On June 26, 2023 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and AdvanCell, a company developing an innovative pipeline of targeted alpha therapies with a platform technology to produce 212Pb radiopharmaceuticals, reported a collaboration on the development of a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of 212Pb-labeled radioligands by each company (Press release, Point Biopharma, JUN 26, 2023, View Source [SID1234632906]).

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212Pb is differentiated as both an alpha and beta-emitting isotope with a simple decay chain that has demonstrated promising clinical results1 in compassionate use and phase 1 settings. 212Pb is produced via a generator using thorium (228Th, 1.9 year half-life) or radium (224Ra, 3.6 day half-life) sources. 228Th is available in significant quantities and has a half-life that supports 212Pb generators with ~1 year shelf-lives stationed at a selected number of regional locations globally. The short half-life of 212Pb (10.6 hours) has the benefit of delivering >99% of the tumor cell–killing radiation in only 72 hours, which reduces the time that the ligand needs to be retained in the tumor, a common limitation for targeted radioligand therapies. The short half-life may also promote the earlier maintenance of functional immune cells infiltrating the tumor relative to longer-lived isotopes. In contrast, only ~20% of the decays from 225Ac occur in 72 hours, so prolonged tumor retention is required to achieve the same payload delivery.

"We constantly strive to use the right isotope for the job, and variations in ligand and tumor characteristics require different isotope properties," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "Adding 212Pb to our toolbox increases the optionality for new programs with the goal of developing new therapeutic options with improved clinical outcomes. Importantly, AdvanCell’s proprietary 212Pb generator technology based on 228Th sources is next-generation technology that we believe can scale to commercial quantities. Having a greater range of isotope choices, combined with supply chain visibility and control over access, will facilitate not only robust clinical development programs but also make eventual supply for commercialization more predictable as we look to expand our pipeline to bring next-generation radioligands to more patients."

"AdvanCell is delighted to collaborate with POINT Biopharma, whose excellence and track record in manufacturing and clinical development we have admired and respected for some time," said Andrew Adamovich, Chief Executive Officer of AdvanCell. "AdvanCell was founded on the belief that targeted alpha therapies will change the course of cancer treatment. These treatments have demonstrated incredible efficacy but have been hampered by manufacturing and supply issues. AdvanCell’s technology, in combination with POINT’s demonstrated manufacturing expertise and our joint commitment to developing life-saving therapies, will deliver on the promise of targeted alpha therapy and positively impact the lives of many. As AdvanCell progresses ADVC001, our lead clinical program for the treatment of metastatic prostate cancer, this collaboration will accelerate clinical development and ensure the scaled supply of these important medicines."

On June 26, 2023 Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, reported that it has completed the second closing of its previously announced securities purchase agreement, resulting in $34 million of new capital before placement agent and transaction fees (Press release, Orchard Theraputics, JUN 26, 2023, View Source [SID1234632905]).

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In March 2023, the company completed the first closing of an innovative financing arrangement, led by RA Capital Management with participation from other leading healthcare investors that resulted in $34 million of new capital before placement agent and transaction fees. Per the terms of the agreement, the company could bring in an aggregate of up to $188 million (inclusive of the $68 million raised at the first and second closings) at increasing valuations following the achievement of certain U.S. regulatory milestones for OTL-200 for MLD. The conditions of the second closing included shareholder approval and the company’s intention to initiate a biologics license application (BLA) submission following receipt of minutes from a productive pre-BLA meeting with the U.S. Food and Drug Administration for OTL-200, both of which have been achieved. The second closing comprises the sale of units at a purchase price of $8.00 per unit for aggregate proceeds of $34 million, including the issuance of 4.25 million American Depository Shares (ADSs) as well as warrants.

"The initiation of our BLA submission marks a significant de-risking event for Orchard and our OTL-200 program ahead of a potential U.S. approval in MLD," said Frank Thomas, president and chief operating officer of Orchard Therapeutics. "This next wave of funding from the second closing is expected to provide important capital to support preparations for our anticipated first U.S. launch and advance our next-in-line neurometabolic programs derived from our HSC gene therapy platform. We want to thank each of the participating investors for supporting this unique and innovative structure and partnering with us to develop a standout company in the field of gene therapy."

Guggenheim Securities, LLC acted as the sole placement agent for the private placement.

Orchard intends to use the net proceeds from the offering to support its growing commercial capabilities for Libmeldy, prepare for a potential U.S. approval for OTL-200 and advance its HSC gene therapy portfolio. The company expects that its existing cash, cash equivalents and investments, inclusive of the proceeds from the second closing, will fund its anticipated operating, debt service and capital expenditure requirements into mid-2025, with the potential for additional runway extension pending the exercise of the warrants issued as part of the financing.

The securities were sold in a private placement and have not been registered under the Securities Act of 1933, as amended (Securities Act), and may not be offered or sold in the U.S. absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission (SEC), for purposes of registering the resale of the ordinary shares issued or issuable in connection with the offering.

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

On June 26, 2023 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") and Kyushu University reported that they have commenced a joint research initiative aimed at developing novel reactive groups for the discovery of covalent drugs targeting specific proteins (Press release, Taiho, JUN 26, 2023, View Source [SID1234632902]).

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Covalent drugs, due to their mechanism of action, can offer advantages such as enhanced efficacy and extended duration of action compared to traditional reversible drugs. Taiho has been pioneering the development of Cysteinomix, a drug discovery technology platform for creating drugs that form covalent bonds with a specific amino acid (cysteine) present in target proteins. This technology platform has led to the creation of multiple in-house pipelines, including an FGFR inhibitor approved in the U.S. in 2022.

Kyushu University, a pioneering advocate of covalent drugs, has simultaneously been working on the development of proprietary novel covalent reactive groups. Its researchers have been developing agents for the treatment of cancer and infectious diseases using these reactive groups, and have succeeded in identifying multiple covalent inhibitors that combine strong efficacy with excellent target selectivity.

In March 2023, Taiho and Kyushu University concluded a joint research agreement aimed at developing novel covalent reactive groups for specific amino acids by merging drug discovery techniques in which each institution excels. This collaboration is expected to expand the range of target proteins and contribute to the provision of new covalent drugs.

Takeshi Sagara, Executive Director, Board Member, Clinical Development Medical Affairs Division, Discovery and Preclinical Research Division at Taiho commented, "We believe that the expansion of Cysteinomix drug discovery in partnership with Kyushu University will enable the creation of drugs for diseases previously considered challenging in drug discovery. We will continue to advance Cysteinomix to bring new drugs to areas with high unmet medical needs."

Akio Ojida, Professor at the Graduate School of Pharmaceutical Sciences, Kyushu University, noted, "We believe that our collaboration with Taiho will further advance our research in the medicinal chemistry of covalent drugs. We will leverage the innovative ideas of academic researchers and work collaboratively with Taiho to contribute to the creation of superior pharmaceuticals."

About Cysteinomix Drug Discovery

Cysteinomix drug discovery is Taiho’s proprietary drug discovery technology designed to continuously produce covalent drugs1 for a variety of cysteine-containing target proteins. The Cysteinomix drug discovery platform consists of a target protein database, a covalent binder library, and various compound evaluation systems. It has a proven track record of creating multiple pipelines.

On June 26, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that it has agreed to sell approximately 12.1 million shares of its common stock (or pre-funded warrants in lieu thereof) to a select group of institutional and accredited healthcare specialist investors in a private placement, at a price per share of $7.00, representing a premium of approximately 15% to ORIC’s 30-day volume-weighted average price and approximately 8% to the closing price on June 23, 2023 (Press release, ORIC Pharmaceuticals, JUN 26, 2023, View Source [SID1234632901]). The pre-funded warrants will have an exercise price of $0.0001 per share of common stock, will be immediately exercisable, and will remain exercisable until exercised in full. The financing is expected to close on June 27, 2023, subject to customary closing conditions. ORIC anticipates the gross proceeds from the private placement to be approximately $85 million, before deducting any offering related expenses.

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The financing includes participation from new and existing institutional investors and is being led by Nextech1 with participation from EcoR1 Capital, Frazier Life Sciences, Venrock Healthcare Capital Partners, and Boxer Capital. Participating investors entered into confidentiality agreements and executed lock-up agreements with ORIC to restrict their ability to sell ORIC shares.

"As the competitive profiles of multiple of our clinical programs begin to emerge with respect to internally generated data and competitor updates, the added financial firepower provided by this blue-chip syndicate of investors, both new and existing and with whom we’ve had longstanding relationships, allows us to aggressively advance our pipeline for the benefit of patients," said Jacob M. Chacko, MD, chief executive officer. "The extended cash runway positions us well, and we look forward to presenting initial clinical data from our three clinical programs over the coming quarters while continuing to advance our mission of overcoming resistance in cancer."

"We are thrilled to become long-term partners to ORIC’s ambitious management team at this critical inflection point as they look to accelerate the development of their pipeline of differentiated programs with clinical profiles that are now emerging," said Kanishka Pothula, Partner at Nextech. "We believe that this team’s broad capabilities spanning discovery research, translational expertise, thoughtfully-designed clinical trials, and strong business development networks, combined with their data driven decision-making and financial discipline, uniquely position ORIC to achieve meaningful impact on patients’ lives."

ORIC anticipates the following upcoming milestones:

ORIC-114: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with EGFR/HER2-mutated cancers in the second half of 2023.
ORIC-533: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with multiple myeloma in the second half of 2023.
ORIC-944: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with prostate cancer in the first quarter of 2024.
ORIC intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates and research programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, is expected to be sufficient to fund the current operating plan into late 2025.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. ORIC has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock and the shares of common stock issuable upon exercise of the pre-funded warrants issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On June 26, 2023 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported that it will host a conference call on Tuesday, June 27, 2023 at 8:00 a.m. ET to review updated clinical data from the ongoing clinical trial of NKX101, its allogeneic, off-the-shelf CAR NK cell therapy candidate engineered to target NKG2D ligands on cancer cells (Press release, Nkarta, JUN 26, 2023, https://ir.nkartatx.com/news-releases/news-release-details/nkarta-host-conference-call-discuss-updated-clinical-data-nkx101 [SID1234632900]).

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Conference Call and Webcast
To access the conference call, please register through this link: View Source

Accompanying slides will also be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with a membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.