On April 12, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported the presentation of results from clinical studies with its lead product candidate, Bria-IMT, summarized in a poster session held at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, a virtual meeting, held over two weeks (Week 1: April 10-15; Week 2: May 17-21) (Press release, BriaCell Therapeutics, APR 12, 2021, View Source [SID1234578327]).

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The findings indicate disease control in advanced breast cancer patients, including stable disease (SD), partial responses (PR) or complete responses (CR). Disease control was especially noted in patients with Grade I/II (i.e. well or moderately differentiated) tumors or those that matched Bria-IMT at 2 or more HLA alleles. Patients with low or undetectable levels of circulating cancer cells were more likely to benefit from therapy.

Patients were treated with the Bria-IMT regimen alone (i.e. monotherapy study) or the Bria-IMT regimen in combination with immune checkpoint inhibitors, including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.), and, more recently, Incyte’s retifanlimab (INCMGA00012, under a corporate collaboration with Incyte Corporation). Dr. Bill Williams, BriaCell’s President & CEO, presented the results of the clinical and pathological analysis. The patient data summarized and discussed belong to previously disclosed patients (i.e., no incremental numbers enrolled).

Details and results on the poster presentation are summarized below:

Poster Title: Predictors of response to a modified whole tumor cell immunotherapy in patients with advanced breast cancer from two phase I/IIa trials

Analysis and Discussion:

• The Bria-IMT regimen with or without checkpoint inhibitors is able to induce an effective immune response and disease control in heavily pre-treated advanced breast cancer patients. The patients were all heavily pretreated and failed multiple prior regimens.
• Delayed Type Hypersensitivity (DTH) to Bria-IMT analysis identified a group with significantly higher rates of disease control and progression-free survival (8 months) in both monotherapy and combination therapy studies suggesting a robust immune response is predictive of clinical benefit in these patients.
• Highest levels of disease control and PFS was observed in patients who matched Bria-IMT at 2 or more HLA alleles in the monotherapy study but not in the combination therapy study supporting our strategy to develop Bria-OTS, an off-the-shelf personalized immunotherapy for advanced breast cancer.
• Patients with Grade I/II tumors (median of 8 prior therapy regimens) were more likely to respond with disease control (67%) and longer progression free survival. The response was more pronounced in the patients in the combination therapy study suggesting additive or synergistic effects of checkpoint inhibitors when combined with the Bria-IMT regimen. Bria-IMT, with a molecular signature most closely related to Grade I/II tumors, may result in disease control and clinical benefit especially in this subset of patients.

A copy of the poster is posted at the following: View Source

On April 12, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported that it has completed the sale of an additional 882,352 shares at the public offering price of US$4.24 per share pursuant to the underwriter’s over-allotment option granted in connection with the Company’s recent public offering, resulting in additional gross proceeds of approximately US$3.7 million (Press release, BriaCell Therapeutics, APR 12, 2021, View Source [SID1234578326]). After giving effect to the full exercise of the over-allotment option, the total gross proceeds for the public offering increased to approximately US$28.7 million.

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ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

The Company intends to use the net proceeds to fund clinical trials and research and development and for general working capital and general corporate purposes.

A registration statement on Form F-1 (File No. 333-234292) relating to the offering was filed with the Securities and Exchange Commission ("SEC") and declared effective on February 23, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

No securities regulatory authority has either approved or disapproved the contents of this news release. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 12, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (Press release, Shanghai Junshi Bioscience, APR 12, 2021, View Source [SID1234578061]). This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy.

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"Following the approval of indications in melanoma and nasopharyngeal carcinoma, toripalimab has reached a new milestone in the treatment of urothelial carcinoma, under the joint efforts of patients, investigators, and our R&D personnel," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Junshi Biosciences has pioneered clinical exploration for unselected UC patients in China and achieved remarkable results, which makes us very excited and confident in the development potential of toripalimab as an anti-tumor drug with a broad therapeutic profile. We also look forward to providing Chinese UC patients with more treatment options that work better and cost less through the company’s collaboration with AstraZeneca."

The supplemental NDA is based on the POLARIS-03 study (NCT03113266) led jointly by Professor Guo Jun of the Peking University Cancer Hospital and Professor Huang Yiran of Renji Hospital affiliated to the Shanghai Jiao Tong University School of Medicine. Among the 136 patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy including neoadjuvant or adjuvant chemotherapy within 12 months, the evaluation results of the Independent Review Committee (IRC) indicated that the overall objective response rate (ORR) was 27.2%, the disease control rate (DCR) was 46.3% and the median overall survival (mOS) reached 14.6 months. The median duration of response (DOR) had not yet reached a mature stage, with 67.1% of patients with objective responses continuing after a 12-month period.

POLARIS-03 is the first pivotal clinical study on the treatment of advanced urothelial carcinoma with an unselected population after failure of first-line standard treatment in China. Data showed that toripalimab demonstrated explicit anti-tumor activity and continuous efficacy among all patients and within each subgroup. ORR of all patients was 27.2%. ORR of PD-L1 positive patients reached 42.2%. ORR of PD-L1 negative patients reached 18.8%. Therefore, advanced urothelial carcinoma patients benefit from toripalimab regardless of PD-L1 expression. In addition, the safety and tolerability of toripalimab were consistent with previous research results.

On April 12, 2021 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 the presentation of a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Bio-Path Holdings, APR 12, 2021, View Source [SID1234578008]).

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The poster, titled "The combination of liposomal Bcl-2 antisense oligonucleotide (BP1002) with decitabine is efficacious in venetoclax-resistant cells," was presented virtually by Dr. Maria Gagliardi, Research Scientist at Bio-Path Holdings.

"We are particularly pleased to have these preclinical results of the BP1002 plus decitabine combination against venetoclax-resistant cells highlighted in a poster before an audience of the world’s leading cancer researchers at this important scientific meeting," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We look forward to filing a second Investigational New Drug (IND) application for BP1002 and to initiating a clinical study in combination with decitabine in acute myeloid leukemia (AML) patients who have relapsed from venetoclax-based treatments."

Venetoclax, an FDA-approved Bcl-2 inhibitor, is indicated for hematologic malignancies. However, venetoclax resistance among these AML patients is a growing problem. A recent study found that AML patients who had relapsed from frontline venetoclax-based treatment were also resistant to salvage therapy and had a median survival of less than 3 months1. Thus, novel treatment approaches for these most vulnerable patients are urgently needed.

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. Prior preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and the Company believes that its benign safety profile should enable BP1002 combination therapy with approved agents.

The data presented in the AACR (Free AACR Whitepaper) poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.

On April 12, 2021 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported the presentation of promising data from the Company’s growing bispecific platform at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 being held April 10th – 15th (Press release, Celldex Therapeutics, APR 12, 2021, View Source [SID1234577983]). The Company described the discovery and characterization of ILT4 inhibitory monoclonal antibodies (mAbs) for engineering bispecific antibodies (bsAbs) that revert myeloid cell suppression by antagonizing ILT4 and activate T-cell responses through PD-(L)1 inhibition (poster # 1865). Based on the results reported today, Celldex is developing clinical bispecific candidates that co-target ILT4 and PD-(L)1.

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Expression of ILT4 in several tumor types is associated with poor outcome. In preclinical models, antagonist antibodies to ILT4 have demonstrated immune enhancing and antitumor effects. More recently, in early clinical studies, combination approaches that combine co-targeting of ILT4 and checkpoint blockade have demonstrated clinical activity and safety, including in patients refractory to checkpoint inhibition therapy. The data Celldex presented at AACR (Free AACR Whitepaper) describe novel humanized antibodies with high affinity and specificity to ILT4 that effectively block immune suppression in macrophages. Candidate bispecific antibodies matched with either PD-L1 or PD-1 antibodies resulted in molecules that retained all the properties of the parental antibodies and simultaneously blocked the inhibitory signals from both ILT4 and PD-1. The data provide proof of concept for development of clinical candidates.

"Celldex continues to draw upon our deep antibody experience to build best-in-class bispecific antibodies to more effectively control antitumor immunity," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "The ILT4/PD-(L)1 approach combines two critical checkpoint pathways into one molecule, which may provide advantages from a development perspective and the potential for greater activity than the combination of the individual antibodies. We look forward to completing this work and selecting a lead candidate for advancement."

Celldex’s deep antibody experience and in-house manufacturing capabilities support efficient development of bispecific antibody targets. Targets are selected based on new science as well as their compatibility to be used in bispecific antibody formats with existing Celldex antibody programs. CDX-527, which combines CD27 activation and PD-1 blockade, was the first candidate to enter the clinic from the platform and is currently enrolling patients in a Phase 1 dose escalation study. Celldex is also exploring important targets controlling inflammation and auto-immune pathways.