On June 19, 2026 Fapon Biopharma, a clinical-stage biotech company innovating therapeutic antibodies and fusion proteins, and MOTE Therapeutics, a preclinical-stage biotech company developing a novel targeted LNP delivery platform and in vivo CAR-T therapies, reported their participation in the BIO International Convention 2026, taking place June 22–25 at the San Diego Convention Center. Both companies are members of Fapon Group. They will present their dual-targeting (CD19×BCMA), dual-platform (TCE + in vivo CAR-T) franchise designed to achieve deep and durable B-cell depletion through complementary therapeutic modalities, with both assets advancing toward human trials in the next six months.

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The companies will exhibit at Booth 5435-2 in the Shanghai Pudong Pavilion, highlighting their complementary technology platforms, innovative pipeline across immuno-oncology and autoimmune diseases, and global partnership opportunities.

Two proprietary technology platforms serve as the engine behind this pipeline. Fapon Biopharma brings its proprietary VHH human-cynomolgus cross-binding T-cell engager platform, an innovative approach designed to overcome developability and therapeutic window constraints associated with traditional multi-specific immune cell engagers, featuring human-cynomolgus cross-reactivity, scalable GMP manufacturing with proven cell line development, and versatile molecular design. MOTE Therapeutics’ breakthrough mobilize targeted LNP (tLNP) platform is a next-generation in vivo gene delivery system that enables cell-specific targeted delivery and extrahepatic tissue distribution through a non-covalent, modular surface functionalization approach that requires no chemical conjugation.

The companies’ B-cell depletion franchise takes center stage at BIO 2026. This franchise features two differentiated programs targeting CD19 and BCMA, designed to deliver potent and sustained B-cell depletion: FPE024, a potential best-in-class CD19×BCMA×CD3 tri-specific T-cell engager for autoimmune indications, with IND filing targeted Q1 2027; and MTX001, a CD19×BCMA in vivo CAR-T program powered by the mobilize tLNP platform, with an investigator-initiated first-in-human study expected in Q4 2026.

In addition to the B-cell depletion franchise, the companies have built a robust pipeline spanning discovery, preclinical and clinical stages. Leading the clinical-stage pipeline is FP008, a global first-in-class PD1×IL10M fusion protein for immuno-oncology, currently in Phase I development with key readout anticipated in 2026. FP012 is a global first-in-class TL1A×IL10MM fusion protein for inflammatory bowel disease and other inflammatory and autoimmune indications. FPE021 is a potential best-in-class CDH17-targeting T-cell engager with a second co-stimulation signal for gastrointestinal tract cancers. Both FP012 and FPE021 are entering IND-enabling CMC/GLP toxicology in 2026.

Attendees interested in the science behind these programs can gain deeper insights during a dedicated company presentation, titled "Building a Dual-Targeting / Dual-Platform Franchise for B-Cell Immunotherapy" on Monday, June 22 at 4:30 PM PT in Room 3. The session will detail the technical design, development roadmap and commercial potential of the companies’ integrated dual-platform strategy for B-cell immunotherapy.

(Press release, Fapon Biopharma, JUN 19, 2026, View Source [SID1234668812])

On June 19, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of neurofibromatosis type 2 (NF2) for the anti-cancer agent/humanized anti-VEGF*1 monoclonal antibody Avastin Intravenous Infusion 100 mg/4 mL and 400 mg/16 mL [generic name: bevacizumab (genetical recombination)] (hereinafter, "Avastin"). Avastin is the first drug approved in the world for the treatment of this disease.

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"We are very pleased to deliver Avastin as the world’s first therapeutic drug for neurofibromatosis type 2 in Japan. NF2 is a rare disease that causes symptoms such as hearing loss and dizziness, significantly impacting patients’ daily lives, and there has been a strong need for effective treatment options. Avastin represents a new therapeutic option, suggesting potential for the maintenance or improvement of hearing and a trend toward tumor reduction. We will continue our efforts to promptly provide appropriate use information so that we can contribute to patient treatment and improvement in quality of life," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results from the investigator-initiated Japanese Phase II clinical study, the BeatNF2 study, which evaluated the efficacy and safety of Avastin in NF2.

Approval Information *Relevant sections only, with modifications underlined

Indications:
◯ Unresectable advanced or recurrent colorectal cancer
◯ Unresectable advanced or recurrent non-small cell lung cancer excluding squamous cell carcinoma
◯ Inoperable or recurrent breast cancer
◯ Malignant glioma
◯ Ovarian cancer
◯ Advanced or recurrent cervical cancer
◯ Unresectable hepatocellular carcinoma
◯ Neurofibromatosis type 2

Dosage and Administration:

The usual adult dosage is 5 mg/kg (body weight) of bevacizumab (genetical recombination) administered by intravenous infusion every two weeks.

[Reference Information]

Chugai Files for Additional Indication of Avastin for the Treatment of Neurofibromatosis Type 2 (News release dated September 24, 2025)
View Source

About the BeatNF2 study

The BeatNF2 study (FMU2019-01-NF2 study / jRCT2080224914) is an investigator-initiated, multicenter, domestic Phase II, placebo-controlled, double-blind, randomized clinical study conducted in Japan to evaluate the efficacy and safety of Avastin in patients with NF2, a rare hereditary disease. Twelve institutions in Japan, including Fukushima Medical University Hospital, participated in the study.
The study enrolled 62 patients. During the initial treatment period, Avastin or placebo was administered every two weeks through week 22. From week 24 to week 46, all patients received Avastin every two weeks. During the follow-up period, Avastin could be administered up to six times if the attending physician judged disease progression.
The primary endpoint, "the proportion of patients with improved hearing at 24 weeks after treatment initiation compared to baseline, based on the evaluation using maximum speech discrimination score*2," was 16.1% (5/31; 95% CI: 5.5-33.7) in the Avastin group and 3.2% (1/31; 95% CI: 0.1-16.7) in the placebo group, with no statistically significant difference (P = 0.0858). Meanwhile, improvement in hearing measures and a trend toward reduction in tumor volume, a secondary endpoint, were suggested during the treatment period. Regarding safety, adverse reactions were observed in 57.4% (35/61) of patients who received Avastin, and hypertension was the most common adverse reaction at 18.0% (11/61).

*1 VEGF：Vascular Endothelial Growth Factor
*2 Maximum speech discrimination score is an indicator of speech comprehension ability. It refers to the percentage of correct answers in a monosyllabic word recognition test at the volume level that yields the highest accuracy while adjusting sound intensity. The higher this value, the better one’s ability to accurately understand speech when sounds are audible. It also serves as a measure for evaluating the effectiveness of hearing aids.

About the Neurofibromatosis Type 2 (NF2)1

NF2 is an autosomal dominant hereditary disease characterized by bilateral acoustic nerve tumors (vestibular schwannomas). Symptoms associated with these tumors include hearing loss, dizziness, unsteadiness, and tinnitus. Additionally, symptoms related to spinal schwannomas may include numbness, sensory impairment, and weakness in the limbs.
Management of vestibular schwannomas includes observation, surgery, and radiation therapy. While these tumors are benign and may show minimal growth, surgical removal may be performed when symptoms develop or tumor growth is evident, which may affect long-term prognosis. Preservation of hearing through surgery is difficult, and there remains a risk of postoperative neurological complications.
According to overseas reports, NF2 is a rare disease with an incidence of approximately 1 in 25,000 to 60,000 individuals. In Japan, approximately 800 patients submitted clinical registry data between 2009 and 2013. Onset is most common in individuals in their teens to twenties.

About Avastin

Avastin is an antibody medicine that binds specifically to VEGF2, which plays an important role in angiogenesis essential for tumor growth and metastasis, thereby inhibiting its activity. In Japan, Avastin was launched in June 2007 and is positioned as one of the standard therapies in treatment guidelines for various cancers. It has been approved for seven indications: unresectable advanced or recurrent colorectal cancer, unresectable advanced or recurrent non-squamous non-small cell lung cancer, inoperable or recurrent breast cancer, malignant glioma, ovarian cancer, advanced or recurrent cervical cancer, and unresectable hepatocellular carcinoma.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JUN 19, 2026, View Source [SID1234668811])

On June 18, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by 9 February 2027.

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The sBLA acceptance is based on results from the phase III SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59% reduction in risk of disease progression or death (progression-free survival [PFS]) compared to MabThera/Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx) (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001) and a three-times longer median PFS at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1).1 The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines.1 The incidence of cytokine release syndrome events (CRS) in the Lunsumio VELO plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events.1

Updated data were presented recently at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, which showed that with longer follow-up, this treatment combination continued to demonstrate clinical benefit in PFS, particularly in the second-line setting, with no new safety signals.2,3

"Relapsed or refractory large B-cell lymphoma is an aggressive disease thereby representing one of the highest unmet needs in lymphoma care," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "If approved, this Lunsumio/Polivy combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting."

"When treating large B-cell lymphoma, the second-line setting represents a critical window where we must act quickly with effective therapies," said Tara M. Graff, DO, MS, Director of Clinical Research at Mission Cancer and Blood. "Current advanced therapies may present complex logistical and geographical barriers for many patients. Since most patients in the US are treated in the community setting, we need more chemotherapy-free, outpatient-ready treatments, like Lunsumio and Polivy."

LBCL, composed predominantly of DLBCL, is the most common type of non-Hodgkin lymphoma with more than 18,000 new diagnoses each year in the US.4 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.5,6 Because this stage of disease is time-sensitive, delays caused by referral requirements, inpatient coordination, or complex treatment logistics can have meaningful clinical consequences.7,8

"Navigating relapsed or refractory large B-cell lymphoma can be challenging, particularly for patients who do not live near a major academic centre," said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "The potential new Lunsumio VELO and Polivy combination may address this critical access issue by offering treatment options closer to where a patient lives. It fills a gap in care for people who can’t afford to travel far distances or for long periods of time for treatment."

Lunsumio is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous (IV) and subcutaneous administration routes. Lunsumio IV and Lunsumio VELO are approved for people with third-line or later follicular lymphoma (FL). Lunsumio holds the most extensive long-term data for any bispecific antibody in lymphoma. Ongoing development of Lunsumio in combination with other treatments includes the phase III CELESTIMO and MorningLyte studies in second-line or later and frontline FL, respectively.

About the SUNMO study
The SUNMO study [NCT05171647] is a phase III, randomised, open-label, multicentre trial evaluating the efficacy and safety of Lunsumio VELO (mosunetuzumab) in combination with intravenously administered Polivy (polatuzumab vedotin) versus MabThera/Rituxan (rituximab) plus gemcitabine and oxaliplatin in patients with relapsed or refractory large B-cell lymphoma who have received at least one prior systemic therapy and are ineligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes.

About Large B-cell Lymphoma (LBCL)
Large B-cell lymphomas, composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cell.5 DLBCL is a highly aggressive and life-threatening disease.9 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.5,6 While existing intensive standard-of-care treatments exist, structural, geographical, and clinical access barriers mean that many patients — particularly those in rural communities or receiving care outside of specialised academic transplant centres — face significant burdens and inequities in obtaining timely treatment.10,11 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.

About Lunsumio (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate malignant B cells. Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous (Lunsumio VELO) formulations. A robust, global development programme is ongoing to explore the clinical utility of Lunsumio earlier in the disease course and in novel combinations, including the phase III CELESTIMO trial in second-line or later FL.

About Polivy (polatuzumab vedotin)
Polivy is a first-in-class antibody-drug conjugate (ADC) targeted against CD79b, a protein preferentially expressed on the surface of mature B cells. Polivy binds to CD79b on the lymphoma cells and delivers a cytotoxic chemotherapy agent directly into the cell, inducing cell death via apoptosis while minimising damage to healthy tissue. Polivy is widely approved globally in combination with MabThera/Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone for previously untreated (first-line) diffuse large B-cell lymphoma (DLBCL), as well as in combination with bendamustine and MabThera/Rituxan for relapsed or refractory DLBCL.

(Press release, Hoffmann-La Roche, JUN 18, 2026, View Source [SID1234668810])

On June 18, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB) ("Alvotech" or the "Company"), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported the closing on June 17, 2026 of its previously announced underwritten public offering (the "Offering") of 26,066,667 of its ordinary shares at an offering price of $3.75 per share, which includes 3,400,000 ordinary shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional ordinary shares in the Offering. All ordinary shares sold in the Offering were offered by Alvotech. Before deducting the underwriting discounts and commissions and offering expenses, the aggregate gross proceeds to the Company were approximately $98 million.

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Concurrent with the Offering, Alvotech entered into Subscription Agreements with certain investors that are professional clients or eligible counterparties in the European Economic Area falling within article 1(4) of Regulation (EU) 2017/1129, pursuant to which Alvotech will issue and sell 17,826,666 ordinary shares to such investors at a price of $3.75 per ordinary share, which represents the per share public offering price, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended. The gross proceeds from the concurrent private placement, before deducting any transaction-related expenses, are expected to be approximately $67 million. The concurrent private placement is expected to close on or about June 25, 2026, subject to customary conditions. The consummation of the Offering was not contingent on the consummation of the concurrent private placement.

The board of directors of Alvotech has resolved to issue 43,893,333 ordinary shares to be delivered to investors participating in the Offering and the concurrent private placement and following closing of the concurrent private placement the issued share capital of Alvotech will amount to 390,431,480 ordinary shares in total.

The total gross proceeds from the Offering, including gross proceeds from the underwriters’ exercise in full of their option to purchase additional shares, and the concurrent private placement are expected to be approximately $165 million, before deducting underwriting discounts and commissions and estimated offering expenses payable.

Alvotech intends to use the net proceeds from this Offering and the concurrent private placement to fund the continued development of its biosimilar assets, as well as working capital and general corporate purposes, which may include, among others, intellectual property protection and enforcement, commercial expenditures, capital expenditures, acquisitions or collaborations, pre-clinical and clinical development of its product candidates, research and development and product development, pre-commercialization activities and repayment or refinancing of indebtedness or other corporate borrowings.

BofA Securities, Jefferies and Evercore ISI acted as joint book-running managers for the Offering.

The Offering was made pursuant to a registration statement on Form F-3, including a base prospectus, that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on October 20, 2023, and declared effective on October 30, 2023. The ordinary shares referred to in this press release were offered in the United States only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement. Copies of the final prospectus supplement and the accompanying prospectus related to this Offering may be obtained from: BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255-0001, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

(Press release, Alvotech, JUN 18, 2026, View Source [SID1234668809])

On June 18, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported that the Company has generated new in vitro proof-of-concept data validating its novel BiTAC-ADC technology platform and its potential to enable more precise and targeted cancer therapies. VERAXA will attend the BIO International Convention in San Diego, Calif., June 22-25, 2026, to discuss partnering opportunities based on its novel BiTAC-ADC and BiTAC-TCE platforms.

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The BiTACTM therapeutic strategy is designed to unlock a new level of precision in cancer treatment by using two complementary precursors and enabling a tumor-restricted activation of the desired therapeutic effect. Applied to the development of antibody drug conjugates (ADCs), the technology delivers a systemically inactive prodrug and a cell-impermeable proactivator through two separate antibodies, each addressing a defined tumor-associated antigen. While the single BiTAC-ADC precursors are therefore not toxic by design, the selective internalization of both components into the same cancer cells leads to dose-dependent cytotoxicity. In in vitro studies, BiTAC-ADCs have now been shown to discriminate between breast cancer and healthy cells and have demonstrated efficient and dose-dependent killing of 3D tumor cell spheroids.

"Following our successful listing on NASDAQ earlier this month, the BIO International Convention presents a great opportunity and is the ideal timing to provide more details on how our BiTAC-ADC platform can be applied to the potential benefit of cancer patients," said Heinz Schwer, Ph.D., MBA, Chief Business Officer of VERAXA. "Current ADC technologies have transformed cancer treatment but continue to face challenges associated with off-tumor toxicity caused by payload exposure in healthy tissues. BiTAC-ADCs are specifically designed to address this issue. By doing so, the platform could allow the use of very potent payloads in more settings than previously possible, with the ambition of improving both safety and targeted efficacy of next-generation ADC therapeutics."

"While still early in development, the data now available for our BiTAC-ADC platform indicate that our concept of selectively delivering and activating a toxic payload in tumor cells is working," said Christoph Erkel, Ph.D., Vice President Research & Development at VERAXA. "Following the presentation of our BiTAC-TCE strategy at the recent AACR (Free AACR Whitepaper) Annual Meeting in April, these novel datasets on the BiTAC-ADC platform underpin that the company has two viable and clearly differentiated product platform technologies, which can be applied in a range of solid tumor indications by us and our potential future partners."

(Press release, Veraxa Biotech, JUN 18, 2026, View Source [SID1234668808])