On March 19, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it launched "LUNSUMIO for intravenous infusion 1 mg" and "LUNSUMIO for intravenous infusion 30 mg" (generic name: mosunetuzumab (genetical recombination)) (hereafter, LUNSUMIO), antineoplastic agent / anti-CD20/CD3 humanized bispecific antibody for the treatment of patients with relapsed or refractory follicular lymphoma who have received two or more prior standard therapies (Press release, Chugai, MAR 19, 2025, View Source [SID1234651225]). LUNSUMIO had been approved by the Ministry of Health, Labour and Welfare (MHLW) on December 27, 2024 and was listed on the national health insurance (NHI) reimbursement price list today.

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"Relapsed or refractory follicular lymphoma is a difficult-to-cure disease that repeatedly relapses, and therefore there was a need for new treatment options. LUNSUMIO is expected to provide durable remission with monotherapy, and with a predetermined treatment duration based on each patient’s response to therapy, which can help reduce the burden of treatment on patients. We will strive to promote proper use in order to deliver new value to patients, their families, and healthcare professionals," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results of a Japanese Phase I study with an expansion cohort (FLMOON-1 study) conducted in patients with relapsed or refractory follicular lymphoma who had received two or more prior standard therapies, as well as an overseas Phase I/II clinical trial conducted by Roche in the same patient population. In both studies, the efficacy and safety of this drug were evaluated as a monotherapy. Furthermore, four-year follow-up data from the overseas Phase I/II clinical trial was presented at the 66th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Approval Information

Product name: "LUNSUMIO for intravenous infusion 1 mg" and "LUNSUMIO for intravenous infusion 30 mg"

Generic name: mosunetuzumab (genetical recombination)

Indications: relapsed or refractory follicular lymphoma

Precautions concerning indications:

Treatment with this drug should be targeted at patients who have failed to respond to or have relapsed after two or more standard therapies, including an anti-CD20 monoclonal antibody product.
This drug should be administered to patients diagnosed with Grade 1-3A by a pathologist with sufficient experience.
Dosage and administration:
For adults, the usual dosage of mosunetuzumab (genetically modified) is administered as an intravenous infusion in 21-day cycles as follows:
Cycle 1: 1 mg on Day 1, 2 mg on Day 8, and 60 mg on Day 15
Cycle 2: 60 mg on Day 1
Cycles 3-8: 30 mg on Day 1 of each cycle
After 8 cycles, treatment should be discontinued for patients who achieve a complete response. For patients with stable disease or partial response, treatment may be continued for up to a total of 17 cycles.

Date of approval: December 27, 2024

Date of NHI reimbursement price listing: March 19, 2025

Date of launch: March 19, 2025

Drug price:
LUNSUMIO for intravenous infusion 1 mg　　JPY 83,717 / bottle
LUNSUMIO for intravenous infusion 30 mg　 JPY 2,393,055 / bottle

Reference

Chugai Obtains Regulatory Approval for "LUNSUMIO for Intravenous Infusion" for Relapsed or Refractory Follicular Lymphoma in Japan (Press release December 27, 2024)
View Source

About LUNSUMIO

LUNSUMIO is a CD20/CD3 T cell-engaging bispecific antibody designed to target CD20 on B cells and CD3 on T cells. LUNSUMIO is expected to activate the immune system through cytotoxic T cells and have antitumor effects on CD20 expressing tumor cells. LUNSUMIO has been approved in 61 countries worldwide. LUNSUMIO is currently being developed for the treatment of follicular lymphoma (second-line treatment and previously untreated) and relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma.

About follicular lymphoma

Follicular lymphoma is a type of lymphoma that occurs when B lymphocytes, a type of white blood cell, become cancerous. At diagnosis, 70-85% of patients reach an advanced stage1. Generally, the progression is slow, and chemotherapy is initially effective, but recurrences occur repeatedly in many cases. Repeated recurrences can make it difficult for existing treatments to be effective, and new highly effective treatments are needed. In Japan, approximately 9,000 people reportedly become afflicted with follicular lymphoma each year.

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.