On November 16, 2024 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI) for the treatment of two indications (Press release, Shanghai Junshi Bioscience, NOV 16, 2024, View Source [SID1234656133]):

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Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC);
Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC).
In UK, toripalimab is the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status.

NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancers globally. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option. The latest European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Guidelines recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC.

The approval of the NPC indication is primarily based on the results from the JUPITER-02 study (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study, NCT03581786). JUPITER-02 is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) for overall survival ("OS") in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The study results were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#LBA2) and were subsequently featured on the cover of Nature Medicine. The results were also published in full in the Journal of the American Medical Association (JAMA). Results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival ("PFS") in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (ORR) and longer duration of response (DoR), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data, presented at ASCO (Free ASCO Whitepaper) 2024, reported a 5-year survival rate of 52.0%.

EC is one of the most common malignant tumors in the alimentary tract. According to GLOBOCAN 2022 statistics, esophageal cancer is the 11th most commonly diagnosed cancer and the seventh leading cause of cancer death worldwide, with over 511,000 new cases and over 445,000 deaths in 2022. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer.

The approval of the ESCC indication is primarily based on the results from the JUPITER-06 study (a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study, NCT03829969). The study aimed to evaluate the efficacy and safety of toripalimab in combination with paclitaxel/cisplatin (TP) for the first-line treatment of advanced ESCC compared with placebo in combination with chemotherapy. The results were first presented in an oral session during the ESMO (Free ESMO Whitepaper) Congress 2021 and later published in Cancer Cell and Journal of Clinical Oncology, two leading international oncology journals. Study findings showed that toripalimab in combination with chemotherapy resulted in superior PFS and OS in patients with advanced or metastatic ESCC, the median OS was prolonged by 6 months to 17 months and the risk of disease progression or death in patients was significantly reduced by 42%. Futhermore, there was a significant improvement in survival benefits regardless of PD-L1 status.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "The approval of toripalimab by MHRA marks another significant milestone for toripalimab in Europe, not only making toripalimab the first and only drug in UK for the treatment of NPC, but also the only first-line treatment for ESCC, regardless of PD-L1 status. We are extremely proud to introduce innovative Chinese biopharmaceuticals to Europe that can address longstanding unmet medical needs of the patients there. Moving forward, we will remain committed to our globalization strategy, ‘In China, For Global.’ We will continue working towards the commercialization of toripalimab, and offer high-quality, innovative, domestically developed medicines to benefit more patients around the world."

On November 15, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the third quarter 2024 (Press release, AIM ImmunoTech, NOV 15, 2024, View Source [SID1234648435]). Also, the Company will host a conference call and webcast today, November 15, 2024 at 8:30 AM ET (details below).

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AIM Chief Executive Officer Thomas K. Equels stated, "We are driving significant momentum across multiple clinical programs and studies that are demonstrating Ampligen’s significant potential to address high value and high need indications, especially in the pancreatic cancer space. Over the course of 2024, our team has made important progress in executing our clinical strategy, facilitating potential partnerships with big pharma and leveraging commercialization opportunities to create value. Our Board of Directors is dedicated to helping patients in need and delivering enhanced value for our shareholders."

Recent Highlights

Pancreatic Cancer:
Reported positive preliminary data in Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.
Announced further positive findings from a study evaluating Ampligen in the treatment of pancreatic cancer.
Long-COVID:
Announced that analysis of AMP-518 complete clinical patient data underscores Ampligen’s potential to improve the post-COVID condition of fatigue.
Endometriosis: Company granted U.S. patent for Ampligen for composition of matter and method of treatment of endometriosis.
Please refer to previously released CEO Corner segments for additional highlights around the Company’s news and programs.

Summary of Financial Highlights for Third Quarter 2024

As of September 30, 2024, AIM reported cash, cash equivalents and marketable securities of $7.2 million.
Research and development expenses for the three months ended September 30, 2024 were $1.4 million, compared to $2.7 million for the same period in 2023.
General and administrative expenses were $3.1 million for the three months ended September 30, 2024, compared to $5.4 million for the same period 2023.
The net loss from operations for the three months ended September 30, 2024 was $3.7 million, or $0.06 per share, compared to $7.8 million, or $0.16 per share, for the three months ended September 30, 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q3 2024 operational and financial results on November 15, 2024 at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On November 15, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2024 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2024, View Source [SID1234648436]).

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"The third quarter was a particularly productive period for Bio-Path as we initiated our obesity program, which marks the first application of our DNAbilize platform beyond oncology and highlights its broad therapeutic potential," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Importantly, we continued to advance our oncology programs and were delighted with the swift enrollment of the third cohort in our Phase 1/1b clinical trial of BP1002 in venetoclax-resistant AML patients, which was ahead of our projected timelines. We also published an article highlighting the broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models, including breast, ovarian, and pancreatic cancer, in the peer-reviewed journal, Biomedicines."

Recent Corporate Highlights

Initiated BP1001-A Therapeutic Program for Treatment of Obesity. In October, the Company announced the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases. This program marks the first application of DNAbilize technology for development of a non-cancer application, which highlights the broad therapeutic potential of this technology. The disease pathology leading to obesity suggests that BP1001-A, which suppresses the adaptor protein Grb2, has the potential to treat insulin resistance, a major contributor to obesity, Type 2 diabetes and other related metabolic diseases. Bio-Path expects downregulating Grb2 expression with BP1001-A will enhance insulin sensitivity.

Completion of Enrollment for Third Dosing Cohort of Phase 1/1b Clinical Trial of BP1002 in Venetoclax-Resistant Acute Myeloid Leukemia (AML) Patients. In October, Bio-Path announced completion of enrollment for the third dosing cohort of the Company’s Phase 1/1b trial of BP1002 in venetoclax-resistant AML patients. The cohort enrolled more quickly than projected, which underscores the ongoing need for new treatment options for these relapsed/refractory patients.

Publication in Peer-Reviewed Journal, Biomedicines. In September, Bio-Path published an article highlighting the therapeutic potential of BP1003 in a variety of cancer types in the peer-reviewed journal, Biomedicines. The article describes the broad anti-tumor effect of BP1003 in numerous preclinical solid tumor models including breast, ovarian, and pancreatic cancer. BP1003 is a neutral liposome incorporated with a nuclease resistant P-ethoxy antisense oligodeoxynucleotide targeting the STAT3 mRNA and its unique design enhances stability, cellular uptake, and target affinity.

Reported Solid Tumor Patient Response Supporting BP1001-A’s Compelling Potential as Treatment for Advanced Solid Tumors. Bio-Path’s first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through six cycles of treatment. Moreover, it appears that these positive outcomes may have contributed to allow her to continue with rigorous exercise and improved quality of life.

The dose finding portion of the Phase 1/1b trial is comprised of BP1001-A monotherapy with no accompanying chemotherapy. This clinical trial of BP1001-A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m2 and began enrollment in the higher dose cohort of 90 mg/m2. The Phase 1b portion of the study is expected to commence after completion of three planned BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer.
Closed $4.0 Million Private Placement. In October, Bio-Path announced closing of a private placement priced at-the-market under Nasdaq rules for the issuance and sale of an aggregate of 4,597,702 shares of its common stock (or common stock equivalents in lieu thereof), series A warrants to purchase up to 6,407,657 shares of common stock and short-term series B warrants to purchase up to 6,407,657 shares of common stock at a purchase price of $0.87 per share of common stock (or per common stock equivalent in lieu thereof) and accompanying warrants in a private placement. The gross proceeds to the Company from the offering were approximately $4.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the warrants.
Financial Results for the Third Quarter Ended September 30, 2024

The Company reported a net loss of $2.1 million, or $0.70 per share, for the three months ended September 30, 2024, compared to a net loss of $3.2 million, or $6.36 per share, for the three months ended September 30, 2023.

Research and development expense for the three months ended September 30, 2024 decreased to $1.3 million, compared to $2.3 million for the three months ended September 30, 2023 primarily due to decreased manufacturing expenses related to drug product releases as well as a decrease in expense related to our clinical trial for BP1001 in AML due to timing of patient enrollment during the quarter.

General and administrative expense for the three months ended September 30, 2024 increased to $1.3 million, compared to $1.0 million for the three months ended September 30, 2023 primarily due to increased legal fees and salaries and benefits expense.

As of September 30, 2024, the Company had cash of $0.6 million, compared to $1.1 million as of December 31, 2023. Net cash used in operating activities for the nine months ended September 30, 2024 was $7.7 million compared to $9.7 million for the comparable period in 2023. Net cash provided by financing activities for the nine months ended September 30, 2024 was $7.2 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2024 financial results and to provide a general update on the Company. To access the conference call please dial (844) 481-3014 (domestic) or (412) 317-1879 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On November 15, 2024, Allakos Inc., (the "Company"), reported to have entered into an Agreement for Termination of Lease and Voluntary Surrender of Premises (the "Lease Termination Agreement") with ARE-San Francisco No. 63, LLC, a Delaware limited liability company (the "Landlord"), amending the terms and conditions of its existing Lease Agreement, dated as of December 4, 2019, as amended (the "Lease") for certain premises located at 825 Industrial Road, San Carlos, California 94070 (the "Premises") that serve as the Company’s headquarters (Filing, 8-K, Allakos, NOV 15, 2024, View Source [SID1234648463]).

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The term of the Lease was scheduled to expire on November 30, 2031. The Lease Termination Agreement provides for, among other things, amendment of the term such that the Lease will terminate no earlier than January 1, 2025, and no later than March 31, 2025. As consideration for the Landlord’s agreement to enter into the Lease Termination Agreement and accelerate the expiration date of the Lease, the Company has agreed to pay a lease modification payment to the Landlord in an amount of approximately $2.3 million, of which approximately $1.5 million will be paid on or after January 1, 2025, by the Landlord drawing down and retaining the Company’s security deposit for the Premises in the form of a letter of credit secured by restricted cash, and the remainder will be paid upon the early lease termination date described above. The Company also incurred broker commissions of approximately $1.7 million. The net effect on cash and cash equivalents of these costs related to the termination is approximately $2.5 million.

Prior to the Lease Termination Agreement, the Lease represented annual expenditures of approximately $11 million. The Company is evaluating options to achieve significant reductions in future rent expense while meeting the Company’s operational needs.

The foregoing summary of the Lease Termination Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Lease Termination Agreement, a copy of which the Company anticipates filing as an exhibit to the Companyʼs Annual Report on Form 10-K for the year ending December 31, 2024.

On November 15, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC) (Press release, Bristol-Myers Squibb, NOV 15, 2024, View Source [SID1234648437]). Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79% (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001) compared to chemotherapy in this patient population. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the recommendation and make their decision.

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"Approximately 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumors, and current treatment options often do not provide sufficient benefit," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. "This is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, delivering a transformative benefit for MSI-H/dMMR patients in this population. We are focused on bringing Opdivo plus Yervoy to these patients in the European Union and look forward to EC’s upcoming decision."

The positive opinion is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier this year. These data formed the basis for the Company’s Type II variation application, which was validated by the European Medicines Agency (EMA). In the study, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS) compared to the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review. In addition to the risk of disease progression or death the results noted, the safety profile for the dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

In October 2024, it was announced that Opdivo plus Yervoy also demonstrated a statistically significant and clinically meaningful improvement in the dual endpoint of PFS per BICR compared to Opdivo monotherapy across all lines of therapy. The study is ongoing to assess various secondary endpoints, including overall survival (OS).

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

About CheckMate -8HW

CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or the investigator’s choice chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).

839 patients were randomized to receive either Opdivo monotherapy ( Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W ), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the firstline setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy.

CheckMate-8HW has also met its other dual primary point of PFS per BICR Opdivo plus Yervoy compared to Opdivo across all lines therapy in randomized subjects with centrally confirmed MSI-H/dMMR mCRC at the second interim analysis in September 2024, and data disclosure is planned for an upcoming medical conference. The trial also evaluates several secondary safety and efficacy endpoints, including overall survival, which is ongoing.

About dMMR or MSI-H Colorectal Cancer

Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined.

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors. These patients are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.