On September 15, 2022 Galvanize Therapeutics, Inc., a commercial-stage biomedical platform company operating at the convergence of engineering, biology and healthcare delivery, reported it has completed a $100 million Series B financing to advance and commercialize its unique AliyaTM Pulsed Electric Field (PEF) energy platform for the treatment of chronic bronchitis symptoms, cardiac arrhythmias, solid tumors, and for drug delivery (Press release, Galvanize Therapeutics, SEP 15, 2022, View Source [SID1234619611]). Galvanize was created and incubated by the life sciences venture capital firm ATP (Apple Tree Partners), originally as three companies—Gala Therapeutics, Galaxy Medical, and Galvanize Therapeutics—that recently merged into one company under the Galvanize Therapeutics name . The funding round was led by Fidelity Management & Research Company with participation by Intuitive Surgical, ATP, and Gilmartin Capital.

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Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP
Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP
"We are energized by this vote of confidence from our investors in our technology platform and team as we seek to bring transformative electrosurgical therapies to patients worldwide," said Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP. "We designed the customizable Aliya energy platform to serve patients in a variety of challenging disease categories, and the integration of our market-specific strategies and innovative products within Galvanize is an exciting milestone in the execution of our vision. We are investing meaningfully to prove safety and demonstrate enhanced outcomes in our initial clinical targets, and we continue to explore additional platform applications."

Centered on disease biology and how energy can alter cellular physiology, Galvanize developed the Aliya energy platform to produce high voltage, high frequency electrical current to interfere with cellular function in tissue. Unlike other ablation modalities, Aliya energy is non-thermal. The electrical waveforms are designed to be delivered through single monopolar electrodes to enable more consistent and predictable treatment zones with minimal muscle contraction that previously plagued high voltage technologies.

One Core Platform, Several Targets

Galvanize is developing and commercializing its energy platform for several indications, adapting its core technology for each application:

Chronic Bronchitis: The RheOx system is a minimally invasive bronchoscopic therapy that reduces the abnormal mucus-producing cells in the airways of chronic bronchitis patients. RheOx has CE Mark and recently launched in select hospitals in Italy, Switzerland, Denmark and Germany, with new customers adopting RheOx each week. Following Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), the RheSolve pivotal clinical trial is enrolling in the United States and Europe to support a U.S. Premarket Approval (PMA) submission for RheOx.

Cardiac Arrhythmias: The CENTAURI system disrupts aberrant electrical signals in the heart which cause cardiac arrhythmias, including atrial fibrillation. CENTAURI delivers a novel proprietary waveform and is compatible with several marketed catheters and mapping systems. CENTAURI has CE Mark and currently is launching in Europe.

Soft Tissue Ablation: The Aliya system recently received 510(k) clearance from the U.S. FDA for soft tissue ablation. Through a single percutaneous electrode inserted in the target tissue, the physician delivers a pre-programmed dose of energy. Aliya is now launching at select U.S. hospitals.

Immuno-Oncology: The Aliya energy platform is being studied to treat solid tumors by combining PEF-mediated cell death and neoantigen creation, designed to stimulate the patient’s own immune system to activate against the tumor. Galvanize’s preclinical data and early clinical data from the INCITE-ES trial conducted outside the U.S. have demonstrated signals of immune activation.

Drug Delivery: A system for local delivery of therapeutic agents is under development.
RheOx and CENTAURI were developed in ATP portfolio companies Gala Therapeutics (founded 2015) and Galaxy Medical (founded 2020), respectively, both of which now are part of Galvanize Therapeutics.

"ATP makes investments to translate incredible science into treatments that can transform lives, and I believe the Galvanize PEF energy platform exemplifies the remarkable breakthroughs we can accomplish with our singular investment and incubation model," said Seth Harrison, M.D., ATP’s founder and managing partner. "ATP invested over a period of years to build an adaptable therapeutic device platform capable of addressing some of the most intractable medical problems that have not been solved yet by drugs, and it is gratifying to see the vision being realized. The Galvanize team has developed ingenious solutions for patients and their doctors that they are now delivering to healthcare systems every day."

Doug Godshall, president & CEO of Shockwave Medical, and chair of Saluda Medical, who previously was chair of Gala Therapeutics, has been appointed chair of the board of Galvanize Therapeutics. Mr. Godshall commented: "At Gala over the last few years, we observed the life-changing outcomes that RheOx can achieve in debilitated chronic bronchitis patients, and I am excited to work with the broader Galvanize team as they expand their efforts." He added:

"Galvanize is unique because of the way Jon and his talented team have created a single, highly sophisticated technology across three unique clinical applications. With a deep portfolio of clinical studies already under way, I am highly impressed by what the team has accomplished to-date and am quite enthusiastic about the significant impact Galvanize is going to have for a wide spectrum of patients."

On September 15, 2022 Mission Bio, Inc., the pioneer in high-throughput single-cell DNA analysis, reported new data supporting the use of its Tapestri Platform in clinical development, including clonal evolution patterns in patients with IDH1-mutated acute myeloid leukemia (AML) treated with Servier Pharmaceuticals’ TIBSOVO (ivosidenib tablets) plus azacitidine (Press release, Mission Bio, SEP 15, 2022, View Source [SID1234619603]). Data previously generated via single-cell DNA sequencing with Tapestri supported analyses for Servier’s ongoing pivotal phase 3 AGILE trial, the basis for U.S. Food and Drug Administration approval of the combination in newly diagnosed patients with IDH1-mutated AML in May 2022.

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AML is one of the most common and dangerous leukemias, as the majority of patients with AML eventually relapse after initial treatment – with poor prognoses. However, improving methods of molecular profiling has brought new hope by supporting the development and targeted use of precision therapies like TIBSOVO, the first FDA-approved IDH1 inhibitor. Researchers at Agios (later acquired by Servier) previously leveraged Tapestri to fully characterize the clonal architecture of AML at the single-cell level, revealing mechanisms of resistance to TIBSOVO monotherapy and enabling Servier to further explore the advantages of the combination therapy trial strategy.

Through their continuing collaboration, Servier has worked with Mission Bio’s Pharma Assay Development (PAD) services to utilize the Tapestri single-cell DNA sequencing technology to serially assess hundreds of samples from patients with IDH1-mutated AML who have been treated with TIBSOVO. At the World Clinical Biomarkers & CDx Summit this month, Servier will discuss Tapestri-powered findings revealing differences in the clonal evolution that occurs after TIBSOVO treatment in frontline and relapsed/refractory settings, both as a monotherapy and a combination therapy. This includes new insights into acquired resistance to TIBSOVO and azacitidine and the potential for serial molecular testing using single-cell analytics to enable physicians to dynamically sequence therapies to suppress emerging clones in AML.

"Targeted therapies play a key role in the continued evolution of precision cancer treatment, but it is critical to examine disease resistance in order to maximize the impact of these medicines," said Scott Daigle, Director of Translational Medicine at Servier. "Tapestri has shown that it can play an important role in helping drug developers discover insights that bring the right therapies to patients at the right time."

"The latest data on TIBSOVO, as well as the collaboration with Servier itself, is a great demonstration of Tapestri’s utility in retrospective studies. We are excited to see how this can potentially progress to prospective use of Tapestri in clinical trials for patient stratification, therapy monitoring, and measurable residual disease detection," said Todd Druley, Chief Medical Officer of Mission Bio. "Servier is again leading the pharmaceutical field, showing the potential for single-cell DNA sequencing to be used to predict relapse and help impact patient outcomes."

Servier is presenting a talk entitled "Clonal evolution underlying clinical responses and relapses in patients with IDH1-mutated AML treated with ivosidenib monotherapy or ivosidenib + azacitidine" at the 12th Annual World Clinical Biomarkers & CDx Summit at 4:15 p.m. on September 28th in Boston, Mass.

Visit Mission Bio during the World Clinical Biomarkers & CDx Summit from September 28-29 at booth 26.

On September 15, 2022 Specialised Therapeutics Asia reported A NEW targeted therapy to treat a rare bile duct cancer called cholangiocarcinoma has been approved for use in Australia (Press release, Specialised Therapeutics Asia, SEP 15, 2022, View Source [SID1234619602]).

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PEMAZYRE (pemigatinib) has been provisionally approved by the Therapeutic Goods Administration (TGA) "for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s)." 1

This means it will be available to Australian patients with cholangiocarcinoma who have been tested for an abnormal gene change in their tumour called an FGFR2 fusion or rearrangement – a defect that can drive cancer growth.

This defect is estimated to be present in around 15% of patients diagnosed with cholangiocarcinoma.2

Australian oncologist Dr David Goldstein said the approval of PEMAZYRE was "a significant step forward" for Australian patients who are diagnosed with this rare and aggressive cancer.

He commented: "This TGA approval of a targeted therapy heralds an era of precision medicine in this rare cancer.

"The study underpinning this approval, FIGHT 202, saw clinical outcomes you would not expect from previous experience after initial treatment ceases to be effective.

"This is one of only a few second-line therapies to offer serious real benefits to patients and will be very focused upon the right tumour type.

"Up until now, we have had some chemotherapies that were effective, but only in a minority of patients.

"This TGA approval is a positive first step. Subsequent reimbursement via the Pharmaceutical Benefits Scheme is really the only way forward to translate this scientific knowledge of targeting a specific tumour type into everyday clinical practice."

PEMAZYRE, developed by Incyte (NASDAQ:INCY) and partnered with independent pharmaceutical company Specialised Therapeutics (ST) for commercialisation in Australia, New Zealand and Singapore, belongs to a class of drugs called kinase inhibitors and works by blocking the abnormal FGFR2 protein in bile duct tumour cells and preventing cell growth.

The TGA approval follows PEMAZYRE’s approval in the United States, Europe, Great Britain, Canada and Japan.

While PEMAZYRE is not yet reimbursed in Australia, it is currently being made available to eligible patients via a co-pay access program.

ST CEO Carlo Montagner said PEMAZYRE was a "wonderful inclusion" to the company’s portfolio of rare cancer therapies and was synergistic with its mission of providing therapies to patient populations where there is a high unmet medical need.

He said: "We look forward to providing this new highly-targeted treatment to eligible patients with cholangiocarcinoma who have limited therapy options."

PEMAZYRE’s approval is based on a clinical trial known as the FIGHT-202 study – a Phase 2 investigation evaluating the safety and efficacy of PEMZYRE in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. 2

In the primary analysis of 108 patients enrolled in the trial, treatment with PEMAZYRE resulted in an objective response rate of 37% with 3.7% of patients having a confirmed complete response and 33.3% having a confirmed partial response. The disease control rate was 82.2%.1

The safety analysis, including 147 patients, demonstrated that PEMAZYRE was generally well tolerated.

The most common adverse reactions were hyperphosphataemia: includes hyperphosphataemia and increased blood phosphorous (60.5%), alopecia (49.7%), diarrhoea (46.9%), nail toxicity (44.9%), fatigue (43.5%), nausea (41.5%), dysgeusia (40.8%), stomatitis (37.4%), constipation (36.7%), dry mouth (34.0%), dry eye (27.9%), arthralgia (25.9%), hypophosphataemia (23.1%), dry skin (21.8%) and palmar-plantar erythrodysaesthesia syndrome (16.3%).1

On September 15, 2022 Medtronic plc (the "Company") ( NYSE:MDT) reported that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. ("Medtronic Luxco"), has priced an offering (the "Offering") of €500,000,000 principal amount of 2.625% senior notes due 2025, €1,000,000,000 principal amount of 3.000% senior notes due 2028, €1,000,000,000 principal amount of 3.125% senior notes due 2031 and €1,000,000,000 principal amount of 3.375% senior notes due 2034 (collectively, the "Notes") (Press release, Medtronic, SEP 15, 2022, View Source [SID1234619601]). All of Medtronic Luxco’s obligations under the Notes will be fully and unconditionally guaranteed by the Company and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

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The net proceeds of the Offering are expected to be used to repay at maturity Medtronic Luxco’s outstanding 0.00% Senior Notes due 2022, 0.375% Senior Notes due 2023 and 0.00% Senior Notes due 2023 and for general corporate purposes. While Medtronic Luxco may elect at a later date to repay, redeem or repurchase such notes prior to maturity, it currently has no intention to repay, redeem or repurchase such notes prior to maturity. The Offering is expected to close on September 21, 2022, subject to customary closing conditions. The joint book-running managers for the Offering are Barclays Bank PLC, BofA Securities Europe SA, Citigroup Global Markets Limited and HSBC Continental Europe.

The Offering is being made only by means of a prospectus dated February 28, 2020 and prospectus supplement (together, the "Prospectus"). You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus for the Offering may be obtained by contacting Barclays Bank PLC, toll-free at +1-888-603-5847, BofA Securities Europe SA, at +33(0) 1 8770 0000, Citigroup Global Markets Limited, toll-free at +1-800-831-9146 and HSBC Continental Europe, at +1-866-811-8049.

On September 15, 2022 J INTS BIO reported the poster presentation of its novel, orally administered 4th generation EGFR-TKI ‘JIN-A02’ at the ESMO (Free ESMO Whitepaper) 2022, that showed high potency of JIN-A02 against both cis and trans isomers of C797S mutation (Press release, J INTS BIO, SEP 15, 2022, View Source;esmo-2022-301625927.html [SID1234619600]). This year’s edition of the European Society for Medical Oncology Congress (ESMO 2022) was held in Paris, France from 9th to 13th September.

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Professor Cho, Byoung Chul, poster presentation of further preclinical data of its Novel Oral 4th Generation EGFR-TKI ‘JIN-A02’ at the 2022 European Society for Medical Oncology Congress in Paris, France (ESMO 2022)
Professor Cho, Byoung Chul, poster presentation of further preclinical data of its Novel Oral 4th Generation EGFR-TKI ‘JIN-A02’ at the 2022 European Society for Medical Oncology Congress in Paris, France (ESMO 2022)
Even though EGFR-TKI have improved treatment outcomes of patients with EGFR mutant NSCLC, resistance inevitably emerges with disease progression and often with CNS metastasis. C797S mutation is one of the most common on-target resistance mutation after the use of 3rd generation TKIs such as Osimertinib. ‘JIN-A02’ is a novel 4th generation EGFR-TKI, which is highly selective and potent against C797S double and triple mutations, with high BBB penetrance and intracranial efficacy.

The allelic context in which this C797S mutation is acquired, cis or trans isomers, have significant implications for treatment outcomes. This is especially so when C797S positive tumor are in cis form together with T790M mutation. In such situations, there are no available treatments.

J INTS BIO believes that JIN-A02 will be pivotal in the treatment of patients with EGFR mutant NSCLC harboring C797S double or triple mutations, regardless of allelic context. And the company is expecting the Phase I/IIa clinical study for JIN-A02 to start recruitment before the end of this year.