On September 21, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported determination of the recommended phase 2 dose (RP2D) of NBTXR3 in combination with pembrolizumab or nivolumab for the treatment of patients suffering from inoperable locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) that is resistant to prior immunotherapy (Press release, Nanobiotix, SEP 21, 2022, View Source [SID1234621302]). RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab for patients with LRR or R/M HNSCC that has not received prior immunotherapy, lung metastases (mets) from any primary tumor, or liver mets from any primary tumor as well.

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The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients. The complete dose escalation part enrolled 29 patients in three cohorts: (i) head and neck lesions from LRR or R/M HNSCC eligible for anti-PD-1 therapy; (ii) lung mets from any primary cancer eligible for anti-PD-1 therapy; and (iii) liver mets from any primary cancer eligible for anti-PD-1 therapy. Study participants received a one-time intratumoral injection of NBTXR3 prior to their first radiotherapy session. They then received radiotherapy, followed by anti-PD-1. Based on the study’s results, the RP2D for all three cohorts was determined to be 33% of gross tumor volume.

Nanobiotix aims to deliver an industry-leading head and neck cancer treatment franchise powered by NBTXR3, and to replicate that approach across other solid tumor indications. Pursuant to this strategy, the Company has amended the ongoing expansion phase of Study 1100 to further strengthen the rationale behind a registrational protocol evaluating NBTXR3 plus anti-PD-1 for patients with R/M HNSCC that is resistant to prior immunotherapy.

The amended dose expansion part of study 1100 also has three cohorts, however the cohorts have been re-designed to further explore NBTXR3 plus anti-PD-1 in several immunotherapy-eligible indications, with a particular focus on the treatment of patients with LRR or R/M HNSCC primary lesions that are either naïve or resistant to prior immunotherapy. The expansion part cohorts are as follows: (i) LRR or R/M HNSCC that is resistant to prior immunotherapy; (ii) LRR or R/M HNSCC that has not received prior immunotherapy; (iii) lung, liver, or soft tissue mets from inoperable NSCLC, malignant melanoma, hepatocellular carcinoma, renal cell carcinoma (RCC), urothelial cancer, cervical cancer, or triple negative breast cancer (TNBC) primary tumors.

The Company expects to provide updated clinical data from Study 1100 in Q4 2022. The registrational phase 3 protocol submission is expected in Q1 2023, followed by modification of the study design.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across solid tumors that can be treated with radiotherapy and across different therapeutic combinations.

On September 21, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in the Lytham Partners Fall 2022 Investor Conference taking place virtually on September 28-29, 2022 (Press release, Mannkind, SEP 21, 2022, View Source [SID1234621301]).

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The Company’s webcast presentation will be available for viewing at 9:00am ET on Wednesday, September 28, 2022, on the Company’s website at Events & Presentations or View Source The webcast will also be archived and available for replay.

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected].

On September 21, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-RAF inhibitor, KIN-2787, for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable (Press release, Kinnate Biopharma, SEP 21, 2022, View Source [SID1234621300]).

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According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

KIN-2787 is an orally available, potent and selective small molecule pan-RAF inhibitor being evaluated in KN-8701 (NCT04913285), an ongoing Phase 1 global clinical trial in patients with solid tumors harboring BRAF alterations or who have NRAS mutant melanoma. Unlike currently available treatments that target only Class I BRAF kinase mutations, Kinnate has designed KIN-2787 to target Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF alterations, and as a potential treatment for NRAS mutation-positive melanoma.

The company previously announced that the FDA granted Orphan Drug Designation (ODD) for KIN-2787 for the treatment of stage IIb-IV melanoma. An ODD is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.

On September 21, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that it closed on the acquisition of substantially all of the assets of its partner, RubrYc Therapeutics, Inc. ("RubrYc") after it entered into a definitive asset purchase agreement (the "Purchase Agreement") (Press release, iBioPharma, SEP 21, 2022, View Source [SID1234621298]). The transaction marks another important step toward iBio’s mission to bring more – and better – immunotherapies to the clinic, faster, with its continued transformation into a biopharmaceutical discovery and development company.

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The acquired assets include:

AI Drug Discovery Platform: A patented system that uses artificial intelligence ("AI") to design 3D models of epitopes to facilitate the creation of better antibody drug candidates. Unlike other traditional and newer AI-driven methods of drug discovery that often focus upon dominant epitopes, the RubrYc Discovery Engine uses predictive algorithms to identify and model subdominant and conformational epitopes, prospectively enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases.
Previously Licensed Candidates: All rights – with no future milestone payments or royalty obligations – to two molecules. These include IBIO-101, an IL-2 sparing anti-CD25 antibody for depletion of regulatory T cells, as well as "Target 6" that was discovered in Q2 FY2022 using the Discovery Engine.
New Therapeutic Candidates: Three promising immuno-oncology candidates, plus a partnership-ready PD-1 agonist for serious autoimmune diseases, such as systemic lupus erythematosus and multiple sclerosis.
Purchase terms include:

An upfront payment of $1 million in iBio’s common stock to RubrYc investors.
Eligibility for RubrYc’s investors to receive up to $5 million in development milestones over the next five years, to be paid in common stock or cash, at iBio’s sole discretion.
In an effort to focus its resources on the promising new discovery platform and entering the clinic with its lead compounds, iBio has initiated a review of opportunities to accelerate its transformation while extending its cash runway beyond previous guidance of September 30, 2023. These include asset sales, partnerships, portfolio decisions, cost reductions, and non-dilutive efforts to raise additional capital.

"We are excited to pair our new AI Discovery Engine with our existing platforms to create a biotech company with its own end-to-end discovery capabilities and an expanded pipeline of immunotherapy candidates," said Tom Isett, Chairman & Chief Executive Officer of iBio. "We are also happy to welcome four of RubrYc’s talented and experienced computational biology pioneers to our team, the majority of whom will make the move to iBio’s new Drug Discovery Center that is slated to open in San Diego in the coming weeks."

"Instead of relying on traditional ‘trial-and-error’ drug screening methods, we believe adding an AI-powered discovery capability to the front end of our process will enable us to bring better molecules into the clinic faster and more cost-effectively," commented Martin Brenner, DVM. Ph.D., iBio’s Chief Scientific Officer. "This was clearly demonstrated with iBio’s pipeline Target 6, a mutated form of a protein expressed in a number of tumors. RubrYc’s Discovery Engine enabled the rapid identification of antibodies that selectively bind the mutated protein, without binding the wild-type version, which is more commonly expressed in healthy tissues. Due to the unique characteristics of the RubrYc Discovery Engine, we were able to expeditiously advance the program from the Early Discovery to the Late Discovery stage."

The closing of the acquisition was conditioned upon approval of the NYSE American and both parties meeting other customary closing conditions.

Webcast and Conference Call

​The Company will report its fiscal fourth quarter and full year 2022 financial results after market close on Tuesday, September 27, 2022, and will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results, give more information on the RubrYc transaction and strategic review, and provide additional updates. The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. To access the live call by phone, participants should go to this registration link, where they will be provided with the dial-in details.

On September 21, 2022 Sesen Bio, Inc. (Nasdaq: SESN) and Carisma Therapeutics Inc. (Carisma), a privately held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction (Press release, Sesen Bio, SEP 21, 2022, View Source [SID1234621297]). The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Carisma is pioneering the development of chimeric antigen receptor macrophage (CAR-M) therapies and is believed to be the only company developing CAR-M therapies with demonstrated proof of mechanism and safety data in clinical trials. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol "CARM".

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Carisma has also secured commitments from a syndicate of investors for a $30 million financing, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio, which is expected to close concurrently with the completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent financing, the combined company is expected to have approximately $180 million in cash, cash equivalents and marketable securities. These cash resources are expected to be used to advance Carisma’s pipeline through multiple ongoing and planned key data readouts across several clinical trials and to fund operating expenses and capital expenditure requirements through 2024. The merger and related financing are expected to close in the next three to four months.

Carisma’s cell and gene therapies are based on a proprietary platform technology that reprograms a patient’s macrophages and targets them against cancer cells, with the potential for broad anti-tumor immunity. This novel technology is designed to engage with the body’s immune system to treat solid tumors, which remains a persistent clinical challenge that is yet to be comprehensively achieved through CAR-T and other immunotherapy approaches.

Carisma’s CAR-M platform provides the ability to fine-tune the specific targets of the immune cells, potentially enabling multiple therapeutic applications in and beyond oncology. The first clinical application of this technology is CT-0508, a CAR-M cell therapy currently being evaluated by Carisma in a Phase 1 multi-center clinical trial with a lead target indication of advanced HER2+ solid tumors. Carisma believes this Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans. Carisma is leveraging its proprietary CAR-M platform to expand its oncology pipeline both independently and through a strategic partnership with Moderna. Additionally, Carisma is exploring the potential to develop its proprietary macrophage engineering platform for non-oncology applications such as liver fibrosis, as well as autoimmune and neurodegenerative disease indications.

"The proposed merger represents an exciting opportunity for shareholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy," said Steven Kelly, President and Chief Executive Officer of Carisma. "This transaction will provide us with financial strength to not only continue to develop our lead candidate CT-0508, but also allow us to accelerate the growth of our platform and pipeline within and outside of oncology and develop additional strong strategic partnerships beyond those we already have with Moderna and Novartis. Carisma is focused on delivering cutting-edge technology for patients in a way that has never been done before, and we look forward to advancing this important mission."

"This transaction represents the result of a thoughtful and careful review of strategic alternatives over the past four months, during which Carisma’s clinical programs, management team, and corporate strategy stood out amongst the 42 bids reviewed," said Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio. "Carisma is an exciting clinical-stage company with groundbreaking science and an impressive management team, which we believe makes them the optimal partner to provide value for our shareholders. Our mission at Sesen Bio has always been to save and improve the lives of patients with cancer, and we believe Carisma has the science and the unwavering patient focus required to make that mission a reality."

Carisma has several anticipated upcoming catalysts and developmental milestones across its clinical programs over the next 18 months, including:

Additional Phase 1 data readout of safety, manufacturing feasibility, and mechanism of action of CT-0508 with single-day dosing
Completion of the technology transfer to Novartis for the planned clinical manufacturing of CT-0508
Phase 1 data readout for the CT-0508 intraperitoneal trial for patients with HER2+ peritoneal cancer
Phase 1 data readout of CT-0508 in combination with pembrolizumab for patients with HER2+ solid tumors
Investigational New Drug (IND) Application for a new HER2 CAR engineered monocyte cell product
In addition to its exclusively licensed proprietary technologies that were developed by leading scientists at the University of Pennsylvania (Penn), including Saar Gill, MD, PhD, an associate professor of Medicine at Penn’s Perelman School of Medicine and a Carisma co-founder and fellow co-founder and Carisma’s Chief Scientific Officer, Dr. Michael Klichinsky, PharmD, PhD, Carisma has well-established strategic partners to support the advancement of its pipeline. Carisma recently entered into a strategic partnership with Moderna for the discovery, development and commercialization of in vivo CAR-M therapies for up to 12 targets for the treatment of cancer. As part of the collaboration, Carisma received a $45 million up-front cash payment and an investment by Moderna in the form of a $35 million convertible note, which will convert into shares of common stock of the combined company in connection with the merger. Under the collaboration, Carisma will receive full research funding and is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on net sales of any products that are commercialized. Carisma has also partnered with Novartis, which has extensive experience in cell therapy manufacturing, to operate as Carisma’s contract manufacturing organization for clinical supply of its lead clinical program, CT-0508.

About the Proposed Merger

Pre-merger Sesen Bio stockholders are expected to own approximately 41.7% and pre-merger Carisma stockholders are expected to own approximately 58.3% of the combined company, in each case before giving effect to the concurrent financing described above and the conversion of the outstanding Moderna convertible note. Under the terms of the merger agreement, stockholders of Carisma will receive newly issued shares of Sesen Bio common stock pursuant to an exchange ratio formula set forth in the merger agreement. The percentage of the combined company that Sesen Bio stockholders will own upon the closing of the merger is further subject to adjustment based on the amount of Sesen Bio’s net cash at the time of closing.

Immediately prior to the closing of the proposed merger, Sesen Bio stockholders of record will be issued a contingent value right (CVR) for each outstanding share of Sesen Bio common stock held by such Sesen Bio stockholder as of such date, representing the right to receive certain cash payments from proceeds received by Sesen Bio related to the Roche Asset Purchase Agreement, if any, subject to customary deductions, including for expenses and taxes.

Following the consummation of the merger, the combined company will be headquartered in Philadelphia, Pennsylvania, and will be led by Steven Kelly, President and Chief Executive Officer of Carisma. Mr. Kelly was recently named Ernst & Young Entrepreneur of the Year 2022 Greater Philadelphia, an award that recognizes the most ambitious leaders who are building and sustaining successful, dynamic businesses around the world. The board of directors of the combined company is expected to be composed of seven members, consisting of one member designated by Sesen Bio and six members designated by Carisma.

The merger agreement has been unanimously approved by the boards of directors of both companies. The merger and related financing are expected to close in the next three to four months, subject to approval by Sesen Bio’s shareholders and other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Sesen Bio with the Securities and Exchange Commission (SEC) and will be available at www.sec.gov.

SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel. Evercore Group LLC is serving as lead financial advisor to Carisma for the transaction and BofA Securities, Inc. is also serving as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore Group L.L.C. are serving as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel.