1stOncology™: Cancer Intelligence Service – Page 9929 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Adamis Pharmaceuticals Announces Pricing of Public Offering of Common Stock

On January 29, 2021 Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, reported the pricing of its previously announced underwritten public offering of 40,540,540 shares of its common stock at a public offering price of $1.11 per share, resulting in gross proceeds of approximately $45,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company (Press release, Adamis Pharmaceuticals, JAN 29, 2021, View Source [SID1234574423]). All shares of common stock to be sold in the public offering are being sold by Adamis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The offering is expected to close on February 2, 2021, subject to the satisfaction of customary closing conditions. The company has also granted the underwriters a 30-day option to purchase up to 6,081,081 additional shares of its common stock to cover over-allotments, if any.

Raymond James & Associates, Inc. is acting as the sole book-running manager for the offering.

The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, capital expenditures, manufacturing, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

The securities described above are being offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A preliminary prospectus supplement and the related prospectus have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and an accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida, or by telephone at (800) 248-8863, or e-mail at [email protected].

Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the company and the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, 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 jurisdiction.

Myovant Sciences to Host Third Fiscal Quarter 2020 Earnings Conference Call at 8:30 a.m. Eastern Time on February 11, 2021

On January 29, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported it will host a webcast and conference call to discuss corporate updates and financial results for its third fiscal quarter 2020, ended December 31, 2020 (Press release, Myovant Sciences, JAN 29, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-third-fiscal-quarter-2020-earnings [SID1234574422]). The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on February 11, 2021.

Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

A replay of the webcast, along with the earnings press release and presentation slides, will be archived on Myovant’s investor relations website.

Turning Point Therapeutics Reports Updated Interim Data From Registrational Phase 2 Trident-1 Study of Repotrectinib in Patients With ROS1-Positive TKI-Naïve Non-Small Cell Lung Cancer

On January 29, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that updated interim findings from the ongoing TRIDENT-1 registrational study of lead drug candidate repotrectinib in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC) (Press release, Turning Point Therapeutics, JAN 29, 2021, View Source [SID1234574421]).

In a total of 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed the confirmed objective response rate (ORR) by physician assessment was 93% (95% CI: 68-100) and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99).

The findings will be presented in a mini-oral presentation by Dr. Byoung Chul Cho, Division of Medical Oncology, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer.

"These interim data confirm our belief that repotrectinib has the potential to be the best-in-class treatment for patients with ROS1-positive TKI-naïve advanced non-small cell lung cancer," said Mohammad Hirmand, M.D., chief medical officer. "To date, we have enrolled approximately 40 ROS1-positive TKI-naïve patients in the Phase 1 and 2 portions of the TRIDENT-1 study dosed at or above the Phase 2 dose– an encouraging increase in enrollment following our data update from last August—and we look forward to discussing next steps towards registration of repotrectinib in this patient population at a Type B meeting with the FDA anticipated in the first half of the year."

Interim Update
Utilizing a Dec. 31, 2020 cutoff date, the TRIDENT-1 preliminary interim efficacy update includes 22 ROS1-positive TKI-naïve NSCLC patients pooled from the Phase 1 portion of the study (dosed at or above the Phase 2 dose) with patients from the Phase 2 portion who had at least two post-baseline scans. Responses for patients in the Phase 2 portion of the study were determined by physician assessment. The interim safety update includes a total of 185 patients from the Phase 1 and Phase 2 portions of the study utilizing an Oct. 30, 2020 cutoff date.

14 of 15 patients treated in the Phase 2 portion achieved a confirmed ORR of 93% (95% CI: 68-100). At the time of the data cut-off, the one non-responder remained on treatment and in stable disease with a 13% tumor reduction. In addition, one of the 14 patients in a partial response at the time of the data cutoff date has since achieved a confirmed complete response.

Duration of response ranged from 1.3+ to 7.4+ months, and the duration of treatment ranged from 3.7+ to 10.9+ months with 14 of the 15 patients remaining on treatment. As of the cutoff date, one additional patient (not included in the confirmed ORR calculation) had an unconfirmed partial response and was on treatment awaiting a confirmatory scan. The company’s prior Phase 2 update with the data cutoff date of July 10, 2020 in 7 total patients, showed a confirmed ORR of 86% and a wider 95% confidence interval of 42 to 100.

20 of 22 patients pooled from Phase 1 and Phase 2 achieved a confirmed ORR of 91% (95% CI: 71-99). In the 7 patients from the Phase 1 portion dosed at or above the Phase 2 dose, duration of treatment ranged from 10.9 to 37.3 months with a median of 30.9 months, with four patients receiving treatment for longer than 30 months.

Repotrectinib was generally well tolerated in 185 patients treated in the Phase 1 and Phase 2 portions of the study.

Treatment-emergent adverse events (TEAE) found in greater than 15 percent of patients were dizziness (58%), dysgeusia (43%), constipation (32%), dyspnea (31%), fatigue (27%), paresthesia (25%), anemia (22%), nausea (20%), and muscular weakness (16%).

There were four cases of Grade 3 dizziness (2%) and no cases of dizziness have led to treatment discontinuation. Dose modifications due to TEAEs were infrequent, including 18% that led to dose reduction and 9% that led to drug discontinuation.

The majority of treatment related AEs (TRAEs) were Grade 1 or 2 and there were no Grade 4 or Grade 5 TRAEs.

Entry Into a Material Definitive Agreement

On January 29, 2021, Aileron Therapeutics, Inc., a Delaware corporation (the "Company"), reported that it entered into a Capital on Demand Sales Agreement (the "Sales Agreement") with JonesTrading Institutional Services LLC and William Blair & Company, L.L.C. (each, an "Agent" and collectively, the "Agents"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $30,000,000 (the "Shares") from time to time through or to the Agents (the "Offering") (Filing, 8-K, Aileron Therapeutics, JAN 29, 2021, View Source [SID1234574417]). On January 29, 2021, the Company filed a prospectus supplement with the Securities and Exchange Commission in connection with the Offering (the "Prospectus Supplement") under its existing Registration Statement on Form S-3 (File No. 333-226650), which became effective on August 7, 2018 (the "Registration Statement").

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Shares in accordance with the terms set forth in the placement notice and by methods deemed to be "at the market offerings" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act").

The Company or the Agents may suspend or terminate the offering of Shares upon notice to the other party and subject to certain conditions. An Agent will act as sales agent using commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market LLC.

The Company has agreed to pay the Agents commissions for their services in acting as agents in the sale of the Shares in the amount of up to 3.0% of gross sales price per share sold under the Sales Agreement. The Company has also agreed to provide the Agents with indemnification and contribution with respect to certain liabilities, including civil liabilities under the Securities Act.

A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement

On January 29, 2021 Incyte (Nasdaq:INCY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy (Press release, Incyte, JAN 29, 2021, View Source [SID1234574416]).

"The positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying patients during the early disease stages," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "Following the recent FDA approval of pemigatinib (Pemazyre), we are delighted to be closer to offering the first targeted therapy in Europe to benefit these patients."

The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. The CHMP’s opinion to recommend the use of pemigatinib is now being reviewed by the European Commission, which has the authority to grant marketing authorizations for medicinal products in the European Union (EU). If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor1,2. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,0003,4. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients5,6,7.

About FIGHT-202
The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit View Source

About FIGHT
The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type.

FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About FGFR and Pemigatinib
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.