website at whitehawktx.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On March 18, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported its 2024 Annual Results (Press release, Carsgen Therapeutics, MAR 18, 2025, View Source [SID1234651243]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Business Highlights

Zevor-cel was approved by China’s National Medical Products Administration (NMPA).
As of December 31, 2024, certification and filings for zevor-cel completed in 23 provinces or cities, covering over 200 healthcare institutes; CARsgen has received a total of 154 valid orders from its commercialization partner Huadong Medicine.
Satri-cel ST-01 confirmatory Phase II trial for gastric cancer in China: enrollment has been completed, and the study has met its primary endpoint. Satri-cel received BTD designation from CDE of China NMPA. CARsgen plans to submit a New Drug Application (NDA) to the China NMPA during the first half of 2025.
Results from the investigator-initiated trial (IIT) of satri-cel were published in Nature Medicine and at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.
The results of the IIT of an allogeneic BCMA-targeting CAR-T product CT0590, which deploys the THANK-uCAR technology platform, were presented at the 2024 ASH (Free ASH Whitepaper) Annual Meeting.
Developed THANK-u Plus platform as an enhanced version of THANK-uCAR allogeneic CAR-T platform. Multiple allogeneic CAR-T products in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases.
Introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland China.
Cash and bank balances were around RMB1,479 million as of December 31, 2024. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,080 million. Expect to have adequate cash into the 2028.
"In 2024, CARsgen achieved its first drug commercialization and made remarkable progresses in key pipeline products and technological innovations. Looking ahead, we will continue developing innovative CAR T-cell therapies to address the significant unmet medical needs," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.

Zevor-cel: Approved by the NMPA and Launched in China

Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA). On February 23, 2024, zevor-cel was approved by China’s NMPA for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent). CARsgen entered into a collaboration agreement with Huadong Medicine for the commercialization of zevor-cel in mainland China. As of December 31, 2024, certification and regulatory filings for zevor-cel have been completed in 23 provinces or cities, covering over 200 healthcare institutes and we have received a total of 154 valid orders from Huadong Medicine.

Updated results of the pivotal Phase II registrational trial of zevor-cel in China were reported as an oral presentation at the 29th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, and a subgroup analysis was presented a poster at the 66th ASH (Free ASH Whitepaper) annual congress. We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage.

Satri-cel: Confirmatory Phase II trial Met Primary Endpoint, Plans to Submit an NDA

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be first-in-class globally. Satri-cel targets Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Patient enrollment has been completed in confirmatory Phase II trial in China (NCT04581473) in advanced GC/GEJ. The study has met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) as assessed by the Independent Review Committee (IRC). Patients treated with satri-cel infusion achieved statistically significant improvement in PFS compared to those treated with physician’s choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Based on the confirmatory Phase II clinical data, satri-cel has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China NMPA.

CARsgen plans to submit an NDA to the NMPA in China during the first half of 2025. Satri-cel is expected to become the world’s first CAR-T therapy for solid tumors to be approved for market.

Updated results from the investigator-initiated trial (CT041-CG4006, NCT03874897) were published in Nature Medicine in June 2024 and presented orally at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2024. Additionally, more research findings have been published in prestigious academic journals such as the Journal of Clinical Oncology and the Journal for ImmunoTherapy of Cancer.

A Phase I clinical trial for PC adjuvant therapy (CT041-ST-05, NCT05911217), and an investigator-initiated trial for GC/GEJ adjuvant therapy (CT041-CG4010, NCT06857786) are ongoing in China.

Advancing the Development of Allogeneic CAR-T Products

In addition to autologous products, CARsgen has also been advancing differentiated allogeneic CAR T-cell products utilizing the proprietary THANK-uCAR platform. CARsgen has recently developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy.

The results of the IIT proof-of-concept study of an allogeneic BCMA-targeting CAR T-cell product candidate CT0590, which deploys the THANK-uCAR technology platform, were presented as a poster at the 66th ASH (Free ASH Whitepaper) Annual Meeting in December 2024. The data indicates that CT0590 has achieved a DoR of over 20 months in patients with sCR, with a peak CAR copy number exceeding 280,000 copies/µg gDNA, which is comparable to autologous BCMA CAR-T therapies, preliminarily demonstrating the durability of its efficacy.

In addition, there are several universal CAR-T products under development, covering areas such as hematologic malignancies, solid tumors, and autoimmune diseases:

CT059X: Targeting BCMA, for the treatment of R/R MM and R/R PCL. The first patient in the IIT achieved sCR at the Day-28 assessment.
KJ-C2219: Targeting CD19/CD20, for the treatment of B-cell malignancies, as well as SLE and SSc. The IITs are ongoing.
KJ-C2320: Targeting CD38, for the treatment of AML. The IIT is ongoing.
KJ-C2114: For the treatment of solid tumors.
KJ-C2526: Targeting NKG2DL, for the treatment of AML, other malignancies, and senescence.
On February 25, 2025, CARsgen announced reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) ("Zhuhai SB Xinchuang") to jointly invest in UCARsgen Biotech Limited ("UCARsgen"), to accelerate allogeneic CAR-T development in mainland China. Under the agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies. An investment fund managed by Zhuhai SB Xinchuang (currently undergoing registration and filing procedures) subscribed to the newly increased registered capital of UCARsgen for a consideration of RMB 80,000,000, thus retaining an 8% equity stake in the registered capital of UCARsgen upon completion of the transaction, equity stake of CARsgen Therapeutics in UCARsgen will be diluted from 100% to 92%.

Financial Highlights

The revenue was around RMB39.4 million for the year ended December 31, 2024 mainly from zevor-cel, in which was calculated on the basis of ex-works price, rather than end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Besides, the Company received a milestone payment of RMB75 million from Huadong Medicine for zevor-cel for the year ended December 31, 2024. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. The gross profit was around RMB14.8 million for the year ended December 31, 2024, with the selling and distribution expenses around RMB0.88 million. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch.

Cash and bank balances were around RMB1,479 million as of December 31, 2024. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,080 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows.