On July 16, 2024 CatalYm reported the completion of a $150 million Series D financing (Press release, Catalym, JUL 16, 2024, View Source [SID1234644888]). The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion’s Growth Opportunities Fund ("Forbion Growth"), Omega Funds and Gilde Healthcare. Existing investors Jeito Capital, Brandon Capital Partners, Novartis Venture Fund and Vesalius Biocapital III also participated in the round. The proceeds will fund the expansion of the company’s broad Phase 2b development of visugromab into randomized Phase 2b studies in select checkpoint naïve frontline and second-line treatment settings. Visugromab has already demonstrated outstanding anti-tumor activity in combination with checkpoint inhibitor treatment.

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Visugromab is a humanized monoclonal antibody engineered to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), which acts as a key regulator of immune resistance to cancer therapies. CatalYm recently reported impressive follow-up results from its ongoing "GDFATHER" Phase 1/2a trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 1/2a) (NCT04725474) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 in Chicago. The data showed that treatment with visugromab combined with the anti-PD-1 antibody, nivolumab achieves deep and durable anti-tumoral activity, including several complete responses in anti-PD-1/PD-L1 relapsed/refractory patients with non-small cell lung cancer (NSCLC), urothelial cancer (UC) or hepatocellular carcinoma (HCC).

"This substantial raise and strong syndicate recognize our achievements as a company and emphasize the excellent results of visugromab and our broad Phase 2b clinical program. We continue to demonstrate visugromab’s potential to induce cancer remission depth and durability across multiple solid tumor indications emphasizing the substantial role visugromab could play in a novel anti-cancer therapy regimen," said Phil L’Huillier, Managing Director and Chief Executive Officer at CatalYm. "We are building significant momentum for CatalYm’s development strategy and look forward to the support of these high-profile new and existing international investors, who share our vision of breaking immunosuppressive barriers to improve therapeutic outcomes."

In conjunction with the close of the financing, Colleen Cuffaro, Partner at Canaan, Jon Edwards, Managing Partner at Bioqube Ventures and Otello Stampacchia, Managing Director and Founder at Omega Funds, will join the CatalYm Board of Directors. Stefan Luzi, Partner at Gilde Healthcare will join as Board Observer.

"The recent data presented at ASCO (Free ASCO Whitepaper) highlight visugromab’s highly differentiated therapeutic profile and validate the ability of Phil and his team to expeditiously execute on the company’s clinical plan," commented Colleen Cuffaro, Partner at Canaan Partners. "As the company advances into expanded Phase 2b development, we are excited to provide our strategic guidance on the company’s trajectory toward changing the current treatment regimens for hard-to-treat solid tumor indications."

Jon Edwards, Managing Partner at Bioqube Ventures added: "We were initially drawn to the exciting biology around GDF-15 and found CatalYm to be at the forefront of the field. We believe this approach has the potential to significantly increase durability and deepen responses, unlocking the full potential of I/O treatments. We are excited to support this fantastic team, and syndicate, in running robust clinical studies in a variety of promising indications."

Founded in 2016 with support from Forbion Ventures Fund III and BGV, CatalYm is a leader in the development of a new class of cancer treatments aiming to prevent or reverse cancer resistance to checkpoint inhibition, chemotherapy and other targeted treatments. The approach neutralizes GDF-15, a critical immunosuppressant used by tumor cells to survive. With its broad Phase 2b development plan, the company targets high-need solid tumor indications including NSCLC, UC, HCC and bladder cancer where existing and acquired resistance are a major problem. CatalYm is now in preparations to launch further randomized, controlled studies in several major cancer indications in combination with checkpoint inhibitors and standard-of-care in first- and second-line treatment in the first half of 2025.

On July 16, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that preliminary data from the monotherapy dose escalation portion of the ongoing Phase 1/2 clinical trial of CFT1946, a novel BiDAC degrader in mutant BRAF V600 solid tumors, will be presented as a mini oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place September 13 – 17, 2024 in Barcelona, Spain (Press release, C4 Therapeutics, JUL 16, 2024, View Source [SID1234644887]).

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Details of the presentation are as follows:

Title: Preliminary Results from a Phase 1 Study of CFT1946, a Novel BIDAC Degrader in Mutant BRAF V600 Solid Tumors
Presentation Date and Time: Saturday, September 14, 2024, 2:45 – 2:50 CEST
Final Publication Number: 612MO
Session Category: Mini oral session
Session Title: Developmental therapeutics
Location: Oviedo Auditorium – Hall 3
Presenter: Maria Vieito, M.D., Msc (Barcelona, Spain, La Coruña)

On July 16, 2024 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage CTCL, reported to have received notification from the Swiss Agency for Therapeutic Products (SwissMedic) that it has granted Orphan Drug Status to resminostat for the treatment of CTCL (Press release, 4SC, JUL 16, 2024, View Source [SID1234644874]).

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In Switzerland, ODS provides privileged status to drugs that show promise for the treatment of rare diseases and this qualifies 4SC for benefits including fee reductions and a faster review process.

This follows previous announcements that both the European Medicines Agency and the US Food and Drug Administration had granted resminostat (Kinselby) orphan drug designation. This gives a number of benefits, most importantly ten and seven years’ market exclusivity respectively in the EU and US.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "Receiving orphan drug status in Switzerland builds on the solid foundation of regulatory support that we already have in the EU and US and will help our efforts to commercialise Kinselby in these major markets."

On July 16, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has entered into a supply agreement with TerraPower for Ac-225 for Clarity’s 225Ac-bisPSMA program (Press release, Clarity Pharmaceuticals, JUL 16, 2024, View Source [SID1234644867]).

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Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to explore the benefits of our proprietary optimised dual-targeted PSMA product in our first TAT program utilising TerraPower-supplied Ac-225. We have the right team to develop and later commercialise a best-in-class TAT product to complement the treatment paradigm, particularly in later-stage prostate cancer patients, and overcome the hurdles seen with other PSMA-based targeting agents.

"Manufacturing of Ac-225 poses a number of challenges at this time, including access for clinical studies, purity of isotope and scalability to meet requirements for a commercial launch. The Ac-225 from TerraPower fits into our strategy of developing sustainable, scalable and environmentally preferred solutions to radionuclide sourcing at a purity level appropriate for clinical practice and made directly in the United States. This avoids having to supply Ac-225 from Russia and use sources containing significant Ac-227 contamination, a radionuclide more radiotoxic than plutonium. A number of other isotope manufacturers are now developing potentially scalable commercial processes, including our existing partner for copper-67 supply, NorthStar Medical Isotopes LLC, and we will look to continue adding Ac-225 suppliers to our network. As such, with increasing focus on the Ac-225 supply chain, the probability of successfully developing and commercialising these treatments has grown from a supply perspective.

"The new beta-particle therapies, such as Cu-67 and Lu-177, with their favourable energy characteristics and path lengths, are revolutionising the radiopharmaceutical space because of their proven efficacy and excellent safety profiles compared to many other beta and alpha emitting isotopes. The small number of commercially available targeted radiopharmaceutical therapies all use beta emitting isotopes, and they represent the best opportunity to significantly change the treatment paradigm with the potential for much earlier stage treatments and in combination with standard of care treatments or immuno-oncology products. Novartis, the current leader in radiopharmaceuticals, has cornered much of the Lu-177 supply market, given the precarious supply chain of Lu-177 and reliance on a limited number of aging nuclear reactors, inhibiting new companies from entering this space1. Clarity’s unique proprietary position of having a cage that holds copper isotopes and exclusive supply of Cu-67, which is sourced from scalable electron accelerators as opposed to the small and aging fleet of nuclear reactors, means that Clarity is well positioned to drive a global shift in the treatment paradigm for cancer sufferers. As such, beta-particle therapy with Targeted Copper Theranostics (TCTs) remains Clarity’s key focus.

"Clarity’s bisPSMA program could be the game-changer in prostate cancer therapy given the increased uptake and retention in tumours enabled by the dual-targeting molecule and with impressive preclinical and clinical data generated to date. By combining our optimised bisPSMA with Ac-225, we have the opportunity to complement our beta-particle therapy product, 67Cu-SAR-bisPSMA. Developing both alpha- and beta-emitting therapy products for prostate cancer puts Clarity in a unique position to offer powerful treatment approaches to improve outcomes for these patients as using each product at different stages of the disease would provide more options to the patients.

"Our 225Ac-bisPSMA preclinical research program has been underway for some months with investigations to date focused on identifying a lead compound from a number of different analogues through measuring biodistribution, tumour uptake, radiolabelling efficiency and product stability as we move closer to clinical development with an optimised PSMA agent utilising Ac-225.

"By integrating TAT into our existing advanced TCT programs, Clarity is positioning itself to fundamentally transform the arsenal of treatments available for oncologists and their patients. This strategic move allows us to broaden our deep pipeline of clinical and pre-clinical assets and make significant progress towards our ultimate goal of better treating adults and children with cancer."

The Supply Agreement is effective July 2024. Supply under this agreement is expected to commence in November 2024, while supply before November 2024 will be carried out under the existing Limited Product Supply and Evaluation Agreement. The supply agreement is for an initial period of 2 years and can be extended under the terms of the contract. Cancellation provisions are at industry standard rates.

On July 15, 2024, Pulse Biosciences, Inc. (the "Company") reported to have entered into an equity distribution agreement (the "Distribution Agreement") with Canaccord Genuity LLC and Needham & Company, LLC (each a "Sales Agent" and together, the "Sales Agents"), as sales agents, pursuant to which the Company may offer and sell, from time to time, through the Sales Agents, shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), having an aggregate offering price of up to $60.0 million (the "Shares") (Filing, Pulse Biosciences, JUL 15, 2024, View Source [SID1234644892]).

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The Company is not obligated to sell any Shares under the Distribution Agreement. Subject to the terms and conditions of the Distribution Agreement, the Sales Agents will use commercially reasonable efforts, consistent with their normal trading and sales practices, to sell Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions specified by the Company. Under the Distribution Agreement, the Sales Agents may sell Shares in transactions that are deemed to be "at the market" offerings as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), including sales made by means of ordinary brokers’ transactions, including directly on the Nasdaq Capital Market or into any other existing trading market for the Shares, or sales made to or through a market maker, in block transactions or by any other method permitted by law, including negotiated transactions. Sales may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices or at negotiated prices. The Company will pay the Sales Agents a commission of up to 3.0% of the gross sales price per share sold by the Sales Agents. The Company also will reimburse the Sales Agents for certain specified expenses in connection with entering into the Distribution Agreement. The Company has no obligation to sell any of the Shares under the Distribution Agreement and may at any time suspend solicitations and offers under the Distribution Agreement.

The issuance and sale, if any, of the Shares by the Company under the Distribution Agreement will be made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-278322) filed with the U.S. Securities and Exchange Commission (the "SEC") on March 28, 2024, and declared effective as of April 8, 2024, as well as a related registration statement on Form S-3 (File No. 333-280805), filed with the SEC on July 15, 2024 pursuant to Rule 462(b) of the Securities Act, which became effective immediately upon filing. The Company filed a prospectus supplement with the SEC on July 15, 2024 in connection with the offer and sale of the Shares pursuant to the Distribution Agreement.

The foregoing description of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Distribution Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The legal opinion of Baker & Hostetler LLP, counsel to the Company, relating to the validity of the issuance and sale of the Shares being offered pursuant to the Distribution Agreement, is filed as Exhibit 5.1 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 any Shares under the Distribution Agreement nor shall there be any sale of such Shares 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.