On May 14, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported the pricing of the initial public offering of 12,245,631 shares of its common shares at a price of $19.00 per share (Press release, ADC Therapeutics, MAY 14, 2020, View Source [SID1234558148]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by ADC Therapeutics, are expected to be approximately $232.7 million. The shares are expected to begin trading on the New York Stock Exchange on May 15, 2020 under the ticker symbol "ADCT." The offering is expected to close on May 19, 2020, subject to customary closing conditions. In addition, ADC Therapeutics has granted the underwriters a 30-day option to purchase up to 1,836,844 additional common shares.

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Morgan Stanley, BofA Securities and Cowen are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of ADC Therapeutics SA, such as the common shares, in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and these securities will not be listed or admitted to trading on the SIX Swiss Exchange or on any other regulated trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.

On May 14, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported that it has commenced its previously-announced rights offering of up to 4,279,600 of units (the "Units," and each, a "Unit") at the Initial Price (as defined below) with an aggregate offering value of up to $30,000,000 (Press release, Pulse Biosciences, MAY 14, 2020, View Source [SID1234558109]). The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date").

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Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase the Units. Each Unit shall consist 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. The subscription price per Unit shall be equal to the lesser of (i) $7.01 per Unit (the "Initial Price") or (ii) the volume weighted average price of the Company’s common stock for the five trading day period through and including the Expiration Date (the "Alternate Price"). The subscription price will determine the final number of Units issuable, and subsequently the pro rata number of Units to which stockholders can subscribe. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to the subscription price for the Units.

Stockholders wishing to exercise subscription rights must timely pay $7.01 per Unit, the Initial Price, for the number of Units they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional Units in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional Units that are not purchased by other stockholders, on a pro rata basis and subject to availability.

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. Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information, subscription and warrant agent for the rights offering, at the address and phone number provided at the end of this release.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer will be made only by means of the prospectus forming a part of the effective registration statement.

On May 14, 2020 Moffitt Cancer Ctr reported that Chimeric antigen receptor T-cell therapy, or CAR T, has become a game changer for lymphoma and leukemia patients who have relapsed or become resistant to previous treatments (Press release, Moffitt Cancer Ctr, MAY 14, 2020, View Source [SID1234558108]). The therapy uses a patient’s own immune cells that are re-engineered in the lab to seek out and kill cancer cells when infused back into the patient. Yescarta (axicabtagene ciloleucel) was the first CAR T-cell therapy approved for the treatment of adults with large B cell lymphoma. The pivotal ZUMA-1 clinical trial that led to its approval showed that 83% of patients responded to the therapy, with 58% having a complete response. But clinical trials often have stringent eligibility criteria and the outcomes observed may not match what physicians see in a real-world clinical setting.

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Moffitt Cancer Center organized a consortium of 16 cancer treatment facilities across the U.S. that offer Yescarta as a standard-of-care therapy for patients with relapsed/refractory large B cell lymphoma. They wanted to determine if the safety and effectiveness seen in the ZUMA-1 clinical trial were similar for patients treated with the now commercially available CAR T therapy. Their findings were published in the Journal of Clinical Oncology.

The consortium pooled retrospective data on 298 patients who completed apheresis, the process to remove a patient’s T cells, with the intent of having Yescarta manufactured and administered. It is important to point out that of this group, 129 patients (43%) would not have qualified for CAR T-cell therapy based on the ZUMA-1 comorbidity eligibility criteria. Overall, 275 patients (92%) received a Yescarta infusion. In the ZUMA-1 trial, 108 patients received Yescarta.

"Our analysis found that the overall response rate of 82%, and estimated 12 month durable response rate of 47%, for our group of patients compared favorably to the ZUMA-1 trial results," said Frederick Locke, M.D., corresponding author of the study and vice chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy and co-leader of the Immunology Program at Moffitt. "Durable response rates were encouraging even in patients with significant comorbidities, suggesting that patients need not meet ZUMA-1 eligibility criteria to benefit from axicabtagene ciloleucel."

One adverse reaction that can occur following CAR T therapy is cytokine release syndrome (CRS). This occurs when a large number of cytokines, which are small proteins released by immune cells, are rapidly released into the blood. This can cause a patient to have a fever, increased heart rate, difficulty breathing and low blood pressure. In the ZUMA-1 trial, 11% of patients treated with Yescarta experienced severe CRS. However, in the commercial setting, that number was lower at 7%.

"We believe this observation is due to the greater use of tocilizumab and corticosteroids compared to ZUMA-1, in line with evolving practice patterns for toxicity management," said Michael Jain, M.D., Ph.D., co-first author and assistant member of the Blood and Marrow Transplant and Cellular Immunotherapy Department at Moffitt.

The authors believe this study suggests that patients do not need to meet the ZUMA-1 eligibility criteria to benefit from Yescarta, including upper age limits and those with underlying conditions.

This study was funded by the National Cancer Institute through grants to Locke (K23CA201594) and Moffitt (P30CA076292).

On May 14, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that an abstract relating to the dose escalation part of the ONCOS-102 and durvalumab trial in primary ovarian and colorectal cancer that has spread to the peritoneum has been selected for presentation at a Poster Discussion Session during ASCO (Free ASCO Whitepaper) 2020 (Press release, Targovax, MAY 14, 2020, View Source [SID1234558099]).

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The study is an open label, exploratory phase I/II trial assessing the intra-peritoneally delivered ONCOS-102 in combination with systemically administered checkpoint inhibitor durvalumab in patients with platinum-resistant ovarian or colorectal cancers that have metastasized to the peritoneal cavity. The trial is designed with a dose-escalation phase assessing three different dosing levels, followed by an expansion phase with a total of up to 78 patients enrolled into separate groups of ovarian and colorectal cancer.

In the ASCO (Free ASCO Whitepaper) abstract, safety, immune activation and clinical response data for the three dose escalation cohorts will be presented. A total of 17 patients were enrolled, 4 in cohort A (low dose), 5 in cohort B (middle dose) and 8 in cohort C (high dose). No dose-limiting toxicities were observed, and the combination had an acceptable safety profile. Therefore, the high-dose level was selected for the expansion phase of the trial, which is currently enrolling patients. Preliminary analyses indicate that the treatment is triggering immune activation and has clinical activity, which were more pronounced in cohort B and C.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very proud that ONCOS-102 was chosen as the oncolytic virus of choice for this trial and we are equally pleased that the scientific committee has selected our ONCOS-102 and durvalumab combination abstract for a poster discussion at the upcoming ASCO (Free ASCO Whitepaper) meeting. Although it is too early in the trial to interpret the clinical data, we are happy to have moved into the expansion phase following successful completion of the dose escalation phase. This is an important clinical trial as it addresses a disease with a very high unmet medical need while potentially opening up intra-peritoneal administration as an alternative delivery route for ONCOS-102."

Poster discussion sessionAbstract title:

Developmental Therapeutics-ImmunotherapyPhase I/II study to evaluate systemic durvalumab + intraperitoneal (IP) ONCOS-102 in patients with peritoneal disease who have epithelial ovarian (OC) or metastatic colorectal cancer (CRC): Interim phase I clinical and translational results.

Date / time:

29 May 2020, 8-11AM CDT

Abstract / Poster:

3017 / 81

The abstract can be found here View Source

The trial is a collaboration between Targovax, AstraZeneca, Cancer Research Institute (CRI) and Ludwig Cancer Research.

On May 14, 2020 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the first quarter ended March 31, 2020 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, MAY 14, 2020, View Source [SID1234558098]).

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"While the NODE-301 trial of etripamil for patients with paroxysmal supraventricular tachycardia (PSVT) did not meet its primary endpoint over the five hour observation period, we are encouraged by the topline data from the trial. With a favorable safety and tolerability profile as well as efficacy signals observed across earlier time points, topline results from NODE-301 reinforce our belief that etripamil has the potential to serve as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes in the at-home setting," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We look forward to working with regulators to determine next steps, with the goal of ensuring that etripamil is able to realize its full potential in patients with PSVT. In parallel, we continue to execute on the balance of the NODE program, including NODE-301B as well as open-label safety studies NODE-302 and NODE-303."

Recent Updates

Reported Topline Results from Phase 3 NODE-301 Trial, Anticipates Regulatory Update in Early 3Q 2020. In March 2020, Milestone reported topline results from its Phase 3, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial of its investigational new drug, etripamil nasal spray, the Company’s novel short-acting calcium channel blocker, in patients with PSVT. Despite early activity, including the conversion of 61% of etripamil patients vs. 45% of placebo patients by 45 minutes (p=0.02), a time period consistent with etripamil’s known pharmacological activity, the study did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five hour period following study drug administration (p=0.12). The small number of placebo patients and prolonged efficacy measurement period was found to have confounded the results. The study did demonstrate statistically significant improvements in favor of etripamil over placebo in the important secondary endpoint of patient reported treatment satisfaction. Milestone believes the safety and tolerability data from the NODE-301 study will be supportive of at-home use of etripamil, with adverse events consistent with those observed in prior trials.

The Company is determining next steps with regulators and expects to provide an update early in the third quarter of 2020. The Company’s full PSVT clinical program, including NODE-301B, NODE-302 and NODE-303, remains ongoing. NODE-301B, which was designed to collect double-blind data from randomized patients who had not yet experienced an event after the NODE-301 trial reached its target number of adjudicated SVT events, is expected to be analyzed separately as a second safety and efficacy data set.
Reduction in Operating Expenses. Milestone expects to reduce planned operating expenses by 20-25% in order to focus its efforts on an optimized clinical development pathway for etripamil that will be determined following regulatory feedback. The cuts will primarily affect pre-commercialization activities. The goal of the operating cuts is to facilitate an additional efficacy study for etripamil in PSVT and to extend the Company’s cash runway. The Company will update its cash runway guidance after meeting with regulators.
Jeff Nelson Promoted to Chief Operating Officer. In March 2020, Milestone announced the promotion of Jeff Nelson to Chief Operating Officer. Mr. Nelson, who joined the Company in 2018 as Vice President of Program Management, brings to this new role over 15 years of experience in the pharmaceutical and biotech field, working primarily in project management, clinical operations, regulatory affairs, drug supply and distribution and public finance.
First Quarter 2020 Financial Results

As of March 31, 2020, Milestone had cash and cash equivalents of $102 million and 24.6 million shares outstanding.
Research and development expense for the first quarter of 2020 was $11.9 million compared with $7.8 million for the prior year period. The increase in expense was primarily driven by increased clinical development costs and manufacturing and formulation activities supporting its Phase 3 clinical trials.
General and administrative expenses for the first quarter of 2020 were $2.7 million compared with $1.0 million for the prior year period. The increase was driven by additional headcount, professional fees and increased insurance costs.
Commercial expense for the first quarter of 2020 was $2.2 million and remained consistant with the prior year period.
For the first quarter of 2020, operating loss was $16.8 million compared to $10.9 million for the prior year period.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions; however, when calcium channel blockers are used for the termination of SVT episodes, they must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, the Company’s lead investigational product, is designed to be a rapid response therapy for episodic cardiovascular conditions. The novel calcium channel blocker is self-administered via a nasal spray which may shift the current treatment paradigm for many patients with PSVT from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in atrial fibrillation patients with rapid ventricular rate, with subsequent studies expected in other conditions where calcium channel blockers are used.