On October 4, 2022 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, reported receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019 (Press release, Cidara Therapeutics, OCT 4, 2022, View Source [SID1234636985]). The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.

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"With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "If received, these payments have the potential to significantly bolster the Company’s financial position to more rapidly advance our key Cloudbreak programs and complete the ongoing Phase 3 ReSPECT trial and are in addition to any commercial milestones or royalties that Cidara is eligible to receive from these partnerships over the same time period."

Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.

About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a QIDP with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.

On October 4, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the "Company"), a specialty vaccine company, reported the closing of its previously announced global offering to specified categories of investors of an aggregate 21,000,000 new ordinary shares, consisting of a public offering of 375,000 American Depositary Shares ("ADSs"), each representing two ordinary shares, in the United States at an offering price of $9.51 per ADS (the "U.S. Offering"), and a concurrent private placement of 20,250,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.90 per ordinary share (the "European Private Placement", and, together with the U.S. Offering, the "Global Offering") (Press release, Valneva, OCT 4, 2022, View Source [SID1234621777]). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately €102.9 million ($99.9 million).

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Valneva’s ordinary shares are listed on Euronext Paris under the symbol "VLA" and its ADSs are listed on the Nasdaq Global Select Market under the symbol "VALN".

Goldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. acted as joint bookrunners for the Global Offering.

The Company has filed a shelf registration statement on Form F-3 relating to the ADSs and ordinary shares sold in the Global Offering with the U.S. Securities and Exchange Commission ("SEC") on August 12, 2022, which was declared effective on August 19, 2022. The offering was made by means of a prospectus and copies of the prospectus relating to and describing the terms of the Global Offering may be obtained from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at [email protected].

Application was made to list the new ordinary shares issued pursuant to the Global Offering on Euronext Paris pursuant to a listing prospectus (the "Listing Prospectus") which was approved by the Autorité des Marchés Financiers ("AMF") on September 30, 2022 under number 22-405. The Listing Prospectus comprises (i) the 2021 universal registration document filed with the AMF on March 23, 2022 (document d’enregistrement universel 2021) under number D. 22-0140 (the "2021 URD"), as completed by an amendment to the 2021 universal registration document filed with the AMF on September 30, 2022 under number D. 22-0140-A01 (the "Amendment") and (ii) a securities note (Note d’opération) (the "Securities Note"), including (iii) a summary of the prospectus. Copies of the Company’s 2021 URD, as amended, is available free of charge on the Company’s website. The Listing Prospectus has been published on the Company’s website and on the AMF’s website (www.amf-france.org).

On October 4, 2022 Pluristyx, panCELLa, and Implant Therapeutics management reported their corporate merger, pending shareholder approval (Press release, panCELLa, OCT 4, 2022, View Source [SID1234621763]). The merged company will combine complementary portfolios to offer end-to-end customer support and provide increased access to a wide range of induced pluripotent stem cell (iPSC)-related products and services. The integrated technological and service offerings will greatly accelerate the development and delivery of revolutionary cell therapies to patients.

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This merger announcement follows their successful partnership in January 2022 which enables streamlined access to the next generation of safe, universal, cost-effective, "off-the-shelf" iPSCs. Pluristyx/panCELLa’s iPSCs are generated through a proprietary mRNA-based technology and are conveniently available in a ‘try-before-you-buy’ research evaluation model requiring low up-front licensing fees. Packaged in Pluristyx’s Ready-to-Differentiate format, iPSCs containing panCELLa’s FailSafe and hypoimmunogenic technologies offer customers, at any stage of product development, the ability to rapidly assess and select lines for further development and manufacturing. Since Plurisytx/panCELLa iPSC’s are sourced from clinical-grade material, commercial partners can readily transition from development to therapeutic manufacturing.

Regarding this merger, Mahendra Rao, Co-Chairman of the Board at panCELLa and CEO of Implant Therapeutics, commented, "We are extremely excited to be joining forces with Pluristyx. From the start of our collaboration, it was clear that the expertise and strong track record in cell therapy development within the Pluristyx team was the perfect fit to maximize the customer benefit from our technologies. By coming together, we can offer clients an industry-leading suite of technologies and services for the next generation of cell therapies."

Benjamin Fryer, Chief Executive Officer, Pluristyx said: "In discussions with customers, it became evident that panCELLa’s hypoimmune and FailSafe technologies are seen as industry gold-standards. This merger takes us one step farther in our journey to become the leading provider of iPSC and cell therapy solutions for research, diagnostic, and clinical applications. Together with the expertise and technology portfolio of panCELLa, we can now provide a full suite of tools and provide the fastest path to gene-edited iPSC-based therapies."

The merged companies will retain the Pluristyx name with panCELLa becoming a wholly owned subsidiary of Pluristyx. Benjamin Fryer will continue as the Chief Executive Officer and Mahendra Rao will take on the role of Chief Science Officer. Current Pluristyx and panCELLa executives will maintain their roles with Jason Carstens as the Chief Operating Officer, Brian Hawkins as the Chief Technology Officer, Kaye Reiter as General Counsel, Jake Krembil as VP of Business Development/Toronto Site Lead, and James Laing as VP of Finance.

On October 4, 2022 TrialSpark reported a new partnership with global pharmaceutical company Sanofi to explore novel methods of bringing new treatments to patients faster and more efficiently (Press release, Sanofi, OCT 4, 2022, View Source [SID1234621761]). The collaboration will focus on jointly pursuing the acquisition/in-licensing and development of best-in-class, clinical-stage Phase II and Phase III drug candidates in areas of high unmet patient need.

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The partnership aims to leverage Sanofi’s global commercial expertise and TrialSpark’s tech-enabled drug development capabilities, exploring new and innovative models of clinical development, such as behavioral intervention and digital technologies to achieve better patient outcomes.

Sanofi + TrialSpark will jointly pursue the acquisition/in-licensing and development of Phase II & III drug candidates

"We are excited to initiate this novel collaboration with TrialSpark, as another example of our commitment to innovation in the healthcare ecosystem" said, Alban de La Sablière, Partnering Head, Sanofi. "This collaboration will not only identify attractive late-stage assets, but will also use innovative development plans which could bring meaningful outcomes to patients in areas of mutual interest."

"It is a privilege to partner with Sanofi to jointly acquire and develop new treatments," said Benjamine Liu, TrialSpark’s CEO and Co-Founder. "Sanofi is a world leader in drug development, with extensive global commercial expertise. TrialSpark is delighted to have such an exceptional partner to work together with on bringing new treatments to patients faster than ever before."

The Sanofi and TrialSpark partnership formally launched in September 2022, jointly targeting six transactions over the course of the next three years.

On October 4, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, reported the United States Food and Drug Administration (FDA) has granted Fast Track designation to eftilagimod alpha ("efti" or "IMP321") in combination with pembrolizumab for the treatment of 1st line non-small cell lung cancer (NSCLC) (Press release, Immutep, OCT 4, 2022, View Source [SID1234621717]). Efti is the Company’s first-in-class soluble LAG-3 clinical stage candidate which activates antigen presenting cells (APC) to engage both the innate and adaptive immune system to target solid tumors.

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"We are pleased to receive this Fast Track designation as it acknowledges efti’s unique potential to empower the human immune system against cancer and significantly enhance patient responses to standard-of-care immunotherapy. Efti also offers a chemotherapy-free option for NSCLC patients in need of less toxic and more durable solutions," stated Marc Voigt, CEO of Immutep.

"This important designation that efti has now received across two indications, 1st line NSCLC and 1st line HNSCC, enables us to work more closely with the FDA to bring this novel treatment option to cancer patients in the most timely and efficient manner possible. We look forward to providing additional clinical data in 1st line NSCLC later this year," he concluded.

The FDA’s Fast Track designation process is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. Immutep will now have access to more frequent interactions with the FDA to discuss efti’s development path and, if relevant criteria are met, eligibility for Rolling Review, Accelerated Approval, and Priority Review.

Fast Track designation has been granted for the development of efti in combination with pembrolizumab in 1st line treatment of Stage IIIB/IV NSCLC patients expressing PD-L1 Tumor Proportion Score ≥1%, not amenable to EGFR/ALK based therapy. The designation is based on the encouraging TACTI-002/KEYNOTE-798 Phase II clinical data in 1st line NSCLC for PD-L1 all-comers shared earlier this year via an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting.

This represents the second Fast Track designation that efti has received, following receipt of the same designation in April 2021 for efti in combination with pembrolizumab in 1st line treatment of recurrent or metastatic Head and Neck Squamous Cell Carcinoma.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, in particular solid tumors. Efti capitalises on LAG3’s unique characteristics to activate both innate and adaptive immunity via binding to antigen presenting cells such as dendritic cells, monocytes, and macrophages via MHC II molecules. Activation of APCs leads to expansion of anti-tumor cells, presentation of antigens to the adaptive immune system, and proliferation of CD4+ (helper) and CD8+ (cytotoxic) T cells. Efti’s favorable safety profile enables its use in various combination settings, including with anti-PD-[L]1 immunotherapy and/or chemotherapy.

Efti is under evaluation for a variety of solid tumors including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and HER2–/HR+ metastatic breast cancer. Efti has received Fast Track Designation in 1st line recurrent or metastatic HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).