On March 18, 2025 Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) reported that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.

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Ovarian cancer (OC) ranks as the third most common gynecologic malignancy in China and continues to show a rising incidence, with the highest mortality rate among all malignant gynecologic tumors. The standard treatment regimens recommended by authoritative guidelines both domestically and internationally include surgery combined with platinum-based chemotherapy and targeted therapy maintenance. However, about 80% of OC cases recur, and eventually progress to platinum-resistant ovarian cancer (PROC), leaving patients with limited effective treatment options and poor prognosis. Non-platinum chemotherapy, with or without bevacizumab, is the standard treatment for PROC. Previous studies have shown that the objective response rate (ORR) of PROC treated with non-platinum chemotherapy is only 10% to 15%. The median progression-free survival (PFS) is only 3 to 4 months, and the median overall survival (OS) approximately 12 months, highlighting an urgent need for new treatment options.

The grant of Breakthrough Therapy Designation is based on the pooled analysis of two clinical studies, JSKN003-101 and JSKN003-102. JSKN003-101 (NCT05494918) is an open-label, multicenter, dose-escalation Phase I clinical study conducted in Australia, enrolling patients with advanced solid tumors expressing HER2 (IHC≥1+) or with HER2 mutations. JSKN003-102 (NCT05744427) is a Phase I/ II study conducted in China. The Phase I part enrolled patients with histologically confirmed HER2 expression (IHC≥1+) or HER2 mutations advanced solid tumors. The Phase II part enrolled patients with advanced solid tumors regardless of HER2 expression or mutation status. Pooled results have demonstrated that JSKN003 monotherapy has a favorable tolerability and safety profile, with promising efficacy signals in patients with advanced PROC, and the efficacy was observed across patients with (IHC 1+/2+3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor. Preliminary data from the pooled analysis of these two studies were presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

The Phase III clinical study of JSKN003 for this indication is currently in the enrollment phase and the study is progressing smoothly. As a novel bispecific ADC, JSKN003 leverages the synergistic mechanism of enzyme catalysis and click chemistry to enhance serum stability and bystander effects, while demonstrating superior efficacy. The grant of Breakthrough Therapy Designation is expected to accelerate the clinical development, review and approval process of JSKN003, enabling more patients with PROC to benefit sooner.

About JSKN003

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC), or high HER2-expressing solid tumors.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, MAR 18, 2025, View Source [SID1234657003])

As previously disclosed in the Aptose Biosciences Inc.’s (the "Company") current report on Form 8-K filed August 30, 2024, the Company and Hanmi Pharmaceutical Co., Ltd. ("Hanmi") reported to have entered into a facility agreement on August 27, 2024 (the "Facility Agreement") whereby Hanmi agreed to loan certain amounts to the Company (the amounts loaned are referred to herein as the "Indebtedness Amount") (Filing, 8-K, Aptose Biosciences, MAR 24, 2025, View Source [SID1234651362]). On March 18, 2025, the Company entered into a debt conversion and interest payment agreement ("Debt Conversion Agreement") with Hanmi pursuant to which the Company and Hanmi agreed to convert $1,513,533.10 of the Indebtedness Amount, into 409,063 common shares (the "Conversion Shares") at $3.70 per share which is the average closing price of the Company’s common shares on Nasdaq for the five trading days immediately prior to entering into the Debt Conversion Agreement which such price being equal to Nasdaq’s "Minimum Price" as defined in Nasdaq’s Listing Rule 5635(d). The Company and Hanmi agreed that without prejudice with respect to interest payments owed to Hanmi as set forth in the Facility Agreement for the period commencing on December 21, 2024 and ending on March 31, 2025 (the "Interest Payments") that the Interest Payments may be made on before the final closing date of the Capital Raise (as defined in the Debt Conversion Agreement) and shall not be considered an event of default under the Facility Agreement is such interest payments are made no later than June 27, 2025. The Debt Conversion Agreement reiterated that failure to pay the Interest Payments would constitute an event of default under the Facility Agreement.

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The Debt Conversion Agreement also provides that additional conversions of Indebtedness Amount will be available in Hanmi’s discretion after the completion of the Capital Raise subject to certain additional conditions, including, but not limited to, Hanmi’s ownership threshold not exceeding 19.99%.

Investor’s Rights Agreement

In connection with the Debt Conversion Agreement, the Company and Hanmi entered into a Second Amended and Restated Investor’s Rights Agreement (the "Investor Rights Agreement"), which amends and restates the Amended and Restated Investor’s Rights Agreement entered by the parties on January 25, 2024. The Investor Rights Agreement provides, among other things, that Hanmi shall benefit from Rule 144 of the U.S. Securities Act of 1933, as amended ("Rule 144"), such as receiving from the Company a written statement that it has complied with the requirements of Rule 144 and other such information that may be reasonably requested by Hanmi so that it may sell its securities pursuant to Rule 144 without registration. So long as Hanmi owns at least 10% of the Company’s issued and outstanding common shares, Hanmi will have the right to designate for employment one or more individuals that are legally able to work in the United States or Canada (each, an "Hanmi Nominee") to a position or positions within the Company in applicable areas based on each Hanmi Nominee’s skills, education and experience. The parties agreed that the Hanmi Nominee shall be subject to the Company’s usual employment rules, practices, policies, evaluation procedures, as amended from time to time and the Company shall retain the right, in its sole discretion, to terminate such Hanmi Nominee’s appointment with the Company for violations of the Company’s employment rules, practices, policies and procedures. The parties also agreed that the Hanmi Nominee shall be entitled to salary, bonus, vacation, incentive payments and bonuses, expenses, allowances and any applicable benefits in amounts and to the extent consistent with employees of the Company serving or having recently served in a similar capacity with the Company with such amounts to be reimbursed to the Company by Hanmi. In the event that a visa or other permit is required to be obtained to permit the Hanmi Nominee to work in the United States or Canada the parties agreed that the Company would use its commercially reasonable efforts to assist the Hanmi Nominee with obtaining such visa or permit. The parties agreed that upon the nomination of the Hanmi Nominee that the parties would enter into a separate service agreement to outline the specific terms and conditions of the Hanmi Nominee’s appointment.

The Investor Rights Agreement also provides for customary demand and piggyback registration rights to Hanmi. Among other things, Hanmi is entitled to four (4) demand registrations where Hanmi can require the Company to register on a registration statement the common shares it has received in prior issuances, including pursuant to the Debt Conversion Agreement, and common shares issuable upon the exercise of the warrants under which Hanmi is entitled to purchase up to an additional 77,972 common shares. Hanmi was also granted piggyback registration rights where if the Company proposes to file a registration statement, Hanmi, at the Company’s own cost and expense can have such common shares included on that registration statement on the same term and conditions as any similar securities of the Company. Further, upon Hanmi’s request, the Company must provide inspection rights for Hanmi to access the Company’s books and records, and to the Company’s management to the extent that such access to management does not materially interfere with the operations of the Company.

The foregoing is only a summary of the Debt Conversion Agreement and Investor’s Rights Agreement, and does not purport to be complete descriptions. The summaries of the Debt Conversion Agreement and Investor’s Rights Agreement are qualified in their entirety by reference to the Debt Conversion Agreement and Investor’s Rights Agreement, which are attached hereto as Exhibit 10.1 and Exhibit 10.2 respectively, and are incorporated herein by reference.

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.

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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]).

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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]).

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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.