Quarterly Activities Report and 4C – to 30 June 2022

On July 29, 2022 Avecho (ASX:AVE) reported that it has published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 30 June 2022 (Press release, Phosphagenics, JUL 29, 2022, View Source [SID1234617118])

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Key highlights from this period include:

Essential preparation underway for the commencement of Phase III CBD soft-gel program;
High profile exposure for Phase II data trialling the effectiveness of cannabinoids for treating arthritis of the hand, in top tier media and as part of the International Cannabis Research Society (ICRS) Conference in Galway;
Promising business development and partnership discussions ongoing for cannabinoid and broader portfolio of human health products;
Receipt of $1,007,990.22 under the Australian Government’s R&D Tax Incentive Scheme.
Avecho’s cash balance on 30 June was $3.13m.

Science Publication First to Describe Modifi Bio’s Novel Approach to Fight Cancer Cells with DNA Modification

On July 28, 2022 Modifi Biosciences reported that the journal Science has published a critical study validating the company’s novel oncology platform based on new classes of molecules that exploit tumor-associated DNA repair defects through direct cancer cell DNA modification (Press release, , JUL 28, 2022, View Source [SID1234629035]). The company closed a $6.4M seed round, which will support IND-enabling studies and expansion of the platform to target cancers with other DNA repair defects. Key investors in this round include HighCape Capital; Connecticut Innovations; Ironwood Capital; the Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society; and Yale Ventures.

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"This approach redefines the rules on how to selectively kill cancer cells via direct DNA modification and positions our company as a leader in this emerging field of oncology drug development," said study co-lead author and Modifi Bio co-founder, Ranjit Bindra, MD, PhD. Bindra is the Harvey and Kate Cushing Professor of Therapeutic Radiology at Yale School of Medicine and Scientific Director of the Yale Brain Tumor Center at Smilow Cancer Hospital. "As a brain tumor doctor treating patients for over a decade, my colleagues and I have seen gliomas take the lives of too many patients. Our discovery represents a major step forward in changing the treatment paradigm for this devastating disease, as well as for many other cancers with intrinsic DNA repair defects."

The technology bypasses conventional approaches that indirectly target proteins in cancer cells and demonstrates robust anti-tumor activity in glioma, one of the deadliest forms of brain cancer, while sparing normal tissue. In the Science publication, the group’s new class of molecules were found to be exquisitely active and selective against cancer cells that lack expression of a key DNA repair protein called MGMT (O6-methylguanine methyl transferase).

Approximately half of all glioblastomas and up to 80% of gliomas lack MGMT. Emerging research indicates that MGMT deficiency is seen in many other tumor types, suggesting broad applicability for this strategy in treating cancer.

Modifi Bio is creating a new class of molecules, based on research conducted at Yale, that fragment in cells and induce DNA modifications, which are irreparable in cancer cells with DNA repair defects. Modifi Bio’s compounds are designed to be orally bioavailable and possess favorable drug-like properties, which will allow them to rapidly file an Investigative New Drug application with the U.S. Food and Drug Administration in anticipation of Phase I clinical trials in 2024.

"These molecules are particularly promising as therapeutics because of their ability to directly modify DNA of cancer cells, which we believe will not only be effective in fighting cancer but will also allow us to overcome key resistance mechanisms," said Seth Herzon, PhD, study co-lead author, Modifi Bio co-founder, and the Milton Harris ’29 PhD Professor of Chemistry in Yale’s Faculty of Arts and Sciences.

"Novel treatments for these types of brain cancer are urgently needed. I am enthusiastic that this paradigm-shifting discovery may lead to the first clinically meaningful pharmacological advances in the treatment of glioma in over two decades," said Roger Stupp, MD, a member of the Modifi Bio Scientific Advisory Board, Paul C. Bucy Professor of Neurological surgery, and Chief of Neuro-oncology at Northwestern University. Stupp first published the pivotal studies over 20 years ago, which define the current standard of care for glioma.

The research was conducted at Yale University and the co-first authors of the Science study are Kingson Lin and Susan Gueble. Co-authors are Ranjini Sundaram and Eric Huseman. The technology highlighted in the research has been exclusively licensed to Modifi Bio with support from Yale Ventures. Co-founders of Modifi Bio include Herzon, Bindra, Lin, and Kevin Rakin.

Funding for the research came, in part, from the National Institutes of Health and the Yale Cancer Center. Additionally, Bindra received CureSearch for Children’s Cancer’s Catapult Award. CureSearch’s mission is to end childhood cancer by driving targeted and innovative research with measurable results in an accelerated time frame.

PharmAbcine Newsletter – 2Q22

On July 28, 2022 PharmAbcine reported newsletter 2Q 2022 (Press release, PharmAbcine, JUL 28, 2022, View Source;bmode=view&idx=12445566&t=board [SID1234618960]).

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Entry Into a Material Definitive Agreement

On July 28, 2022, Apellis Pharmaceuticals, Inc. (the "Company") reported that entered into separate, privately negotiated exchange agreements (the "Exchange Agreements") with certain holders of its 3.500% Convertible Senior Notes due 2026 (the "Notes") (Filing, 8-K, Apellis Pharmaceuticals, JUL 28, 2022, View Source [SID1234617323]). Under the terms of the Exchange Agreements, the holders have agreed to exchange with the Company approximately $22.5 million in aggregate principal amount of Notes held by them for (i) 456,128 shares of the Company’s common stock, which is equal to 20.2724 shares per $1,000 principal amount of Notes exchanged plus (ii) an additional number of shares of the Company’s common stock per $1,000 principal amount of Notes exchanged equal to the quotient of (a) $591.91 divided by (b) the average of the daily volume-weighted average prices of the Company’s common stock over the three consecutive trading days commencing on July 29, 2022 (collectively, the "Shares"). These exchange transactions are expected to close on August 4, 2022, subject to the satisfaction of customary closing conditions.

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Entry into a Definitive Material Agreement

On July 28, 2022, Radius Health, Inc. ("Radius") and Teijin Pharma Limited ("Teijin") reported that it entered into an Amendment to License and Development Agreement ("Amendment") to the License and Development Agreement ("LDA") entered into between Radius and Teijin on July 13, 2017 (Filing, 8-K, Radius, JUL 28, 2022, View Source [SID1234617277]).

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The LDA contemplates the commercialization of the active pharmaceutical ingredient abaloparatide for subcutaneous injection ("abaloparatide-SC") for the treatment of osteoporosis and included a joint commercialization opportunity between Teijin and Radius. Under the LDA, Radius grants Teijin a license to Radius intellectual property related to abaloparatide-SC in exchange for a royalty on net sales of abaloparatide-SC in Japan.

The LDA has been amended by the Amendment to remove references to the joint commercialization opportunity. The LDA has also been amended to waive the royalty on net sales of any abaloparatide-SC purchased by Teijin through a Commercial Supply Agreement ("CSA") entered into between Teijin and Radius concurrently with the Amendment. The Amendment does not have any impact on royalties owed on sales of abaloparatide-SC not purchased through the CSA, and accordingly, for any abaloparatide-SC sold by Teijin but not purchased through the CSA, royalty payments will be owed by Teijin to Radius under the LDA in consideration for the license granted by Radius to Teijin thereunder.

The Amendment also provides that the LDA may be terminated by either party due to a material breach of the CSA by the other party.

Under the CSA, Radius will supply to Teijin, and Teijin will purchase from Radius, a finished product comprising a cartridge filled with abaloparatide-SC ("Drug Product").

Specifically, Radius will purchase, for Teijin, the abaloparatide-SC from a material supplier and then have a commercial supplier fill the cartridges with abaloparatide-SC and supply final Drug Product for commercialization and distribution by Teijin in Japan. As consideration, Radius will receive an annual fee and a per-unit supply price for all Drug Product purchased by Teijin through Radius under the CSA. Any other costs borne by Radius for the purchase of abaloparatide-SC or manufacture of the Drug Product will be reimbursed by Teijin.

Radius has also agreed under the CSA, in the event of any breach of the supply agreement by the commercial supplier resulting in a Radius breach of the CSA, to pursue any potential claims against commercial supplier on behalf of Teijin to the extent required under the CSA.

The CSA will remain in effect, unless terminated earlier for breach, until the earlier of the expiration or termination of the LDA, the expiration or termination of Radius’s commercial supply agreement with the commercial supplier, or termination by either party in the event of the other party’s bankruptcy.