On June 30, 2022 Race Oncology Limited ("Race") reported to share further interim results from our preclinical cardioprotection program in collaboration with researchers from the University of Newcastle (ASX announcement: 28 April 2021) (Press release, Race Oncology, JUN 30, 2022, View Source [SID1234616398]). This program aimed at exploring the use of Zantrene (bisantrene dihydrochloride) as a cardioprotective agent which offered synergy with anti-cancer treatments.

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Zantrene was found to protect the hearts of mice from the damaging effects of anthracyclines (specifically doxorubicin) even when the chemotherapeutic dose was increased without significant additional toxicity or bone marrow suppression.

On June 30, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it has achieved key business objectives in the first half of 2022 and provided a review of progress with its two clinical stage drug candidates (Press release, Cyclacel, JUN 30, 2022, View Source [SID1234616414]).

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"We are highly encouraged by clinical safety and anticancer activity observed with oral fadraciclib monotherapy to date," said Spiro Rombotis, President and Chief Executive Officer. "Based on available information we believe that a favorable tolerability profile, daily dosing and target engagement against CDK2 and CDK9 differentiates fadraciclib as potentially best-in-class. Data collected to date in fifteen patients suggest that fadraciclib may have activity across a range of solid tumors and lymphomas. With respect to our second strategic priority, we are actively advancing development of CYC140, our oral PLK1 inhibitor, and enrolling patients in a registration-directed Phase 1/2 study in solid tumors and lymphomas. We look forward to reporting additional data at our R&D Day in the fall of 2022."

"It is exciting to observe dose-related efficacy signals in certain solid tumors and lymphomas, and in particular endometrial cancer and T-cell lymphoma," noted Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer. "Based on the absence of dose-limiting toxicities at all dose levels, we are adding two dose levels in a protocol amendment to test higher doses of oral fadraciclib before determining the recommended Phase 2 dose which we anticipate in the second half of 2022."

1H 2022 Key Achievements and Corporate Updates

Fadraciclib

Fifteen patients with advanced solid tumors and lymphomas treated with oral fadraciclib at all five dose levels as per protocol in the 065-101 dose escalation study.
Demonstrated evidence of target engagement for CDK2 and CDK9 in cell assay system and patient PK data suggested that these targets are potentially inhibited at 100mg twice daily levels.
A cutaneous T cell lymphoma (CTCL) patient achieved partial response (PR) in the first oral treatment cycle.
A peripheral T cell lymphoma (PTCL) patient achieved 38% reduction in target lesions by PET scan in the first oral treatment cycle.
An endometrial cancer patient achieved stable disease with 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after two and a half years of treatment.
A pancreatic cancer patient achieved stable disease by confirmatory scan for five oral treatment cycles.
As no dose limiting toxicities have been observed, the Company has submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) to escalate to two additional dose levels before determining recommended Phase 2 dose (RP2D).
Based on good tolerability in 065-101, a protocol amendment in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes has enabled acceleration of the study by omitting dose levels two and three and now enrolling at dose level 4.
CYC140

No dose limiting toxicities observed to date in 140-101, a Phase 1/2 study of oral CYC140 in solid tumors.
An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle.
Corporate Updates

The Company is planning an R&D Day in the fall of 2022 to present updated data from the 065-101 and 140-101 clinical trials.
The Company has also submitted an abstract to potentially present fadraciclib data from 065-101 at a cancer conference in the fall of 2022.

On June 30, 2022 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel CXCR4-targeted small molecule therapeutics to benefit people with rare immune system disorders, reported that it has agreed to sell an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 50,925,365 shares of common stock, to certain institutional accredited investors in a private investment in public equity (PIPE) financing (Press release, X4 Pharmaceuticals, JUN 30, 2022, View Source [SID1234616452]). X4 anticipates that gross proceeds from the PIPE will be approximately $55 million, before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The closing of the financing is expected to occur on or about July 6, 2022, subject to customary closing conditions.

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In addition, on June 30, 2022, contemporaneous with the execution of the PIPE, X4 entered into an amendment to its loan and security agreement with Hercules Capital Inc. to extend the interest-only period of its loan facility by up to twelve months (into 2024), subject to achieving certain financial and business milestones. This amendment results in a potential reduction of X4’s cash burn by $20 million over the interest-only period.

Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE, X4 will issue an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 50,925,365 shares of common stock. The purchase price per share and accompanying warrant is $1.095 (or $1.094 per pre-funded warrant and accompanying warrant). The warrants will have a per share exercise price of $1.095 and may be exercised at any time on or after the closing date and through the fifth anniversary of the closing date. The price per share and accompanying warrant was based in part upon the last reported sale price of the common stock on the Nasdaq Capital Market. If exercised for cash, the warrants would result in additional gross proceeds to X4 of up to approximately $55 million.

X4 expects to use these funds for continued clinical development and commercial readiness of its lead candidate, mavorixafor, and for business development activities, working capital, and general corporate purposes.

The PIPE financing included participation from new investors including co-lead investor New Enterprise Associates (NEA), Acorn Bioventures and Lumira Ventures, as well as existing investors including co-lead investor Bain Capital Life Sciences, OrbiMed, AXA Investment Managers and Hercules Capital, Inc (NYSE: HTGC). Stifel served as sole placement agent for the financing. B. Riley Securities and H.C. Wainwright & Co. acted as financial advisors to X4 in the financing.

The securities sold in this financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and 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. X4 has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of its common stock underlying the pre-funded warrants and accompanying warrants sold in this financing. In connection with the PIPE, the Company has agreed to convene a special meeting of its stockholders no later than 90 days
ACTIVE/117881138.4

following the closing to seek approval of an increase in the number of its authorized shares of common stock.

This press release shall not constitute an offer to sell or a 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.

On June 30, 2022 Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that LG Chem Life Sciences (LG Chem), the life sciences division of the South Korean LG Group, has exercised its renewal option as part of the ongoing collaboration with Avacta, triggering a license renewal fee payment to Avacta of $2 million (Press release, LG Chem, JUN 30, 2022, View Source [SID1234616415]).

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Under the terms of the agreement, LG Chem has the exclusive rights to develop and commercialise, on a global basis, Avacta’s Affimer PD-L1 inhibitor with Affimer XT serum half-life extension for a range of indications. LG Chem has exercised its license renewal option and will progress the PD-L1/XT candidate by commencing pre-clinical studies which are intended to form the basis of an Investigational New Drug (IND) submission.

In December 2018, Avacta and LG Chem entered into a multi-target development agreement to develop Affimer therapeutics in several disease areas. In 2020 the companies agreed to expand this drug development partnership to include Avacta’s Affimer XT technology, which can be used to control the time a drug spends in the blood.

Dr Alastair Smith, Chief Executive Officer of Avacta, commented: "I am very pleased with the progress being made by our partners LG Chem with the Affimer PD-L1 checkpoint inhibitor programme, which includes the Affimer XT serum half-life extension technology. The initiation of IND enabling studies represents a significant step towards first-in-human clinical trials of the Affimer platform, which is a key value driver for the technology and for Avacta."

On June 30, 2022 Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, has expanded the license agreement with Synaffix (announced in August 2021) by adding a third ADC target to its research evaluation and development efforts under this deal (Press release, Synaffix, JUN 30, 2022, View Source [SID1234616400]). In addition it exercised its option to take exclusive development and commercialization rights for an undisclosed ADC target under the terms of this agreement.

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This follows a successful initial research collaboration between the companies whereby Kyowa Kirin has demonstrated a highly competitive preclinical therapeutic index for its lead program under this collaboration, prepared from a Kyowa Kirin antibody using Synaffix’s ADC technology.

The technology licensed from Synaffix include GlycoConnect, HydraSpace, and multiple toxSYN linker-payloads, which allow for the drug-to-antibody ratio (DAR) to be tailored to 1, 2 or 4 to optimize the therapeutic index of the ADC.

Under the terms of the amended license agreement, Synaffix will receive an immediate payment of $5 million and is eligible to receive total potential payments for the first ADC program alone of up to $171m plus royalties on commercial sales.

Floris van Delft, Ph.D., Chief Scientific Officer of Synaffix, said:

We are thrilled with the successful ADC data, expansion of this license agreement and to see a leading global pharmaceutical company like Kyowa Kirin deploying Synaffix ADC technology in order to fulfill its mission of improving the lives of patients with cancer worldwide.