On November 15, 2023 RefleXion Medical, a therapeutic oncology company, reported the initial closing of a $105M equity raise, led by The Rise Fund, TPG’s multi-sector global impact investing strategy (Press release, RefleXion Medical, NOV 15, 2023, View Source [SID1234637721]). These new funds will allow RefleXion to extend commercialization of its breakthrough SCINTIX therapy for treating all stages of indicated solid tumor cancers, including metastatic disease.

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"Closing an equity round of this size strongly affirms the conviction of our new and existing investors in fueling innovation for breakthrough treatment options, like SCINTIX therapy, in the battle against cancer," said Todd Powell, president and chief executive officer at RefleXion. "TPG’s support has been foundational in our journey, and we are gratified that they are leading a significant investment in RefleXion.

"We also welcome the support and contributions from new investors, including, Pictet and Square Point Capital," continued Powell.

In addition to TPG, existing RefleXion investors participating in the round include Ally Bridge, global pharmaceutical leaders, Pfizer Ventures and Johnson & Johnson Innovation (JJDC Inc.), funds and accounts advised by T.Rowe Price Associates, Inc., Venrock, Catalio and Hillenbrand.

"RefleXion is singularly focused on expanding the world of radiotherapy to include patients with all stages of disease, not just early-stage patients," said Matthew Hobart, co-managing partner of TPG Growth who leads the investment in RefleXion on behalf of TPG’s Rise Fund. "We are delighted to see RefleXion reach a stage where they can accelerate their impact and deliver treatment and outcomes at scale. We look forward to continuing to work with Todd and the team to support RefleXion’s growth."

SCINTIX is the first and only technology designed to transform an injected radiotracer into real-time signals that drive autonomous radiotherapy. In doing so, SCINTIX therapy becomes the first unified solution that overcomes targeting and motion management, two of the longest-standing barriers to using radiotherapy for definitive treatment of metastatic disease. SCINTIX therapy is delivered via the RefleXion X1 platform, the world’s only dual-treatment modality platform that also offers image-guided radiotherapy for treating early-stage disease.

On November 15, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 2,424,243 of its shares of common stock at a purchase price of $1.65 per share in a registered direct offering (Press release, MAIA Biotechnology, NOV 15, 2023, View Source [SID1234637720]). In a concurrent private placement, MAIA has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 2,424,243 shares of its common stock. The offering is expected to close on or about November 17, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The unregistered warrants will have an exercise price $1.86 per share, will become exercisable six months following issuance and will expire five and one-half years from the date of issuance.

The gross proceeds to MAIA from the offering are expected to be approximately $4 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. MAIA currently intends to use the net proceeds from the offering for working capital and general corporate purposes as well as to fund research and development activities.

The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-273984), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on August 15, 2023 and declared effective by the SEC on August 23, 2023. The offering of the shares of common stock to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the unregistered warrants in the private placement are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants offered in the private placement and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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 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 jurisdiction.

On November 15, 2023 Ionetix Corporation reported the signing of a supply agreement for the therapeutic radioisotope actinium-225 (Ac-225) with Bayer (Press release, Bayer, NOV 15, 2023, View Source [SID1234637719]). Under the terms of the agreement, Ionetix will provide Bayer with high-purity, non-carrier added (n.c.a.) Ac-225.

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Ac-225 is an alpha-emitter and when attached to a tumor seeking molecule, can deliver therapeutic doses of radiation directly to tumors, destroying the cancer cells while sparing the surrounding healthy tissue. Precision targeting of cancer using targeted radionuclide therapies (TRT) is a promising new cancer treatment approach. However, the global availability of Ac-225 is limited and currently there are very few production resources. Therefore, there is an immediate need for new sources of Ac-225 supply that can scale effectively to support the development of these new cancer treatments.

"We recognized the emerging demand and made the early investment to develop a commercial-scale production solution for Ac-225 using our expertise in cyclotron accelerator and target technology," said David Eve, VP of Medical Affairs for Ionetix Corporation. Located in Lansing, Michigan, Ionetix has established a new isotope production facility that is dedicated to manufacturing alpha-emitters. The first cyclotron was commissioned at the facility earlier this year and installation of a second cyclotron is planned for 2024. Both cyclotrons will be used to produce alpha-emitters, providing both onsite redundancy and increased capacity to scale output. Distribution of GMP grade, n.c.a. Ac-225 will begin in early 2024.

On November 15, 2023 Henlius（2696.HK）reported its financial results and business update for the first three quarters of 2023 (Press release, Henlius Biopharmaceuticals, NOV 15, 2023, View Source [SID1234637718]). As of September 30, 2023, Henlius generated a total revenue of RMB3.9278 billion, rising by 84.0% YoY, and a profit totaled RMB407.8 million, attributed to the highly efficient commercial operation and successive growth in core products. Among which, HANQUYOU (trastuzumab, trade name in Europe: Zercepac, trade names in Australia: Tuzucip and Trastucip) and HANSIZHUANG (serplulimab) gained sales revenues of RMB2.0145 billion and RMB865.4 million, respectively.

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As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biologic medicines to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 self-developed products have been launched, benefiting over 495,000 patients and reaching more than 40 markets. Over 10 marketing applications have been accepted for review in the European Union (EU), the United States (U.S.), Canada, Brazil, Columbia, Indonesia, Singapore and other countries and regions.

Wenjie Zhang, Chairman and Executive Director of Henlius, said: "During the first three quarters of 2023, Henlius delivered strong financial report, our integrated biopharmaceutical platform was further validated while the commercialisation potential gradually being unlocked. As we maximised the value of our products and continued our growth momentum, we have also strengthened our internal operations and management to enhance the foundations of high-quality development, working together to build a more valuable global biopharma."

Jason Zhu, Chief Executive Officer, President and Chief Financial Officer, said: "In 2023, we continued to address unmet clinical needs worldwide, and our strategy of innovation and globalisation has yielded remarkable results. Looking forward, we will adhere to our mission and fortify our core competencies, providing high-quality and accessible biologics to patients around the world."

Keep robust momentum of commercialisation, actively expand global footprint

In the third quarter of 2023, Henlius has maintained a positive growth momentum through the fast market penetration of its core products and achieved remarkable milestones, reaching a sales revenue of approximately RMB1.2256 billion. HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB737.8 million, RMB309.1 million and RMB36.4 million, respectively. In addition, the company received a profit-sharing of RMB131.0 million and RMB11.3 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.

Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefitting about 155,000 Chinese patients. Following the acceptance of the biologics license application (BLA) by the U.S. Food and Drug Administration (FDA), the Health Canada accepted the New Drug Submission (NDS) of HANQUYOU in July 2023. As of now, HANQUYOU has been launched in more than 40 countries, including China, the UK, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia, making it the China-developed biosimilar with the most marketing approvals.

HANSIZHUANG (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). Since its launch in March 2022, HANSIZHUANG has earned wide recognitions and has seen rapid sales uptick with its breakthrough efficacy and differentiation advantages in the relevant treatment fields，benefitting about 43,000 Chinese patients. In September 2023, HANSIZHUANG has been approved for the first-line treatment of esophageal squamous cell carcinoma (ESCC), took a step forward in the company’s layout in the field of treatment of gastrointestinal tumours. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and ESCC. Henlius also plans to submit New Drug Application (NDA) for HANSIZHUANG in the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) in the fourth quarter of 2023.

In 2023, Henlius has yielded remarkable results in global development and obtained new opportunities for growth. During the reporting period, the company earned approximately RMB546.7 million in overseas licensing and R&D services revenues, increasing by 232.1% YoY. Henlius deepened collaboration with partners to expand the global coverage of HANSIZHUANG. In September 2023, Henlius extended its collaboration with KGbio, the current partner on HANSIZHUANG in 10 ASEAN member countries, on the exclusive rights to develop and commercialise HANSIZHUANG in 12 Middle East and North African (MENA) countries. Henlius further expanded its collaboration with Intas in October 2023 to grant the company exclusive rights to develop and commercialise HANSIZHUANG in Europe and India, with a potential value of EUR€185 million.

Bolster competitiveness with relentless innovation and high quality

Henlius continued its differentiated innovation and R&D layout, speeded up the innovation progress by strengthening internal innovation capabilities and external collaboration. Currently, Henlius has pro-actively built a diversified and high-quality product pipeline, including over 60 molecules across monoclonal antibody (mAb), bispecific antibody (BsAb), ADC, fusion protein, and small molecule drug conjugate, of which more than 80% are self-developed.

Henlius has actively expanded its differentiated advantages for HANSIZHUANG and has launched over 10 clinical trials of combination therapy worldwide with over 3,600 subjects enrolled globally. In the field of lung cancer treatment, the phase 3 clinical study of HANSIZHUANG as a first-line treatment for patients with advanced nsNSCLC has met the primary endpoint. While the first subjects have been dosed in two clinical trials including the international phase 3 clinical study of HANSIZHUANG in combination with chemotherapy and concurrent radiotherapy for the treatment of LS-SCLC, as well as the phase 2 clinical trial of HLX26 (anti-LAG-3 mAb) in combination with HANSIZHUANG and chemotherapy for the first-line treatment of advanced NSCLC. What’s more, the phase 1/2 clinical trial of HLX04-O was completed in patients with wet age-related macular degeneration (wAMD) in July 2023.

Meanwhile, the company is actively exploring novel targets and molecular mechanisms in more disease areas, pursuing clinical trial approvals for a couple of potential first/best-in-class products. In October 2023, the novel EGFR-targeting ADC HLX42 and PD-L1-targeting ADC HLX43 have been simultaneously approved by the National Medical Products Administration (NMPA), for the treatment of advance/metastatic solid tumours. And the results of the non-clinical studies of these two ADC candidates debuted at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

In 2023, Henlius continues to improve its production capacity and accessibility of the company’s products based on an integrated production platform, as well as a sound quality management system. The current commercial production capacity is 48,000 litres, forming synergy, and developing scale effects that allow the company to supply products stably to markets beyond China, including Europe and Latin America. Henlius is also constructing Songjiang Second Plant to further meet the global commercial production needs, with the total production capacity expected to reach 144,000 litres in 2026. In addition, the company has always been upholding the highest quality standards, allowing its products to go global. As of now, Henlius’ commercial production facilities and supporting quality management system have also passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. Among which, Xuhui Facility has been certificated by China and the EU GMP while Songjiang First Plant obtained China GMP and the EU Qualified Person (QP) certification. In July 2023, Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU. In August 2023, Xuhui Facility has undergone the on-site GMP inspection conducted by Health and Youth Care Inspectorate (a health supervision agency in the Netherlands) for HANSIZHUANG before launch in EU, and part of Songjiang First Plant has also undergone the GMP extended inspection. In October 2023, Xuhui Facility successively passed the GMP Inspections for HANSIZHUANG by PIC/S Member Indonesia BPOM, and for HANLIKANG and HANQUYOU by PIC/S Member Brazil ANVISA.

Committed to meeting unmet medical needs, Henlius will further solidify its industry-leading capabilities in "integrated research, manufacturing and commercialisation", consistently invest in innovation and foster global collaboration. By doing so, the company aims to evolve into a higher-value global biopharmaceutical, providing more affordable and better therapies for patients worldwide.

On November 15, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that the Society of Neuro-Oncology 2023 Annual Meeting late breaking abstract entitled "PNOC022: a combination therapy trial using an adaptive platform design for patients with diffuse midline gliomas (DMGs) at initial diagnosis, post-radiation therapy and at time of therapy" was released by the conference organizers on 10 November 2023 (Press release, Kazia Therapeutics, NOV 15, 2023, View Source [SID1234637717]). The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada. Sixty-eight children and young adults with DMG who completed standard of care radiation treatment received paxalisib (an investigational PI3K-mTOR dual inhibitor) and ONC201 (an investigational dopamine receptor D2 (DRD2) and ClpP agonist). The abstract reported that median overall survival (OS) from time of diagnosis was 16.5 months.

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"We are very excited to see the OS preliminary results of 16.5 months from this cohort of patients, keeping in mind there are two other cohorts of patients in this study for which data is anticipated in 2024. The average (median) OS rate for children with DMG receiving standard of care is less than 1 year, generally ranging from 8-11 months," stated John Friend, MD, CEO Kazia Therapeutics. "The PNOC022 study has exceeded expectations in terms of enrolment rates and has partnered with 29 leading children’s cancer centers and physicians across the globe."

Key Points from the Abstract

Sixty-eight patients with biopsy-proven DMG were enrolled between November 2021 and June 2023 (median age 9 years [range 3-37], n=41 female [60%])

Median OS from time of diagnosis was 16.5 months (lower 95% confidence interval (CI) 11.6 months) with a median follow-up time of 9.9 months (95% CI: 8.5, 11.4)

Most common grade 3 and above treatment-related adverse events were decreased neutrophil count (n=4); mucositis (n=3); and, colitis, drug reaction with eosinophilia and systemic symptoms, decreased lymphocyte count, hyperglycemia, and hypokalemia (n=2)
About the PNOC022 Phase 2 study

The PNOC DMG Adaptive Combination Trial (PNOC022) Phase 2 study is an adaptive platform study that is examining paxalisib in combination with ONC201, an experimental DRD2 antagonist developed by Chimerix, Inc. (Durham, NC). PNOC022 is enrolling children and young adults with DMG, a category of brain tumours that includes diffuse intrinsic pontine glioma (DIPG). The study includes three cohorts comprising of newly diagnosed patients, patients who have completed initial radiotherapy, and patients who have experienced disease progression after treatment. The primary endpoint will be the proportion of patients who are progression-free at six months for newly diagnosed patients, and OS for recurrent patients.

Rare Pediatric Disease Designation

In 2020, the United States Food and Drug Administration (FDA) awarded Rare Pediatric Disease Designation (RPDD) to paxalisib for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG). With RPDD granted, Kazia may now be eligible to receive a ‘priority review voucher’ (PRV) if paxalisib is first approved for DIPG. A PRV grants the holder an expedited six-month review of a new drug application by FDA. PRVs can be sold to other companies and have historically commanded prices in excess of US$100 million.

This announcement was authorized for release by Dr. John Friend, CEO.