On June 9, 2023 AbbVie (NYSE: ABBV) reported new findings demonstrating sustained long-term safety and efficacy of VENCLYXTO/ VENCLEXTA (venetoclax)-based combination therapies in patients with previously untreated CLL with co-existing conditions, as well as R/R CLL (Press release, AbbVie, JUN 9, 2023, View Source [SID1234632582]). The results are being presented during oral sessions at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Frankfurt, Germany.

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"Results from the CLL14 and MURANO studies demonstrate the long-term benefits of fixed-duration venetoclax combinations for patients living with CLL," said Mariana Cota Stirner, M.D., Ph.D., vice president, hematology, AbbVie. "These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off treatment."

CLL14 Long-Term Analysis

New six-year follow-up results from the Phase 3 CLL14 study showcase updated outcomes in previously untreated patients with CLL and co-existing conditions. Patients treated with fixed-duration venetoclax plus obinutuzumab continued to experience improved PFS (95% Confidence Interval (CI) 0.31-0.52; Hazard Ratio (HR) 0.40) and higher rates of undetectable minimal residual disease (uMRD) when treated with fixed-duration venetoclax plus obinutuzumab compared to those who received chlorambucil plus obinutuzumab (53.1% vs 21.7%, respectively).

The data also showed significantly improved rates of time to next treatment (TTNT) with venetoclax plus obinutuzumab at 65.2 percent (95% CI 0.33-0.58; HR 0.44) compared to chlorambucil plus obinutuzumab at 37.1 percent.1 The observed differences in PFS and TTNT benefits between venetoclax-based treatment and chemoimmunotherapy were maintained across all risk groups, including patients with high-risk molecular features of CLL.

No new safety signals were observed in this six-year analysis. The most frequently occurring Grade 3 (≥2%) adverse events (AEs) in patients receiving the venetoclax-based combination were neutropenia, thrombocytopenia, infusion-related reaction (during treatment), anemia, febrile neutropenia, pneumonia and leukopenia.1

"The latest findings show that patients can experience long-term disease control, five years after stopping treatment," said Othman Al-Sawaf, M.D., investigator in the CLL14 study, hematologist-oncologist at the University Hospital Cologne in Germany, and study physician at the German CLL Study Group. "These results confirm the treatment benefits of fixed-duration venetoclax and obinutuzumab for previously untreated CLL patients with co-existing conditions."

Results will also be featured at EHA (Free EHA Whitepaper)’s Press Briefing.

MURANO Long-Term Analysis

Final data from the Phase 3 MURANO trial showcase that R/R CLL patients treated with two-year fixed-duration venetoclax plus rituximab sustained significantly longer median PFS at 54.7 months (95% CI 52.3, 59.9), the study’s primary endpoint, compared to 17.0 months (95% CI 15.5, 21.7; HR 0.23) with bendamustine plus rituximab after 7 years of median follow-up.2

Seven-year OS rates were 69.6 percent (95% CI 62.8, 76.5) for patients treated with the venetoclax-based combination versus 51 percent (95% CI 43.3, 58.7) for study participants who received bendamustine-based combination (HR 0.53).2 Furthermore, most of the patients treated with the full two-year venetoclax-based combination achieved uMRD (70.3%) at the end of their treatment course, and those patients were shown to have improved PFS and OS compared to patients with detectable MRD (29.7%).

The safety profile of the venetoclax-rituximab combination is consistent with the known safety profile of each individual therapy alone. No new serious safety issues were observed in the MURANO updated analysis. The most common adverse reactions (ARs) (≥20%) of any grade were neutropenia, diarrhea, upper respiratory tract infection, fatigue, and nausea.

"We are pleased to find that uMRD was associated with prolonged PFS in R/R CLL patients after seven years," said study investigator Prof. John Seymour, Director of the Integrated Haematology Department of the Peter MacCallum Cancer Center and the Royal Melbourne Hospital in Melbourne. "Overall, these findings continue to support the use of treatment with venetoclax plus rituximab in this patient population."

VENCLYXTO/VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

About the CLL14 Phase 3 Trial1,3
The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (GCLLSG), evaluated the efficacy and safety of a combined regimen of VENCLYXTO/VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously untreated patients with CLL and co-existing medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed-duration of 12 months for VENCLYXTO/VENCLEXTA in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated, according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Efficacy was based on PFS, as assessed by an independent review committee.

Key secondary endpoints were rates of MRD in peripheral blood and bone marrow, overall and complete response rates, MRD in complete response in peripheral blood and bone marrow, and OS.

In patients with CLL receiving venetoclax combination therapy with obinutuzumab, the most frequently occurring ≥ Grade 3 AEs (≥2%) were neutropenia (51.9%), thrombocytopenia (14.2%), infusion-related reaction (9.0%), anemia (7.5%), febrile neutropenia (4.2%), pneumonia (3.8%) and leukopenia (2.4%). Serious ARs were most often due to febrile neutropenia and pneumonia (5% each). The most common ARs (≥20%) of any grade were neutropenia (60%), diarrhea (28%), and fatigue (21%). Fatal ARs that occurred in the absence of disease progression and with onset within 28 days of the last study treatment were reported in 2 percent (4/212) of patients, most often from infection.

About the MURANO Phase 3 Trial2,4
A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized Phase 3 MURANO trial. The trial was designed to evaluate the efficacy and safety of VENCLYXTO/VENCLEXTA and rituximab (n=194) compared with bendamustine and rituximab (n=195). The median age of patients in the trial was 65 years (range: 22 to 85).

The trial met its primary efficacy endpoint of investigator (INV)-assessed PFS. At the time of the primary analysis, median PFS with VENCLYXTO/VENCLEXTA and rituximab was not reached compared with 17.0 months for bendamustine and rituximab (HR: 0.17; 95% CI: 0.11- 0.25; p<0.0001). In the primary efficacy analysis, the median follow-up for PFS was 23.8 months (range: 0 to 37.4). Additional efficacy endpoints included independent review committee (IRC)-assessed PFS, INV- and IRC-assessed overall response rate (defined as complete response + complete response with incomplete marrow recovery + partial response + nodular partial response), OS and rates of MRD-negativity.

In patients with CLL receiving combination therapy with rituximab, the most frequent serious adverse reaction (AR; ≥5%) was pneumonia (9%). The most common ARs (≥20%) of any grade were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), and nausea (21%). Fatal ARs that occurred in the absence of disease progression and within 30 days of the last venetoclax treatment and/or 90 days of the last rituximab were reported in 2% (4/194) of patients.

About VENCLYXTO (venetoclax)

VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Indication and Important VENCLYXTO (venetoclax) EU Safety Information5

Indications

Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

Venclyxto monotherapy is indicated for the treatment of CLL:

In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as Venclyxto efficacy may be reduced.

Special Warnings & Precautions for Use

Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC).

Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS. The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase.

Neutropenia (grade 3 or 4) has been reported. Complete blood counts should be monitored throughout the treatment period.

In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.

For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.

Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment including antimicrobials and dose interruption or reduction as appropriate.

Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

Drug Interactions

In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.

In CLL, at initiation and dose-titration phase, Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.

In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the VENCLYXTO SmPC.

Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

CYP3A4 inducers may decrease Venclyxto plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

Adverse Reactions

CLL

The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

The most frequently occurring serious adverse reactions (>=2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (>=2%) were pneumonia and febrile neutropenia.

Discontinuations due to adverse reactions occurred in 16% of patients treated with venetoclax in combination with obinutuzumab or rituximab in the CLL14 and Murano studies, respectively. In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.

Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in CLL14, in 15% of patients treated with the combination of venetoclax and rituximab in Murano, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia.

AML

The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.

The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

Discontinuations due to adverse reactions occurred in 24% of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.

Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65% of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia. The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.

Special Populations

Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.

For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.

On June 8, 2023 EpimAb Biotherapeutics, a clinical stage biotechnology company specializing in the development of bispecific antibodies, reported the appointment of Yonghong Zhu, M.D., Ph.D., as Chief Medical Officer (CMO) (Press release, Adaptimmune, JUN 8, 2023, View Source [SID1234648260]). As CMO, Dr. Zhu will be responsible for overseeing all clinical development activities for the company’s clinical stage assets. This strategic addition to the executive team further strengthens the company’s commitment to innovation and mission of advancing cutting-edge bispecific therapies. Dr. Zhu replaces EpimAb’s previous CMO, Dr. Bin Peng, who recently retired from EpimAb after five years of service at the company.

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With around two decades of experience in the biotech industry, Dr. Zhu brings an outstanding track record and expertise that spans across early to late-stage development in oncology and immunology to EpimAb. Before joining EpimAb, Dr. Zhu was the CMO at MaxiNovel Pharmaceuticals, and prior to this, he held leadership positions in Clinical Development and Translational Medicine at Roche, Takeda and Henlius, where he made significant contributions to developing and executing overall clinical strategies, and evaluating and driving strategic collaborations. Dr. Zhu obtained his Bachelor’s and Medical Degrees (combined 7-year program) at Nanjing University Medical School, and completed his Ph.D. training in Microbiology & Immunology (Major in Virology) at the University of Rochester School of Medicine & Dentistry.

"We are excited to welcome Dr. Zhu as our new Chief Medical Officer," said Dr. Chengbin Wu, Founder and CEO of EpimAb. "His extensive knowledge in the oncology and immunology fields, plus a wealth of experience designing and leading early and late-stage clinical programs align perfectly with our vision. We are confident that Dr. Zhu’s leadership skills and expertise will accelerate our mission of developing breakthrough therapies for diseases with significant unmet need."

Dr. Zhu commented, "I am honored to join and collaborate with the dedicated team at EpimAb. With its multiple proprietary and unique platform technologies and an exceptional R&D team, EpimAb has generated several differentiated clinical programs with tremendous potential. I look forward to further advancing these programs and contributing to the future success of the company."

On June 08, 2023 Lantern Pharma Inc., a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it will be leveraging its AI platform, RADR, in a research collaboration with Bielefeld University (Bielefeld, Germany) to develop antibody-drug conjugates (ADCs) with high therapeutic and antitumor potential (Press release, Lantern Pharma, JUN 8, 2023, View Source [SID1234634303]). The collaboration will leverage insights from Lantern’s recently developed RADR AI ADC module in combination with research from Professor Norbert Sewald, Ph.D., the principal investigator for Bielefeld and leader of Magicbullet::reloaded, a European consortium focused on developing novel drug delivery mechanisms, including ADCs. Outcomes from the collaboration are expected to pave the way for next-generation ADCs and other drug conjugates that are designed using AI and that can be developed with potentially higher efficacy, at a faster pace, and with significantly reduced costs.

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The initial aim of the collaboration will be to synthesize and evaluate novel ADCs linked to cryptophycins, which are promising antitumor molecules, in part because of their potency at ultra-low, picomolar, concentrations. The cryptophycin-ADCs will be tested across multiple cancer cell lines and initial results are expected during 2023.

"We have ample experience in structure-activity relationships of cryptophycins as well in the synthesis of ADCs and small molecule-drug conjugates (SMDCs). Teaming up with top researchers from European academia and industry in the consortium of Magicbullet::reloaded further reinforced this capacity. We now look forward to the collaboration with Lantern," said Dr. Sewald.

"Cryptophycins are an exciting family of highly potent heterocyclic peptides from Cyanobacteria that have demonstrated antitumor potency and can inhibit tumor growth by strongly interfering with microtubule stability and assembly," stated Kishor Bhatia, Ph.D., Lantern’s Chief Scientific Officer. "Dr. Sewald and his group are experts in the synthesis of cryptophycin derivatives and have established extensive groundwork to support the targeted ADC delivery of cryptophycins. By leveraging our RADR platform’s AI ADC development module and partnering with Dr. Sewald, we expect to be able to select and advance cryptophycin-ADCs towards the clinic with better targeting and therapeutic efficacy for patients with advanced cancers with limited therapeutic options," continued Dr. Bhatia.

After the initial aims of the collaboration are completed, Lantern plans to leverage its AI ADC development module, which is fully integrated into RADR, to launch multiple ADCs that can leverage cryptophycins or other promising payloads. Lantern also expects to use the AI ADC development module with other collaborators, both academic and commercial, to develop promising ADC candidates for launch into targeted clinical trials.

This AI-guided strategy has the potential to de-risk the ADC drug development process, while simultaneously enhancing the creation of effective and targeted ADCs. The rapidly growing global ADC market is currently valued at over $4.0 billion and is projected to reach $14.0 billion by 2027. There are currently 12 ADCs that have been approved by the US Food and Drug Administration (FDA) for the treatment of cancer and approximately 37 ADCs in current late-stage oncology trials.

Under the terms of the collaboration, Dr. Sewald and his group will synthesize, optimize, and provide initial testing of the cryptophycin-ADCs. Lantern is also receiving an exclusive and worldwide option to license intellectual property (IP) from Bielefeld University related to the collaboration and IP generated from the collaboration.

On June 8, 2023 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported the pricing of $500.0 million aggregate principal amount of 1.75% Convertible Senior Notes due 2028 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ionis Pharmaceuticals, JUN 8, 2023, View Source [SID1234632661]). Ionis also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $75.0 million aggregate principal amount of notes from Ionis. The sale of the notes is expected to close on June 12, 2023, subject to customary closing conditions.

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The notes will be general unsecured obligations of Ionis, and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2023, at a rate of 1.75% per year. The notes will mature on June 15, 2028, unless earlier converted or repurchased.

Ionis estimates that the net proceeds from the offering will be approximately $487.6 million (or approximately $560.8 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Ionis. Ionis expects to use approximately $420.4 million of the net proceeds from the offering to repurchase $434.1 million in aggregate principal amount of its 0.125% Convertible Senior Notes due 2024 (the "2024 notes") in privately negotiated transactions. Ionis expects to use the remaining net proceeds from the offering for additional repurchases of the 2024 notes from time to time following the offering, including the repayment of any remaining 2024 notes at maturity, and for general corporate purposes.

Before March 15, 2028, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after March 15, 2028 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate for the notes will initially be 18.6120 shares of Ionis’ common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $53.73 per share of Ionis’ common stock). The initial conversion price represents a premium of approximately 32.5% over the last reported sale price of $40.55 per share of Ionis’ common stock on June 7, 2023. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

Ionis may not redeem the notes prior to June 20, 2026. Ionis may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after June 20, 2026 if the last reported sale price of Ionis’ common stock has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Ionis provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. However, Ionis may not redeem less than all of the outstanding notes unless at least $100.0 million aggregate principal amount of notes are outstanding and not called for redemption as of the time Ionis sends the related notice of redemption. No sinking fund is provided for the notes.

If Ionis undergoes a "fundamental change" (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Ionis to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Ionis delivers a notice of redemption, Ionis will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of redemption, as the case may be.

In connection with any repurchase of the 2024 notes, Ionis expects that holders of the 2024 notes who agree to have their 2024 notes repurchased and who have hedged their equity price risk with respect to such notes (the "hedged holders") will unwind all or part of their hedge positions by buying Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders or in connection with such derivative transactions may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders may result in an increase in the effective conversion price of the notes.

The notes and any shares of Ionis’ common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

On June 8, 2023 Aviko Radiopharmaceuticals, a Deerfield Management-founded biotechnology company developing medicines to unlock the potential of boron neutron capture therapy (BNCT), and Neutron Therapeutics, the leading provider of accelerator-based neutron systems for targeted radiation therapy of solid tumors, reported the formation of a strategic partnership to advance BNCT to treat cancer (Press release, Aviko Radiopharmaceuticals, JUN 8, 2023, View Source [SID1234632629]). The partnership aligns the companies’ efforts to build the first BNCT treatment center in the United States and to establish additional BNCT facilities through collaborations with premier academic medical centers.

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"To bring BNCT to patients in need, it’s critical to foster collaboration among key stakeholders who are working to advance this precision medicine modality," said Dave Greenwald, Ph.D., chief executive officer of Aviko and vice president of business development at Deerfield. "This strategic partnership brings together Aviko’s expertise in drug development and Neutron’s industry-leading neutron delivery technology with the goal of improving outcomes for patients with a variety of cancers."

BNCT involves a non-toxic boron medicine that is designed to accumulate in cancer cells. The boron medicine remains inert until it is irradiated by safe, low-energy neutrons at the site of the tumor, releasing alpha particles that destroy cancerous cells. Aviko has developed a pipeline of boron medicines that exhibit properties to enable effective BNCT, including high tumor selectivity. Neutron’s nuBeam system is a comprehensive BNCT treatment suite with an accelerator that produces the highest neutron flux available in the clinical setting, leading to potentially shorter treatment times and improved patient experience.

"BNCT has demonstrated the ability to eradicate tumors in as few as one or two treatments, while minimizing damage to healthy tissue," said Elizabeth Reczek, Ph.D., chief executive officer of Neutron Therapeutics. "We’re thrilled to partner with Aviko in our efforts to expand BNCT as a treatment modality in the U.S. and globally."

Neutron has installed its nuBeam system at Helsinki University Hospital in Helsinki, Finland, and at Shonan Kamakura General Hospital in Kamakura City, Kanagawa prefecture, Japan.

"Recent innovations related to neutron acceleration have expanded the opportunities for BNCT to be used in a wide range of medical centers," said Bill Buckley, co-founder of Neutron Therapeutics and founder of New Zealand-based Buckley Systems. "This partnership is an example of how two companies can collaborate to advance a promising therapy to help patients who are in need of more effective treatment options."

Ted Smick, chief technology officer and co-founder of Neutron Therapeutics, added: "Together, Aviko and Neutron Therapeutics offer a complete solution for BNCT, enabling more medical centers to provide this powerful new treatment to patients."