On July 19, 2021 SUNY Upstate reported that Cancer patients undergoing treatment frequently require assistance getting to and from facilities, often creating a financial and logistical burden (Press release, SUNY Upstate, JUL 19, 2021, View Source [SID1234584963]). That’s why the American Cancer Society has awarded a $10,000 transportation grant to the Upstate Cancer Center. These funds will be used to address the transportation needs of cancer patients in Central New York.

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To help patients get the critical care they need, American Cancer Society community transportation grants are awarded at a local level to health systems, treatment centers and community organizations. These grants are available in select communities through an application process and focus on addressing unmet transportation needs of cancer patients, particularly vulnerable populations experiencing an unequal burden of cancer.

"Disparities predominantly arise from inequities in work, wealth, income, education, housing and overall standard of living, as well as social barriers to high-quality cancer prevention, early detection and treatment services," said Joanie Richter of the American Cancer Society. "The Society collaborates with community health partners to reach individuals in areas with higher burdens of cancer and limited or no access to transportation because even the best treatment can’t work if a patient can’t get there."

The Upstate Cancer Center received a $10,000 transportation grant.

"The goal of this project is to remove transportation as a barrier to receiving cancer treatment," said Richard Kilburg, associate administrator of the Upstate Cancer Center. "We hope to ensure that no Upstate Cancer Center patient misses an appointment due to lack of transportation or lack of transportation resources."

"On behalf of our patients, we thank the American Cancer Society for their generous support," Kilburg said.

Caption: From left: Amy Williams, social worker; Joni Richter, American Cancer Society manager, Strategic Partnerships, Cancer Control Northeast Region; Dick Kilburg, associate administrator of the Upstate Cancer Center; and Linda Naples, financial counselor.

On July 19, 2021 Orion Group reported that Half-Year Financial Report 1-6/2021 (Press release, Orion , JUL 19, 2021, View Source [SID1234584946])

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This is a summary of Orion’s Half-Year Financial Report 1-6/2021. The complete report is attached to this stock exchange release and is available at View Source

Net sales totalled EUR 524 million (EUR 572 million in 1–6/2020).
Operating profit was EUR 146 (181) million.
Profit before taxes was EUR 145 (180) million.
Equity ratio was 68% (65%).
ROCE before taxes was 36% (44%).
ROE after taxes was 32% (38%).
Basic earnings per share were EUR 0.82 (1.02).
Cash flow per share before financial items was EUR 0.53 (0.90).
The outlook for 2021 remains unchanged. Orion estimates that net sales in 2021 will be slightly lower than in 2020 (net sales in 2020 were EUR 1,078 million). Operating profit is estimated to be lower or clearly lower than in 2020 (operating profit in 2020 was EUR 280 million).

President and CEO Timo Lappalainen:
Orion’s operating profit excluding milestone payments on par with previous year

"2021 has marched on steadily despite the exceptional circumstances brought on by the COVID-19 pandemic. For Orion, this has meant continuing to focus on looking after the health and safety of our employees and ensuring production continuity, product availability and patient safety in ongoing clinical trials.

Orion’s net sales in January-June 2021 were EUR 524 (572) million and the company’s operating profit was EUR 146 (181) million. The anticipated decline in net sales and operating profit was mainly attributable to three factors: the milestone payments that were clearly smaller than in the comparison period, a drop in the sales of Dexdor and Simdax owing to the expiration of their product patent protection and the expiration of a significant distribution agreement for veterinary drugs last year. Nubeqa product net sales booked by Orion increased as strongly as expected. The Specialty Products unit’s net sales were at a good level on the whole, although they did decrease from the strong comparison period. In some product groups, the demand has been clearly weaker than normal. This owes itself to various restrictions relating to the COVID-19 pandemic, which have resulted in a reduced prevalence of seasonal illnesses as opposed to the norm and a dip in the number of medical appointments. These consequences of the pandemic also had a negative effect on the demand for the Easyhaler products. The Animal Health unit’s business developed vigorously in all markets due to new product launches and distribution agreements, among other things. On the whole, the unit’s net sales fell short of the comparison period because of the said expiration of a significant distribution agreement.

During the review period, we received positive news of our research and development projects, as Tessie, a veterinary drug developed by Orion, was recommended for marketing authorisation by the Committee for Medical Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) and Bonqat, another veterinary drug developed by Orion, received a marketing authorisation from the European Commission.

More good news came in from Orion’s digital therapies development projects, as the VIRPI trial, which examined the effects of utilising virtual reality therapy in the treatment of chronic low back pain, reported positive results in June.

In the review period, we decided to discontinue the development of a new dry powder inhaler and focus on developing the existing Easyhaler platform as well as improving competitiveness. The Easyhaler technology has been on the market for decades and is the subject of continued development.

The estimate concerning the completion of the Phase III ARASENS clinical trial on darolutamide with Bayer was updated in the review period, and the trial is currently expected to reach primary completion in the final quarter of 2021. Orion’s other key clinical development projects proceeded as expected in the review period.

The global pharmaceutical supply chains have functioned fairly well from Orion’s perspective throughout the pandemic, and so far we have not experienced any material disruptions or shortages. To our current knowledge, no disruptions or shortages are expected to affect the outlook for the rest of 2021 either. The risk associated with disturbances in global supply and logistics chains continues to be higher than usual, and we have taken various measures to mitigate it, such as increasing the stock levels of products, raw materials and supplies clearly above their long-term averages. Travel and other restrictions resulting from the pandemic have not caused labour shortages at Orion so far, and we have been able to carry out all maintenance procedures and scheduled production shutdowns as planned, even those requiring special expertise.
In the review period, we continued our determined work to achieve Orion’s strategic growth target and commenced preparations to expand our non-European operations to Australia and New Zealand, among other things. Last year, we expanded our operations to Singapore, Malaysia and Thailand, and operations in these countries have started as planned. We have also continued our systematic work to identify and evaluate targets for product and business acquisitions."

Outlook for 2021 (provided on 9 February 2021)

Orion estimates that net sales in 2021 will be slightly lower than in 2020
(net sales in 2020 were EUR 1,078 million).

Operating profit is estimated to be lower or clearly lower than in 2020
(operating profit in 2020 was EUR 280 million).

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Monday, 19 July 2021 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

On July 19, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that following a pre-planned interim safety review of 55 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2 (Press release, Celsion, JUL 19, 2021, View Source [SID1234584949]). The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported.

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The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

The OVATION 2 Study is designed with an 80% confidence interval for an observed Progression Free Survival (PFS) Hazard Ratio of 0.75, which would mean an approximate 33% improvement in risk for cancer progression when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only). GEN-1 is an immunotherapy that produces safe and durable local levels of IL-12, a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

The Company also announced that more than 50% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from the first 36 patients who have undergone interval debulking surgery are as follows:

Of the 36 patients who have undergone interval debulking surgery in the OVATION 2 Study:
20 patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16 out of 20 patients (80%) having a complete tumor resection (R0), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed; and
16 patients were treated with NACT only, with 9 out of 16 patients (56%) having R0 resections.

When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to NACT:
% Patients with R0 Resections
0, 36, 47 mg/m² of GEN-1 plus NACT n=22 50 %
61, 79, 100 mg/m² of GEN-1 plus NACT n=28 82 %

The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 16 patients treated with NACT only were comparable, as expected, to the 20 patients treated with GEN-1 at a dose of 100 mg/m² plus NACT, with both groups demonstrating an approximate 80% ORR.
"These findings show a consistent dose-dependent clinical response in both surgical outcome and tumor response, which is further supported by translational data of the tumor microenvironment," noted Nicholas Borys, M.D., Celsion’s executive vice president and chief medical officer. "Continuing our clinical research program at the 100 mg/m2 dose in patients with advanced-stage ovarian cancer holds promise and is strongly encouraged by our study investigators and medical advisors."

"We thank the DSMB members for their work and advice," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are encouraged by the current rate of patient recruitment and expect to complete enrollment around the end of this year. FDA Fast Track and Orphan Drug Designations for GEN-1 in advanced ovarian cancer are important for our future commercialization efforts. In addition, under the Biologics Price Competition and Innovation Act of 2009, sponsors of new, licensed biological products like GEN-1 that are approved through a Biologics License Application receive 12 years of market exclusivity. The FDA cannot license any 351(k) application for a biosimilar or interchangeable product that relies on the previously approved product as a reference for biosimilarity during this 12-year period."

In February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data announced today.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

On July 19, 2021 Cytokinetics, Incorporated (Nasdaq:CYTK) reported plans to offer, subject to market and other conditions, $200,000,000 of shares of its common stock in an underwritten public offering (Press release, Cytokinetics, JUL 19, 2021, View Source [SID1234584979]). There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares of common stock in the offering will be sold by Cytokinetics.

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J.P. Morgan and Morgan Stanley are acting as joint book-running managers for the offering. Mizuho Securities and JMP Securities are acting as passive book-runners.

The securities described above are being offered by Cytokinetics pursuant to a shelf registration statement (including a prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone: 1-866-803-9204, or by email at [email protected]; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

On July 10, 2021 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that it has converted all of the $28.0 million aggregate principal of the Company’s 2020 5.00% Convertible Senior Notes due 2048 (the 2020 Notes) in exchange for approximately 8.6 million shares of the Company’s common stock, based on the Company’s existing Mandatory Conversion right (Press release, Verastem, JUL 19, 2021, View Source [SID1234584947]). This transaction, which eliminates substantially all of the Company’s outstanding debt, preserves approximately $31.2 million in cash, including $3.2 million in future interest payments that would have been payable through November 1, 2023.

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Robert Gagnon, Chief Financial Officer of Verastem Oncology, commented: "This conversion of our 2020 Notes eliminates substantially all outstanding debt and provides us with greater financial flexibility, all while reducing future cash needs for interest payments and to repay the notes at maturity. We now enter the second half of 2021 with a stronger balance sheet and believe we are well positioned to execute on our corporate objectives, including the advancement of VS-6766 and defactinib through registration-directed Phase 2 clinical trials in low-grade serous ovarian cancer (LGSOC) and KRAS G12V-mutant non-small cell lung cancer (NSCLC)."

On November 6, 2020, the Company entered into a privately negotiated agreement with an investor who held the Company’s 2018 5.00% Convertible Senior Notes due 2048 (the 2018 Notes), and exchanged approximately $28.0 million aggregate principal amount of the 2018 Notes for approximately $28.0 million aggregate principal amount of newly issued 2020 Notes. Under the terms of the 2020 Notes, Verastem became eligible to exercise its right to cause all outstanding 2020 Notes to be converted automatically because the daily volume weighted average price (VWAP) per share of the Company’s common stock was equal to or exceeded 123.08% of the conversion price on each of at least 20 VWAP trading days during a 30 consecutive VWAP trading day period. The conversion rate for the 2020 Notes was 307.6923 shares of the Company’s common stock per $1,000 principal amount of the 2020 Notes, which is equivalent to a conversion price of approximately $3.25 per share, representing an approximately 153.9% premium to the sale price of $1.28 per share of the Company’s common stock on November 5, 2020.

Verastem Oncology ended the first quarter 2021 with cash, cash equivalents and investments of $127.1 million. With the anticipated proceeds from the sale of COPIKTRA, the Company expects that it will have a cash runway until at least 2024 to deliver on the current programs for VS-6766 and defactinib, including clinical and regulatory milestones and development in LGSOC and KRAS mutant NSCLC.