On August 13, 2024 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Convergent Therapeutics, Inc., a clinical stage radiopharmaceutical company, reported the signing of a strategic contract manufacturing services agreement (Press release, NorthStar Medical Radiostopes, AUG 13, 2024, View Source [SID1234645837]). Convergent’s lead asset CONV01-α is a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to Ac-225 and is currently being investigated as a treatment for prostate cancer.

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Under the terms of the expanded collaboration, NorthStar will:

Provide Convergent with its environmentally preferred, high purity non-carrier-added (n.c.a) Ac-225 for use in CONV01-α,
Utilize its new, state-of-the-art contract development and manufacturing facility to manufacture CONV01-α to serve patients in Convergent’s clinical trials, and
Perform research and development activities to support continued development of CONV01-α and other Convergent assets.
In March of this year, Convergent received U.S. Food and Drug Administration ("FDA") clearance for its investigational new drug ("IND") application for CONV01-α, a key milestone that enables Convergent to advance CONV01-α into Phase 2 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies. The manufacturing supply agreement announced today will support these trials and, if U.S. FDA approved, the manufacturing of CONV01-α for commercial purposes.

"The last several years have seen an explosion of research and clinical trials in the area of radiotherapies, especially those using Ac-225," said Frank Scholz, Chief Executive Officer of NorthStar, "and yet today there are still far too few effective therapies for patients suffering from a variety of serious diseases including many cancers. Why? Because the processes to develop, manufacture and deliver therapeutically effective radiopharmaceuticals like Convergent’s CONV01-α to market – in particular at a scale able to meet patient demand for an approved, marketed medicine — are highly specialized and complex. At NorthStar, our passion is to reduce technological and operational barriers to help companies like Convergent Therapeutics not only secure a reliable source of Ac-225, but manufacture a finished, patient-ready drug product and continue to develop new and additional therapeutic indications for the patients who need new and better medicines. We are proud to be supporting Convergent and look forward to working with them to help make new medicines like CONV01-α therapeutic reality."

"We are excited to expand our partnership with NorthStar and the opportunity to leverage NorthStar’s unique position to scale both Ac-225 generation and manufacturing capacity," said Caitlyn Harvey, Head of Manufacturing at Convergent. "Convergent will begin enrolling patients into the CONVERGE-01 Phase 2 clinical trial in the next couple of months as we continue building on extensive clinical experience which will allow us to rapidly move into our Phase 3 study."

About CONV01-α

CONV01-α, Convergent’s alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called Ac-225, which releases alpha particles which kill cancer cells through DNA double strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers.

On August 13, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the second quarter ended June 30, 2024 (Press release, Adicet Bio, AUG 13, 2024, View Source [SID1234645836]).

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"We believe ADI-001 has best-in-class potential for autoimmune diseases and we are excited about the opportunity to expand ADI-001 clinical development beyond LN to include patients with SLE, SSc and AAV. We have initiated startup activities at multiple clinical sites and expect to begin enrolling patients with LN in our Phase 1 study in the third quarter of 2024," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "Looking ahead, with the ADI-270 IND cleared for RCC, and Fast Track Designation in hand, we expect to initiate the Phase 1 trial of ADI-270 in patients with RCC, the most common type of kidney cancer, in the fourth quarter of 2024. This progress underscores the unique potential of our gamma delta 1 CAR T cell platform in both autoimmune diseases and solid tumors."

Second Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

Fast Track Designation for ADI-001 in relapsed/refractory class III or class IV LN. In June 2024, the FDA granted ADI-001 Fast Track Designation for the potential treatment of relapsed/refractory class III or class IV LN. The Company has initiated startup activities at multiple clinical sites and plans to commence enrollment in its Phase 1 clinical trial of ADI-001 in lupus nephritis in the third quarter of 2024, with preliminary clinical data expected in the first half of 2025, subject to site initiation and patient enrollment.
Expansion of clinical development of ADI-001 beyond LN to include SLE, SSc and AAV. The Company recently received clearance for its IND to include three additional indications: SLE, SSc and AAV. In connection with the Company’s Phase 1 clinical trial of ADI-001 in autoimmune disease, enrollment of SLE, SSc and AAV patients is expected to commence in the second half of 2024. Clinical data from the Company’s Phase 1 clinical trial of ADI-001 in SLE, SSc and AAV patients are anticipated during the first half of 2025, subject to site initiation and patient enrollment expectations.
Hematologic malignancies and solid tumor indications

IND clearance and FDA Fast Track Designation for ADI-270. Adicet received FDA clearance of its IND application for ADI-270 in RCC and the FDA also granted Fast Track Designation for ADI-270 for the potential treatment of patients with metastatic/advanced clear cell RCC who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor. Contingent upon study initiation progress, the Company intends to initiate the Phase 1 clinical trial of ADI-270 in RCC patients in the fourth quarter of 2024 and present preliminary clinical data from the study in the first half of 2025, subject to site initiation and patient enrollment.
Presentation of preclinical data from ADI-270 at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress. In June 2024, Adicet presented promising preclinical data supporting ADI-270’s robust anti-tumor activity in an encore poster presentation at the EHA (Free EHA Whitepaper) Hybrid Congress.
Enrollment of mantle cell lymphoma (MCL) patients ongoing in ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma. The Company plans to provide a clinical update in the fourth quarter of 2024.
Financial Results for Second Quarter 2024:

Research and Development (R&D) Expenses: R&D expenses were $25.9 million for the three months ended June 30, 2024, compared to $28.4 million during the same period in 2023. The decrease in research and development expenses was primarily due to a net $1.9 million decrease in expenses related to contract development and manufacturing organization and other externally conducted research and development as well as a $0.6 million decrease in payroll and personnel expenses resulting from a decrease in overall headcount.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended June 30, 2024, compared to $6.5 million during the same period in 2023. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation of $0.7 million. The increase was partially offset by a $0.2 million decrease in recruiting fees as well as a $0.1 million decrease in consultant fees.
Net Loss: Net loss for the three months ended June 30, 2024 was $29.9 million, or a net loss of $0.33 per basic and diluted share, including non-cash stock-based compensation expense of $6.0 million, as compared to a net loss of $32.4 million, or a net loss of $0.75 per basic and diluted share, including non-cash stock-based compensation expense of $5.0 million during the same period in 2023.
Cash Position: Cash and cash equivalents were $224.1 million as of June 30, 2024, compared to $159.7 million as of December 31, 2023. The Company expects that current cash and cash equivalents as of June 30, 2024, will be sufficient to fund its operating expenses into the second half of 2026.

On August 13, 2024 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage oncology company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, reported the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for the company’s lead program, PTM-101, to proceed in a phase 1b clinical study in patients with pancreatic ductal adenocarcinoma (PDAC) (Press release, PanTher Therapeutics, AUG 13, 2024, View Source [SID1234645835]).

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This phase 1b dose escalation / dose expansion study will be conducted across multiple sites and will enroll patients who have treatment naïve, borderline resectable and locally advanced PDAC, offering the potential to improve therapeutic response for those with limited treatment options.

"Receiving FDA clearance for our phase 1b study of PTM-101 marks a pivotal achievement for PanTher and represents a significant milestone in our mission to transform clinical outcomes for patients with challenging pancreatic cancer diagnoses," said Laura Indolfi, PhD, Chief Executive Officer, and co-founder of PanTher Therapeutics. "This study will build upon the company’s positive, early clinical data in patients with borderline resectable and locally advanced PDAC. PTM-101 was developed using PanTher’s Sagittari drug development platform, which creates products that provide continuous delivery of high drug concentrations exclusively at the tumor site for an extended period of time. This novel approach, which maximizes killing of tumor cells, has not previously been possible with other technologies."

Earlier this year, PanTher presented positive first-in-human data in small phase 1 study of three pancreatic cancer patients treated with PTM-101. Two of the three patients who received the lowest dose of PTM-101 followed by standard of care chemotherapy had a >40% reduction in overall tumor volume. PTM-101 was shown to have a favorable safety profile, as it was well-tolerated with no peritonitis, pancreatitis, infection, or hematological toxicity. The chemotherapeutic agent remained localized in the pancreas in all patients, with no detection of systemic paclitaxel at any timepoint.

On August 13, 2024 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the second quarter 2024 (Press release, Grail, AUG 13, 2024, View Source [SID1234645834]).

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Revenue in the second quarter was $32.0 million, representing 43% growth year over year. Net loss for the quarter, which includes amortization and impairment of acquisition-related intangible items, was $(1.6) billion. Our gross loss was $(17.9) million. Non-GAAP adjusted gross profit was $16.0 million and Non-GAAP adjusted EBITDA was $(139.4) million.1

"GRAIL completed the separation from Illumina on June 24, 2024, and we are pleased to report our quarterly results for the first time as an independent public company. In the second quarter of 2024, GRAIL continued to deliver U.S. commercial growth, and as of June 30, we have sold more than 215,000 Galleri tests. We are focused on detecting cancer early, when it can be cured, and are committed to serving Galleri patients, providing support for ordering physicians, advancing our commercial and research partnerships, and building our clinical and real-world evidence base," said Bob Ragusa, Chief Executive Officer at GRAIL. "We have an unprecedented opportunity to establish a new standard of care by adding Galleri to existing single-cancer screenings, and to establish and maintain the market leading position in multi-cancer detection."

For the three months ended June 30, 2024, as compared to the three months ended July 2, 2023, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $32.0 million, an increase of $9.6 million or 43%.
Net loss: Net loss was $1.59 billion, an increase of $1.39 billion or 721%. Net loss includes goodwill and intangible impairment of $1.42 billion.
Gross loss: Gross loss was $(17.9) million, an improvement of $6.4 million or 26%.
Adjusted gross profit1: Adjusted gross profit was $16.0 million, an increase of $6.4 million or 66%.
Adjusted EBITDA1: Adjusted EBITDA was $(139.4) million, a decrease of $2.8 million or 2%.
Cash position: Cash and cash equivalents totaled $958.8 million as of June 30, 2024.
Recent business highlights include:

Commenced enrollment in the REACH study. The REACH study, also known as the Galleri-Medicare study, will enroll 50,000 individuals and allow for three annual screens to provide clinical validation and utility in the Medicare population, with a focus on health equity. Medicare beneficiaries are among those most at risk for cancer due to age and other risk factors, representing an important unmet need for early cancer detection.
Completed enrollment of more than 35,000 participants in the registrational PATHFINDER 2 study. The PATHFINDER 2 study is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in a population of individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.
Completed final study visits for the registrational NHS-Galleri trial. The NHS-Galleri trial is a prospective, randomized controlled clinical utility trial of over 140,000 participants between the ages of 50-77 at the time of enrollment, each of whom provided three annual blood samples to evaluate the implementation of Galleri alongside existing NHS standard of care screenings.
Strategic update:

Following a portfolio review, we are reducing our overall spend and focusing our resources on our core multi-cancer early detection ("MCED") priorities, including progress toward completion of our registrational studies and our premarket approval application submission.

As part of this restructure, we are reducing existing headcount and planned hires for 2024 by approximately 30% and substantially decreasing investment in product programs beyond Galleri. We are also reducing the size of our commercial organization, focusing our field-based activities on the most productive provider territories and streamlining investments in our enterprise business, which includes the Company’s employer and life insurance businesses. In addition, we are making reductions in general and administrative expense to reflect the focus on our MCED opportunity. We will continue to invest in our biopharmaceutical partnerships, and are committed to working with our partners to leverage GRAIL’s proprietary methylation technology in precision oncology applications.

We expect these cost reductions to extend our existing cash runway from the second half of 2026 into 2028. As a result, we anticipate reducing our burn in 2025 to $325 million. In 2024, we expect $27 million in savings, net of anticipated severance and benefits costs.

Conference Call and Webcast
A webcast and conference call will be held today, Aug. 13, 2024, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

A replay of the webcast will be available on GRAIL’s website for 30 days.

On August 13, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported it has entered into definitive agreement for the purchase and sale of 2,000,000 shares of its American Depository Shares and Pre-Funded Warrants at an offering price of $1 per share in a registered direct offering and an additional 2,000,000 cash exercise only Series G warrants with an exercise price of £0.78 with a single investor (Press release, TC Biopharm, AUG 13, 2024, View Source [SID1234645833]).

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The gross proceeds to the Company from the offering are expected to be $2.0 million.

The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the offering, nor shall there be any sale of these securities in any state or 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.