On March 13, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported the signing of a Product Supply Agreement with the Idaho State University Idaho Accelerator Center (IAC) for the production and commercial supply of copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAR 13, 2020, View Source [SID1234555497]).

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!

Under the new agreement, IAC will supply Clarity with Cu-67 for planned clinical development, including the SARTATETM trial in children with neuroblastoma and SAR-bisPSMA trial in prostate cancer patients in the United States. IAC has been Clarity’s long-term partner, providing a reliable supply of high purity and high specific activity Cu-67 for some years. IAC’s proven experience in the production and supply of Cu-67 has already allowed Clarity to initiate and complete therapeutic studies in a range of cancer types both in the United States and in Australia.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to bolster our relationship with IAC to further progress our pipeline of theranostic agents in the fight against cancer. IAC’s electron accelerator capability enables Clarity to eliminate the reliance on supply from the limited number of aging nuclear reactors which currently produce therapeutic radionuclides such as lutetium-177. This gives Clarity the opportunity to move swiftly through clinical trials with its three main products, SARTATETM, SAR-bisPSMA and SAR-BBN in such indications as neuroblastoma, neuroendocrine tumours, prostate cancer, breast cancer and brain cancers.

"We are pleased to have signed the Product Supply Agreement with Clarity and are looking forward to continuing our supply of this copper isotope using our increased capacity and our world leading e-linac process to produce a high purity product at very high specific activity," said Jon Stoner, director of the IAC. "Clarity’s proprietary chelator technology along with our patent protected commercially produced Cu-67 combine to showcase a future market leading medical isotope."

Dr Taylor further commented, "Clarity is a clinical stage radiopharmaceutical company that is uniquely placed to control its full supply chain within the United States. With IAC further planning on additional facilities to support the development of Cu-67 production and with Clarity having recently signed a Letter of Intent with NorthStar Medical to supply and industrialise the production of this therapeutic isotope, we are well underway towards building stable and reliable commercial-scale supply of Cu-67 for our late-phase trials and market entry of our products in a number of large cancer indications".

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumours (NETs), neuroblastoma, glioma, lymphoma, ovarian cancer and bladder cancers. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. The IAC has developed a proprietary process for production of high purity and high specific activity Cu-67 to meet demand for clinical research and treatment.

On March 13, 2020, Aclaris Therapeutics, Inc. (the "Company") reported tha it has entered into an Open Market Sale Agreement (the "Agreement") with Jefferies LLC ("Jefferies") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.00001 per share (the "Common Stock"), having an aggregate offering price of up to $25,000,000 through Jefferies as its sales agent (Filing, 8-K, Aclaris Therapeutics, MAR 13, 2020, View Source [SID1234555548]). The issuance and sale, if any, of Common Stock by the Company under the Agreement is subject to the effectiveness of the Company’s registration statement on Form S-3, to be filed with the Securities and Exchange Commission on March 13, 2020. The Company makes no assurances as to if or whether the registration statement will become effective or, if it does become effective, as to the continued effectiveness of the registration statement.

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!

Jefferies may sell the Common Stock by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended. Jefferies will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission equal to three percent (3.0%) of the gross sales proceeds of any Common Stock sold through Jefferies under the Agreement. The Company has provided customary representations, warranties and covenants and the parties have agreed to customary indemnification rights.

The Company is not obligated to make any sales of Common Stock under the Agreement. The offering of shares of Common Stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On March 13, 2020 Moleculin Biotech Presented the Corporate Presentation (Presentation, Moleculin, MAR 13, 2020, View Source [SID1234555607]).

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!

On March 12, 2020 Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and Context Therapeutics LLC, a clinical stage biopharmaceutical company focused on hormone driven cancers, reported the signing of collaboration agreements for the development, manufacturing, registration and future commercialization of onapristone extended release (ER) (Press release, Tyligand Bioscience, MAR 12, 2020, View Source [SID1234644992]).

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!

Onapristone ER is currently being evaluated in patients with progesterone receptor positive (PR+) ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Initiation of additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and endometrial cancers are planned for mid-2020.

Under the terms of the agreements, Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs, and standards for quality, safety and cost. Upon completion of specific performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for the development and commercialization of onapristone ER in China, Hong Kong and Macau (the "Territory"), and Context will be eligible to receive royalties on net sales of onapristone ER in the Territory. Context will retain rest of world rights to commercialize onapristone ER.

"We are thrilled to partner with Tyligand as we accelerate onapristone ER’s Phase 2 evaluation and prepare for Phase 3," said Martin Lehr, CEO of Context. "Tyligand is renowned for its expertise in process development and has strong networks with manufacturing and clinical capabilities in China and the U.S. Partnering with Tyligand will enable Context to optimize and efficiently scale our manufacturing and clinical capacity to support the evaluation and future commercialization of onapristone ER, our experimental oral therapy, to address the unmet need in treating patients with PR+ cancers."

"Even with the major advances in cancer therapies in recent years, treatment options for patients with hormone driven cancers remain limited," said Tony Zhang, CEO of Tyligand."Onapristone ER has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and the best-in-class treatment option for breast, endometrial and ovarian cancers. We are proud to partner with Context to develop onapristone ER and make this innovative medicine ultimately more accessible for patients around the world."

On March 12, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the pricing of an underwritten public offering of 8,333,334 ordinary shares at a price to the public of $9.00 per share (Press release, Compugen, MAR 12, 2020, View Source [SID1234555454]). The gross proceeds to Compugen from the offering are expected to be approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Compugen. In addition, Compugen has granted the underwriters a 30-day option to purchase up to an additional 1,250,000 ordinary shares, at the public offering price less underwriting discounts and commissions. The offering is expected to close on or about March 16, 2020, subject to customary closing conditions.

SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. SunTrust Robinson Humphrey is acting as lead manager for the offering and Oppenheimer & Co. is acting as co-manager for the offering.

The securities described above are being offered by Compugen pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by Compugen with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 12, 2019. A final 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 located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at +1(800) 808-7525, ext. 6218, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1(415) 364-2720 or by email at [email protected].

This press release does 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

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!