On June 8, 2020 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, reported that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a "Study May Proceed" letter for the Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities (Press release, Helsinn, JUN 8, 2020, View Source [SID1234560919]).

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The study is intended to be conducted globally and is due to commence in the third quarter of 2020.

TAS0953/HM06 is being developed together with its partner Taiho Pharmaceutical Co., Ltd. In 2017, Helsinn and Taiho signed a global co-development and commercialization agreement for TAS0953/HM06.

TAS0953/HM06 is an investigational oral treatment which inhibits several RET abnormalities identified as oncogenic driver alterations in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. This innovative drug candidate offers several differentiating features as compared to other RET inhibitors.

Sergio Cantoreggi, Group Chief Scientific Officer and Head of R&D at Helsinn, commented: "Helsinn and Taiho have been working closely together as part of a global development partnership and we’re delighted to have reached this latest milestone that will allow us to start treating patients with TAS0953/HM06 in a Phase 1/2 clinical trial starting in the next quarter. We are excited by the potential of TAS0953/HM06 to treat NSCLC and other tumors which harbor RET abnormalities and look forward to working with Taiho to progress the treatment through the clinic."

TAS0953/HM06 is an investigational agent and is not approved for commercial use in any country.

About TAS0953/HM06

TAS0953/HM06 is an oral RET inhibitor in development for advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) and other tumors which express RET gene abnormalities. Preclinical data showed several differentiating features in comparison to other targeted therapies acting on RET abnormalities.

Taiho and Helsinn signed a co-development and commercialization agreement for TAS0953/HM06 in 2017 and will continue to pursue together all preclinical, clinical and CMC developments. This alliance also includes efforts to reach as many patients as possible around the world through their own commercial infrastructures or through valued partners.

About RET abnormalities in NSCLC and other cancers1

RET kinase abnormalities have been identified as targetable oncogenic drivers in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. In NSCLC, RET fusions are more common in younger patients with no prior history of smoking and in those with adenocarcinomas, however the underlying mechanisms remain unknown.

1Helsinn and Taiho research and analysis of ASCO (Free ASCO Whitepaper) 2018; ASCO (Free ASCO Whitepaper) 2019; Cancer Biol Ther 2015; Cell Rep 2017; JCO 2018; Johns Hopkins 2019; Nat Med 2012; Nat Rev Clin Oncol 2018; OMIM; Onco Targets Ther 2019

On June 8, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported preliminary results of its rights offering, which expired at 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date") (Press release, Pulse Biosciences, JUN 8, 2020, View Source [SID1234560918]).

In accordance with the pricing structure described in the prospectus relating to the rights offering, the final subscription price for the units offered (the "Units") is $7.01 per Unit, which is the initial price established at commencement of the rights offering. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to $7.01, the subscription price for the Units. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company received basic subscriptions and over-subscriptions exceeding the maximum number of up to 4,279,600 Units offered in the rights offering. Available Units will be allocated proportionately among rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under their basic subscription rights, in accordance with the procedures described in the prospectus relating to the rights offering. The common stock and warrants comprising the Units will separate upon the closing of the rights offering and will be issued individually. The Company expects the Subscription Agent to distribute such shares and warrants, as well as the sale proceeds, on or about June 11, 2020.

The Company will receive aggregate gross proceeds from the rights offering of $30 million, excluding proceeds of up to $4.5 million from the exercise of warrants issued in the rights offering (if any such exercises occur). The results of the rights offering are preliminary and subject to change pending finalization of subscription procedures by the Subscription Agent.

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

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On June 8, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported that it has selected development candidate, IDE397, for its Methionine adenosyltransferase 2a (MAT2A) Synthetic Lethality program (Press release, Ideaya Biosciences, JUN 8, 2020, View Source [SID1234560913]). The MAT2A program targets patients with tumors having methylthioadenosine phosphorylase (MTAP) deletions. With the nomination of IDE397 as a development candidate for the MAT2A program, IDEAYA has initiated IND-enabling studies and is targeting filing the Investigational New Drug (IND) application in the fourth quarter 2020.

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"With IDE397, we have achieved our preclinical target product profile of a differentiated compound, including potency, safety assessment, and physicochemical property characteristics. Based on the preclinical in vivo efficacy data we have generated, we believe IDE397 has the potential for evaluation in both monotherapy and combination studies in select solid tumor types with the genetic alteration of MTAP-deletion," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE397 Product Profile and MAT2A Program Summary:

Monotherapy activity with robust tumor growth inhibition and pharmacodynamic (PD) modulation in multiple endogenous MTAP-/- in vivo models
Monotherapy activity and tumor regression in HCT116 MTAP-/- xenograft model
No changes in liver enzymes or increased unconjugated bilirubin levels observed in preclinical studies
Favorable physicochemical properties and pharmacokinetics observed across multiple species
MAT2A program enabled by structure-based drug design; over 17 high resolution co-crystal structures have been resolved to enable lead optimization
About MAT2A and MTAP-Deletion:
MTAP-null cells lack the ability to metabolize 5-methylthioadenosine, or MTA, which is an essential step in a biochemical pathway involved in salvaging metabolite S-adenosyl methionine, or SAM. Increased levels of MTA partially inhibit the methyltransferase PRMT5 for which SAM is the substrate. This partial inhibition renders MTAP-null cells more dependent on the activity of methionine adenosyltransferase II alpha or MAT2A, an enzyme that is responsible for the synthesis of SAM. Because of this dependence, loss of MTAP results in synthetic lethality when MAT2A is pharmacologically inhibited.

MTAP deletions are prevalent in approximately 15% of all human tumors across various tumor types. Genetic profiling tests for the deletion of MTAP or for the commonly co-deleted gene CDKN2A are commercially available.

On June 8, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), intends to offer, subject to market conditions and other factors, $850 million aggregate principal amount of exchangeable senior notes due 2026 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Jazz Pharmaceuticals, JUN 8, 2020, View Source [SID1234560912]). The Issuer also expects to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes.

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The notes will be exchangeable under certain circumstances for cash, ordinary shares ("ordinary shares") of Jazz Pharmaceuticals plc ("Jazz Pharmaceuticals"), or a combination thereof. The interest rate, initial exchange rate and other terms of the notes will be determined at the time of pricing of the offering. The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears. The Issuer’s obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals and will rank pari passu in right of payment with the Issuer’s existing 1.875% exchangeable senior notes due 2021 (the "2021 notes") and 1.500% exchangeable senior notes due 2024.

The Issuer intends to use a portion of the net proceeds from the offering to repurchase for cash up to approximately $400 million aggregate principal amount of the 2021 notes through individual privately negotiated transactions concurrently with the offering of the notes. The remaining net proceeds will be used for general corporate purposes, which may include additional repurchases of 2021 notes from time to time following the offering. Note repurchases occurring concurrently with the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes. Note repurchases that may occur from time to time following the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares or the trading price of the notes.

None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act 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 does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On June 8, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that it submitted a Clinical Trial Application (CTA) (IND) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 monoclonal antibody for the treatment of multiple myeloma and other hematological malignancies (Press release, CASI Pharmaceuticals, JUN 8, 2020, View Source [SID1234560911]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Submitting this CTA is an important step in the clinical development of this promising therapy in our hematology oncology franchise. CID-103 demonstrated encouraging efficacy in preclinical models and we believe it has the potential to be best in class and can offer meaningful clinical benefits over the standard of care for patients with CD38 malignancies, including multiple myeloma."

Alexander Zukiwski, M.D., CASI’s Chief Medical Officer commented, "We look forward to launching our study for this novel biological entity as a potential treatment for patients with hematological malignancies. We will continue to monitor the COVID-19 related circumstances in the UK and are working on administrative activities in support of this trial. Based on the current environment and timetable of our clinical sites, we are targeting the study initiation in late 2020 or early 2021."

About CID-103 (Anti-CD38 Mab)

CID-103 (f/k/a TSK011010) is a novel anti-CD38 monoclonal antibody program. CASI licensed the global rights to CID-103, from Tusk Therapeutics, Ltd in April 2019. Preclinical data demonstrate CID-103 possesses enhanced activity against a broad array of malignancies expressing CD38, and potentially enhance safety and efficacy benefits when compared to other CD38 monoclonal antibodies. CASI maintains exclusive global rights to CID-103.